# Health - General (GHG) ## Title 21. Food, Drugs, and Cosmetics ### Subtitle 1. Definitions; General Provisions #### Section 21-101 (a) In this title the following words have the meanings indicated. (b) "Advertisement" means any representation that: (1) Is intended or is likely to induce, directly or indirectly, any person to purchase any food, drug, device, or cosmetic; and (2) Is published by any means other than labeling. (c) (1) "Color additive" means any material that: (i) Is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source; or (ii) When added or applied to a food, drug, or cosmetic, or to any part of the human body, is capable, alone or through reaction with any other substance, of imparting color, including black, white, or intermediate grays, to the food, drug, cosmetic, or body. (2) "Color additive" does not include any material that is not a color additive under the federal act. (d) "Consumer commodity" means any food, drug, device, or cosmetic that is not: (1) Tobacco or a tobacco product; (2) A commodity that is subject to packaging or labeling requirements imposed under the Federal Insecticide, Fungicide, and Rodenticide Act or the federal Animal Virus, Serum, Toxin, Antitoxin Act; (3) A drug that is subject to the provisions of Sec. 353(b)(1) of the federal act; (4) A beverage that is subject to or complies with packaging or labeling requirements imposed by the federal Bureau of Alcohol, Tobacco, Firearms and Explosives; or (5) A seed or other commodity that is subject to the provisions of Sec.Sec. 9-206 through 9-213 of the Agriculture Article. (e) (1) "Cosmetic" means any substance, or any component of a substance, that is intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance. (2) "Cosmetic" does not include soap. (f) "Device" means any instrument, apparatus, or contrivance, or any part or accessory of an instrument, apparatus, or contrivance, that is intended: (1) For use in the diagnosis, cure, mitigation, treatment, or prevention of human disease; or (2) To affect the structure or any function of the human body for medical, surgical, or therapeutic purposes. (g) (1) "Drug" means any substance or component of a substance: (i) That is recognized in an official compendium; (ii) That is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in human beings; or (iii) Except for food, that is intended to affect the structure or any function of the human body. (2) "Drug" does not include a device. (h) "Federal act" means the Federal Food, Drug, and Cosmetic Act as that act appears at 21 U.S.C. Sec. 301 et seq. (i) "Food" means: (1) Any substance that is used as food or drink for human beings or as a component of food or drink for human beings; or (2) Chewing gum or any substance that is used as a component of chewing gum. (j) (1) "Food additive" means any substance: (i) The intended use of which results or reasonably may be expected to result, directly or indirectly, in the substance becoming a component of food or otherwise affecting the characteristics of food, including any substance used to produce, manufacture, pack, process, prepare, treat, package, transport, or hold food, or any source of radiation that is intended for any of these uses; and (ii) That is not recognized generally by qualified scientific experts as having been shown to be safe under the conditions of its intended use: (1) Through scientific procedures; or (2) Through either scientific procedures or experience based on common use, if the substance was used in a food before January 1, 1958. (2) "Food additive" does not include a color additive. (k) "Label" means a display of written, printed, or graphic matter on the container, other than the package liner, of a substance. (l) "Labeling" means any label or other written or graphic material that: (1) Is on a substance or its container or its wrapping; or (2) Accompanies a substance. (m) "Official compendium" means the most recent revision of the United States Pharmacopoeia and National Formulary, the official Homeopathic Pharmacopoeia of the United States, or any of their current supplements. (n) (1) "Package" means any container or wrapping of a consumer commodity that is used for delivery or display to retail consumers. (2) "Package" does not include any container or wrapping that is used only for: (i) Transportation of a consumer commodity in bulk or quantity to a manufacturer, packer, processor, or wholesale or retail distributor; or (ii) Shipment or delivery of a consumer commodity to a retail customer, if the container or wrapping bears no printed material that relates to a particular consumer commodity. (o) "Person" includes: (1) An operator of a facility that is owned by a State or local unit of government; or (2) A State or local unit of government if the State or local unit of government is the operator of the facility. (p) "Secretary" means for the purposes of this subtitle and Subtitles 2, 3, 4, 8, and 11 of this title, the Secretary of Health or the Secretary's designee. #### Section 21-102 (a) The provisions of this title that relate to the sale of a consumer commodity also apply to: (1) Manufacturing, producing, processing, packing, exposing, offering, possessing, or holding the consumer commodity for sale; (2) Dispensing or giving the consumer commodity; and (3) Supplying or applying the consumer commodity in the operation of any food, drug, or cosmetic establishment. (b) If a substance is alleged to be misbranded because the labeling is misleading or if an advertisement is alleged to be false because it is misleading, there shall be taken into account: (1) The representations made or suggested by statement, word, design, symbol, or sound, alone or in combination; and (2) The extent to which the labeling or advertisement fails to reveal consequences that may result from use of the substance. ### Subtitle 2. Maryland Food, Drug, and Cosmetic Act #### Section 21-201 (a) In this subtitle the following words have the meanings indicated. (b) "Counterfeit drug" means a drug that: (1) Bears, or the container or labeling of which bears, without authorization, the trademark, trade name, imprint, symbol, or any other identifying mark, or any likeness of any of these markings, of a manufacturer, processor, packer, or distributor other than the one who, in fact, manufactured, processed, packed, or distributed the drug; and (2) By use of these markings falsely purports or is represented to be the product of, or to have been packed or distributed by, the other drug manufacturer, processor, packer, or distributor. (c) (1) "Established name" means, in regard to a drug or an ingredient of a drug: (i) The name designated under the federal act; (ii) If a name has not been designated under the federal act, but the drug or ingredient has been recognized in an official compendium, then the title used in the compendium; or (iii) If a name cannot be determined under item (i) or (ii) of this paragraph, the common or usual name of the drug or ingredient. (2) In applying the provisions of paragraph (1)(ii) of this subsection, if a drug or an ingredient of a drug is recognized in both the United States Pharmacopoeia and National Formulary and in the Homeopathic Pharmacopoeia of the United States under different official titles, the title used in the United States Pharmacopoeia and National Formulary is the established name, unless the drug is labeled and offered for sale as a homeopathic drug, in which event the official title used in the Homeopathic Pharmacopoeia of the United States is the established name. (d) "New drug" means any drug that: (1) Among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, is not recognized generally as safe and effective for use under the conditions specified, recommended, or suggested in the labeling of the drug; or (2) As a result of investigations to determine its safety and effectiveness for use, has become recognized by these experts as safe and effective under the conditions, but that, other than in the investigations, has not been used to a material extent or for a material time under the conditions. (e) "Prescription drug" means a drug that, under Sec. 21-220 of this subtitle, may be dispensed only on the prescription of a health practitioner who is authorized by law to prescribe the drug. (f) "State adopted federal rule or regulation" means any rule or regulation that is adopted by the federal government under the federal act and that becomes a rule or regulation by automatic adoption under the provisions of this subtitle. #### Section 21-202 (a) Any drug that is designated as a "controlled dangerous substance" under Title 5 of the Criminal Law Article is governed by that title as well as by this subtitle. (b) If, as to any drug that is a "controlled dangerous substance", there is any conflict between the provisions of this subtitle and those of Title 5 of the Criminal Law Article, the provisions of the Criminal Law Article apply. #### Section 21-203 If there is an outside container or wrapper for a food, drug, device, or cosmetic, then, to comply with any requirement that is imposed under this subtitle that a word, statement, or any other information appear on the label or the article, the word, statement, or other information also shall: (1) Be placed on the outside container or wrapper; or (2) Be legible through the outside container or wrapper. #### Section 21-204 Unless the drug is purported to be an antiseptic for inhibitory use as a wet dressing, ointment, or dusting powder, or as some other substance that involves prolonged contact with the body, the representation of any drug, in its labeling or in an advertisement, as an antiseptic shall be considered to be a representation that the drug is a germicide. #### Section 21-205 For purposes of the construction and enforcement of this subtitle, an act or omission of any officer, agent, employee, or any other person acting for or employed by any corporation, company, society, or association, shall be considered to be the act or omission of the corporation, company, society, or association, as well as of the person. #### Section 21-207 (a) In addition to any other ground that may be applicable under this title, a food is considered to be adulterated for purposes of this subtitle if the standards in this section or in Sec. 21-208 or Sec. 21-209 of this subtitle apply. (b) A food is adulterated if: (1) It contains any poisonous or otherwise deleterious substance that, in the quantity present, reasonably would be expected to make it injurious to health; (2) It contains any added poisonous or added deleterious substance: (i) That is not a food or color additive; and (ii) The particular use of which has not been found safe as provided under Sec. 21-239 of this subtitle; (3) It is or contains any food additive or color additive the particular use of which has not been found safe as provided under Sec. 21-239 of this subtitle; (4) Any part of it is a diseased, contaminated, filthy, putrid, or decomposed substance; (5) It was produced, prepared, packed, or held under unsanitary conditions that reasonably would be expected to have: (i) Contaminated it with filth; or (ii) Caused it to be diseased, unwholesome, or injurious to health; (6) Any part of its container is composed of any poisonous or otherwise deleterious substance that reasonably would be expected to have caused the food to be injurious to health; (7) It has been subjected intentionally to radiation, unless the use of the radiation conforms to that allowed by a rule or regulation under the federal act or under Sec. 21-239 of this subtitle; (8) At any time after its manufacturing, processing, or packaging, it was refrozen after having been permitted to thaw from a prior freezing; or (9) It otherwise is unfit as food for human beings. #### Section 21-208 In addition to any other ground that may be applicable under Sec. 21-207 or Sec. 21-209 of this subtitle, a food is adulterated if: (1) Any part of an important component that normally would be present in the food has been omitted or withdrawn from it; (2) Any substance has been substituted for any part of an important component that normally would be present in the food; (3) Any damage to or inferiority of the food has been concealed in any way; or (4) It has had any substance added, mixed, or packed with it solely for any of the following purposes: (i) To increase its bulk or weight; (ii) To reduce its quality or strength below that which normally would be expected of the food; or (iii) To mislead the consumer by making the food appear to be better or more valuable than it is. #### Section 21-209 (a) In addition to any other ground that may be applicable under Sec. 21-207 or Sec. 21-208 of this subtitle, a confectionary food product is adulterated if: (1) It contains any nonnutritive object, except as permitted by the rules and regulations adopted under subsection (b)(1) of this section; or (2) It contains any nonnutritive substance other than a safe substance: (i) That is in or on the confectionery because of some practical functional purpose in the manufacture, packaging, or storing of the confectionery; and (ii) The use of which does not promote deception of the consumer or otherwise result in any adulteration or misbranding in violation of this subtitle. (b) (1) If, in the judgment of the Secretary, a nonnutritive object is of practical, functional value to a confectionary food product and its use is not injurious or hazardous to health, the Secretary may adopt a rule or regulation that permits an exception to subsection (a)(1) of this section, regarding nonnutritive objects. (2) To avoid or resolve uncertainty, the Secretary may by rule or regulation: (i) Interpret subsection (a)(2) of this section as that subsection applies to use of a particular nonnutritive substance; and (ii) Allow or prohibit the use of the particular nonnutritive substance. #### Section 21-210 (a) For purposes of this subtitle, a food is considered to be misbranded under any condition specified in this section. (b) A food is misbranded if: (1) Its labeling or packaging is false or misleading in any way; (2) It is an imitation of another food, and it does not have a label that bears, in type of uniform size and prominence, the word "imitation" followed immediately by the name of the food imitated; (3) It is in package form and it does not bear a label that contains the name and place of business of the manufacturer, packer, or distributor; (4) Any word, statement, or other information required under this subtitle to appear on its labeling is not placed prominently on the labeling in a manner that is: (i) Conspicuous, as compared with other words, statements, designs, or devices on the labeling; and (ii) In terms likely to be read and understood by the ordinary individual under customary conditions of purchase and use; (5) It purports to be or is represented as a food for which a definition and standard of identity has been set by a rule or regulation as provided under Sec. 21-237 of this subtitle and: (i) The food does not conform to the definition or standard; or (ii) Its label either does not bear the name of the food specified in the definition and standard or, contrary to the rule or regulation, it does not bear the common name of an optional ingredient, other than spices, flavoring, and coloring, that is in the food; (6) It purports to be or is represented as a food for which a standard of quality has been set by a rule or regulation under Sec. 21-237 of this subtitle and its quality falls below that standard, unless its label bears, in the manner and form that the rule or regulation specifies, a statement that the food falls below the standard; (7) It is not subject to item (5) of this subsection and does not bear labeling that clearly gives: (i) The common or usual name of the food, if there is such a name; and (ii) Except as provided under subsections (d) and (e) of this section, if the food is made from 2 or more ingredients, the common or usual name of each ingredient; (8) It purports to be or is represented for special dietary uses, unless its label bears the information about its vitamin, mineral, and other dietary properties that the Secretary determines by a rule or regulation adopted under Sec. 21-213 of this subtitle to be necessary to inform purchasers fully of its value for those uses; (9) Except as provided under subsections (c) and (e) of this section, it contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears labeling that states that fact; (10) It is a color additive and its packaging and labeling do not conform to the applicable requirements of the federal act; (11) After it was manufactured, processed, or packaged, the food was in a frozen state and it then is offered for sale in an unfrozen state, unless its labeling clearly and conspicuously states that the food was previously frozen and should not be refrozen; (12) It is a product that: (i) Is intended to be used as an ingredient of another food; and (ii) If used according to the directions of the supplier, would result in the final food product being adulterated or misbranded; or (13) It is offered for sale under the name of another food. (c) As they relate to the use of artificial coloring, the provisions of subsection (b)(7), (9), and (10) of this section do not apply to butter, cheese, or ice cream. (d) Notwithstanding the provisions of subsection (b)(7)(ii) of this section, regarding the labeling requirements for a food that is made from 2 or more ingredients, spices, flavorings, and coloring ingredients may be designated as "spices", "flavorings", and "colorings", without naming each specific item. However, this exception does not apply if the food product itself is sold as a spice, flavoring, or food coloring. (e) (1) If, as applied to a particular food, compliance with the requirement that each of the 2 or more ingredients in the food be set forth in its labeling is impractical or results in deception or unfair competition, the Secretary shall adopt a rule or regulation that exempts that food product from the provisions of subsection (b)(7)(ii) of this section. (2) If, as applied to a particular food product, it is impractical to comply with the requirement that the labeling disclose the presence of an artificial flavoring, an artificial coloring, or a chemical preservative, the Secretary shall adopt a rule or regulation that, to the extent appropriate, exempts that food product from any appropriate provision of subsection (b)(9) of this section. #### Section 21-211 (a) By the issuance, denial, or suspension of permits as provided in this section, the Secretary may regulate the distribution in this State of any class of food that may be contaminated with microorganisms. (b) (1) The Secretary shall adopt rules and regulations that provide for the issuance of permits to food manufacturers, processors, or packers in any locality if, on investigation, the Secretary finds: (i) That the distribution in this State of any class of food manufactured, processed, or packed in that locality may be injurious to health because of possible contamination with microorganisms; and (ii) That the danger imposed by the food normally would not be determinable after the food has entered commerce. (2) For whatever temporary period of time that may be necessary, the rules and regulations shall specify the conditions necessary to govern the manufacturing, processing, and packing of the class of food in question in order to protect the public from the dangers imposed by that food. These conditions shall be attached to and be considered part of any permit that is issued under this section. (c) A person may not introduce or deliver for introduction into commerce in this State any food that was manufactured, processed, or packed by an establishment that was required by rule or regulation adopted under this section to hold a permit, unless each manufacturer, processor, and packer of the food held the required permit. (d) (1) At any reasonable time, a representative of the Secretary may enter any establishment that holds a permit issued under this section and inspect the establishment to determine if it is in compliance with the permit conditions. (2) If access for inspection is denied to a representative of the Department who is acting under this subsection, the Secretary may suspend the permit of the establishment involved until access is allowed. (e) (1) If the Secretary finds that an establishment has violated any condition of a permit issued under this section, the Secretary may suspend the permit immediately after giving notice to the permit holder. (2) The holder of a suspended permit may apply to the Secretary at any time for reinstatement of the permit. (3) On receipt of an application for reinstatement, the Secretary shall hold a hearing and have the establishment inspected. (4) If the Secretary finds that adequate measures have been taken to assure compliance with the permit, the Secretary immediately shall reinstate the permit: (i) As originally issued; or (ii) With any amendment that, under the provisions of this section, the Secretary considers proper. #### Section 21-212 (a) A food is not subject to the labeling requirements of this subtitle if a rule or regulation is adopted as provided under this section to exempt it. (b) Subject to the provisions of Sec. 21-241 of this subtitle, any rule or regulation adopted under the federal act to exempt a food from labeling requirements is effective automatically in this State. (c) In addition to the State adopted federal rules and regulations, the Secretary shall adopt rules and regulations to exempt from the labeling requirements of this subtitle any food that is to be transported in substantial quantities from one establishment to another, if: (1) In accordance with the practice of the trade, the food is to be processed, labeled, or repacked at the second establishment; and (2) The Secretary has a reasonable basis to believe that the food will not be misbranded or adulterated when it is removed from the second establishment. #### Section 21-213 (a) Subject to the provisions of Sec. 21-241 of this subtitle, any special dietary use rule or regulation that is adopted by the federal government under the federal act automatically is adopted as a rule or regulation of this State. (b) Whether or not in accordance with any rule or regulation adopted under the federal act, the Secretary may adopt special dietary use rules or regulations if the Secretary finds that it is necessary to inform purchasers of the value of a food for special dietary use. #### Section 21-214 (a) This subtitle may not be construed to prohibit the addition of alcohol to a food product, including a confectionery and a frozen dessert. (b) A food product that is manufactured or sold that contains more than one-half of one percent of alcohol per volume: (1) May not be sold to individuals under 21 years of age; and (2) Shall state on the label of the food product: (i) That the sale of the product to individuals under 21 years of age is prohibited; (ii) That the product contains alcohol; and (iii) The product's alcohol percent per volume. (c) Subsection (b) of this section may not be construed to limit the application of relevant provisions of the Alcoholic Beverages and Cannabis Article, and regulations adopted under that article, to a manufacturer or seller of a food product regulated under subsection (b) of this section. #### Section 21-216 (a) For purposes of this subtitle, a drug or device is adulterated if the standards in this section apply. (b) A drug or device is adulterated if: (1) Any part of it is a filthy, putrid, or decomposed substance; or (2) It was produced, prepared, packed, or held under unsanitary conditions that reasonably would be expected to have: (i) Contaminated it with filth; or (ii) Caused it to be injurious to health. (c) In addition to the grounds specified in subsection (b) of this section, a drug is adulterated if: (1) Any part of its container is composed of any poisonous or otherwise deleterious substance that reasonably would be expected to have caused the drug to be injurious to health; (2) For purposes of coloring only, it is or it contains a color additive, the particular use of which has not been found safe as provided under Sec. 21-239 of this subtitle; (3) The mixing or packing of any substance with the drug has reduced the quality or strength of the drug; (4) Any substance has been substituted for any part of the drug; (5) The methods, facilities, or controls used in the manufacture, processing, packing, or holding of the drug do not conform to, or are not administered in conformity to, good practice to assure that the drug: (i) Meets the requirements of this subtitle as to safety; and (ii) Has the identity, strength, quality, and purity that it purports to have; (6) It is purported to be a drug the name of which is recognized in an official compendium and: (i) The strength of the drug differs from, or the quality or purity of the drug falls below, the standard set in the official compendium; and (ii) The difference in strength, quality, or purity is not stated plainly on its label; or (7) Although not purported to be a drug recognized in an official compendium, the strength of the drug differs from, or the quality or purity of the drug falls below that which the drug purports to possess. (d) (1) For purposes of administering subsection (c)(6) of this section, any determination as to whether the strength of a drug differs from or as to whether its quality or purity falls below the standard set in an official compendium shall be made in accordance with the tests or methods of assay set forth in the official compendium, or, in the absence of or inadequacy of those tests or methods of assay, those provided under the federal act. (2) (i) Except as provided in subparagraph (ii) of this paragraph, if a drug is recognized in both the United States Pharmacopoeia and National Formulary and in the Homeopathic Pharmacopoeia of the United States, it is subject to the requirements of the United States Pharmacopoeia and National Formulary. (ii) If the drug is labeled and offered for sale as a homeopathic drug, it is subject to the provisions of the Homeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia and National Formulary. #### Section 21-217 (a) For purposes of this subtitle, a drug or device is misbranded if the standards in this section or in Sec. 21-218 or Sec. 21-220(d) or (e) of this subtitle apply. (b) A drug or device is misbranded if: (1) Its labeling is false or misleading in any way; (2) Its labeling or packaging does not conform with any provision of Sec. 21-248 of this subtitle; (3) It is in package form and it does not bear a label that contains the name and place of business of the manufacturer, packer, or distributor; (4) Any word, statement, or other information required under this subtitle to appear on its labeling is not placed prominently on the labeling in a manner that is: (i) Conspicuous as compared with other words, statements, designs, or symbols on the labeling; and (ii) In terms likely to be read and understood by the ordinary individual under customary conditions of purchase and use; (5) Its labeling does not include, in whatever manner and form that may be necessary to protect the user of the drug or device: (i) Adequate directions for the use of the drug or device; and (ii) Adequate warnings against: (1) The use of the drug or device by anyone suffering from a pathological condition that may cause its use to be dangerous to health; (2) The use of the drug or device by a child if its use by a child may be dangerous; and (3) Unsafe dosages, methods of administration, or duration of administration of the drug or device; (6) It is dangerous to health when used in the dosage, with the frequency, or for the duration specified, recommended, or suggested in the labeling of the drug or device; or (7) The trademark, trade name, imprint, symbol, or other identifying mark of another drug or any likeness of any of these markings of another drug or device is placed on the drug or device or its container with the intent to defraud. (c) (1) Subsection (b)(5)(i) of this section, which concerns the provision of directions for the use of a drug or device, does not apply to a drug or device that is exempted by: (i) A rule or regulation adopted under the federal act; or (ii) A rule or regulation adopted by the Secretary under this subsection. (2) If the Secretary finds that, as applied to a particular drug or device, any requirement of subsection (b)(5)(i) of this section is not necessary for the protection of the public health, the Secretary shall adopt a rule or regulation to exempt the drug or device from that requirement. #### Section 21-218 (a) In this section, "antibiotic drug" means any drug that: (1) Is intended for use by a human being; (2) Contains any quantity of a chemical substance or the chemically synthesized equivalent of a chemical substance that is produced by microorganisms; and (3) Can inhibit or destroy microorganisms in dilute solution. (b) In addition to any other ground that may apply under Sec. 21-217 or Sec. 21-220 of this subtitle, a drug is misbranded if: (1) It is for use by a human being and contains any quantity of the narcotic or hypnotic substance alpha-eucaine, barbituric acid, beta-eucaine, bromal, cannabis, carbromal, chloral, coca leaves, cocaine, codeine, heroin, morphine, opium, paraldehyde, peyote, sulphonmethane, or any chemical derivative of any of these substances, which derivative, after investigation, has been designated as habit forming under a rule or regulation adopted under the federal act or by the Secretary under this subtitle, unless its label states the name and quantity or proportion of the substance or derivative and, immediately beside that information, a warning that states: "Warning -- May be habit forming."; (2) It has an established name and, to the exclusion of any other nonproprietary name except the applicable systematic chemical name or the chemical formula of the drug, its label does not bear the established name of the drug; (3) Except as otherwise permitted by a rule or regulation adopted under the federal act or by the Secretary under subsection (d)(2) of this section, it is made from 2 or more ingredients and its label does not bear the established name, if any, of and the quantity of each active ingredient, including the kind and quantity or proportion of any alcohol and, whether active or not, the established name and quantity or proportion of any bromides, ether, chloroform, acetanilid, acetophenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of any of these substances, but a nonprescription drug is not misbranded under this item on the ground that its label does not show the quantity or proportion of an active ingredient unless the ingredient is specifically named in this item; (4) Except as otherwise permitted by a rule or regulation adopted under the federal act or by the Secretary under subsection (d)(2) of this section, it is a prescription drug, and the established name of the drug and any of its ingredients are not: (i) Printed prominently on the label of the drug in type at least half as large as that used to print any proprietary name or other designation of the drug or of its ingredients; and (ii) Printed in this same manner on any labeling of the drug on which any name for the drug or for an ingredient is used; (5) It purports to be a drug whose name is recognized in an official compendium and it is not: (i) Labeled as required by the applicable official compendium; or (ii) Packaged as required by: (1) The applicable official compendium; or (2) A consent order granted under the federal act or by the Secretary to modify the packaging requirements of the official compendium; (6) It has been found under the federal act or by the Secretary to be a drug liable to deterioration, and: (i) It is not packaged in the form and manner required by the rules and regulations adopted under the federal act or by the Secretary; or (ii) Its label does not bear a statement of precautions as required by those rules and regulations; (7) It is a prescription drug that was manufactured after July 1, 1976, and its label does not bear the name of the actual manufacturer of the drug; (8) Its container is made, formed, or filled in a manner that is misleading; (9) It is an imitation of another drug; (10) It is offered for sale under the name of another drug; (11) It is or it is purported to be a drug that is composed in whole or in part of insulin and it is not from a batch for which a currently unexpired certificate or release has been issued under the federal act; (12) It is or it is purported to be a drug composed in whole or in part of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any other antibiotic drug, or of any derivative of these drugs and, unless the drug has been exempted by rules and regulations adopted under the federal act, it is not from a batch for which a currently unexpired certificate or release has been issued under the federal act; (13) It is a color additive that is intended to be used in or on a drug for the purpose of coloring only and its packaging or labeling does not conform to any requirement adopted under Sec. 21-239 of this subtitle; or (14) It is a prescription drug that is distributed or offered for sale in this State, and the manufacturer, packer, or distributor of the drug does not include in any advertisement, or in any other descriptive printed matter that it issues or causes to be issued regarding the drug, a true statement of: (i) The established name of the drug, which name is printed prominently and in type at least half as large as that used for any printed trade or brand name of the drug; (ii) The formula of the drug showing quantitatively each ingredient of the drug to the extent required for labels under the federal act; and (iii) A brief summary of any other information that relates to the side effects, contraindications, or effectiveness of the drug, as is required by the rules and regulations adopted under the federal act. (c) (1) For purposes of subsection (b)(5) of this section, which imposes packaging and labeling requirements on any drug that is purported to be recognized in an official compendium, the provisions of this subsection shall apply. (2) (i) Except as otherwise provided in this subsection, if the drug is recognized in both the United States Pharmacopoeia and National Formulary and in the Homeopathic Pharmacopoeia of the United States, it is subject to the packaging and labeling requirements of the United States Pharmacopoeia and National Formulary. (ii) If the drug is labeled and offered for sale as a homeopathic drug, it is subject to the packaging and labeling requirements of the Homeopathic Pharmacopoeia of the United States and not to the requirements of the United States Pharmacopoeia and National Formulary. (3) If there is an inconsistency between the provisions of paragraph (2) of this subsection and the requirements of subsection (b)(2), (3), or (4) of this section as to the name by which a drug or its ingredients shall be designated, the requirements of subsection (b)(2), (3), or (4) of this section control. (d) (1) For purposes of subsection (b)(1) of this section, after investigation, the Secretary may adopt a rule or regulation that designates any chemical derivative of any substance named in that subsection as habit forming. (2) If, as to a particular drug, compliance with any requirement of subsection (b)(3) or (4) of this section is impractical, the Secretary shall adopt a rule or regulation that, to the extent appropriate, exempts the drug from the provisions of those subsections. (3) (i) If the Secretary finds that a drug is liable to deterioration, the Secretary may adopt a rule or regulation that specifies how the drug is to be packaged and requires that its label bear a statement of precautions. (ii) The Secretary may not adopt a rule or regulation under subparagraph (i) of this paragraph before the Secretary has informed the appropriate body that is charged with the revision of the official compendium of the need for the packaging or labeling requirements and that body has failed to adopt the requirements within a reasonable time. #### Section 21-219 (a) A drug or device is not subject to the labeling or packaging requirements of this subtitle if a rule or regulation is adopted under the federal act or as provided under this section to exempt it. (b) The Secretary shall adopt rules and regulations to exempt from the labeling requirements of this subtitle any drug or device that is to be transported in substantial quantities from one establishment to another, if in accordance with the practice of the trade, the drug or device is to be processed, labeled, or repacked at the second establishment. #### Section 21-220 (a) A drug that is intended for use by human beings and is in any of the following classifications may be dispensed by a pharmacist only on a written prescription, an electronic prescription, as defined in Sec. 5-101 of the Criminal Law Article, or an oral prescription from a health practitioner authorized by law to prescribe the drug: (1) A habit-forming drug to which Sec. 21-218(b)(1) of this subtitle applies. (2) A drug that because of its toxicity or other potentiality for harmful effect, the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a health practitioner who is authorized by law to administer such a drug. (3) A drug that is limited by an approved application under Sec. 355 of the federal act or Sec. 21-223 of this subtitle to use under the professional supervision of a health practitioner authorized by law to administer such a drug. (b) (1) Subject to paragraph (2) of this subsection and subsection (c) of this section, a prescription may be written or oral or made through an electronic prescription. (2) A pharmacist may not dispense a drug on an oral prescription unless the pharmacist promptly writes out and files the prescription. (c) (1) Except as provided in paragraph (2) of this subsection, a health practitioner authorized by law to prescribe a controlled dangerous substance within the meaning of Title 5 of the Criminal Law Article shall issue a prescription for a controlled dangerous substance using an electronic prescription, as defined in Sec. 5-101 of the Criminal Law Article. (2) A health practitioner may issue a written or, if authorized by State and federal law, oral prescription for a controlled dangerous substance only if: (i) Electronic prescribing is not available due to temporary technological or electrical failure; (ii) The prescription is to be dispensed by a pharmacy located outside the State; (iii) The prescription is issued by a health practitioner outside the State; (iv) The health practitioner is prescribing and dispensing the controlled dangerous substance directly to the patient; (v) The prescription is being dispensed directly to the patient in accordance with Sec. 12-102(c)(2)(iv) of the Health Occupations Article; (vi) The prescription is for an individual who: (1) Resides in a nursing or assisted living facility; (2) Is receiving care through a hospice or palliative care program and the prescription is related to the care provided; (3) Is receiving care at an outpatient renal dialysis facility and the prescription is related to the care provided; or (4) Is detained or confined in a correctional facility, as defined in Sec. 1-101 of the Correctional Services Article; (vii) The prescription is issued by a licensed veterinarian; (viii) The prescription includes elements that are not supported by the most recent version of the National Council for Prescription Drug Programs Prescriber/Pharmacist Interface SCRIPT Standard; (ix) The prescription is issued for a drug for which the federal Food and Drug Administration requires the prescription to contain certain elements that cannot be transmitted electronically; (x) The prescription prescribes a drug under a research protocol; (xi) The prescription is issued by a health practitioner who has received a waiver under subsection (d)(1) of this section; (xii) The prescription is issued by a health practitioner who requested a waiver under subsection (d)(1) of this section and the Department has not issued a waiver to the practitioner or has not rejected the practitioner's request for a waiver; (xiii) The health practitioner issuing the prescription or the drug for which the prescription is issued falls under a waiver issued by the Secretary under subsection (d)(2) of this section; (xiv) The prescription is issued by a health practitioner who writes a low volume of prescriptions for controlled dangerous substances, as determined by the Maryland Health Care Commission; or (xv) The prescription is issued by a health practitioner under circumstances in which, although the practitioner has the ability to issue an electronic prescription as required by paragraph (1) of this subsection, the health practitioner reasonably determines that: (1) It would be impracticable for the practitioner to prescribe the drug or device by electronic prescription in a timely manner; and (2) The delay would adversely impact the patient's medical condition. (3) This subsection may not be construed to limit the right of a patient to designate a specific pharmacy to dispense a prescribed drug or device to the individual. (d) (1) The Secretary shall adopt regulations, in collaboration with the Maryland Health Care Commission, to establish a process for the Department to issue a waiver from the electronic prescription requirements in subsection (c)(1) of this section. (2) (i) The Secretary may issue a waiver that applies generally to a group of health practitioners or drugs that meet conditions specified by the Secretary. (ii) Any waiver issued under subparagraph (i) of this paragraph for a group of health practitioners shall apply to a health practitioner in that group without requiring the health practitioner to go through the process established in regulations under paragraph (1) of this subsection. (3) Except for a waiver issued under paragraph (2) of this subsection, the regulations adopted under paragraph (1) of this subsection shall specify that a waiver: (i) May not exceed 1 year; and (ii) May be granted for the following reasons: (1) Economic hardship; (2) Technological limitations that are not reasonably within the control of the health practitioner; or (3) Any other exceptional circumstances as demonstrated by the health practitioner. (4) The Secretary may adopt regulations on: (i) Which temporary technological or electrical failures constitute an exception to the requirement to issue an electronic prescription under subsection (c)(1) of this section; and (ii) The circumstances under which a health practitioner is exempt from the requirement to issue an electronic prescription under subsection (c)(1) of this section because the prescription will be dispensed by a pharmacy located outside the State. (e) The appropriate health occupations board established under the Health Occupations Article may take disciplinary action against a health practitioner who violates subsection (c) of this section. (f) (1) A pharmacist may dispense a drug on a written or oral prescription for a controlled dangerous substance that meets the requirements of this section. (2) A pharmacist who receives a written or oral prescription is not required to verify that the prescription is an authorized exception to the electronic prescription requirement under subsection (c)(2) of this section. (g) (1) If a prescription for a controlled dangerous substance within the meaning of Title 5 of the Criminal Law Article is written, it may not be written on a preprinted prescription form that states the name, quantity, or strength of the controlled dangerous substance. (2) When a prescription is written, a separate prescription form is required for each controlled dangerous substance. If a pharmacist is otherwise satisfied that a prescription is valid the pharmacist may fill the prescription if the pharmacist promptly writes out and files a prescription for each substance and also files the original prescription. (3) A written prescription shall be legible. (h) A pharmacist may not refill and dispense a prescription unless the refilling is authorized by: (1) The health practitioner's specification in the original prescription as to how many times it may be refilled; or (2) An oral order of the health practitioner that promptly is written out and filed by the pharmacist. (i) The dispensing of a drug without complying with the requirements of this section is the dispensing of a misbranded drug. (j) (1) A drug that is subject to the prescription requirements of this section is misbranded if, at any time before it is dispensed, its label does not bear the statement "Caution: Federal Law Prohibits Dispensing Without Prescription", or "Caution: State Law Prohibits Dispensing Without Prescription". (2) A drug to which the prescription requirements of this section do not apply is misbranded if, at any time before it is dispensed, its label bears the caution statement quoted in paragraph (1) of this subsection. (k) (1) The prescription requirements of this section do not apply to any drug that is exempted under a rule or regulation adopted by the Secretary. (2) The Secretary, by rule or regulation, may exempt any drug from the requirements of this section if the Secretary finds that, as to the drug, the requirements of this section are not necessary for the protection of the public health. (3) The Secretary, by rule and regulation, may exempt from the requirements of this section any drug that is removed from the prescription requirements of the federal act by a rule or regulation adopted under that act. #### Section 21-221 (a) A drug that is dispensed under a prescription shall bear a label that states: (1) The name and address of the dispenser; (2) The serial number of the prescription; (3) The date of the prescription or the date that the prescription was filled; (4) The name of the prescriber; and (5) If stated in the prescription: (i) The name of the patient; (ii) Any directions for use; and (iii) Any cautionary statements. (b) If a drug dispensed under a prescription meets the label requirements of this section, it is exempt from the provisions of: (1) Section 21-217(b)(3) through (7) of this subtitle; and (2) Section 21-218(b)(1) through (4), (7), (8), (13), and (14) of this subtitle. (c) The exemptions under this section do not apply to any drug that is dispensed in the course of the conduct of a business of dispensing drugs on the basis of diagnosis made through the mail. #### Section 21-222 Nothing in Sec. 21-220 or Sec. 21-221 of this subtitle relieves any person from any requirement imposed by law with respect to any drug that is classified as a controlled dangerous substance within the meaning of Title 5 of the Criminal Law Article or the applicable federal law. #### Section 21-223 (a) This section does not apply to any drug that: (1) Was sold in this State or introduced into interstate commerce at any time before the enactment of the federal act, if its labeling contained the same representations concerning the conditions of its use; or (2) Is licensed under the Public Health Service Act of July 1, 1944, or under the Animal Virus, Serum, Toxin, Antitoxin Act of March 4, 1913. (b) A person may not sell, give away, or deliver any new drug: (1) Unless an approved application for the drug is in effect under Sec. 355 of the federal act; or (2) Unless an application has been approved by the Secretary and is in effect under this section, if the drug is not subject to the federal act. (c) To have an application approved by the Secretary, an applicant shall file with the Secretary an application that sets forth: (1) Full reports of the investigations that have been made to show whether the drug is safe for use and whether the drug is effective in use; (2) A full statement of the composition of the drug; (3) A full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of the drug; (4) Any sample of the drug and of any article used as a component of the drug that the Secretary requires; and (5) A specimen of the labeling that is proposed to be used for the drug. (d) The Secretary may not approve an application filed under this section unless the drug has been tested and, under the conditions specified, recommended, or suggested in the proposed labeling of the drug, has been found to be safe for and effective in use. (e) An application filed with the Secretary under this section shall be considered approved on the 180th day after it is filed, unless before that day and after giving the applicant notice and an opportunity for a hearing, the Secretary issues an order of disapproval under subsection (f) of this section on a finding that: (1) The drug has not been tested properly, as required by subsection (d) of this section; (2) Under the conditions specified, recommended, or suggested in the proposed labeling of the drug, it is not safe for or effective in use; (3) The methods used in, and the facilities and controls used for, the manufacture, processing, and packing of the drug are inadequate to preserve its identity, strength, quality, and purity; or (4) Based on a fair evaluation of all material facts, the proposed labeling is false or misleading in any way. (f) If, before the date that the application otherwise would be considered approved the Secretary makes any of the findings that are enumerated in subsection (e) of this section concerning the drug, the Secretary shall issue an order that disapproves the application. (g) (1) The Secretary may revoke an order that disapproved an application and the application then shall be considered approved. (2) After providing an opportunity for a public hearing and judicial appeal, the Secretary may revoke an application that was approved under this section if, based on evidence that is acquired after approval, the Secretary finds that: (i) The drug may not be safe for or effective in its intended use; or (ii) The facilities or controls used in the manufacture, processing, or labeling of the drug may present a hazard to the public health. (h) In accordance with any rule or regulation that is adopted or any order that is issued by the Secretary under this section, the person who holds an application for a drug that is approved under this section shall: (1) Keep records; and (2) Submit reports to the Secretary. (i) (1) The Secretary may adopt rules and regulations that apply generally to persons whose applications for drugs have been approved or, as to a particular person whose application has been approved, issue an order that requires an applicant: (i) To keep records of information that relates to clinical experience with the drug and any other information that the applicant obtains about the drug; and (ii) To submit reports to the Secretary concerning that information. (2) When adopting a rule or regulation or issuing an order that requires the submission of information under this subsection, the Secretary shall consider the professional ethics of the medical profession and the interests of patients. (3) Any rule, regulation, or order under this section shall provide that if any person to whom the rule, regulation, or order applies requests it, and if the Secretary considers it to be appropriate, the person may examine similar information that is obtained by the Secretary concerning the drug. #### Section 21-224 (a) (1) A new drug is not subject to the requirements of Sec. 21-223 of this subtitle if it is exempted by a rule or regulation adopted under this section. (2) This section does not require any clinical investigator to submit directly to the Secretary any report on the investigational use of a drug. (b) The Secretary shall adopt rules and regulations to exempt from the requirements of Sec. 21-223 of this subtitle any drug that is intended only for investigational use by experts who are qualified by scientific training and experience to investigate the safety and effectiveness of the drug. In addition to any other conditions that may be imposed for the protection of the public health, the rules and regulations may require as a condition for the exemption of a drug that: (1) Before any clinical testing of a new drug is undertaken, the manufacturer of the drug or the sponsor of the investigation of the drug submit to the Secretary reports of preclinical tests of the drug, including tests on animals, that are adequate to justify the proposed clinical testing; (2) The manufacturer of a new drug that is proposed to be distributed to investigators for clinical testing or the sponsor of the investigation obtain a signed agreement from each investigator who is involved that: (i) The patients to whom the drug is administered will be under that investigator's personal supervision or under the supervision of an investigator who is responsible to that investigator; and (ii) The investigator will not supply the drug to any other investigator, or to any clinic, for administration to a human being; and (3) The manufacturer of a new drug or the sponsor of the investigation of the drug keep records of, and make reports to the Secretary of, the information obtained from the investigational use of the drug, including analytical reports by investigators, as the Secretary finds will assist in the evaluation of the safety and effectiveness of the drug if an application for the drug is filed under Sec. 21-223 of this subtitle. (c) (1) When adopting a rule or regulation that requires the submission of information under this subsection, the Secretary shall consider the professional ethics of the medical profession and the interests of patients. (2) Any rule, regulation, or order under this section shall provide that if any person to whom the rule, regulation, or order applies requests it, and if the Secretary considers it to be appropriate, the person may examine any similar information that is obtained by the Secretary concerning the drug. (d) (1) Any rule or regulation adopted under Sec. 355(i) of the federal act automatically shall be a rule or regulation of this State, as provided in Sec. 21-241 of this subtitle. (2) However, the Secretary may adopt a rule or regulation under this section even if it is not in accord with the rules and regulations adopted under the federal act. #### Section 21-225 Any person who is required under Sec. 21-223 or Sec. 21-224 of this subtitle to keep records and any person who is in charge or custody of any of these records, on the request of the Secretary, shall permit the Secretary to have access to, copy, and verify the records at any reasonable time. #### Section 21-226 (a) The manufacturer, packer, or distributor of any prescription drug that is sold or distributed in this State shall: (1) Keep correct copies of any printed matter that is: (i) Required to be included in any package in which the drug is sold or distributed; or (ii) Approved under the federal act; and (2) Send copies of the printed matter to any health practitioner who is authorized to administer the drug and who makes a written request for information about the drug. (b) This section does not exempt any person from any labeling requirement imposed under any other provision of this subtitle. #### Section 21-227 On a specific written request by the Secretary, the manufacturer, packer, or distributor of any prescription drug that is sold or distributed in this State shall give the Secretary: (1) Any information that the manufacturer, packer, or distributor has about the biological availability and clinical performance of the drug; and (2) Any comparative information that the manufacturer, packer, or distributor has about any drug, of the same established name, that is manufactured, packed, or distributed by another person. #### Section 21-228 A person may not sell or offer for sale a natural membrane condom by means of a vending machine or other automatic device. #### Section 21-230 (a) In Part IV of this subtitle, "hair dye" does not mean eyelash dye or eyebrow dye. (b) For purposes of this subtitle, a cosmetic is considered adulterated if: (1) Except as provided for coal tar hair dye in subsection (c) of this section, it contains any poisonous or otherwise deleterious substance that, in the quantity present, reasonably would be expected to make it injurious to a user under the conditions of use: (i) That are instructed, recommended, or suggested in the labeling or advertisement of the cosmetic; or (ii) That are customary or usual for the cosmetic; (2) It contains a filthy, putrid, or decomposed substance; (3) It was produced, prepared, packed, or held under unsanitary conditions that reasonably would be expected to have: (i) Contaminated it with filth; or (ii) Caused it to be injurious to health; (4) Any part of its container is composed of any poisonous or otherwise deleterious substance that reasonably would be expected to have caused the cosmetic to be injurious to health; or (5) It is not a hair dye and it is or it contains a color additive the particular use of which has not been found safe as provided under Sec. 21-239 of this subtitle. (c) A coal tar hair dye is not considered adulterated under subsection (b)(1) of this section if it: (1) Has on its label a conspicuously displayed warning that states: "Caution -- This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness."; and (2) Has on its labeling adequate directions for the preliminary testing that is referenced on the label. #### Section 21-231 (a) For purposes of this subtitle, a cosmetic is considered misbranded if: (1) Its labeling or packaging is false or misleading in any way; (2) It is in package form and it does not bear a label that contains the name and place of business of the manufacturer, packer, or distributor; (3) Any word, statement, or other information required under this subtitle to appear on its labeling is not: (i) Placed prominently on the labeling so that it is conspicuous, as compared with other words, statements, designs, or symbols, on the labeling; and (ii) Expressed in terms likely to be read and understood by the ordinary individual under customary conditions of purchase and use; or (4) Except as provided in subsection (b)(1) of this section for color additives to be used in hair dyes, it is a color additive and its packaging and labeling do not meet the applicable requirements of the federal act. (b) (1) A package of color additive is not misbranded under subsection (a)(4) of this section if it is marketed and intended for use only in or on a hair dye. (2) A cosmetic that, in accordance with the practice of the trade, is to be processed, labeled, or repacked in substantial quantities at an establishment other than the establishment in which it originally is processed or packed, is exempt from the affirmative labeling requirements of this section while the cosmetic is in transit from the one establishment to the other, if the transit is made for completion only. #### Section 21-234 (a) The Secretary may adopt rules and regulations to carry out the provisions of this subtitle. (b) Except for a State adopted federal rule or regulation, the Secretary may not adopt any rule or regulation under this subtitle unless the requirements of this subtitle and the Administrative Procedure Act are met. #### Section 21-235 (a) So far as practicable, the Secretary may conform any rule or regulation adopted under this subtitle to the rules and regulations adopted under the federal act. (b) The Secretary may adopt for purposes of this subtitle any rule or regulation adopted by the United States Department of Agriculture. #### Section 21-236 The Secretary shall give notice of and hold any hearing authorized or required by this subtitle in accordance with the Administrative Procedure Act. #### Section 21-237 (a) (1) Except as provided for meat and poultry products under paragraph (3) of this subsection and for frozen desserts under Subtitle 8 of this title, the definitions and standards of identity and quality adopted by rule or regulation under the federal act for foods are the definitions and standards of identity and quality for foods in this State. (2) By rule or regulation, the Secretary may adopt a definition or standard of identity or quality for any food if: (i) A definition or standard has not been adopted for the food under the federal act; and (ii) The Secretary finds that the definition or standard will promote honesty and fair dealing in the interest of consumers. (3) Any definition or standard of identity or quality for a meat or poultry product that is adopted under a rule or regulation of the State Department of Agriculture is the definition or standard of identity or quality for that product in this State. (b) (1) For purposes of this subtitle, the standards for the quality, purity, and strength of any drug are the standards set by an official compendium. (2) If a drug is not standardized by an official compendium, then subject to Sec. 21-241 of this subtitle, the standards of quality, purity, and strength adopted by rule or regulation under the federal act are the standards of quality, purity, and strength for the drug in this State. #### Section 21-238 (a) If a temporary permit is issued under the federal act to authorize an interstate shipment that varies from the definitions and standards of identity set under the federal act, the permit is effective in this State under the conditions provided in the permit. (b) For experimental or other purposes, the Secretary may issue a permit that authorizes variations from the definitions and standards of identity and quality that are set under this subtitle if: (1) The Secretary finds that issuance of the permit is in the public interest; and (2) The permit is issued on terms and with safeguards that adequately protect the interests of consumers and potential consumers. #### Section 21-239 (a) (1) For purposes of Sec.Sec. 21-207(b)(3), 21-216(b)(2), and 21-230(b)(5) of this subtitle, regarding food, drugs, and cosmetics respectively, the use of any added poisonous or otherwise deleterious substance, any food additive, or any color additive is considered unsafe unless the use of the substance or additive for the particular purpose is authorized by and the quantity of the substance that may be used for that purpose is limited by: (i) A State adopted federal rule or regulation, as provided under subsection (b) of this section; or (ii) A rule or regulation adopted by the Secretary under subsection (c) of this section. (2) If a food, drug, or cosmetic contains any added poisonous or otherwise deleterious substance, any food additive, or any color additive in a quantity that is allowed by a rule or regulation as provided by paragraph (1) of this subsection, the food, drug, or cosmetic may not be considered adulterated because it contains that substance or additive. (b) Subject to the provisions of Sec. 21-241 of this subtitle, any rule or regulation that regulates the use of a food additive or a color additive and that is adopted by the federal government under the federal act automatically is adopted as a rule or regulation of this State. (c) Whether or not in accordance with any rule or regulation that sets tolerances under the federal act and if public health or other considerations in this State make it necessary, the Secretary may adopt a rule or regulation that: (1) As to any added poisonous or otherwise deleterious substance, any food additive, or any color additive: (i) Prohibits its use; or (ii) Sets tolerances for its use; or (2) As to any food additive or any color additive: (i) Sets conditions under which it may be used safely; or (ii) Provides exemptions for its use for investigational or experimental purposes. (d) (1) The rule or regulation may be adopted by the Secretary either on the Secretary's own initiative or on the petition of any interested party. (2) Before the Secretary may adopt the rule or regulation on the basis of a petition, the petitioner shall establish by information that is submitted to the Secretary that the rule or regulation is needed and that the effect of the rule or regulation will not harm the public health. (3) If the information submitted by the petitioner is not sufficient to allow the Secretary to determine whether, under the standards set forth in subsection (e) of this section, the rule or regulation should be adopted, the Secretary may require that additional information be submitted. Failure by the petitioner to comply with the Secretary's request is a sufficient ground to deny the petition. (e) The Secretary, in determining whether to adopt a rule or regulation under this section, shall consider: (1) The name of and all pertinent information that concerns the substance or additive, including, if available: (i) Its chemical identity and composition; (ii) The conditions of its proposed use, including directions, recommendations, and suggestions; (iii) Samples of the proposed labeling for the substance or additive; and (iv) All relevant information bearing on the physical or other technical effect of the substance or additive and the quantity of the substance or additive that is required to produce the effect; (2) The probable composition of any substance that may be formed in or on a food, drug, or cosmetic as a result of the use of the substance or additive; (3) The probable amount of the substance or additive that would be consumed in the average human diet, taking into account any chemically or pharmacologically related substance in the diet; (4) Safety factors that, in the opinion of experts qualified by scientific training and experience to evaluate the safety of the substance or additive for its proposed use, are generally recognized as appropriate for the use of animal experimentation information; (5) The availability of a practicable method of analysis for determining the identity and quantity of: (i) The substance or the additive in or on an article; (ii) Any other substance that is formed in or on the article because of the use of the added substance or color additive; and (iii) The pure substance or additive and any intermediate or impurity of the substance or additive; (6) Any fact that supports a contention that the proposed use of the substance or additive would serve a useful purpose; and (7) Any other factor that is relevant to the issues of whether there is a need for the use of the substance or additive or whether the use would harm the public health. #### Section 21-240 (a) Unless a written protest is filed with the Secretary, a rule or regulation proposed by the Secretary under this subtitle takes effect on the date the Secretary designates but not earlier than 90 days after publication. (b) Any person who may be affected adversely by a rule or regulation that is proposed by the Secretary under this subtitle may: (1) File a protest within 30 days after publication of the proposed rule or regulation; and (2) Request a hearing. #### Section 21-241 (a) Unless a written protest is filed with the Secretary, a State adopted federal rule or regulation takes effect in this State on the date that it becomes effective as a federal rule or regulation. (b) Any person who may be affected adversely by a State adopted federal rule or regulation may: (1) File a protest against the federal rule or regulation not more than 30 days after its effective date; and (2) Request a hearing. (c) A protest under this section stays the effect of the State adopted federal rule or regulation as a rule or regulation of this State. #### Section 21-242 If a written protest against a rule or regulation is filed in accordance with Sec. 21-240 or Sec. 21-241 of this subtitle, the Secretary shall hold a public hearing: (1) To receive evidence on the issues raised by the protest; and (2) To hear any interested person. #### Section 21-243 (a) (1) As soon as practicable after a hearing on a protest to a rule or regulation under Sec. 21-242 of this subtitle, the Secretary shall: (i) Act on the protest by issuing an order; and (ii) Send a copy of the order to each protester by certified mail, return receipt requested, bearing a postmark from the United States Postal Service. (2) Each order issued under this section shall be based on substantial evidence in the record of the hearing. (b) An order issued by the Secretary under this section may: (1) Reinstate, rescind, or modify a State adopted federal rule or regulation as a rule or regulation of this State; or (2) As to any other rule or regulation proposed under this subtitle: (i) Withdraw the proposal; (ii) Modify the proposal and set an effective date for the modified proposal that is at least 60 days after publication of the order; or (iii) Set a new effective date for the original proposal that is at least 60 days after publication of the order. #### Section 21-244 (a) The Secretary shall provide a copy of this subtitle and Subtitle 1 of this title: (1) To the extent possible, to any person who in this State manufactures, packs, stores, or sells, at wholesale or retail, any food, drug, device, or cosmetic; and (2) To any person who requests it. (b) The Secretary may: (1) Publish summaries of judgments, decrees, or court orders issued under this subtitle; (2) Otherwise collect, report, or illustrate the results of any investigation conducted under this subtitle; and (3) Disseminate any information regarding any food, drug, device, or cosmetic if the Secretary considers the information necessary for the public health or for the protection of consumers against fraud. #### Section 21-247 For purposes of this subtitle, an advertisement for a food, drug, device, or cosmetic is considered to be false if it is false or misleading in any way. #### Section 21-248 (a) In addition to any finding that may be made under Sec. 21-247 of this subtitle and except as otherwise provided in this section, an advertisement is considered to be false if it represents that a drug or device has any effect regarding albuminuria, appendicitis, arteriosclerosis, blood poison, bone disease, Bright's disease, cancer, carbuncles, cholecystitis, diabetes, diphtheria, dropsy, erysipelas, gallstones, any heart or vascular disease, high blood pressure, mastoiditis, measles, meningitis, mumps, nephritis, otitis media, paralysis, pneumonia, poliomyelitis (infantile paralysis), any prostate gland disorder, pyelitis, scarlet fever, sexual impotence, sinus infection, smallpox, tuberculosis, tumors, typhoid, uremia, or any venereal disease. (b) If an advertisement for a drug or device is not otherwise considered to be false under Sec. 21-247 of this subtitle, it is not false under this section if: (1) It is disseminated only to members of the medical, dental, or veterinary professions; (2) It appears only in the scientific periodicals of these professions; or (3) It is disseminated only for the purpose of public health education by a person who does not have a direct or indirect commercial interest in the sale of the drug or device. (c) (1) An advertisement for a drug or device is not false under this section if a rule or regulation is adopted that authorizes the advertisement, as provided in this subsection. (2) (i) If the Secretary finds that an advance in medical science has made any type of self-medication safe for the treatment of any disease or disorder named in subsection (a) of this section, the Secretary shall adopt a rule or regulation that authorizes the advertisement of any drug or device that has a curative or therapeutic effect for the disease or disorder. (ii) A rule or regulation that authorizes an advertisement is subject to any condition or restriction that the Secretary considers necessary to protect the public health. (d) This section does not indicate that self-medication for any disease or disorder other than the diseases and disorders named in subsection (a) of this section is safe or effective. (e) Any representation made in the labeling of a drug or device that would be a false advertisement under this section if it appeared elsewhere, is a misbranding of the drug or device under Sec. 21-217 of this subtitle. #### Section 21-249 (a) (1) For the purpose of enforcing this subtitle and after presentation of appropriate credentials to the owner, operator, or agent in charge, the Secretary or a representative of the Secretary may enter and inspect at any reasonable time: (i) Any factory, warehouse, or other establishment in which any food, drug, device, or cosmetic is manufactured, processed, packed, or held for a commercial purpose; and (ii) Any vehicle used to transport or hold any food, drug, device, or cosmetic for a commercial purpose. (2) An inspection carried out under this section may include an inspection of the establishment or vehicle itself and of any pertinent equipment, labeling, and finished and unfinished products. (3) An inspection carried out under this section shall be completed with reasonable promptness. (b) (1) As to any factory, warehouse, consulting laboratory, or other establishment in which any prescription drug is manufactured, processed, packed, or held, an extended inspection under this section shall include everything in the establishment that may have a bearing on whether the establishment has violated a provision of this subtitle regarding prescription drugs, including the records, processes, controls, and facilities. (2) The authority under this subsection to conduct extended inspections of the records of an establishment that relate to prescription drugs does not include the authority to inspect records of the establishment that relate to: (i) Financial information; (ii) Sale information, other than shipment information; (iii) Pricing information; (iv) Personnel information, other than information as to the qualifications of technical and professional personnel who perform functions subject to this subtitle; or (v) Research information, other than information that: (1) Relates to a new drug or an antibiotic drug and is subject to requirements for reporting and inspection that are imposed by rules and regulations adopted under Sec. 355(i) or (k) or Sec. 357(d) or (g) of the federal act; or (2) Relates to any other drug and would be subject to reporting or inspection under rules and regulations adopted under Sec. 355(k) of the federal act. (3) Authority to conduct extended inspections under this subsection does not apply to: (i) Any pharmacy that complies with the laws of this State that regulate practicing pharmacy or medicine and that does not, through a subsidiary or otherwise, manufacture, prepare, propagate, compound, or process any drug for sale, other than in the regular course of its business of dispensing or selling drugs at retail; (ii) Any health practitioner who is authorized by law to prescribe or administer drugs and who manufactures, prepares, propagates, compounds, or processes a drug solely for use in the course of the practitioner's professional practice; (iii) Any person who manufactures, prepares, propagates, compounds, or processes any drug for use only in research, teaching, or chemical analysis, and not for sale; or (iv) Any other class of person that the Secretary by rule or regulation exempts from the application of this subsection after a finding that, for that class of person, an inspection in accordance with this subsection is not necessary for the protection of the public health. (c) (1) During any inspection under this section, the Secretary may obtain a sample of any item that is subject to the inspection. (2) When obtaining a sample from an establishment under this subsection, the Secretary shall give the owner, operator, or agent in charge a receipt that describes the sample obtained. (d) On completing an inspection under this section and before leaving the establishment, the Secretary or representative of the Secretary shall: (1) Make a written report that sets forth any condition or practice that was observed during the inspection and that indicates that any food, drug, device, or cosmetic in the establishment: (i) Contains any filthy, putrid, or decomposed substance; or (ii) Has been prepared, packed, or held under unsanitary conditions by which it: (1) May have become contaminated with filth; or (2) Otherwise may have been rendered injurious to health; and (2) Give the owner, operator, or agent in charge of the establishment a copy of the report. #### Section 21-250 (a) For the purpose of enforcing this subtitle and after presentation of appropriate credentials to any person who is in charge of or has custody of the records, the Secretary or a representative of the Secretary may have access to and may copy any record of a carrier in commerce if the record concerns the movement or holding, for commercial purposes, of any food, drug, device, or cosmetic, including information that shows the quantity, shipper, and consignee of the article. (b) Any evidence that is obtained under this section may not be used in any criminal prosecution of the person from whom it is obtained. (c) A carrier in commerce is not subject to any other provision of this subtitle other than this section simply because the carrier receives, carries, holds, or delivers any food, drug, device, or cosmetic in the usual course of its business as a carrier. #### Section 21-251 (a) If, while conducting an inspection under Sec. 21-249 of this subtitle or while performing any other function under this subtitle, the Secretary obtains a sample of a food or drug, the Secretary may have an analysis or other examination made in a laboratory of the Department to determine: (1) As to a food sample, whether the food: (i) Is misbranded; (ii) Contains any filthy, putrid, or decomposed substance; or (iii) Is otherwise adulterated or unfit for food; or (2) As to a drug sample, whether the drug: (i) Is adulterated; or (ii) Is misbranded. (b) The results of an analysis or other examination conducted under this section shall be set forth in a written report and a copy of the report shall be given promptly to the owner, operator, or agent in charge of the establishment from which the sample was obtained. #### Section 21-252 In addition to and not instead of any other remedy authorized under this subtitle, the Secretary may bring an action to temporarily or permanently enjoin any violation of Sec.Sec. 21-256 through 21-259 of this subtitle. #### Section 21-253 (a) Under this section, there is a ground for action against a food, drug, device, or cosmetic if it is: (1) Adulterated; (2) So misbranded that it is dangerous or fraudulent; (3) A food that violates any requirement imposed under Sec. 21-211 of this subtitle; or (4) A drug that violates the provisions on new drugs under Sec. 21-223 of this subtitle. (b) If the Secretary finds or has probable cause to believe that there is ground for action against a food, drug, device, or cosmetic, the Secretary shall attach to the article a tag or other appropriate marking that gives notice that the article is, or is suspected of being, adulterated, misbranded, or in violation of Sec. 21-211 or Sec. 21-223 of this subtitle and that the article has been detained. The tag or other marking also shall warn all persons not to remove or dispose of the article, by sale or otherwise, until permission for removal or disposal is given by the Secretary, an authorized agent of the Secretary, or a court. (c) If, after an article has been marked as provided in subsection (b) of this section, the Secretary finds that there is not a ground for action against the article, the Secretary shall remove the marking and release the article. (d) (1) The Secretary may proceed further against any article as to which there is a ground for action by filing a petition for an order with the circuit court for the county in which the article is located. The petition may request any relief permitted by this subsection. (2) If the court finds that there is a valid ground for action against the article, the court may proceed by issuing an order: (i) Of forfeiture for destruction; or (ii) To have the article delivered to its claimant and have the violation corrected by proper labeling or processing. (3) If the court issues an order of forfeiture for destruction, the article shall be destroyed under the supervision of the Secretary and the owner shall pay all court, storage, and destruction costs, and any other cost that is incurred through the enforcement of this subtitle against the article. (4) If the court issues an order to have the article delivered to its claimant for correction of the violation, the order shall require that the claimant: (i) Correct the violation under the supervision of a representative of the Secretary; (ii) Pay all court and storage costs, the expense of supervision by the representative of the Secretary, and any other cost that is incurred through the enforcement of this subtitle against the article; and (iii) Post a bond that is conditioned on the obligation that the article be labeled or processed properly and that the expense of supervision by the representative of the Secretary be paid. (5) A bond that is posted under this subsection shall be discharged on a representation to the court by the Secretary that there no longer is a ground for action against the article and that the expense of supervision has been paid. #### Section 21-254 (a) (1) For purposes of this section, an "immediate threat" exists if any meat, seafood, poultry, vegetable, fruit, or any other perishable substance that is intended for consumption as food: (i) Contains any filthy, decomposed, or putrid substance; (ii) Is poisonous or otherwise would be injurious to health if consumed; or (iii) Is otherwise unsafe. (2) If a food poses an immediate threat, it shall be considered a public nuisance. (b) If the Secretary finds that a food poses an immediate threat, the Secretary immediately shall destroy the food or otherwise make the food unusable for consumption by human beings. (c) The owner of a substance that is destroyed or otherwise made unusable under this section may bring a suit for damages against the Secretary. (d) The Secretary shall have the immunity from liability described under Sec. 5-633 of the Courts Article. #### Section 21-255 (a) Except as otherwise provided in this section, the Secretary shall report to the State's Attorney any alleged criminal violation of this subtitle. (b) Before the Secretary reports any alleged violation of this subtitle to a State's Attorney for the institution of a criminal proceeding, the Secretary shall give the alleged violator notice and an opportunity to present that person's views to the Secretary either orally or in writing. The views of the alleged violator may be presented by counsel. (c) If the Secretary believes that there has been a violation of this subtitle, but that the violation was minor and the public interest would be served adequately in the circumstances by a written notice or warning, the Secretary may issue a written notice or warning instead of reporting the violation to the State's Attorney. #### Section 21-256 A person may not: (1) Manufacture or sell any food, drug, device, or cosmetic that is adulterated or misbranded; (2) Adulterate or misbrand any food, drug, device, or cosmetic; (3) Make a food, drug, device, or cosmetic become adulterated by altering, mutilating, destroying, obliterating, or removing any part of its labeling while the food, drug, device, or cosmetic is held for sale; (4) Receive in commerce any adulterated or misbranded food, drug, device, or cosmetic; (5) Deliver or offer for delivery any adulterated or misbranded food, drug, device, or cosmetic, whether or not for pay; (6) Disseminate any false advertisement; (7) Sell any food in violation of any requirement imposed under Sec. 21-211 of this subtitle; (8) Fail to comply with Sec. 21-249 or Sec. 21-250 of this subtitle by refusing to permit: (i) An entry or inspection; (ii) The taking of a sample; or (iii) Access to or copying of any record; (9) Remove or dispose of any article that is detained or restricted under Sec. 21-253 of this subtitle; or (10) Forge, counterfeit, simulate, falsely represent, or, without proper authority, use any mark, stamp, tag, label, or other identifying symbol that is authorized or required by any rule or regulation that is adopted under the provisions of the federal act or of this subtitle. #### Section 21-257 (a) Except to the extent that the person is engaged in the packing or labeling of the commodity or specifies, by any means, the manner in which the commodity is packed or labeled, this section does not apply to any person who is engaged in business as a wholesale or retail distributor of a consumer commodity. (b) A person may not distribute a consumer commodity in commerce if: (1) The commodity is contained in a package that does not conform to a requirement that is imposed under this subtitle; or (2) A label that does not conform to a requirement imposed under this subtitle is attached to the commodity. #### Section 21-258 (a) In this section, "counterfeit marking tool" means any punch, die, plate, stone, or other thing that is designed to print, imprint, or otherwise reproduce the trademark, trade name, imprint, symbol, or any other identifying mark of a drug, or a likeness of any of these markings, on a drug or on the container of a drug, other than the drug or container to which the marking belongs. (b) A person may not: (1) Sell any new drug in violation of Sec. 21-223 of this subtitle; (2) On the labeling of any drug or in any advertisement relating to the drug, use any representation or suggestion that an application as to the drug is effective under Sec. 21-223 of this subtitle, or that the drug complies with that section; (3) Fail to maintain and to provide to a health practitioner on request printed matter that relates to prescription drugs, as required under Sec. 21-226 of this subtitle; (4) Place or cause to be placed on any drug or device or on its container, with intent to defraud, the trade name, imprint, or other identifying mark of any other drug or any likeness of any of these markings; (5) With knowledge that the trade name, imprint, or other identifying mark of another drug, or any likeness of any of these markings has been placed on a drug or device or its container in violation of item (4) of this subsection: (i) Sell, dispense, or dispose of the drug or device or its container; (ii) Cause the drug or device or its container to be sold, dispensed, or disposed of; or (iii) Conceal or keep possession, control, or custody of the drug or device or its container with intent to sell, dispense, or dispose of it; (6) Make, sell, or dispose of any counterfeit marking tool; (7) Cause any counterfeit marking tool to be made, sold, or disposed of; (8) Keep possession, control, or custody of any counterfeit marking tool; (9) Conceal any counterfeit marking tool; (10) Cause a drug to be a counterfeit drug; (11) Sell or dispense a counterfeit drug or hold a counterfeit drug for sale or dispensing; (12) Except as permitted under Sec. 12-504 of the Health Occupations Article, dispense or cause to be dispensed, without the permission of the prescriber, a different drug or brand of drug instead of the drug or brand of drug prescribed; (13) Prescribe any drug on a written prescription form without clearly identifying the name of the prescriber; (14) Dispense any drug based on a prescription form that lacks the prescriber's name and signature which: (i) May not be made by use of a rubber stamp; but (ii) Except as otherwise required by State law for a controlled dangerous substance, is not required for oral prescription orders; or (15) Fail to provide to the Secretary on request information about prescription drugs, as required under Sec. 21-227 of this subtitle. #### Section 21-259 A person may not: (1) Make a written report that falsely certifies the results of any inspection, examination, or test that is made to determine if there is a violation of any provision of this part; (2) Use to that person's own personal advantage any information that is acquired under authority of this subtitle and concerns any method or process that is entitled to protection as a trade secret; or (3) Other than to the Secretary, to the Secretary's authorized representative, or to a court in a judicial proceeding under this subtitle, reveal any information that: (i) Is acquired under authority of this subtitle; and (ii) Concerns any method or process that is entitled to protection as a trade secret. #### Section 21-259.1 (a) A person may not open a sealed, closed, or fastened food container in a food store or supermarket if opening the package or container will leave the item in an unsalable condition, unless the person: (1) Intends to purchase the item; or (2) Has received from the proprietor authority to open the item. (b) A person who violates this section is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $25. (c) The penalty provisions of Subtitle 12 of this title do not apply to this section. #### Section 21-259.2 (a) In this section: (1) "Ingredient" means any single chemical entity or mixture used as a component in the manufacture of a cosmetic product; and (2) "Ingredient" does not include an incidental ingredient, as described in 21 C.F.R. Sec. 701.3(l). (b) Except as provided in subsection (c) of this section, a person may not knowingly manufacture, sell, deliver, hold, or offer for sale in the State a cosmetic product that contains any of the following intentionally added ingredients: (1) Dibutyl phthalate (CAS no. 84-74-2); (2) Diethylhexyl phthalate (CAS no. 117-81-7); (3) Formaldehyde (CAS no. 50-00-0); (4) Paraformaldehyde (CAS no. 30525-89-4); (5) Methylene glycol (CAS no. 463-57-0); (6) Quaternium-15 (CAS no. 51229-78-8); (7) Mercury (CAS no. 7439-97-6); (8) Isobutylparaben (CAS no. 4247-02-3); (9) Isopropylparaben (CAS no. 4191-73-5); (10) m-Phenylenediamine and its salts (CAS no. 108-45-2); (11) o-Phenylenediamine and its salts (CAS no. 95-54-5); (12) Lead (CAS no. 7439-92-1); or (13) The following per- and polyfluoroalkyl substances (PFAS) and their salts: (i) Perfluorooctane sulfonate (PFOS) or heptadecafluorooctane-1-sulfonic acid (CAS no. 1763-23-1); (ii) Potassium perfluorooctanesulfonate or potassium heptadecafluorooctane-1-sulfonate (CAS no. 2795-39-3); (iii) Diethanolamine perfluorooctane sulfonate (CAS no. 70225-14-8); (iv) Ammonium perfluorooctane sulfonate or ammonium heptadecafluorooctanesulfonate (CAS no. 29081-56-9); (v) Lithium perfluorooctane sulfonate or lithium heptadecafluorooctanesulfonate (CAS no. 29457-72-5); (vi) Perfluorooctanoic acid (PFOA) (CAS no. 335-67-1); (vii) Ammonium pentadecafluorooctanoate (CAS no. 3825-26-1); (viii) Nonadecafluorodecanoic acid (CAS no. 335-76-2); (ix) Ammonium nonadecafluorodecanoate (CAS no. 3108-42-7); (x) Sodium nonadecafluorodecanoate (CAS no. 3830-45-3); (xi) Perfluorononanoic acid (PFNA) (CAS no. 375-95-1); (xii) Sodium heptadecafluorononanoate (CAS no. 21049-39-8); or (xiii) Ammonium perfluorononanoate (CAS no. 4149-60-4). (c) A person is not in violation of this section if the person manufactures, sells, delivers, holds, or offers for sale in the State a cosmetic product that: (1) Was manufactured through a process intended to comply with this section; and (2) Contains a technically unavoidable trace quantity of an ingredient listed in subsection (b) of this section due to: (i) An impurity of a natural or synthetic ingredient; (ii) The manufacturing process; (iii) Storage; or (iv) Packaging. (d) (1) In addition to any other penalties under this title, a person who violates this section is liable for civil damages resulting from actual harm sustained by the individual resulting from the violation. (2) An action under this section must be brought within 3 years after the date on which the plaintiff discovered or reasonably should have discovered that the exposure to an ingredient in violation of this section was the proximate cause of the injury sustained by the plaintiff. (3) In any action brought to enforce this section, a court may award to a prevailing plaintiff: (i) Treble damages; (ii) If the violation was willful, punitive damages; and (iii) Reasonable attorney's fees. (e) (1) The Department may investigate any complaint alleging that a person has violated this section. (2) On receipt of a complaint, a representative of the Department, at a reasonable time, may enter and inspect the premises of the person located in the State to determine compliance with this section. (3) The person may not: (i) Refuse to grant access to a representative who requests to enter and inspect the premises of the person under paragraph (2) of this subsection; or (ii) Interfere with an inspection under paragraph (2) of this subsection. (4) An investigation of a premises of a person conducted under this subsection may include sampling of a cosmetic product to determine if the cosmetic product contains a technically unavoidable trace quantity of an ingredient listed in subsection (b) of this section. #### Section 21-259.3 (a) (1) In this section the following words have the meanings indicated. (2) "Animal testing" means the internal or external application or exposure of a cosmetic or any component of a cosmetic to the skin, eye, or any other body part of a live nonhuman vertebrate. (3) "Ingredient" has the meaning stated in 21 C.F.R. Sec. 700.3(e). (4) "Manufacturer" means any person whose name appears on the label of a cosmetic in accordance with the requirements of 21 C.F.R. Sec. 701.12. (b) (1) Except as provided in subsection (c) of this section, a person may not conduct or contract for animal testing in the development of a cosmetic. (2) Except as provided in subsection (c) of this section, beginning July 1, 2022, a manufacturer may not sell or offer for sale in the State a cosmetic if the manufacturer knows or reasonably should have known that the final product or any individual component of the final product was developed or manufactured using animal testing that was conducted or contracted by or for the manufacturer or any entity that supplies, directly or through a third party, any ingredient used by a manufacturer in the formulation of a cosmetic on or after January 1, 2022. (c) The provisions of subsection (b) of this section do not apply to animal testing that is: (1) Conducted or contracted to comply with a requirement of a federal or state regulatory agency if: (i) The cosmetic or ingredient in the cosmetic that is tested is in wide use and cannot be replaced by another ingredient that is capable of performing a similar function in the product; (ii) A specific human health problem relating to the cosmetic or an ingredient in the cosmetic is substantiated and the need to conduct animal testing is justified and supported by a detailed protocol for research that is proposed as the basis for the evaluation of the cosmetic or ingredient in the cosmetic; and (iii) Animal testing is the only method of testing that is accepted for the relevant purpose by the federal or state regulatory agency; (2) Conducted or contracted to comply with the requirement of a regulatory agency of a foreign jurisdiction if: (i) No evidence derived from the testing was relied on to substantiate the safety of a cosmetic sold by the manufacturer within the State; and (ii) The testing was not conducted in the State; (3) Performed on a cosmetic or an ingredient in a cosmetic subject to the requirements of Subchapter V of the Federal Food, Drug, and Cosmetic Act; (4) Conducted or contracted to comply with a requirement of a federal, state, or foreign regulatory agency for purposes unrelated to cosmetics testing if: (i) No evidence derived from the testing was relied on to substantiate the safety of a cosmetic sold by the manufacturer within the State; or (ii) (1) Documentary evidence demonstrates that the intent of the test that was performed was unrelated to cosmetics testing; and (2) The ingredient that was the subject of the testing has been used for purposes unrelated to cosmetics for at least 12 months; or (5) Performed on: (i) A cosmetic that, in its final form, was tested on animals before January 1, 2022, whether or not the cosmetic is manufactured on or after January 1, 2022; or (ii) A cosmetic ingredient that was sold in the State and tested on animals before January 1, 2022, whether or not the ingredient is manufactured on or after January 1, 2022, if any animal testing of the cosmetic ingredient after January 1, 2022, is conducted or relied on in accordance with this section. (d) This section may not be construed to prevent a cosmetics manufacturer from reviewing, assessing, or retaining data resulting from animal testing. (e) A political subdivision of the State may not adopt or enforce a provision of a local law relating to animal testing on cosmetics or animal testing on ingredients used in cosmetics. (f) (1) A person who violates this section is subject to a civil penalty: (i) Not exceeding $5,000 for the first offense; and (ii) Not exceeding $1,000 for each subsequent offense. (2) Each violation of this section with respect to a separate animal and each day on which a violation occurs is a separate violation under this section. (3) If a person who is alleged to have violated this section claims the prohibition in subsection (b) of this section does not apply because the testing falls under subsection (c)(1)(ii) of this section, the person shall provide clear, documented evidence of the date on which the data were generated. (g) (1) A local law enforcement agency may enforce the provisions of this section. (2) (i) The State's Attorney for each county may seek appropriate relief for violations of this section. (ii) A State's Attorney, in determining whether a violation of this section occurred, may review any testing data on which a manufacturer has relied in determining the safety of a cosmetic or an ingredient in a cosmetic sold in the State. (iii) Any testing data reviewed under subparagraph (ii) of this paragraph is entitled to protection as a trade secret. #### Section 21-260 (a) Except as to an alleged violation that is enumerated under subsection (b)(2) of this section, a person may not be convicted of any violation of this part, if, with respect to the alleged violation, the person establishes by a preponderance of evidence that the person did not commit the alleged violation purposely, knowingly, recklessly, or negligently. (b) (1) A person may not be convicted of any violation of the provisions of this subtitle that are enumerated under paragraph (2) of this subsection, if, with respect to the alleged violation, the person establishes by a preponderance of the evidence that: (i) For the purpose of disclosing the possible existence of the violation, the person: (1) Made an inspection, examination, or test; or (2) Received a written report that certified the results of an inspection, examination, or test that was made; (ii) The inspection, examination, or test and the instruments, personnel, and methods used in connection with it reasonably would be expected to disclose the existence of the violation; (iii) The inspection, examination, test, or the written report provided no basis for a belief that the alleged violation existed; and (iv) The person did not commit the alleged violation purposely, knowingly, recklessly, or negligently. (2) The provisions of paragraph (1) of this subsection apply to any violation of any of the following provisions of this subtitle: (i) Sec. 21-256(1) of this subtitle, concerning the manufacture or sale of an adulterated or misbranded article; (ii) Sec. 21-256(2) of this subtitle, concerning the adulteration or misbranding of any article; (iii) Sec. 21-256(4) of this subtitle, concerning the receipt in commerce of any adulterated or misbranded article; (iv) Sec. 21-256(5) of this subtitle, concerning the delivery of any adulterated or misbranded article; (v) Sec. 21-258(b)(13) of this subtitle, concerning the failure to identify on a prescription form the name of the prescriber of a drug; (vi) Sec. 21-258(b)(14) of this subtitle, concerning the dispensing of a drug on a written prescription that lacks the name of the prescriber; and (vii) Sec. 21-258(b)(15) of this subtitle, concerning the provision to the Secretary of information about prescription drugs. (c) For purposes of this section, an inspection, examination, or test by representative samples of a lot, delivery, or other mercantile quantity is considered to be a method that reasonably would be expected to disclose the existence of a violation with respect to all of the articles included in the lot, delivery, or other mercantile quantity. (d) Unless the person also is the manufacturer, packer, distributor, or seller of the article, a publisher, radio or television broadcast license holder, or other agency or medium for the dissemination of an advertisement is not liable under this subtitle for the dissemination by that person of a false advertisement concerning a food, drug, device, or cosmetic. #### Section 21-261 (a) If the Department believes that a person is violating any provision of this subtitle or any regulation adopted under this subtitle, the Department may have the person served with a written order that directs the person served to abate the violation within a time specified in the order. (b) Except as otherwise provided in the Administrative Procedure Act, the Department shall give any person served with an order under this section an opportunity for a hearing before the Department. (c) After a hearing under this section, the Department may affirm, modify, or withdraw the order. #### Section 21-263 This subtitle may be cited as the "Maryland Food, Drug, and Cosmetic Act". ### Subtitle 2A. Prescription Drug Monitoring Program #### Section 21-2A-01 (a) In this subtitle the following words have the meanings indicated. (b) "Board" means the Advisory Board on Prescription Drug Monitoring. (c) (1) "Dispense" has the meaning stated in Sec. 12-101 of the Health Occupations Article. (2) "Dispense" does not include: (i) Directly administering a monitored prescription drug to a patient; or (ii) Giving out prescription drug samples. (d) (1) "Dispenser" means a person authorized by law to dispense a monitored prescription drug to a patient or the patient's agent in the State. (2) "Dispenser" includes a nonresident pharmacy. (3) "Dispenser" does not include: (i) A licensed hospital pharmacy that only dispenses a monitored prescription drug for direct administration to an inpatient of the hospital; (ii) An opioid treatment services program; (iii) A veterinarian licensed under Title 2, Subtitle 3 of the Agriculture Article when prescribing controlled substances for animals in the usual course of providing professional services; (iv) A pharmacy issued a waiver permit under COMAR 10.34.17.03 that provides pharmaceutical specialty services exclusively to persons living in assisted living facilities, comprehensive care facilities, and developmental disabilities facilities; and (v) A pharmacy that: (1) Dispenses medications to an inpatient hospice; and (2) Has been granted a waiver under Sec. 21-2A-03(f) of this subtitle. (e) "Licensing entity" means an entity authorized under the Health Occupations Article to license, regulate, or discipline a prescriber or dispenser. (f) (1) "Monitored prescription drug" means a prescription drug that contains a Schedule II, Schedule III, Schedule IV, or Schedule V controlled dangerous substance designated under Title 5, Subtitle 4 of the Criminal Law Article. (2) "Monitored prescription drug" does not include naloxone medication. (g) "Naloxone medication" means an opioid antagonist approved by the federal Food and Drug Administration for the reversal of an opioid overdose. (h) "Naloxone medication data" means the information submitted to the Program for naloxone medication. (i) "Office" means the Office of Controlled Substances Administration in the Department. (j) "Opioid treatment services program" means a program that: (1) Is certified in accordance with Sec. 8-401 of this article or licensed by the State under Sec. 7.5-401 of this article; (2) Is authorized to treat patients with opioid dependence with a medication approved by the federal Food and Drug Administration for opioid dependence; (3) Complies with: (i) The Code of Federal Regulations 42, Part 8; (ii) COMAR 10.47.02.11; and (iii) Requirements for the secure storage and accounting of opioid medication imposed by the federal Drug Enforcement Administration and the Office; and (4) Has been granted a certification for operation by the Department, the federal Substance Abuse and Mental Health Services Administration, and the federal Center for Substance Abuse Treatment. (k) "Pharmacist" means an individual who is licensed under Title 12 of the Health Occupations Article, or by another state, to dispense a monitored prescription drug. (l) "Pharmacist delegate" means an individual who is: (1) Authorized by a registered pharmacist to request or access prescription monitoring data; and (2) Employed by or under contract with the same professional practice as the registered pharmacist. (m) "Prescriber" means a licensed health care professional authorized by law to prescribe a monitored prescription drug. (n) "Prescriber delegate" means an individual who is: (1) Authorized by a registered prescriber to request or access prescription monitoring data; and (2) Employed by or under contract with the same professional practice as the prescriber. (o) "Prescription drug" has the meaning stated in Sec. 21-201 of this title. (p) "Prescription monitoring data" means the information submitted to the Program for a monitored prescription drug. (q) "Program" means the Prescription Drug Monitoring Program established under this subtitle. (r) "Registered" means registered with the Program to request or access prescription monitoring data for clinical use. (s) "Terminal illness" means a medical condition that, within reasonable medical judgment, involves a prognosis for a patient that likely will result in the patient's death within 6 months. #### Section 21-2A-02 (a) There is a Prescription Drug Monitoring Program in the Department. (b) The mission of the Program is to: (1) Assist prescribers, pharmacists, and public health professionals in: (i) The identification and prevention of prescription drug abuse; and (ii) The identification and investigation of unlawful prescription drug diversion; and (2) Promote a balanced use of prescription monitoring data to assist appropriate law enforcement activities while preserving the professional practice of health care providers and the access of patients to optimal pharmaceutical care. (c) To carry out its mission, the Program shall monitor the prescribing and dispensing of all Schedule II, Schedule III, Schedule IV, and Schedule V controlled dangerous substances and the dispensing of naloxone medication by all prescribers and dispensers in the State. #### Section 21-2A-03 (a) The Department shall implement the Program, subject to the availability of funds. (b) The Secretary may: (1) Assign responsibility for the operation of the Program to any unit in the Department; (2) Contract with any qualified person for the efficient and economical operation of the Program; and (3) Identify and publish a list of monitored prescription drugs that have a low potential for abuse by individuals. (c) Except as provided in subsection (d) of this section, each dispenser shall submit prescription monitoring data and naloxone medication data to the Program by electronic means, in accordance with regulations adopted by the Secretary. (d) The Secretary, for good cause shown, may authorize a dispenser to submit prescription monitoring data or naloxone medication data by an alternative form of submission. (e) The Secretary, in consultation with the Maryland Health Care Commission and the Board, shall: (1) Determine the appropriate technology to support the operation of the Program; and (2) Educate dispensers, prescribers, pharmacists, prescriber delegates, pharmacist delegates, and consumers about the purpose and operation of the Program. (f) (1) The Secretary shall grant a waiver to a pharmacy that dispenses medications to an inpatient hospice from reporting to the Program prescription monitoring data for hospice inpatients if: (i) The pharmacy demonstrates how it will distinguish hospice inpatients from other consumers receiving medications from the pharmacy; and (ii) The pharmacy agrees that it will be subject to onsite, unannounced inspections by the Department to verify its reporting of the prescription data of consumers who are not hospice inpatients. (2) A waiver granted under this subsection may remain in effect for up to 2 years. (3) The Secretary may establish an application process for a pharmacy to apply for a waiver under this subsection. #### Section 21-2A-04 (a) The Secretary, in consultation with the Board, shall adopt regulations to carry out this subtitle. (b) The regulations adopted by the Secretary shall: (1) Specify the prescription monitoring data and naloxone medication data required to be submitted under Sec. 21-2A-03 of this subtitle; (2) Specify the electronic or other means by which information is to be submitted: (i) Without unduly increasing the workload and expense on dispensers; and (ii) In a manner as compatible as possible with existing data submission practices of dispensers; (3) Specify that the information be submitted by dispensers once every 24 hours; (4) Specify that the Program: (i) Shall provide the information technology software to dispensers necessary to upload prescription drug monitoring data and naloxone medication data to the Program; and (ii) May not impose any fees or other assessments on prescribers or dispensers to support the operation of the Program; (5) Identify the mechanism by which: (i) Prescription monitoring data are disclosed to a person, in accordance with Sec. 21-2A-06 of this subtitle; and (ii) Naloxone medication data are disclosed to a person, in accordance with Sec. 21-2A-06.1 of this subtitle; (6) Identify the circumstances under which a person may disclose prescription monitoring data or naloxone medication data received under the Program; (7) Specify the process for the Program's review of prescription monitoring data and naloxone medication data and reporting of: (i) Possible misuse or abuse of a monitored prescription drug under Sec. 21-2A-06(c) of this subtitle; or (ii) A possible violation of law or possible breach of professional standards under Sec. 21-2A-06(d) of this subtitle; (8) Establish requirements for Program retention of prescription monitoring data and naloxone medication data; and (9) Require that: (i) Confidential or privileged patient information be kept confidential; and (ii) Records or information protected by a privilege between a health care provider and a patient, or otherwise required by law to be held confidential, be filed in a manner that, except as otherwise provided in Sec.Sec. 21-2A-06 and 21-2A-06.1 of this subtitle, does not disclose the identity of the person protected. #### Section 21-2A-04.1 (a) A prescriber shall be registered with the Program before obtaining a new or renewal registration with the Department under Sec. 5-304(a) of the Criminal Law Article or by July 1, 2017, whichever is sooner. (b) A pharmacist shall be registered with the Program by July 1, 2017. (c) Before registering with the Program, a prescriber and a pharmacist shall complete a course of instruction and training developed by the Department, including the effective use of the Program. #### Section 21-2A-04.2 (a) (1) Beginning July 1, 2018, a prescriber: (i) Shall request at least the prior 4 months of prescription monitoring data for a patient before initiating a course of treatment for the patient that includes prescribing or dispensing an opioid or a benzodiazepine; (ii) Shall, if a patient's course of treatment continues to include prescribing or dispensing an opioid or a benzodiazepine for more than 90 days after the initial request for prescription monitoring data, request prescription monitoring data for the patient at least every 90 days until the course of treatment has ended; and (iii) Shall assess prescription monitoring data requested from the Program before deciding whether to prescribe or dispense or continue prescribing or dispensing an opioid or a benzodiazepine. (2) If a prescriber decides to prescribe or continue to prescribe an opioid or a benzodiazepine after requesting prescription monitoring data from the Program and assessing the prescription monitoring data, the prescriber shall document in the patient's medical record that the prescription monitoring data was requested and assessed. (b) A prescriber is not required to request prescription monitoring data from the Program if the opioid or benzodiazepine is prescribed or dispensed to an individual: (1) In an amount indicated for a period not to exceed 3 days; (2) For the treatment of cancer or cancer-related pain; (3) Who is: (i) A patient receiving treatment in an inpatient unit of a hospital; (ii) (1) A patient in a general hospice care program as defined in Sec. 19-901 of this article; or (2) Any other patient diagnosed with a terminal illness; (iii) A patient who resides in: (1) An assisted living facility; (2) A long-term care facility; (3) A comprehensive care facility; or (4) A developmental disabilities facility; or (4) To treat or prevent acute pain for a period of not more than 14 days following: (i) A surgical procedure; (ii) A fracture; (iii) Significant trauma; or (iv) Childbirth. (c) A prescriber may not be required to comply with the provisions of this section when: (1) Prescribing or dispensing an opioid or a benzodiazepine drug that has been listed by the Secretary under Sec. 21-2A-03(b)(3) of this subtitle as having a low potential for abuse; (2) Accessing prescription monitoring data would result in a delay in the treatment of a patient that would negatively impact the medical condition of the patient; (3) Electronic access to prescription monitoring data is not operational as determined by the Department; or (4) Prescription monitoring data cannot be accessed by the prescriber due to a temporary technological or electrical failure. (d) If a prescriber does not access prescription monitoring data for any of the reasons provided under subsection (c)(2), (3), or (4) of this section: (1) The prescriber shall use reasonable medical judgment in determining whether to prescribe or dispense an opioid or a benzodiazepine; and (2) The prescriber shall enter an appropriate record in the patient's medical chart, including the reason why prescription monitoring data was not accessed. (e) If a pharmacist or pharmacist delegate has a reasonable belief that a patient may be seeking a monitored prescription drug for any purpose other than the treatment of an existing medical condition: (1) Before dispensing a monitored prescription drug to the patient, the pharmacist or pharmacist delegate shall request prescription monitoring data to determine if the patient has received other prescriptions that indicate misuse, abuse, or diversion of a monitored prescription drug; and (2) The pharmacist shall have the responsibility described in 21 C.F.R. Sec. 1306.04. (f) The Secretary may adopt regulations to provide additional clinical, technical, or administrative exemptions based on new standards of practice. #### Section 21-2A-04.3 A prescriber or pharmacist may authorize a prescriber delegate or pharmacist delegate to request prescription monitoring data on behalf of the prescriber or pharmacist if: (1) The prescriber or pharmacist takes reasonable steps to ensure that the prescriber delegate or pharmacist delegate is competent in the use of the Program; (2) The prescriber or pharmacist remains responsible for: (i) Ensuring that access to the Program by the prescriber delegate or pharmacist delegate is limited to purposes authorized by law; (ii) Protecting the confidentiality of the prescription monitoring data; and (iii) Any breach of confidentiality by the prescriber delegate or pharmacist delegate; and (3) The decision whether to prescribe or dispense a monitored prescription drug for a patient: (i) Remains with the prescriber or pharmacist; and (ii) Is reasonably informed by the prescription monitoring data obtained from the Program. #### Section 21-2A-05 (a) There is an Advisory Board on Prescription Drug Monitoring in the Department. (b) The Board shall consist of the following members: (1) The Secretary, or the Secretary's designee; (2) The President of the State Board of Pharmacy, or the President's designee; (3) The Chair of the State Board of Physicians, or the Chair's designee; (4) The President of the State Board of Nursing, or the President's designee; (5) The President of the State Board of Dental Examiners, or the President's designee; (6) The President of the State Board of Podiatric Medical Examiners, or the President's designee; (7) The Chairman of the Maryland Health Care Commission, or the Chairman's designee; (8) Four physicians and one nurse practitioner with expertise in clinical treatment using controlled dangerous substances, including pain management, substance abuse, and behavioral disorders, appointed by the Secretary after consultation with: (i) For the physician appointments, MedChi, The Maryland State Medical Society, the Maryland Physical Medicine and Rehabilitation Society, the Maryland Society of Anesthesiologists, the Maryland-D.C. Society of Clinical Oncology, the Hospice and Palliative Care Network of Maryland, and the Maryland Chapter of the American Academy of Pediatrics; and (ii) For the nurse practitioner appointment, the Maryland Nurses Association; (9) One pediatrician, appointed by the Secretary after consultation with the Maryland Chapter of the American Academy of Pediatrics; (10) Three pharmacists who represent the perspective of independent and chain pharmacies, appointed by the Secretary after consultation with the Maryland Pharmacists Association, the Maryland Association of Chain Drug Stores, and any other appropriate organization; (11) A local law enforcement official, appointed by the Secretary after consultation with the Maryland Chiefs of Police Association and the Maryland Sheriff's Association; (12) The Secretary of State Police, or the Secretary's designee; (13) The President of the Maryland Association of County Health Officers, or the President's designee; (14) An academic or research professional; and (15) Two Maryland residents who represent the perspective of patients, appointed by the Secretary. (c) The Secretary shall designate the chair of the Board. (d) (1) The term of a member appointed by the Secretary is 3 years. (2) The terms of members appointed by the Secretary are staggered as required by the terms provided for members of the Board on October 1, 2011. (3) If a vacancy occurs during the term of an appointed member, the Secretary shall appoint a successor who shall serve until the term expires. (e) A member of the Board: (1) May not receive compensation as a member of the Board; but (2) Is entitled to reimbursement for expenses under the Standard State Travel Regulations, as provided in the State budget. (f) The Board shall: (1) Meet not fewer than three times annually; (2) Make recommendations to the Secretary relating to the design and implementation of the Program, including recommendations relating to: (i) Regulations; (ii) Legislation; and (iii) Sources of funding, including grant funds under the Harold Rogers Prescription Drug Monitoring Program and other sources of federal, private, or State funds; (3) Provide annually to the Governor and, in accordance with Sec. 2-1257 of the State Government Article, the General Assembly a report that includes: (i) The number of prescribers and prescriber delegates registered with and using the Program; (ii) The number of pharmacists and pharmacist delegates registered with and using the Program; (iii) The number of disclosures made to federal law enforcement agencies or State or local law enforcement agencies; (iv) An analysis of the impact of the Program on patient access to pharmaceutical care and on curbing prescription drug diversion in the State; (v) (1) The number of providers, by provider type, who received outreach and education from the Program; and (2) The number of cases for which the providers received outreach and education from the Program; (vi) (1) The number of cases that were identified for technical advisory committee review before referral to the Office; and (2) The number of providers, by provider type, involved in the cases; (vii) (1) The number of cases that were referred to the Office for further evaluation and the outcomes of the Office evaluations; and (2) The number of providers, by provider type, involved in the cases; and (viii) Any recommendations related to modification or continuation of the Program; and (4) Provide ongoing advice and consultation on the implementation and operation of the Program, including recommendations relating to: (i) Changes in the Program to reflect advances in technology and best practices in the field of electronic health records and electronic prescription monitoring; (ii) Changes to statutory requirements; and (iii) The design and implementation of an ongoing evaluation component of the Program. (g) The Secretary and the Board shall consult with stakeholders and professionals knowledgeable about prescription drug monitoring programs as appropriate to obtain input and guidance about implementation of the Program. #### Section 21-2A-06 (a) Prescription monitoring data: (1) Are confidential and privileged, and not subject to discovery, subpoena, or other means of legal compulsion in civil litigation; (2) Are not public records; and (3) Except as provided in subsections (b), (c), (d), and (f) of this section or as otherwise provided by law, may not be disclosed to any person. (b) The Program shall disclose prescription monitoring data, in accordance with regulations adopted by the Secretary, to: (1) A prescriber, or a licensed health care practitioner authorized by the prescriber, in connection with the medical care of a patient; (2) A dispenser, or a licensed health care practitioner authorized by the dispenser, in connection with the dispensing of a monitored prescription drug; (3) A federal law enforcement agency or a State or local law enforcement agency, on issuance of a subpoena, for the purpose of furthering an existing bona fide individual investigation; (4) A licensing entity, on issuance of an administrative subpoena, for the purposes of furthering an existing bona fide individual investigation; (5) A rehabilitation program under a health occupations board, on issuance of an administrative subpoena; (6) A patient with respect to prescription monitoring data about the patient; (7) The Office of the Attorney General, on issuance of a subpoena for the purpose of furthering a bona fide existing investigation; (8) Subject to subsection (i) of this section, authorized users of another state's prescription drug monitoring program or any other authorized local, state, territorial, or federal agency in connection with the provision of medical care; (9) The following units of the Department, on approval of the Secretary, for the purpose of furthering an existing bona fide individual investigation: (i) The Maryland Medical Assistance Program; (ii) The Office of the Inspector General; (iii) The Office of Health Care Quality; and (iv) The Office; (10) The technical advisory committee established under Sec. 21-2A-07 of this subtitle for the purposes set forth in subsections (c), (d), and (e) of this section; (11) The medical director of a health care facility, as defined in Sec. 19-114 of this article, or the medical director's designee, for the purpose of providing health care practitioners employed or contractually employed at the health care facility access to the prescription monitoring data in connection with the provision of medical care or the dispensing of a monitored prescription drug to a patient of the health care facility; (12) The Office of the Chief Medical Examiner in accordance with Sec. 5-309 of this article; or (13) The following entities, on approval of the Secretary and for the purpose of furthering an existing bona fide individual case review: (i) The State Child Fatality Review Team or a local child fatality review team established under Title 5, Subtitle 7 of this article, on request from the chair of the State or local team; (ii) A local drug overdose fatality review team established under Sec. 5-902 of this article, on request from the chair of the local team; (iii) The Maternal Mortality Review Program established under Sec. 13-1203 of this article, on request from the Program; and (iv) A medical review committee described in Sec. 1-401(b)(3) of the Health Occupations Article, on request from the committee. (c) (1) In accordance with regulations adopted by the Secretary: (i) The Program shall review prescription monitoring data for indications of possible misuse or abuse of a monitored prescription drug; and (ii) If the Program's review of prescription monitoring data indicates possible misuse or abuse of a monitored prescription drug, the Program shall: (1) Report the possible misuse or abuse to the prescriber or dispenser of the monitored prescription drug; and (2) Provide education to the prescriber or dispenser. (2) Before the Program reports the possible misuse or abuse of a monitored prescription drug to a prescriber or dispenser under this subsection, the Program may obtain from the technical advisory committee: (i) Clinical guidance regarding indications of possible misuse or abuse; and (ii) Interpretation of the prescription monitoring data that indicates possible misuse or abuse. (d) (1) In accordance with regulations adopted by the Secretary and subject to paragraph (3) of this subsection, the Program shall review prescription monitoring data for indications of a possible violation of law or a possible breach of professional standards by a prescriber or a dispenser. (2) If the Program's review indicates a possible violation of law or a possible breach of professional standards by a prescriber or a dispenser, the Program: (i) (1) Shall notify the prescriber or dispenser of the possible violation of law or possible breach of professional standards; and (2) Shall provide education to the prescriber or dispenser; and (ii) Subject to paragraph (4) of this subsection, may provide prescription monitoring data to the Office for further investigation. (3) (i) Before the Program provides notification of a possible violation of law or a possible breach of professional standards to a prescriber or a dispenser, the Program shall obtain from the technical advisory committee: (1) Clinical guidance regarding methods used to identify a possible violation of law or a possible breach of professional standards; and (2) Interpretation of the prescription monitoring data advising whether the method identifies a possible violation of law or a possible breach of professional standards. (ii) In determining whether its review indicates a possible violation of law or a possible breach of professional standards by a prescriber or dispenser, the Program shall take into account to the extent practicable the particular specialty, circumstances, patient type, and location of the prescriber or dispenser. (4) (i) If methods developed under paragraph (3)(i) of this subsection indicate a possible violation of law or a possible breach of professional standards and the Program determines that outreach and education to the prescriber or dispenser is inadequate to address the possible breach or violation, the Program may refer the possible violation of law or a possible breach of professional standards along with prescription monitoring data to the Office for further investigation, provided that the Program: (1) Provides notice and an opportunity to the technical advisory committee to make recommendations within 10 business days regarding interpretation of the data; (2) Provides the recommendations of the technical advisory committee, if any, to the Office; and (3) Notifies the prescriber or the dispenser that the prescription monitoring data will be provided to the Office for further investigation. (ii) On receipt of prescription monitoring data and relevant records under paragraph (2) of this subsection, the Office shall: (1) Review the prescription monitoring data and records, along with any additional information the Office may obtain as part of its investigation; and (2) If it determines that there has been a violation of law or a breach of professional standards, take any action authorized by law regarding the violation or breach, including providing the prescription monitoring data and records to the appropriate licensing entity for possible disciplinary action. (e) (1) Before the Program discloses information under subsection (b)(3), (5), (6), (8), or (9) of this section, the Program may request that the technical advisory committee: (i) Review the requests for information; (ii) Provide clinical guidance and interpretation of the information requested to the Secretary to assist in the Secretary's decision on how to respond to a judicial subpoena, administrative subpoena, or other request; and (iii) Provide clinical guidance and interpretation of the information requested to the authorized recipient of the information. (2) The Program, in consultation with the Board, shall consider policies and procedures for determining the circumstances in which the review of requests for information and the provision of clinical guidance and interpretation of information by the technical advisory committee under paragraph (1) of this subsection is feasible and desirable. (f) Except as provided by regulations adopted by the Secretary, a person who receives prescription monitoring data from the Program may not disclose the data. (g) (1) In addition to the disclosures required under subsection (b) of this section, the Program may disclose prescription monitoring data for research, analysis, public reporting, and education: (i) After redaction of all information that could identify a patient, prescriber, dispenser, or any other individual; and (ii) In accordance with regulations adopted by the Secretary. (2) The Secretary may require submission of an abstract explaining the scope and purpose of the research, analysis, public reporting, or education before disclosing prescription monitoring data under this subsection. (h) The Office of the Attorney General may seek appropriate injunctive or other relief to maintain the confidentiality of prescription monitoring data as required under this section. (i) The Program may provide prescription monitoring data to another state's prescription drug monitoring program only if the other state's prescription drug monitoring program agrees to use the prescription monitoring data in a manner consistent with the provisions of this subtitle. (j) The Program may: (1) Request and receive prescription monitoring data from another state's prescription drug monitoring program and use the prescription monitoring data in a manner consistent with the provisions of this subtitle; and (2) Develop the capability to transmit prescription monitoring data to and receive prescription monitoring data from other prescription drug monitoring programs employing the standards of interoperability. (k) The Program may enter into written agreements with other states' prescription drug monitoring programs for the purpose of establishing the terms and conditions for sharing prescription monitoring data under this section. (l) Prescription monitoring data may not be used as the basis for imposing clinical practice standards. #### Section 21-2A-06.1 (a) Naloxone medication data: (1) Are confidential and privileged, and not subject to discovery, subpoena, or other means of legal compulsion in civil litigation; (2) Are not public records; and (3) Except as provided in subsection (b) of this section or as otherwise by law, may not be disclosed to any person. (b) (1) The Program shall disclose naloxone medication data, in accordance with regulations adopted by the Secretary, for public health surveillance, research, analysis, public reporting, and education after redaction of all information that could identify a patient, prescriber, dispenser, or any other individual. (2) The Secretary may require submission of an abstract explaining the scope and purpose of the research, analysis, public reporting, or education before disclosing naloxone medication data under paragraph (1) of this subsection. #### Section 21-2A-07 (a) There is a technical advisory committee to the Program. (b) The purpose of the technical advisory committee is to: (1) Review requests for information from the Program under Sec. 21-2A-06(b)(3), (4), (5), (8), or (9) of this subtitle; and (2) Provide clinical guidance and interpretation to the Program regarding indications of possible misuse or abuse of a monitored prescription drug or a possible violation of law or a possible breach of professional standards by a prescriber or a dispenser under Sec. 21-2A-06(c) and (d) of this subtitle. (c) The technical advisory committee consists of members appointed by the Secretary, including: (1) A board certified anesthesiologist licensed and practicing in the State, nominated by the Maryland Society of Anesthesiologists; (2) A certified addiction medicine specialist licensed and practicing in the State, nominated by the Maryland Society for Addiction Medicine; (3) A pharmacist licensed and practicing in the State; (4) A medical professional, licensed and practicing in the State, who is treating cancer patients; (5) A board certified physician specializing in the treatment of patients with pain, licensed and practicing in the State, nominated by the Maryland Society of Physical Medicine and Rehabilitation; (6) Two medical professionals, licensed and practicing in the State with expertise or experience in providing care for patients with substance-related or mental health disorders; (7) A dentist licensed and practicing in the State; and (8) A medical professional licensed and practicing in the State in the field of internal medicine or family practice. #### Section 21-2A-08 (a) With respect to the administration and operation of the Program, the Department and its agents and employees are not subject to liability arising from: (1) The inaccuracy of any information submitted to the Program in accordance with this subtitle; or (2) The unauthorized use or disclosure of prescription monitoring data or naloxone medication data by a person to whom the Program was authorized to provide prescription monitoring data or naloxone medication data under this subtitle. (b) Except as provided in Sec. 21-2A-09(b)(3) of this subtitle, a prescriber, prescriber delegate, pharmacist, or pharmacist delegate, acting in good faith, is not subject to liability or disciplinary action arising solely from: (1) Requesting or receiving, or failing to request or receive, prescription monitoring data from the Program; or (2) Acting, or failing to act, on the basis of prescription monitoring data provided by the Program. #### Section 21-2A-09 (a) A dispenser who knowingly fails to submit prescription monitoring data or naloxone medication data to the Program as required under this subtitle shall be subject to a civil penalty not exceeding $500 for each failure to submit required information. (b) (1) A person who knowingly discloses, uses, obtains, or attempts to obtain by fraud or deceit, prescription monitoring data or naloxone medication data in violation of this subtitle shall be guilty of a misdemeanor and on conviction is subject to imprisonment not exceeding 1 year or a fine not exceeding $10,000 or both. (2) In addition to the penalties under paragraph (1) of this subsection, a prescriber, prescriber delegate, pharmacist, or pharmacist delegate who knowingly discloses or uses prescription monitoring data or naloxone medication data in violation of this subtitle shall be subject to disciplinary action by the appropriate licensing entity. (3) A prescriber or pharmacist who violates Sec. 21-2A-04.1 or Sec. 21-2A-04.2 of this subtitle shall be subject to disciplinary action by the appropriate licensing entity. (4) The release of prescription monitoring data by a prescriber, prescriber delegate, pharmacist, or pharmacist delegate to a licensed health care professional solely for treatment purposes in a manner otherwise consistent with State and federal law is not a violation of this subtitle. ### Subtitle 2B. Right to Try Act #### Section 21-2B-01 (a) In this subtitle the following words have the meanings indicated. (b) "Carrier" has the meaning stated in Sec. 15-10A-01(c) of the Insurance Article. (c) "Eligible facility" means an institution operating under a federalwide assurance for the protection of human subjects in accordance with 42 U.S.C. Sec. 289(a) and 28 C.F.R. Part 46. (d) "Eligible patient" means an individual who: (1) Has a life-threatening or severely debilitating illness, attested to by the individual's treating physician; (2) Has considered all other treatment options currently approved by the United States Food and Drug Administration; (3) Has received a recommendation from the individual's physician for an individualized investigational treatment based on analysis of the individual's genomic sequence, human chromosomes, deoxyribonucleic acid, ribonucleic acid, genes, gene products, including enzymes and other types of proteins, or metabolites; (4) (i) Has given informed consent for the use of the individualized investigational treatment; or (ii) If the individual is a minor or lacks the mental capacity to provide informed consent, has a parent or legal guardian who has given informed consent on the individual's behalf for the use of the individualized investigational treatment; and (5) Has documentation from the individual's physician that the individual meets the requirements of items (1) through (4) of this subsection. (e) "Health occupations board" means a board established under the Health Occupations Article that issues licenses to practice a health occupation in the State. (f) (1) "Individualized investigational treatment" means a drug, biological product, or device that is unique to and produced exclusively for use by an individual based on the genetic profile of the individual. (2) "Individualized investigational treatment" includes individualized gene therapy, antisense oligonucleotides, and individualized neoantigen vaccines. (g) "Informed consent" means a written document prepared using the informed consent form developed by the Office of the Attorney General in accordance with Sec. 21-2B-02(b)(1) of this subtitle that: (1) Is signed by the patient or a parent or legal guardian of the patient; (2) Is attested to by the patient's treating physician and a witness; and (3) At a minimum: (i) Explains the currently approved products and treatments for the life-threatening or severely debilitating illness from which the patient suffers, including alternative procedures or courses of treatment, if known to the treating physician, that might be advantageous to the patient; (ii) Attests to the fact that the patient concurs with the patient's treating physician in believing that all currently approved and conventionally recognized treatments are unlikely to prolong the patient's life; (iii) Identifies clearly the specific proposed individualized investigational treatment that the patient is seeking to use; (iv) Informs the provider and eligible patient of any known, anticipated, or reasonably foreseeable side effects, risks, or reported patient discomfort that is likely related to the treatment; (v) Describes the best and worst potential outcomes of using the individualized investigational treatment with a realistic description of the most likely outcome, including the possibility that new, unanticipated, different, or worse symptoms might result and that death could be hastened by the proposed treatment, based on the treating physician's knowledge of the proposed treatment in conjunction with an awareness of the patient's condition; (vi) Makes clear that the patient's carrier and health care provider are not obligated to pay for any care or treatments that are necessary as a result of the use of the individualized investigational treatment except as required by federal or State law or contract; (vii) Makes clear that the patient's eligibility for hospice care may be withdrawn if the patient begins curative treatment with the individualized investigational treatment and that hospice care may be reinstated if this treatment ends and the patient meets hospice eligibility requirements; (viii) States that the patient understands that the patient may be liable for all expenses relating to the use of the individualized investigational treatment and that this liability extends to the patient's estate, but not the heirs or legatees of the patient; and (ix) Includes a statement describing the extent to which confidentiality of records that identify the patient will be maintained. (h) "Life-threatening" has the meaning stated in 21 C.F.R. Sec. 312.81. (i) "Severely debilitating" has the meaning stated in 21 C.F.R. Sec. 312.81. #### Section 21-2B-02 (a) A manufacturer of an individualized investigational treatment operating within an eligible facility and in compliance with all laws applicable to an eligible facility may: (1) Provide the manufacturer's individualized investigational treatment to an eligible patient without compensation; or (2) Require an eligible patient to pay the costs of or associated with the manufacture of the individualized investigational treatment provided to the eligible patient. (b) (1) The Office of the Attorney General shall develop an informed consent form that: (i) Complies with the requirements of Sec. 21-2B-01(g)(3) of this subtitle; (ii) Includes instructions for the physician or patient on how to complete the form; and (iii) Provides spaces for a physician to include the information relating to a particular patient and the physician's recommendation for the patient. (2) This subsection may not be construed to prohibit a treating physician or a manufacturer of an individualized investigational treatment from including additional information or advisements with the informed consent form developed under paragraph (1) of this subsection. #### Section 21-2B-03 (a) A health occupations board may not revoke, fail to renew, suspend, or take any action against a health care provider's license based solely on the health care provider's recommendation to an eligible patient regarding access to or treatment with an individualized investigational treatment. (b) The Department may not take action against a health care provider's Medicare certification based solely on the health care provider's recommendation that an eligible patient have access to an individualized investigational treatment or the health care provider's treatment of an eligible patient with an individualized investigational treatment. #### Section 21-2B-04 (a) An official, employee, or agent of the State may not block or attempt to block an eligible patient's access to an individualized investigational treatment. (b) This section does not prohibit a licensed health care provider from providing counsel, advice, or a recommendation that is consistent with medical standards of care. #### Section 21-2B-05 This subtitle does not create a private cause of action against a manufacturer of an individualized investigational treatment or against another person involved in the care of an eligible patient using the individualized investigational treatment for any harm to the eligible patient resulting from the individualized investigational treatment if the manufacturer or other person is complying in good faith with this subtitle and has exercised reasonable care. #### Section 21-2B-06 (a) This subtitle does not affect the coverage requirements under Title 15, Subtitle 8 of the Insurance Article. (b) A carrier, third-party administrator, or government agency may provide coverage for the cost of an individualized investigational treatment or the cost of services related to the use of an individualized investigational treatment under this subtitle. (c) This subtitle does not require: (1) A government agency to pay costs associated with the use, care, or treatment of an individual with an individualized investigational treatment; or (2) A hospital or another health care facility to provide new or additional services unless approved by the hospital or health care facility. ### Subtitle 2C. Prescription Drug Affordability Board #### Section 21-2C-01 (a) In this subtitle the following words have the meanings indicated. (b) "Biologic" means a drug that is produced or distributed in accordance with a biologics license application approved under 42 C.F.R. Sec. 447.502. (c) "Biosimilar" means a drug that is produced or distributed in accordance with a biologics license application approved under 42 U.S.C. Sec. 262(k)(3). (d) "Board" means the Prescription Drug Affordability Board. (e) (1) "Brand name drug" means a drug that is produced or distributed in accordance with an original new drug application approved under 21 U.S.C. Sec. 355(c). (2) "Brand name drug" does not include an authorized generic as defined by 42 C.F.R. Sec. 447.502. (f) "Current shortage" means a drug: (1) Listed as current on the federal Food and Drug Administration's Drug Shortage Database; or (2) Otherwise determined by the Board to be in short supply in the State. (g) "Generic drug" means: (1) A retail drug that is marketed or distributed in accordance with an abbreviated new drug application, approved under 21 U.S.C. Sec. 355(j); (2) An authorized generic as defined by 42 C.F.R. Sec. 447.502; or (3) A drug that entered the market before 1962 that was not originally marketed under a new drug application. (h) "Manufacturer" means an entity that: (1) (i) Engages in the manufacture of a prescription drug product; or (ii) Enters into a lease with another manufacturer to market and distribute a prescription drug product under the entity's own name; and (2) Sets or changes the wholesale acquisition cost of the prescription drug product it manufactures or markets. (i) "Prescription drug product" means a brand name drug, a generic drug, a biologic, or a biosimilar. (j) "Stakeholder Council" means the Prescription Drug Affordability Stakeholder Council. #### Section 21-2C-02 (a) (1) There is a Prescription Drug Affordability Board. (2) (i) The Board is a body politic and corporate and is an instrumentality of the State. (ii) The Board is an independent unit of State government. (iii) The exercise by the Board of its authority under this subtitle is an essential governmental function. (b) The purpose of the Board is to protect State residents, State and local governments, commercial health plans, health care providers, pharmacies licensed in the State, and other stakeholders within the health care system from the high costs of prescription drug products. #### Section 21-2C-03 (a) (1) The Board consists of the following members, who must have expertise in health care economics or clinical medicine: (i) One member appointed by the Governor; (ii) One member appointed by the President of the Senate; (iii) One member appointed by the Speaker of the House of Delegates; (iv) One member appointed by the Attorney General; and (v) One member appointed jointly by the President of the Senate and the Speaker of the House of Delegates, who shall serve as chair of the Board. (2) The Board shall have the following alternate members, who must have expertise in health care economics or clinical medicine and who shall be designated by the Board chair to participate in deliberations of the Board when a member is recused: (i) One alternate member appointed by the Governor; (ii) One alternate member appointed by the President of the Senate; and (iii) One alternate member appointed by the Speaker of the House of Delegates. (3) At least one member of the Board shall have expertise in: (i) The 340B Program under the federal Public Health Service Act; (ii) The State's all-payer model contract; (iii) How the program and contract interact; and (iv) How decisions made by the Board will affect the model and contract. (4) A member or an alternate member may not be an employee of, a board member of, or a consultant to a manufacturer, pharmacy benefits manager, health insurance carrier, health maintenance organization, managed care organization, or wholesale distributor or related trade association. (5) Any conflict of interest, including whether the individual has an association, including a financial or personal association, that has the potential to bias or has the appearance of biasing an individual's decision in matters related to the Board or the conduct of the Board's activities, shall be considered and disclosed when appointing members and alternate members to the Board. (6) To the extent practicable and consistent with federal and State law, the membership of the Board shall reflect the racial, ethnic, and gender diversity of the State. (b) (1) The term of a member or an alternate member is 5 years. (2) The terms of the members and alternate members are staggered as required by the terms provided for members on October 1, 2019. (c) (1) The chair shall hire an executive director and staff for the Board. (2) The chair shall develop a 5-year budget and staffing plan and submit it to the Board for approval. (3) Staff of the Board shall receive a salary as provided in the budget of the Board. (d) A member of the Board: (1) May receive compensation as a member of the Board in accordance with the State budget; and (2) Is entitled to reimbursement for expenses under the Standard State Travel Regulations, as provided in the State budget. (e) (1) (i) Subject to subparagraphs (ii) and (iv) of this paragraph, the Board shall meet in open session at least four times a year. (ii) At the chair's discretion, the chair may cancel or postpone a meeting. (iii) The following actions by the Board shall be made in open session: (1) The study required under Sec. 21-2C-07 of this subtitle; (2) Deliberations on whether to subject a prescription drug product to a cost review under Sec. 21-2C-08(d) of this subtitle; (3) Any vote on whether to impose an upper payment limit on purchases and payor reimbursements of prescription drug products in the State; and (4) Any decision by the Board. (iv) Notwithstanding the Open Meetings Act, the Board may meet in closed session to discuss trade secrets or confidential and proprietary data and information. (2) The Board shall provide public notice of each Board meeting at least 2 weeks in advance of the meeting. (3) (i) Materials for each Board meeting shall be made available to the public at least 1 week in advance of the meeting. (ii) Materials containing trade secrets or confidential and proprietary data or information that is not otherwise available to the public may not be made available to the public. (4) The Board shall provide an opportunity for public comment at each open meeting of the Board. (5) The Board shall provide the public with the opportunity to provide written comments on pending decisions of the Board. (6) The Board may allow expert testimony at Board meetings, including when the Board meets in closed session. (7) To the extent practicable, the Board shall access pricing information for prescription drug products by: (i) Entering into a memorandum of understanding with another state to which manufacturers already report pricing information; and (ii) Accessing other available pricing information. (8) A majority of the members of the Board constitutes a quorum. (9) (i) Members of the Board shall recuse themselves from decisions related to a prescription drug product if the member, or an immediate family member of the member, has received or could receive any of the following: (1) A direct financial benefit of any amount deriving from the result or finding of a study or determination by or for the Board; or (2) A financial benefit from any person that owns, manufactures, or provides prescription drug products, services, or items to be studied by the Board that in the aggregate exceeds $5,000 per year. (ii) For the purposes of subparagraph (i) of this paragraph, a financial benefit includes honoraria, fees, stock, the value of the member's or immediate family member's stock holdings, and any direct financial benefit deriving from the finding of a review conducted under this subtitle. (f) In addition to the powers set forth elsewhere in this subtitle, the Board may: (1) Adopt regulations to carry out the provisions of this subtitle; and (2) Enter into a contract with a qualified, independent third party for any service necessary to carry out the powers and duties of the Board. (g) Unless permission is granted by the Board, a third party hired by the Board in accordance with subsection (f)(2) of this section may not release, publish, or otherwise use any information to which the third party has access under its contract. (h) (1) Except as provided in paragraph (2) of this subsection, any procurement for services to be performed or for supplies to be delivered to the Board is not subject to Division II of the State Finance and Procurement Article. (2) The Board is subject to the following provisions of the State Finance and Procurement Article: (i) Title 3.5, Subtitle 3 (Information Processing), to the extent that the Secretary of Information Technology determines that an information technology project of the Board is a major information technology development project; (ii) Title 12, Subtitle 4 (Policies and Procedures for Exempt Units); and (iii) Title 14, Subtitle 3 (Minority Business Participation). (i) (1) The Attorney General is the legal adviser to the Board. (2) The Attorney General shall designate an assistant attorney general as counsel to the Board. (3) As needed, the Attorney General may assign additional assistant attorneys general to the Board to give effective legal advice and counsel. (4) The counsel to the Board may not have a duty other than to: (i) Give the legal aid, advice, and counsel required by the Board; (ii) Supervise the other assistant attorneys general assigned to the Board, if any; and (iii) Perform for the Board the duties that the Attorney General assigns. (5) The counsel shall perform these duties subject to the control and supervision of the Attorney General. (6) After the Attorney General designates the counsel to the Board, the Attorney General may not reassign the counsel without consulting the Board. #### Section 21-2C-04 (a) There is a Prescription Drug Affordability Stakeholder Council. (b) The purpose of the Stakeholder Council is to provide stakeholder input to assist the Board in making decisions as required under this subtitle. (c) (1) The Stakeholder Council consists of members appointed in accordance with this subsection. (2) The Speaker of the House of Delegates shall appoint: (i) One representative of generic drug corporations; (ii) One representative of nonprofit insurance carriers; (iii) One representative of a statewide health care advocacy coalition; (iv) One representative of a statewide advocacy organization for seniors; (v) One representative of a statewide organization for diverse communities; (vi) One representative of a labor union; (vii) One representative of the rare disease community; (viii) One health services researcher specializing in prescription drugs; and (ix) One public member at the discretion of the Speaker of the House of Delegates. (3) The President of the Senate shall appoint: (i) One representative of brand name drug corporations; (ii) One representative of physicians; (iii) One representative of nurses; (iv) One representative of hospitals; (v) One representative of dentists; (vi) One representative of oncologists; (vii) One representative of managed care organizations; (viii) One representative of the Department of Budget and Management; (ix) One clinical researcher; and (x) One public member at the discretion of the President of the Senate. (4) The Governor shall appoint: (i) One representative of brand name drug corporations; (ii) One representative of generic drug corporations; (iii) One representative of biotechnology companies; (iv) One representative of for-profit health insurance carriers; (v) One representative of employers; (vi) One representative of pharmacy benefits managers; (vii) One representative of pharmacists; (viii) One pharmacologist; (ix) One representative of a patient advocacy organization; and (x) One public member at the discretion of the Governor. (5) Collectively, the members of the Stakeholder Council shall have knowledge of the following: (i) The pharmaceutical business model; (ii) Supply chain business models; (iii) The practice of medicine or clinical training; (iv) Consumer or patient perspectives; (v) Health care costs trends and drivers; (vi) Clinical and health services research; or (vii) The State's health care marketplace. (6) To the extent practicable and consistent with federal and State law, the membership of the Stakeholder Council shall reflect the racial, ethnic, and gender diversity of the State. (7) From among the membership of the Stakeholder Council, the Board chair shall appoint two members to be cochairs of the Stakeholder Council. (d) (1) The term of a member is 3 years. (2) The initial members of the Stakeholder Council shall serve staggered terms as required by the terms provided for members on October 1, 2019. (e) A member of the Stakeholder Council: (1) May not receive compensation as a member of the Stakeholder Council; but (2) Is entitled to reimbursement for expenses under the Standard State Travel Regulations, as provided in the State budget. #### Section 21-2C-05 (a) (1) A conflict of interest shall be disclosed: (i) By the Board when hiring Board staff; (ii) By the appointing authority when appointing members and alternate members to the Board and members to the Stakeholder Council; and (iii) By the Board, when a member of the Board is recused in any final decision resulting from a review of a prescription drug product. (2) A conflict of interest shall be disclosed: (i) In advance of the first open meeting after the conflict is identified; or (ii) Within 5 days after the conflict is identified. (b) (1) A conflict of interest disclosed under subsection (a) of this section shall be posted on the website of the Board unless the chair of the Board recuses the member from any final decision resulting from a review of a prescription drug product. (2) A posting under paragraph (1) of this subsection shall include the type, nature, and magnitude of the interests of the member involved. #### Section 21-2C-06 Members and alternate members of the Board, Board staff, and third-party contractors may not accept any gift or donation of services or property that indicates a potential conflict of interest or has the appearance of biasing the work of the Board. #### Section 21-2C-07 On or before December 31, 2021, the Board, in consultation with the Stakeholder Council, shall: (1) Study: (i) The entire pharmaceutical distribution and payment system in the State; and (ii) Policy options being used in other states and countries to lower the list price of pharmaceuticals, including: (1) Setting upper payment limits; (2) Using a reverse auction marketplace; and (3) Implementing a bulk purchasing process; and (2) Report its findings and recommendations, including findings for each option studied under item (1)(ii) of this section and any legislation required to implement the recommendations, to the Senate Finance Committee and the House Health and Government Operations Committee in accordance with Sec. 2-1257 of the State Government Article. #### Section 21-2C-08 (a) On or before December 31, 2021, the Board shall: (1) Collect and review publicly available information regarding prescription drug product manufacturers, health insurance carriers, health maintenance organizations, managed care organizations, wholesale distributors, and pharmacy benefits managers; and (2) (i) Identify states that require reporting on the cost of prescription drug products; and (ii) Initiate a process of entering into memoranda of understanding with the states identified under item (i) of this item to aid in the collection of transparency data for prescription drug products. (b) Based on the information collected under subsection (a)(1) of this section and obtained through memoranda of understanding under subsection (a)(2) of this section, the Board, in consultation with the Stakeholder Council, shall adopt regulations to: (1) Establish methods for collecting additional data necessary to carry out its duties under this subtitle; and (2) Identify circumstances under which the cost of a prescription drug product may create or has created affordability challenges for the State health care system and patients. (c) The Board shall use the information collected under subsection (a)(1) of this section and obtained through memoranda of understanding under subsection (a)(2) of this section to identify prescription drug products that are: (1) Brand name drugs or biologics that, as adjusted annually for inflation in accordance with the Consumer Price Index, have: (i) A launch wholesale acquisition cost of $30,000 or more per year or course of treatment; or (ii) A wholesale acquisition cost increase of $3,000 or more in any 12-month period, or course of treatment if less than 12 months; (2) Biosimilar drugs that have a launch wholesale acquisition cost that is not at least 15% lower than the referenced brand biologic at the time the biosimilars are launched; (3) Generic drugs that, as adjusted annually for inflation in accordance with the Consumer Price Index, have a wholesale acquisition cost: (i) Of $100 or more for: (1) A 30-day supply lasting a patient for a period of 30 consecutive days based on the recommended dosage approved for labeling by the United States Food and Drug Administration; (2) A supply lasting a patient for fewer than 30 days based on the recommended dosage approved for labeling by the United States Food and Drug Administration; or (3) One unit of the drug if the labeling approved by the United States Food and Drug Administration does not recommend a finite dosage; and (ii) That increased by 200% or more during the immediately preceding 12-month period, as determined by the difference between the resulting wholesale acquisition cost and the average of the wholesale acquisition cost reported over the immediately preceding 12 months; and (4) Other prescription drug products that may create affordability challenges for the State health care system and patients, in consultation with the Stakeholder Council. #### Section 21-2C-09 (a) (1) After identifying prescription drug products as required by Sec. 21-2C-08 of this subtitle, the Board shall determine whether to conduct a cost review as described in subsection (b) of this section for each identified prescription drug product by: (i) Seeking Stakeholder Council input about the prescription drug product; and (ii) Considering the average cost share of the prescription drug product. (2) (i) To the extent there is no publicly available information to conduct a cost review as described in subsection (b) of this section, the Board shall request the information from: (1) The manufacturer of the prescription drug product; and (2) As appropriate, a wholesale distributor, pharmacy benefits manager, health insurance carrier, health maintenance organization, or managed care organization with relevant information on setting the cost of the prescription drug product in the State. (ii) The information to conduct a cost review may include any document and research related to the manufacturer's selection of the introductory price or price increase of the prescription drug product, including life cycle management, net average price in the State, market competition and context, projected revenue, and the estimated value or cost-effectiveness of the prescription drug product. (iii) Failure of a manufacturer, wholesale distributor, pharmacy benefits manager, health insurance carrier, health maintenance organization, or managed care organization to provide the Board with the information requested under this paragraph does not affect the authority of the Board to conduct a review as described in subsection (b) of this section. (b) (1) If the Board conducts a review of the cost of a prescription drug product, the review shall determine whether use of the prescription drug product that is fully consistent with the labeling approved by the United States Food and Drug Administration or standard medical practice has led or will lead to affordability challenges for the State health care system or high out-of-pocket costs for patients. (2) To the extent practicable, in determining whether a prescription drug product identified under Sec. 21-2C-08 of this subtitle has led or will lead to an affordability challenge, the Board shall consider the following factors: (i) The wholesale acquisition cost and any other relevant prescription drug cost index for the prescription drug product sold in the State; (ii) The average monetary price concession, discount, or rebate the manufacturer provides to health plans in the State or is expected to provide to health plans in the State as reported by manufacturers and health plans, expressed as a percent of the wholesale acquisition cost for the prescription drug product under review; (iii) The total amount of the price concession, discount, or rebate the manufacturer provides to each pharmacy benefits manager operating in the State for the prescription drug product under review, as reported by manufacturers and pharmacy benefits managers, expressed as a percent of the wholesale acquisition costs; (iv) The price at which therapeutic alternatives have been sold in the State; (v) The average monetary concession, discount, or rebate the manufacturer provides or is expected to provide to health plan payors and pharmacy benefits managers in the State for therapeutic alternatives; (vi) The costs to health plans based on patient access consistent with United States Food and Drug Administration labeled indications; (vii) The impact on patient access resulting from the cost of the prescription drug product relative to insurance benefit design; (viii) The current or expected dollar value of drug-specific patient access programs that are supported by the manufacturer; (ix) The relative financial impacts to health, medical, or social services costs as can be quantified and compared to baseline effects of existing therapeutic alternatives; (x) The average patient copay or other cost-sharing for the prescription drug product in the State; and (xi) Any other factors as determined by the Board in regulations adopted by the Board. (3) If the Board is unable to determine whether a prescription drug product will produce or has produced challenges to the affordability of the drug for the State health care system, using the factors listed in paragraph (2) of this subsection, the Board may consider the following factors: (i) The manufacturer's research and development costs, as indicated on the manufacturer's federal tax filing or information filed with the Federal Securities and Exchange Commission for the most recent tax year in proportion to the manufacturer's sales in the State; (ii) The portion of direct-to-consumer marketing costs eligible for favorable federal tax treatment in the most recent tax year that are specific to the prescription drug product under review and that are multiplied by the ratio of total manufacturer in-State sales to total manufacturer sales in the United States for the product under review; (iii) Gross and net manufacturer, pharmacy benefits manager, and wholesale distributor revenues for the prescription drug product under review for the most recent tax year; (iv) Any additional factors proposed by the manufacturer and appropriate health insurance carriers, health maintenance organizations, managed care organizations, wholesale distributors, and pharmacy benefits managers that the Board considers relevant; and (v) Any additional factors as established by the Board in regulations. (c) On or before December 31, 2020, and each December 31 thereafter, the Board shall submit to the Senate Finance Committee and the House Health and Government Operations Committee, in accordance with Sec. 2-1257 of the State Government Article, a report that includes: (1) Price trends for prescription drug products; (2) The number of prescription drug products that were subject to Board review and the results of the review; and (3) Any recommendations the Board may have on further legislation needed to make prescription drug products more affordable in the State. (d) If the Board sets a new upper payment limit, to the extent practicable, the Board shall include in the first report that is required under subsection (c) of this section after the upper payment limit has been in effect for 1 year information on the effects of the upper payment limit, based on available timely data, for the following: (1) Patient out-of-pocket costs including whether the upper payment limit was associated with increases or decreases in what patients pay for prescription drug products; (2) Patient health insurance premiums, including whether the upper payment limit is associated with increases or decreases in health insurance costs for patients; (3) Pharmacies operating in the State, including the impact on reimbursement rates and financial viability of retail and independent pharmacies; (4) Patient health insurance formularies, including whether the prescription drug product subject to the upper payment limit remained on formularies; (5) Provider-administered medications subject to the upper payment limit, including whether providers were able to acquire the prescription drug product subject to the upper payment limit at a rate to account for acquisition costs and whether there was an impact on provider reimbursement; (6) Patient access to the prescription drug product subject to the upper payment limit, which may include: (i) Whether prescription drug product shortages or other supply disruptions occurred after the upper payment limit took effect; (ii) Whether formulary placement or plan design changes made the prescription drug product subject to the upper limit more difficult for patients to access, including if insurance plans preferred a prescription drug product without an upper payment limit over a prescription drug product subject to an upper payment limit; (iii) Whether the distribution and delivery of specialty or rare disease medications from out-of-state pharmacies to providers, pharmacies, or patients was impacted; (iv) Whether patients in communities of color, patients who are women, patients with a rare disease, or patients in rural areas experienced disproportionate access challenges; and (v) Whether cost differences as a result of the upper payment limit affected patients, pharmacies, or providers and, if the cost difference resulted in an increase in costs, who was ultimately responsible for bearing the increased cost; (7) Covered entity providers participating in the 340B drug discount program, including the impact of the upper payment limit on the operations of the providers and their contracted pharmacies; and (8) The biotechnology industry in the State, including the impact on pharmaceutical research and development, investment, and job growth. (e) (1) The Board may request information necessary to complete the report required under subsections (c) and (d) of this section from an affected entity. (2) The entity from which information was requested under paragraph (1) of this subsection shall make a good faith effort to provide the requested information. #### Section 21-2C-10 (a) All information and data obtained by the Board under this subtitle, that is not otherwise publicly available: (1) Is considered to be a trade secret and confidential and proprietary information; and (2) Is not subject to disclosure under the Public Information Act. (b) Only Board members and staff may access trade secrets and confidential and proprietary data and information obtained under this subtitle that is not otherwise publicly available. (c) The provisions of Title 11, Subtitle 12 of the Commercial Law Article shall apply to any trade secrets and confidential and proprietary data and information obtained under this subtitle that is not otherwise publicly available. #### Section 21-2C-11 (a) In this section, "Fund" means the Prescription Drug Affordability Fund. (b) (1) The Board shall assess and collect an annual fee on: (i) Manufacturers that sell or offer for sale prescription drug products to persons in the State; (ii) Pharmacy benefits managers, as defined in Sec. 15-1601 of the Insurance Article; (iii) Carriers, as defined in Sec. 19-132 of this article; and (iv) Wholesale distributors, as defined in Sec. 12-6C-01 of the Health Occupations Article, that sell or offer for sale prescription drug products to persons in the State. (2) The Board shall: (i) Assess and collect the annual fee under paragraph (1) of this subsection in accordance with criteria established in regulations adopted by the Board; and (ii) Calculate the annual fee under paragraph (1) of this subsection in a fair and equitable manner. (3) (i) On or before October 1 each year, each entity assessed a fee under this subsection shall pay the fee assessed by the Board. (ii) The Board shall allow entities to make partial payments when paying the fee assessed under this subsection. (iii) Any fee not paid within 30 days after the payment due date may be subject to an interest penalty to be determined and collected by the Board. (4) The total amount of fees that the Board collects in each calendar year under paragraph (1) of this subsection may not exceed $2,000,000. (5) The Board shall pay all fees collected under paragraph (1) of this subsection into the Fund. (c) (1) There is a Prescription Drug Affordability Fund. (2) The purpose of the Fund is to provide funding for the Board and to carry out the purpose of this subtitle. (3) The Board shall administer the Fund. (4) (i) The Fund is a special, nonlapsing fund that is not subject to Sec. 7-302 of the State Finance and Procurement Article. (ii) The State Treasurer shall hold the Fund separately, and the Comptroller shall account for the Fund. (5) The Fund consists of: (i) Revenue distributed to the Fund under subsection (b) of this section; (ii) Money appropriated in the State budget to the Fund; (iii) Interest earnings; and (iv) Any other money from any other source accepted for the benefit of the Fund. (6) The Fund may be used only to provide funding for the Board and for the purposes authorized under this subtitle, including administrative expenses and any costs expended by any State agency to implement this subtitle. (7) (i) The State Treasurer shall invest the money of the Fund in the same manner as other State money may be invested. (ii) Any interest earnings of the Fund shall be credited to the Fund. (8) Expenditures from the Fund may be made only in accordance with the State budget. (9) The Fund is subject to audit by the Office of Legislative Audits as provided for under Sec. 2-1220 of the State Government Article. (10) This subsection may not be construed to prohibit the Fund from receiving funds from any other source. #### Section 21-2C-12 The Office of the Attorney General may pursue any available remedy under State law when enforcing this subtitle. #### Section 21-2C-13 (a) If, under Sec. 21-2C-07 of this subtitle, the Board finds that it is in the best interest of the State to establish a process for setting upper payment limits for prescription drug products that it determines have led or will lead to an affordability challenge, the Board, in conjunction with the Stakeholder Council, shall draft a plan of action for implementing the process in accordance with the requirements of this section. (b) The criteria for setting upper payment limits shall include consideration of: (1) The cost of administering the prescription drug product; (2) The cost of delivering the prescription drug product to consumers; (3) The effect the upper payment limit will have on providers of 340B drugs; (4) For an upper payment limit on a drug that is designated as a drug for a rare disease or condition, the impact of the upper payment limit on patients with rare diseases; and (5) Other relevant administrative costs related to the prescription drug product. (c) (1) If the Board previously set an upper payment limit for a drug that becomes a current shortage, the Board may reconsider the previously set upper payment limit. (2) The Board may not: (i) Apply a new upper payment limit to a drug in a current shortage; (ii) Enforce an upper payment limit against provider or pharmacy reimbursement requirements for Medicare Part C or Part D plans; or (iii) Count a pharmacy dispensing fee toward or subject a pharmacy dispensing fee to an upper payment limit. (d) (1) If a plan of action is drafted under subsection (a) of this section, the Board shall submit the plan of action to the Legislative Policy Committee of the General Assembly, in accordance with Sec. 2-1257 of the State Government Article, for its approval. (2) The Legislative Policy Committee shall have 45 days to approve the plan of action. (3) If the Legislative Policy Committee does not approve the plan of action, the Board shall submit the plan to the Governor and the Attorney General for approval. (4) The Governor and the Attorney General shall have 45 days to approve the plan of action. (5) The Board may not set upper payment limits unless the plan is approved, in accordance with this subsection, by: (i) The Legislative Policy Committee; or (ii) (1) The Governor; and (2) The Attorney General. #### Section 21-2C-14 In accordance with the plan of action approved by the Legislative Policy Committee on October 22, 2024, the Board may set upper payment limits through regulations for prescription drug products that are: (1) Purchased or paid for by a unit of State or local government or an organization on behalf of a unit of State or local government, including: (i) State or county correctional facilities; (ii) State hospitals; and (iii) Health clinics at State institutions of higher education; (2) Paid for through a health benefit plan on behalf of a unit of State or local government, including a county, bicounty, or municipal employee health benefit plan; or (3) Purchased for or paid for by the Maryland State Medical Assistance Program. #### Section 21-2C-15 (a) A person aggrieved by an upper payment limit set by the Board may request an appeal within 30 days after the Board makes the decision to set the limit. (b) The Board shall hear the appeal and make a final decision within 60 days after the appeal is requested. (c) Any person aggrieved by a final decision of the Board issued under subsection (b) of this section may petition for judicial review as provided by the Administrative Procedure Act. #### Section 21-2C-16 (a) (1) The Board, in consultation with the Stakeholder Council, shall determine whether, in addition to setting upper payment limits in accordance with Sec. 21-2C-14 of this subtitle, it is in the best interest of the State for the Board to establish a process for setting upper payment limits for purchases and payor reimbursements of prescription drug products in the State that the Board determines have led or will lead to an affordability challenge. (2) When making a determination under paragraph (1) of this subsection, the Board shall consider, if applicable: (i) Contract and budget data provided to the Board that demonstrates savings to the State or local governments as a result of upper payment limits set in accordance with Sec. 21-2C-14 of this subtitle; (ii) Success of setting upper payment limits in other states; and (iii) Expected savings from Medicare Maximum Fair Prices set by the Centers for Medicare and Medicaid Services. (b) (1) If the Board makes an affirmative determination under subsection (a) of this section, the Board, in consultation with the Stakeholder Council, shall establish a process for setting upper payment limits for purchases and payor reimbursements of prescription drug products in the State that the Board determines have led or will lead to an affordability challenge. (2) The process established under paragraph (1) of this subsection shall: (i) To the extent appropriate, use the plan of action approved under Sec. 21-2C-13(d) of this subtitle; and (ii) Otherwise comply with the requirements for setting upper payment limits established under this subtitle. (3) Before establishing an upper payment limit that applies to the Maryland Medical Assistance Program, the Board shall confer with the Maryland Medical Assistance Program to approve the application of the upper payment limit by assessing whether the proposed upper payment limit will: (i) Conflict with the Medicaid Drug Rebates Program, the Covered Outpatient Drug Rule (CMS-2345-FC), or any other federal requirements as applicable; and (ii) Require additional funding to be allocated to the Maryland Medical Assistance Program budget. ### Subtitle 2D. Tianeptine Consumer Protection Act #### Section 21-2D-01 (a) In this subtitle the following words have the meanings indicated. (b) (1) "Retailer" means a person that: (i) Sells, prepares, or maintains tianeptine products; or (ii) Advertises, represents, or holds itself out as selling, preparing, or maintaining tianeptine products. (2) "Retailer" includes a manufacturer, wholesaler, store, restaurant, hotel, catering facility, camp, bakery, delicatessen, supermarket, grocery store, convenience store, gas station, or food or drink company. (c) "Tianeptine product" means a product that is marketed for human consumption containing any amount of tianeptine sodium or tianeptine sulfate. #### Section 21-2D-02 (a) A retailer may not distribute, sell, expose for sale, or advertise for sale a tianeptine product to an individual. (b) A retailer that violates subsection (a) of this section is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $5,000, imprisonment for not more than 90 days, or both. (c) In addition to any other penalties under this section, a retailer who violates this section is liable for civil damages sustained by the individual resulting from the violation. #### Section 21-2D-03 The Department shall adopt regulations to carry out this subtitle. ### Subtitle 2E. Kratom Consumer Protection Act #### Section 21-2E-01 (a) In this subtitle the following words have the meanings indicated. (b) "Kratom product" means a product marketed for human consumption containing any part of the leaf of the plant Mitragyna speciosa. (c) (1) "Retailer" means a person that: (i) Sells, prepares, or maintains kratom products; or (ii) Advertises, represents, or holds itself out as selling, preparing, or maintaining kratom products. (2) "Retailer" includes a manufacturer, wholesaler, store, restaurant, hotel, catering facility, camp, bakery, delicatessen, supermarket, grocery store, convenience store, gas station, or food or drink company. #### Section 21-2E-02 (a) (1) A retailer that prepares, distributes, sells, or exposes for sale a kratom product shall disclose on the product label the factual basis on which the representation is made. (2) A retailer may not prepare, distribute, sell, or expose for sale a kratom product that: (i) Does not comply with the disclosure requirement established under paragraph (1) of this subsection; or (ii) Has not been recognized as a dietary ingredient or approved drug by the U.S. Food and Drug Administration. (b) (1) Subject to paragraph (2) of this subsection, a retailer may not prepare, distribute, sell, or expose for sale any of the following: (i) A kratom product that is adulterated with a dangerous substance other than kratom; (ii) A kratom product that is contaminated with a dangerous substance other than kratom; (iii) A kratom product containing a level of 7-hydroxymitragynine in the alkaloid fraction that is greater than 2% of the alkaloid composition of the product; (iv) A kratom product containing a synthetic alkaloid, including synthetic mitragynine, synthetic 7-hydroxymitragynine, or any other synthetically derived compound of the kratom plant; or (v) A product containing kratom that does not include on its package or label the amount of mitragynine and 7-hydroxymitragynine contained in the product. (2) (i) For the purpose of paragraph (1)(i) of this subsection, a kratom product is adulterated with a dangerous substance other than kratom if: (1) The kratom product is mixed or packed with a substance other than kratom; and (2) That substance affects the quality or strength of the kratom product to a degree as to render the kratom product injurious to a consumer. (ii) For the purpose of paragraph (1)(ii) of this subsection, a kratom product is contaminated with a dangerous substance other than kratom if the kratom product contains a poisonous or otherwise deleterious ingredient other than kratom, including a drug that is designated as a controlled dangerous substance under Title 5 of the Criminal Law Article. (c) A retailer may not distribute, sell, or expose for sale a kratom product to an individual under the age of 21 years. (d) In a prosecution for a violation of this section, it is a rebuttable defense that the defendant relied in good faith on the representations on the manufacturer's label on a kratom product. (e) A retailer that violates subsection (a)(1) of this section is subject to a civil penalty not exceeding: (1) $1,000 for a first violation; and (2) $2,000 for each subsequent violation. (f) A retailer that violates subsection (a)(2), (b), or (c) of this section is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $5,000, imprisonment for not more than 90 days, or both. (g) In addition to any other penalties specified in this section, a retailer who violates this section is liable for any civil damages sustained by the individual resulting from the violation. #### Section 21-2E-03 (a) A retailer may not directly or indirectly advertise a therapeutic benefit of kratom. (b) A retailer may not directly or indirectly advertise or market kratom products to minors. (c) It is a violation of subsection (b) of this section for a retailer to use any of the following in the advertising, promotion, packaging, or labeling of a kratom product: (1) A cartoon; (2) A superhero; (3) A video game reference; (4) An image of a food product primarily intended for minors; (5) A trademark that imitates or mimics the trademark of a product that has been advertised or marketed primarily to minors; (6) A symbol or celebrity that is primarily associated with minors or media primarily directed to minors; (7) An image of an individual who appears to be under the age of 27 years; and (8) Other images, graphics, or features or likenesses to images, graphics, or features that are popularly used to advertise to children, including: (i) Neon colors, signs, or other brightly colored displays; (ii) Animals; (iii) Mascots; or (iv) Statements, artwork, or designs that could reasonably mislead an individual to believe that the package contains anything other than a kratom product. (d) It is a violation of subsection (b) of this section for a retailer to advertise or promote a kratom product: (1) In a newspaper, a magazine, a periodical, or any other publication for which individuals under the age of 21 years constitute 15% or more of the total audience, as measured by competent and reliable survey evidence; (2) At a concert, a stadium, a sporting event, or any other public event for which individuals under the age of 21 years constitute 15% or more of the total audience, as measured by competent and reliable survey evidence; or (3) By placing an advertisement for kratom on the side of a building or another publicly visible location of any form, including a sign, a poster, a placard, a device, a graphic display, an outdoor billboard, or a freestanding signboard. (e) A retailer that violates this section is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $5,000, imprisonment for not more than 90 days, or both. #### Section 21-2E-04 The Department shall adopt regulations to carry out this subtitle. ### Subtitle 2F. Phenibut Consumer Protection Act #### Section 21-2F-01 (a) In this subtitle the following words have the meanings indicated. (b) "Phenibut product" means a product marketed for human consumption containing any beta-phenyl-gamma-aminobutyric acid HCl. (c) (1) "Retailer" means a person that: (i) Sells, prepares, or maintains phenibut products; or (ii) Advertises, represents, or holds itself out as selling, preparing, or maintaining phenibut products. (2) "Retailer" includes a manufacturer, wholesaler, store, restaurant, hotel, catering facility, camp, bakery, delicatessen, supermarket, grocery store, convenience store, gas station, or food or drink company. #### Section 21-2F-02 (a) (1) A retailer that prepares, distributes, sells, or exposes for sale a phenibut product shall disclose on the product label the factual basis on which any representations regarding the phenibut product are made. (2) A retailer may not prepare, distribute, sell, or expose for sale a phenibut product that: (i) Does not comply with the disclosure requirement established under paragraph (1) of this subsection; or (ii) Has not been recognized as a dietary ingredient or approved drug by the U.S. Food and Drug Administration. (b) (1) Subject to paragraph (2) of this subsection, a retailer may not prepare, distribute, sell, or expose for sale any of the following: (i) A phenibut product that is adulterated with a dangerous substance other than phenibut; (ii) A phenibut product that is contaminated with a dangerous substance other than phenibut; or (iii) A product containing phenibut that does not include on its package or label the amount of beta-phenyl-gamma-aminobutyric acid HCl contained in the product. (2) (i) For the purpose of paragraph (1)(i) of this subsection, a phenibut product is adulterated with a dangerous substance other than phenibut if: (1) The phenibut product is mixed or packed with a substance other than phenibut; and (2) That substance affects the quality or strength of the phenibut product to a degree as to render the phenibut product injurious to a consumer. (ii) For the purpose of paragraph (1)(ii) of this subsection, a phenibut product is contaminated with a dangerous substance other than phenibut if the phenibut product contains a poisonous or otherwise deleterious ingredient other than phenibut, including a drug that is designated as a controlled dangerous substance under Title 5 of the Criminal Law Article. (c) A retailer may not distribute, sell, or expose for sale a phenibut product to an individual under the age of 21 years. (d) In a prosecution for a violation of this section, it is a rebuttable defense that the defendant relied in good faith on the representations on the manufacturer's label on a phenibut product. (e) A retailer that violates subsection (a)(1) of this section is subject to a civil penalty not exceeding: (1) $1,000 for a first violation; and (2) $2,000 for each subsequent violation. (f) A retailer that violates subsection (a)(2), (b), or (c) of this section is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $5,000, imprisonment for not more than 90 days, or both. (g) In addition to any other penalties specified in this section, a retailer who violates this section is liable for any civil damages sustained by the individual resulting from the violation. #### Section 21-2F-03 (a) A retailer may not directly or indirectly advertise a therapeutic benefit of phenibut. (b) A retailer may not directly or indirectly advertise or market phenibut products to minors. (c) It is a violation of subsection (b) of this section for a retailer to use any of the following in the advertising, promotion, packaging, or labeling of a phenibut product: (1) A cartoon; (2) A superhero; (3) A video game reference; (4) An image of a food product primarily intended for minors; (5) A trademark that imitates or mimics the trademark of a product that has been advertised or marketed primarily to minors; (6) A symbol or celebrity that is primarily associated with minors or media primarily directed to minors; (7) An image of an individual who appears to be under the age of 27 years; and (8) Other images, graphics, or features or likenesses to images, graphics, or features that are popularly used to advertise to children, including: (i) Neon colors, signs, or other brightly colored displays; (ii) Animals; (iii) Mascots; or (iv) Statements, artwork, or designs that could reasonably mislead an individual to believe that the package contains anything other than a phenibut product. (d) It is a violation of subsection (b) of this section for a retailer to advertise or promote a phenibut product: (1) In a newspaper, a magazine, a periodical, or any other publication for which individuals under the age of 21 years constitute 15% or more of the total audience, as measured by competent and reliable survey evidence; (2) At a concert, a stadium, a sporting event, or any other public event for which individuals under the age of 21 years constitute 15% or more of the total audience, as measured by competent and reliable survey evidence; or (3) By placing an advertisement for phenibut on the side of a building or another publicly visible location of any form, including a sign, a poster, a placard, a device, a graphic display, an outdoor billboard, or a freestanding signboard. (e) A retailer that violates this section is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $5,000, imprisonment for not more than 90 days, or both. #### Section 21-2F-04 The Department shall adopt regulations to carry out this subtitle. ### Subtitle 3. Food Establishments #### Section 21-301 (a) In this subtitle the following words have the meanings indicated. (b) (1) "Bottled water" means any water that is sealed in bottles, packages, or other containers and offered for sale for human consumption, including bottled mineral water. (2) "Bottled water" does not include: (i) Soft drinks; or (ii) A beverage that is labeled "club soda" or "seltzer water". (b-1) "Cottage food business" means a business that: (1) Produces or packages cottage food products in a residential kitchen; (2) Sells the cottage food products in accordance with Sec. 21-330.1 of this subtitle and regulations adopted by the Department; and (3) Has annual revenues from the sale of cottage food products in an amount not exceeding $100,000. (b-2) "Cottage food product" means a nonhazardous food, as specified in regulations adopted by the Department, that is sold in the State in accordance with Sec. 21-330.1 of this subtitle and regulations adopted by the Department: (1) Directly to a consumer from a residence, at a farmer's market, at a public event, by personal delivery, or by mail delivery; or (2) To a retail food store, including a grocery store, or a food cooperative. (c) "Crab meat" means the edible meat of steamed or cooked crabs. (d) "Crab meat plant" means: (1) A picking plant; or (2) A place where crab meat is heat-treated to improve the keeping quality of the crab meat. (e) "Excluded organization" means: (1) A bona fide nonprofit fraternal, civic, war veterans', religious, or charitable organization or corporation that does not serve food to the public more often than 4 days per week except that once a year an organization may serve food to the public for up to 30 consecutive days; and (2) A volunteer fire company that does not serve food to the public more often than 4 days per week except that once a year a volunteer fire company may serve food to the public for up to 30 consecutive days. (f) "Food establishment" means: (1) A food service facility; or (2) A food processing plant. (g) (1) "Food processing plant" means any place used for, or in connection with, the commercial manufacturing, preparing, processing, packaging, canning, freezing, storing, distributing, labeling, or holding of food or drink for human consumption. (2) "Food processing plant" includes: (i) A bakery plant; (ii) A cannery; (iii) A confectionery plant; (iv) A crab meat picking plant; (v) A food manufacturing plant; (vi) A food warehouse or distribution center; (vii) A frozen food processing plant; (viii) An ice manufacturing plant; (ix) A shellfish plant; (x) A soft drink manufacturing plant; or (xi) A bottled water plant. (3) "Food processing plant" does not include: (i) A warehouse or distribution center that: (1) Does not process food; and (2) Stores only sealed containers of whole bean, ground or instant coffee, leaf or instant teas, nondairy dehydrated whiteners, sugar, or sugar-free sweeteners; or (ii) A cottage food business. (h) (1) "Food service facility" means: (i) A place where food or drink is prepared for sale or service on the premises or elsewhere; or (ii) Any operation where food is served to or provided for the public, with or without charge. (2) "Food service facility" includes a micro market licensed under Title 17, Subtitle 17 of the Business Regulation Article. (3) "Food service facility" does not include: (i) A kitchen in a private home where food is prepared at no charge for guests in the home, for guests at a social gathering, or for service to unemployed, homeless, or other disadvantaged populations; (ii) A food preparation or serving area where food is prepared or served only by an excluded organization; (iii) A location in a farmer's market or at a public festival or event where raw agricultural products, as defined in Sec. 21-304(d)(1)(iii) of this subtitle, are sold; or (iv) A cottage food business. (i) "License" means a license issued by the Department under this subtitle to operate a food establishment. (i-1) "Mobile food service facility" means a food service facility which is a mechanically, electrically, manually, or otherwise propelled vehicle operating on land or water. (j) "Picking plant" means a place where: (1) Crabs are steamed or cooked; (2) Crab meat is picked from crabs; and (3) Crab meat is packed for sale. (j-1) "Public festival or event" means a planned gathering that is open to the public and is regulated by the State or local jurisdiction in which it takes place. (j-2) (1) "Semipermanent food service facility" means a food service facility that: (i) Is built at a location other than where it operates; (ii) Is transported as a complete unit that does not require a building permit to install on the location at which it operates; (iii) Has no indoor seating for patrons; and (iv) When serving cooked food, serves only foods cooked for immediate service. (2) "Semipermanent food service facility" does not include a food service facility that is a mechanically, electrically, manually, or otherwise propelled vehicle operating on land or water that moves as part of its routine operation to: (i) Change location for sales; (ii) Obtain food and other supplies; (iii) Fill potable water supply holding tanks; (iv) Empty wastewater holding tanks; or (v) Provide for the cleaning and sanitation of equipment and utensils. (k) (1) Except as provided under paragraph (2) of this subsection, "soft drink" means any nonalcoholic beverage. (2) "Soft drink" does not include: (i) Apple cider; (ii) Soft drinks that are manufactured on the premises of a soda fountain and used at that soda fountain; or (iii) Bottled water. (l) "Surimi" means an intermediate manufactured seafood product derived from minced fish meat, washed to remove water-soluble protein and blood or other undesirable components and mixed with additives to enhance its frozen storage and functional characteristics. #### Section 21-302 This subtitle does not apply to the manufacture of milk, milk products as defined in Sec. 21-401 of this title, or frozen desserts as defined in Sec. 21-801 of this title. #### Section 21-303 The purpose of this subtitle is to provide that all food establishments in this State are constructed, operated, and maintained in a manner that assures that all food manufactured, processed, stored, or prepared for human consumption is done so under conditions necessary to protect the public health, safety, and welfare. #### Section 21-304 (a) (1) The Department shall adopt rules and regulations necessary to carry out the provisions of this subtitle. (2) For excluded organizations, the Department: (i) Shall adopt separate regulations that establish minimum standards that: (1) Ensure food integrity and safety; (2) Preserve public health; and (3) Control foodborne illnesses; (ii) May adopt separate regulations that establish a licensing system, with appropriate standards, that excluded organizations may voluntarily choose to submit to as a rescindable alternative to regulation under item (i) of this paragraph; and (iii) May adopt regulations governing excluded organizations serving potentially hazardous food prepared in a private kitchen. (b) Except as provided in subsection (e) of this section, a political subdivision may not adopt a law, ordinance, rule, or regulation that establishes a standard that is less stringent than rules and regulations adopted under this subtitle. (c) Except as otherwise provided in this section, this subtitle does not limit the power of a home rule or charter county or Baltimore City to adopt and enforce laws, ordinances, and regulations that are consistent with the purposes of this subtitle, including the power to adopt local licensing and enforcement procedures. (d) (1) (i) In this subsection the following words have the meanings indicated. (ii) "Farmer's market" means a public market in the State where producers of raw agricultural products sell the products directly to the public. (iii) "Raw agricultural product" includes: (1) Whole, unprocessed grains, flowers, herbs, nuts, fruits, and vegetables supplied directly from the farm on which they were produced; and (2) Any agricultural products the Department identifies in regulation. (2) A local jurisdiction may not require a license for the sale of raw agricultural products at a farmer's market or at a public festival or event. (e) (1) The governing body of Frederick County may adopt an ordinance to allow a restaurant with an outdoor dining area to allow a patron's dog to accompany the patron in the outdoor dining area. (2) An ordinance adopted under paragraph (1) of this subsection shall: (i) Prohibit a dog from being allowed to travel through an indoor space of a restaurant to enter or exit an outdoor dining area; and (ii) Contain a provision to ensure that the ordinance does not affect the right of an individual to use a service animal, as defined in Sec. 7-701 of the Human Services Article. (f) (1) (i) In this section the following words have the meanings indicated. (ii) "Base of operations" means a location used by the owner or operator of a mobile food service facility that provides: (1) A source of potable water, potable water hoses, and clean connections; (2) A method for the disposal of sewage; (3) Clean, adequate, and covered trash receptacles; (4) If necessary, refrigerated and dry food storage areas; (5) A storage area for single-serve food items; and (6) If necessary, a utensil washing facility. (iii) "County of origin" means the county in which the base of operations of a mobile food service facility is located. (iv) "Mobile food service facility" means a food service facility that: (1) Is a vehicle mechanically, electrically, manually, or otherwise propelled; (2) Operates on land or water; and (3) Changes its location as part of its routine sales operation. (v) "Mobile reciprocity license" means a license issued under paragraph (3) of this subsection. (2) This subsection does not apply to a mobile food service facility that operates solely under a temporary food service license in conjunction with fairs, carnivals, or similar events. (3) A county health department shall issue a mobile reciprocity license to a mobile food service facility that: (i) Is operating in the county; (ii) Is operating within 90 miles of its base of operations; and (iii) Holds a valid license from the county of origin. (4) A county health department may charge a fee for a mobile reciprocity license in an amount not exceeding $300. (5) A mobile reciprocity license is valid for a period of 1 year. (6) If a mobile food service facility has been inspected by the county of origin, a county may not require that the mobile food service facility be inspected before a county health department issues a mobile reciprocity license. (7) A county health department that issued a mobile reciprocity license may inspect the mobile food service facility while the mobile food service facility is operating in the county. (8) A mobile food service facility that is issued a mobile reciprocity license shall comply with all applicable State and local laws and regulations. (9) (i) A county health department may take enforcement action, including the levy of fines, against a mobile food service facility that violates this subtitle or any regulation adopted under this subtitle or any applicable local laws or regulations. (ii) If a county health department takes enforcement action under subparagraph (i) of this paragraph, the county health department shall notify the county of origin of the action taken. #### Section 21-304.1 (a) A volunteer fire company that meets the requirements of an excluded organization under Sec. 21-301(e) of this subtitle shall provide written notice to the Department that the volunteer fire company intends to serve food to the public for up to 30 consecutive days. (b) The written notice shall include the dates on which the food will be prepared, the methods of storing and serving the food, and the methods or procedures to be followed to ensure food safety and security. #### Section 21-304.2 (a) A restaurant with an outdoor dining area may allow a patron's dog to accompany the patron in the outdoor dining area during the hours designated by the owner of the restaurant. (b) The owner of a restaurant: (1) Shall provide written notice to the local health department that the owner intends to allow a patron's dog to accompany the patron in the outdoor dining area of the restaurant not less than 30 days prior to the day on which dogs will be allowed in the outdoor dining area; (2) May determine the location and the amount of space in the outdoor dining area designated for a patron accompanied by a dog; (3) May establish limits on the size and type of dogs and any other limitations relating to dogs that may accompany a patron into the outdoor dining area of a restaurant; (4) May deny entry to the restaurant or eject from the restaurant any patron accompanied by a dog at the discretion of the owner; and (5) Shall place on permanent display a written notice that is in a typeface that is large enough to be easily legible to the average person from a distance of 8 feet and that is in a location that is plainly visible to the patrons of the restaurant notifying the patrons of the policy of the restaurant allowing dogs in the outdoor dining area. (c) A patron accompanied by a dog: (1) May not allow the dog to travel through an indoor space of a restaurant to enter or exit an outdoor dining area; (2) Shall keep the dog on a leash at all times with the patron at the table at which the patron is seated; (3) May not leave the dog unattended at any time in the restaurant; (4) Shall be an adult who is responsible for the behavior of the dog; and (5) Is liable for any damages caused by the dog to the restaurant or any other patron of the restaurant. (d) This section does not affect the right of an individual to use a service animal, as defined in Sec. 7-701 of the Human Services Article. #### Section 21-305 (a) Except as otherwise provided in this subtitle, a person may not operate a food establishment unless the person is licensed by the Department. (b) (1) A separate license is required for each food establishment that a person owns or operates. (2) Except in Baltimore City, the provisions of this subsection may require a license for each location where vending machines are operated, but may not require a separate license for each individual vending machine. (3) Except in Baltimore City, vending machine locations used exclusively for prepackaged and commercially sealed foods that are not potentially hazardous, as defined by regulation, are not required to be licensed. (4) In Baltimore City, a license may be required for each individual vending machine. (5) (i) An excluded organization may operate a food establishment without a license unless the excluded organization has been issued a license under Sec. 21-304(a)(2)(ii) of this subtitle. (ii) If the Department adopts regulations governing excluded organizations serving potentially hazardous foods prepared in a private kitchen, an excluded organization shall meet any requirements in the regulations. (6) A license is not required for a person who: (i) Produces shell eggs; (ii) Sells the shell eggs directly to the public; and (iii) Is registered with or inspected by the Secretary of Agriculture under Sec. 4-310 or Sec. 4-311.1 of the Agriculture Article. (7) A license is not required for a person who: (i) Is licensed by the Department of Natural Resources under Sec. 4-701 or Sec. 4-701.1 of the Natural Resources Article; and (ii) Harvests and processes finfish on a vessel by ikejime for direct sale to restaurants. (8) Except as provided in Sec. 21-304 of this subtitle, nothing in this subtitle shall preempt the right of a county to require a permit under the authority provided by a local law, ordinance, or regulation if this subtitle does not require the food establishment to obtain a State license. (c) A license is not transferable: (1) Except as provided by regulation for transfer of the license on the death of the licensee from person to person; or (2) From location to location, except for a producer mobile farmer's market license under Sec. 21-309.1 of this subtitle. (d) (1) For the purposes of this section a license issued by a county health department under the authority provided by local law, ordinance, or regulation in accordance with Sec. 21-304(b) and (c) of this subtitle shall constitute the license required under this subtitle, unless the Department, after a hearing, determines that the licensee is not in compliance with this subtitle and regulations adopted under this subtitle. (2) After a determination of noncompliance under paragraph (1) of this subsection, the Department shall act to ensure that the food establishment and its operator comply with this subtitle and the rules and regulations adopted under this subtitle. (3) Nothing in this subtitle shall allow the issuance of 2 separate licenses issued solely for the regulation of a food establishment under this subtitle. (e) In Charles County, an issuance, renewal, or transfer of an off-sale alcoholic beverages license shall not require Department approval. (f) In Carroll County, a bona fide religious organization that meets the requirements of an excluded organization under Sec. 21-301 of this subtitle or a county-owned and county-operated park or facility that is hosting a public festival may offer for sale or sell the following types of homemade-style food if the food is produced at the organization, park, or facility and meets the appropriate health and safety standards adopted by the Department: (1) Fruit jellies, jams, and preserves made from apples, apricots, blackberries, blueberries, boysenberries, cherries, cranberries, grapes, nectarines, oranges, peaches, plums, quince, raspberries, red currants, strawberries, or tangerines; (2) Fruit butter made from apples, apricots, grapes, peaches, plums, prunes, or quince; (3) Fruit pies made from apples, apricots, blackberries, blueberries, boysenberries, cherries, cranberries, grapes, nectarines, oranges, peaches, plums, quince, raspberries, red currants, strawberries, or tangerines; and (4) Honey. #### Section 21-306 (a) To apply for a license, an applicant shall submit an application to the Department on the form that the Department requires. (b) The application form shall include: (1) The applicant's name and address; (2) The location of the food establishment for which application is made; (3) The type of food establishment that the applicant proposes to operate; and (4) Any other information the Department requires. #### Section 21-307 (a) To qualify for a license, an applicant shall: (1) Comply with the requirements of this subtitle and the rules and regulations adopted under this subtitle; (2) Agree to permit access to the food establishment for the purpose of any inspection permitted or required under this subtitle; and (3) Pay the license fee assessed under Sec. 21-308 of this subtitle, unless exempted from the fee under this subtitle or any rule or regulation adopted under this subtitle. (b) Before issuing a license, the Department may inspect the food establishment identified in the application to determine if the food establishment meets the requirements for a license. #### Section 21-308 (a) In this section, "on-farm home processing facility" means a home or domestic kitchen located on an individual's farm that manufactures and processes foods for commercial sale. (b) (1) For any license issued for which the authority to conduct a program under this subtitle has been delegated to a county health department: (i) A county governing body or the Mayor and City Council of Baltimore City may and the Anne Arundel County Council shall provide for a license fee schedule based on the anticipated cost of licensing, inspecting, and regulating food establishments and may provide for exemptions from the license fee schedule; and (ii) All license fees shall be paid to the local health department or chief financial officer of the county governing body or Baltimore City. (2) Except in Anne Arundel County, Baltimore City, Montgomery County, and Prince George's County, a license fee under this subsection may not exceed $70 for a seasonal food processing operation that: (i) Uses only food that is grown on the property of the licensee; and (ii) Is in operation for not more than a 3-month continuous period in the calendar year. (3) A seasonal food processing operation may obtain a food establishment license for a fee of $70 under paragraph (2) of this subsection only twice in a calendar year. (c) (1) An on-farm home processing facility may obtain an on-farm home processing plant license for a fee established in regulations. (2) An on-farm home processing facility that obtains an on-farm home processing plant license may manufacture or process only foods provided for in regulations of the Department. (3) A license or permit is not required to deliver prepackaged foods to fill an order of a customer. (d) For any other food establishment license, the Secretary shall establish a license fee in accordance with Sec. 2-104 of this article. (e) Notwithstanding any other provision of this section, a license fee under this section may not exceed $150 annually for a food processing plant that: (1) Is a bona fide civic or nonprofit organization that processes meat for human consumption; and (2) Engages in the processing of meat for human consumption no more than three times a year for 5 days or less each time. #### Section 21-309 (a) (1) In this section the following terms have the meanings indicated. (2) "On-farm food service facility" means a food service facility that: (i) Is located on a farm; (ii) Serves food as designated by the Department; and (iii) Operates during a period of time of not more than 30 consecutive days with up to two renewals in a 1-year period. (3) "Temporary food service facility" means a food service facility that operates during a period of time of not more than 30 consecutive days at a fixed location in conjunction with a fair, carnival, public exhibition, construction project, recreational facility, or similar gathering. (b) (1) Except as provided in Sec. 10-226 of the State Government Article and in paragraphs (2) and (3) of this subsection, and unless it is renewed for another term, a license expires 1 year from the date of issuance or renewal or as provided by local law, ordinance, or regulation in accordance with Sec. 21-304(b) and (c) of this subtitle. (2) Except as provided in Sec. 10-226 of the State Government Article, a license to operate a temporary food service facility expires at the conclusion of the underlying event or after 30 consecutive days of operation, whichever is earlier, or as provided by local law, ordinance, or regulation in accordance with Sec. 21-304(b) and (c) of this subtitle. (3) (i) Except as provided in Sec. 10-226 of the State Government Article, a license to operate an on-farm food service facility expires after 30 consecutive days unless it is renewed in accordance with subparagraph (ii) of this paragraph. (ii) An on-farm food service facility may renew an on-farm food service facility license up to two times within a 1-year period. (c) Except in the case of a temporary food service facility, including a mobile food service facility which operates solely as a temporary food service facility, or an on-farm food service facility, at least 1 month before the license expires, the Department shall send to the licensee, by first-class mail to the last known address of the licensee, a renewal notice that states: (1) The date on which the current license expires; and (2) The date by which the completed renewal application must be received by the Department for the renewal to be issued and mailed before the license expires. (d) The Department may renew a license if the licensee: (1) Has complied with this subtitle and the regulations adopted under this subtitle; (2) Submits to the Department a completed renewal application on the form the Department requires; (3) Pays the renewal fee assessed under Sec. 2-104 of this article, unless exempted from the fee under this subtitle or any regulation adopted under this subtitle; and (4) Agrees to permit access to the food establishment for purposes of any inspection permitted or required under this subtitle. #### Section 21-309.1 (a) (1) The Department shall establish a producer mobile farmer's market license. (2) The fee for a producer mobile farmer's market license: (i) Shall be based on the anticipated cost of licensing, inspecting, and regulating licensees; and (ii) May not exceed $100. (3) A producer mobile farmer's market license shall be valid for a period of 1 year. (b) A producer mobile farmer's market licensee may transport to and sell at a farmer's market or at a public festival or event: (1) Products that were produced by the licensee under an on-farm home processing plant license; (2) Products produced by the licensee, as authorized by the Department in regulation; or (3) Farm products that have been inspected, licensed, or certified for food safety by the Maryland Department of Agriculture. (c) (1) A producer mobile farmer's market license is valid in all jurisdictions in the State. (2) A county or municipality may not require a producer mobile farmer's market licensee to obtain a separate permit or license to sell products authorized for sale under the producer mobile farmer's market license. (d) The Department shall: (1) Issue producer mobile farmer's market licenses; (2) At least once a year, inspect each mobile unit that operates under a producer mobile farmer's market license; and (3) Adopt regulations to implement this section. (e) A producer mobile farmer's market license shall be displayed on any mobile unit operating under the license. (f) (1) A person in violation of this section or a regulation adopted under this section is subject to a fine not to exceed $1,000. (2) A county health department shall enforce and levy fines for a violation of this section or any regulations adopted under this section. (3) Fines assessed by a county health department shall be paid to the county in which the violation occurred. (4) A county health department shall notify the Department of any violations occurring in the county. #### Section 21-309.2 (a) A county may establish a seasonal farmer's market producer sampling license to be required for a producer of a farm product to prepare and offer samples of the farm product for human consumption at a farmer's market or at a public festival or event. (b) A county seasonal farmer's market producer sampling license established under this section shall: (1) Be valid at all farmer's markets in the county; (2) Be valid at any public festival or event in the county; (3) Be valid for the entire season for which it is issued; and (4) Have a single fee as set by the county. (c) A seasonal farmer's market producer sampling licensee shall use the license only to offer samples of a farm product that has been produced by the licensee. (d) The Department shall adopt regulations that: (1) Establish eligibility for the license; (2) Provide for the authorized uses of the license; (3) Establish standards and approved methods under which sampling shall be conducted; (4) Specify the duration of the season during which the license is valid; and (5) Include other provisions that are necessary to protect public health and control foodborne illnesses. (e) A county issuing a seasonal farmer's market producer sampling license shall adopt an ordinance that: (1) Sets the fee for the license; (2) Provides for the enforcement of provisions of law under which the license is issued; and (3) Provides penalties for violations of provisions of law under which the license is issued. #### Section 21-309.3 #### Section 21-310 (a) Within 30 days after the Department receives an application for a license, the Department shall issue a license to any applicant who meets the requirements of this subtitle and all regulations adopted under this subtitle. (b) While it is effective, a license authorizes the licensee to operate the food establishment identified on the license. #### Section 21-311 (a) The Department may deny an application for a food establishment license issued under this subtitle if the Department finds that the applicant: (1) Does not meet the requirements of this subtitle or any rules or regulations adopted under this subtitle; or (2) Fraudulently or deceptively attempts to obtain a license. (b) Within 30 days of receipt of the completed application, the Department shall notify the applicant in writing: (1) That the application has been denied; (2) The specific reasons for the denial of the application; and (3) If any, the actions that must be taken by the applicant to qualify for a license. (c) After a notice of denial is issued, the Department may issue a license to an applicant if the applicant: (1) Takes all actions specified in the notice of denial; and (2) Meets the requirements of this subtitle and all rules and regulations adopted under this subtitle. (d) An applicant who is denied a license is entitled to: (1) A hearing before the Secretary under Sec. 21-316 of this subtitle; and (2) Judicial review under Sec. 21-317 of this subtitle. #### Section 21-312 Each licensee shall display the license conspicuously in the food establishment. #### Section 21-312.1 (a) (1) In this section the following words have the meanings indicated. (2) "Caterer" means a food service facility that offers catering services or identifies itself as a caterer. (3) "Catering services" means the preparation or provision and the serving of food or drink by a food service facility for service at the provider's premises or elsewhere in connection with a specific event or a business or social function or affair. (b) A food service facility that offers catering services or that identifies itself as a caterer shall include its food service facility license number, including the identity of the issuer of the license, on: (1) All advertising on business cards, published print media, flyers, brochures, and any vehicles used in connection with catering services and in telephone directories; and (2) All contracts for catering services. (c) A food service facility that is licensed in more than one political subdivision may satisfy the requirements of this section by displaying the food service facility license number of any or all of its licenses issued by one or more of the political subdivisions. (d) This section does not apply to a person who: (1) Prepares food in a kitchen of another person's private home for service in that private home; or (2) Prepares food in a kitchen of a private home or a kitchen of a school, religious or charitable organization, or nonprofit institution for service or sale to benefit a school, religious or charitable organization, or nonprofit institution. #### Section 21-312.2 (a) This section applies to a semipermanent food service facility that: (1) Operates in Anne Arundel County; and (2) Was licensed under Sec. 21-305 of this subtitle on or before December 1, 2010. (b) An operator of a semipermanent food service facility shall: (1) Pump out the onboard wastewater holding tank as frequently as required by Anne Arundel County to avoid creating a public health nuisance; (2) Remove wastewater by: (i) Hiring a licensed liquid waste hauler to dispose of the wastewater; or (ii) Disposing of the wastewater at a wastewater disposal facility approved by Anne Arundel County; (3) Use a food grade hose and an adequate backflow prevention device to maintain a potable water supply; and (4) Demonstrate compliance with items (1) and (2) of this subsection by quarterly submitting a record of receipts to the issuer of the license. #### Section 21-313 (a) To enforce this subtitle, a representative of the Department, at any reasonable time, may: (1) Enter and inspect any food establishment; and (2) Inspect and sample any item of food that is in a food establishment. (b) A person may not: (1) Refuse to grant access to a representative of the Department who requests to enter and inspect a food establishment under this section; or (2) Interfere with any inspection under this section. #### Section 21-314 If the Department finds that a food establishment is in violation of this subtitle or any rule or regulation adopted under this subtitle, is in an unsanitary condition, or is not equipped properly, the Secretary shall notify the licensee: (1) Of the specific findings; (2) Of a specific, reasonable date by which the licensee shall correct the violations or deficiencies specified in the notice; and (3) That, if the licensee fails to correct the conditions by the date specified, the Department may suspend or revoke the license issued under this subtitle. #### Section 21-315 The Department may suspend or revoke a license issued under this subtitle if the licensee: (1) Violates or fails to meet the requirements of this subtitle or any regulation adopted under this subtitle; or (2) Fraudulently or deceptively obtains a license. #### Section 21-316 (a) Except as otherwise provided in Title 10, Subtitles 2 and 3 of the State Government Article, before the Department takes any final action under Sec. 21-311 or Sec. 21-315 of this subtitle, the Secretary shall give the person against whom the action is contemplated an opportunity for a hearing before the Department. (b) The Department shall give notice and hold the hearing in accordance with Title 10, Subtitle 2 of the State Government Article. (c) The Department shall send the hearing notice to the applicant or licensee by certified mail, return receipt requested, bearing a postmark from the United States Postal Service. (d) Within 30 days after the hearing required under this section, the Department shall decide the issue and immediately notify the parties to the hearing. #### Section 21-317 (a) Any person aggrieved by a final decision of the Department in denying, suspending, or revoking a license issued under this subtitle may take a direct judicial appeal. (b) The appeal shall be made as provided for judicial review of final decisions in Title 10, Subtitle 2 of the State Government Article. (c) Either party may appeal the decision of the circuit court to the Appellate Court of Maryland. #### Section 21-318 (a) If the Department believes that a person is violating any provision of this subtitle or any regulation adopted under this subtitle, the Department may have the person served with a written order that directs the person served to abate the violation within a time specified in the order. (b) Except as otherwise provided in Title 10, Subtitle 2 of the State Government Article, the Department shall give any person served with an order under this section an opportunity for a hearing before the Department. (c) After a hearing under this section, the Department may affirm, modify, or withdraw the order. (d) A person who is served with an order under this section may not violate that order. #### Section 21-321 (a) Except as provided in subsection (d) of this section, before a food establishment is constructed, remodeled, or materially altered, or before an existing building or structure is converted or remodeled for use as a food establishment, properly prepared plans and specifications for the construction, remodeling, or alteration of a food establishment shall be submitted to: (1) The Department, if the food establishment is: (i) A food processing plant; or (ii) A chain or franchise food service facility planning to construct 2 or more facilities in the State from a single uniform set of plans; or (2) Except as provided in item (1)(ii) of this subsection, for food service facilities, to the appropriate county health department. (b) The plans or specifications required under subsection (a) of this section shall include: (1) Layout and arrangement of work areas; (2) Construction materials; (3) The location, size, manufacturer, and model number of equipment and facilities; and (4) Any other information that may be required for the proper review of the plans and specifications. (c) Unless the required plans and specifications are approved by the Department, a person may not: (1) Construct, remodel, or alter a food establishment; or (2) Convert or remodel an existing building or structure for use as a food establishment. (d) The provisions of this section do not apply to the construction, remodeling, or alteration of any areas in a food establishment used solely for office space, or recreational areas. #### Section 21-322 (a) The Maryland Department of Health and the State Department of Agriculture may: (1) Inspect for wholesomeness any food donated to a nonprofit corporation, organization, or association; and (2) Establish procedures for handling food donated to any nonprofit corporation, organization, or association. (b) (1) In this subsection, "person" shall include a nonprofit corporation, organization, or association. (2) A person shall have the immunity from liability described under Sec. 5-634 of the Courts Article for any act or omission that affects the nature, age, condition, or packaging of the donated food. #### Section 21-323 (a) In this section, "group home" means a foster home, emergency shelter, or family type residential facility for children that is: (1) Sponsored by a public or private agency; and (2) Supervised by foster parents, house parents, or counselors. (b) Any group home is exempt from any regulation governing food service facilities that is adopted by the Department or a local government, if the group home: (1) At no time has more than 14 residents including house parents and supervisory, professional, and custodial staff members; and (2) Has among its resident children only children placed in the group home by a court, a licensed child placement agency, or a government agency, including a local department of social services. (c) Each group home that is intended for no more than 14 residents shall be registered with the health officer for the county and is subject to State and local health regulations that govern occupancy and use of private family homes. (d) In each county, the health officer shall inspect each group home that is intended for no more than 14 residents. #### Section 21-323.1 (a) In this section, "bed and breakfast establishment" means a lodging or rooming house as defined in Sec. 9-201 of the Public Safety Article having eight rooms or fewer for rent. (b) A bed and breakfast establishment is exempt from any regulation governing food service facilities that is adopted by the Department or a local government relating to the construction or installation of commercial grade kitchen equipment in the bed and breakfast establishment. (c) Each bed and breakfast establishment that intends to serve hot meals to renters shall be: (1) Licensed in accordance with Sec. 21-305 of this subtitle; and (2) Subject to State and local health regulations that govern food safety and contamination. (d) In each county, the health officer shall inspect each bed and breakfast establishment that intends to serve hot meals to renters for compliance with food safety and contamination regulations in accordance with Sec. 21-313 of this subtitle. #### Section 21-324 (a) (1) The floors, walls, ceilings, sidewalks, furniture, receptacles, implements, and machinery of or in any food establishment shall be kept in a clean and sanitary condition at all times. (2) (i) The design and construction of existing equipment in food establishments shall be accepted by the Department, if the existing equipment: (1) Complied with the Department's standards that prevailed at the time of the installation; (2) Accomplishes its intended and required function in the establishment; (3) Is cleanable; (4) Is free of hazardous materials and toxic food contact surfaces; and (5) Is in good repair. (ii) The Department shall establish guidelines for the replacement of failed existing equipment. (b) Any vehicle that is used to transport food or from which any food is sold shall be kept in a clean and sanitary condition at all times. (c) A condition that is unclean and unsanitary exists whenever any of the following occurs: (1) Any food in the process of manufacture, preparation, packing, canning, freezing, storing, sale, distribution, or transportation is not protected as far as practicable from flies, filth, and any foreign or injurious contamination; (2) Refuse, dirt, or waste products subject to decomposition and fermentation that are incident to the manufacture, preparation, packing, canning, freezing, storing, sale, distribution, or transportation of food are not removed daily, or at a frequency required by the Department; (3) Any receptacle, chute, platform, rack, table, shelf, utensil, or machinery used in moving, handling, cutting, chopping, mixing, canning, freezing, or processing food is not kept clean; (4) The clothing or body of any individual employed in the establishment, place, or vehicle is not kept as clean as the nature of the employment permits; (5) The food establishment lacks an adequate supply of potable water; or (6) The food establishment lacks an adequate sewage disposal facility. #### Section 21-324.1 (a) This section does not apply to an outer door of a food service facility that leads from the kitchen to the outside. (b) A food service facility may operate with the outer windows or outer doors open unless, while the food service facility is operating with the outer doors or outer windows open, the local health department: (1) Finds evidence of vermin in food preparation or food storage areas; or (2) Finds evidence of flying insects in food preparation or food storage areas that pose a significant threat to sanitation or public health. (c) If a local health department finds that a food service facility is operating in violation of subsection (b) of this section, the food service facility shall take immediate action to eliminate the vermin or flying insects. (d) A local health department may close a food service facility found to be operating in violation of subsection (b) of this section, or order a temporary closure of the outer windows and outer doors at the food service facility, until the vermin or flying insects are eliminated from the food preparation or food storage areas, or until another action approved by the local health department is taken. (e) A food service facility found to be operating in violation of subsection (b) of this section on three or more separate occasions shall keep the outer windows and outer doors closed at all times until: (1) Modifications approved by the local health department are made to the food service facility to effectively protect against the entrance of vermin and flying insects; or (2) Another action approved by the local health department is taken. #### Section 21-325 (a) Subject to subsection (d) of this section, each food establishment shall have: (1) A convenient toilet that is: (i) Except as provided in subsection (c) of this section, separated from any room in which food is manufactured, prepared, packed, canned, frozen, sold, or distributed; (ii) Kept in a sanitary condition; and (iii) Properly ventilated; and (2) A convenient lavatory that is: (i) Supplied with soap, water, towels, or other approved hand drying devices; (ii) Kept in a sanitary condition; and (iii) Properly ventilated. (b) (1) This subsection does not apply to a mobile food service facility or a semipermanent food service facility located in Washington County. (2) Each food service facility which prepares food and provides seating for patrons established after January 1, 1979, shall have available for the public: (i) A convenient toilet that is kept in a sanitary condition; and (ii) A convenient lavatory that is: (1) Supplied with soap, water, towels, or other approved hand drying devices; (2) Kept in a sanitary condition; and (3) Properly ventilated. (c) A room that houses a toilet may be constructed within a larger room in which food is manufactured, prepared, packed, canned, frozen, sold, or distributed. (d) (1) This subsection applies only to a food establishment that is: (i) A business that conducts agritourism, as defined in Sec. 4-212 of the Land Use Article; (ii) A Class 4 limited winery licensed under Sec. 2-206 of the Alcoholic Beverages and Cannabis Article; and (iii) A Class 8 farm brewery licensed under Sec. 2-210 of the Alcoholic Beverages and Cannabis Article. (2) A food establishment may comply with the requirement to provide a convenient lavatory by providing a portable toilet that: (i) Otherwise meets the requirements of subsection (a)(2) or (b)(2)(ii) of this section; and (ii) Is placed at least 25 feet from a well. #### Section 21-326 (a) Each food service facility which prepares food and provides seating for patrons shall post a diagram or illustrative directions on the use of manual maneuvers to prevent asphyxiation due to choking. (b) A person who applies the maneuvers depicted in a diagram posted under this section to remove food lodged in the throat of another is liable only if the person's actions amount to gross negligence. #### Section 21-327 A person may not sleep in: (1) Any workroom or food storage room of a food processing plant; or (2) Any kitchen, dining room, or food storage room of a food service facility. #### Section 21-328 (a) A person may not knowingly employ any individual to work in any area or capacity in a food establishment in which there is a likelihood of transmission of disease to patrons or other employees of the food establishment if the individual employed: (1) Has a communicable disease that may be transmitted by food; or (2) Is a carrier of a communicable disease that may be transmitted by food. (b) An individual may not knowingly work in any area or capacity in a food establishment in which there is a likelihood of transmission of disease to patrons or other employees of the food establishment if the individual: (1) Has a communicable disease that may be transmitted by food; or (2) Is a carrier of a communicable disease that may be transmitted by food. #### Section 21-329 (a) Unless the packaging of a food product is clearly and conspicuously labeled in accordance with subsection (c) of this section, no food product containing or consisting of surimi may be sold in the State. (b) Unless all menus and notices advertising a food containing or consisting of surimi are clearly and conspicuously labeled in accordance with subsection (c) of this section, a food service facility may not serve the food in the State. (c) Labeling for a food product or food containing or consisting of surimi shall include 1 or more of the following terms, as appropriate: (1) "Imitation crab"; (2) "Imitation lobster"; (3) "Imitation scallops"; (4) "Imitation shrimp"; (5) "Imitation" followed by the name of the seafood imitated; (6) "Artificial processed seafood"; (7) "Surimi"; (8) "Seafood salad containing imitation" followed by the name of the seafood imitated; or (9) Other terms approved by the Department. (d) In addition to the penalties set forth in Sec. 21-1214 of this title, the Secretary may seize or condemn any food product or food sold or served in violation of this section. #### Section 21-330 (a) A low calorie frozen dessert that contains powders or dry mixes of pasteurized whey, reduced mineral whey, whey protein concentrate, reduced lactose whey, or optional caseinates and is rehydrated with potable water before freezing is not required to be repasteurized. (b) The wheys, caseinates, or egg ingredients that are used in the formulation of a mixture under subsection (a) of this section shall: (1) Have been pasteurized before being used in the mixture; and (2) Contain only those ingredients that: (i) Are recognized as safe by the United States Food and Drug Administration; or (ii) Are authorized under regulations adopted under this subtitle. (c) After the rehydration of a mixture under subsection (a) of this section, the mixture shall be: (1) Cooled to a maximum temperature of 45 degrees Fahrenheit within 4 hours; and (2) Frozen within 24 hours. (d) The Secretary shall adopt regulations that comply with the provisions of this section. #### Section 21-330.1 (a) This section does not: (1) Apply to a food establishment that is required to have a license under Sec. 21-305 of this subtitle; or (2) Exempt a cottage food business from any applicable State or federal tax laws. (b) A cottage food business is not required to be licensed by the Department if the owner of the cottage food business complies with this section. (c) The owner of a cottage food business may sell only cottage food products that are: (1) Stored on the premises of the cottage food business; and (2) Prepackaged with a label that contains: (i) The following information: (1) (A) The name and address of the cottage food business; or (B) The name and phone number of the cottage food business and the identification number assigned to the cottage food business under subsection (d) of this section; (2) The name of the cottage food product; (3) The ingredients of the cottage food product in descending order of the amount of each ingredient by weight; (4) The net weight or net volume of the cottage food product; (5) Allergen information as specified by federal labeling requirements; and (6) If any nutritional claim is made, nutritional information as specified by federal labeling requirements; (ii) The following statement printed in 10 point or larger type in a color that provides a clear contrast to the background of the label: "Made by a cottage food business that is not subject to Maryland's food safety regulations."; and (iii) For a cottage food product offered for sale at a retail food store: (1) The phone number and e-mail address of the cottage food business; and (2) The date the cottage food product was made. (d) At the request of a cottage food business, the Department shall provide to the cottage food business a unique identification number that the cottage food business may use on the label of a cottage food product under subsection (c) of this section. (e) The owner of a cottage food business shall comply with all applicable county and municipal laws and ordinances regulating the preparation, processing, storage, and sale of cottage food products. (f) (1) The Department may investigate any complaint alleging that a cottage food business has violated this section. (2) On receipt of a complaint, a representative of the Department, at a reasonable time, may enter and inspect the premises of a cottage food business to determine compliance with this section. (3) The owner of a cottage food business may not: (i) Refuse to grant access to a representative who requests to enter and inspect the premises of the cottage food business under paragraph (2) of this subsection; or (ii) Interfere with any inspection under paragraph (2) of this subsection. (4) An investigation of a cottage food business conducted under this subsection may include sampling of a cottage food product to determine if the cottage food product is misbranded or adulterated. (g) Before the owner of a cottage food business may sell a cottage food product to a retail food store, the owner shall submit to the Department: (1) Documentation of the owner's successful completion of a food safety course approved by the Department; and (2) The label that will be affixed to the cottage food product in accordance with subsection (c)(2) of this section. (h) Beginning on or before December 30, 2020, and every December 30 thereafter, the Department shall report to the Senate Finance Committee and the House Health and Government Operations Committee, in accordance with Sec. 2-1257 of the State Government Article, on: (1) The documentation and labels submitted under subsection (f) of this section; and (2) Any complaints received by the Department related to a cottage food business or cottage food product. (i) The Department shall adopt regulations to carry out this section. #### Section 21-330.2 (a) Beginning March 1, 2014, a food establishment shall display prominently in the staff area of the food establishment a poster relating to food allergy awareness that includes information regarding the risk of an allergic reaction. (b) On or before January 1, 2014, the Department, in consultation with the Restaurant Association of Maryland and Food Allergy Research and Education, shall create and make available on its website the poster required to be displayed under subsection (a) of this section. #### Section 21-330.3 (a) (1) In this section the following words have the meanings indicated. (2) "Automated external defibrillator (AED)" means a medical heart monitor and defibrillator device that: (i) Is cleared for market by the federal Food and Drug Administration; (ii) Recognizes the presence or absence of ventricular fibrillation or rapid ventricular tachycardia; (iii) Determines, without intervention by an operator, whether defibrillation should be performed; (iv) On determining that defibrillation should be performed, automatically charges; and (v) (1) Requires operator intervention to deliver the electrical impulse; or (2) Automatically continues with delivery of the electrical impulse. (3) "Grocery store" means a store that has: (i) All major food departments, including produce, meat, seafood, dairy, and canned and packaged goods; or (ii) (1) At least one of the major food departments; and (2) At least 12,000 square feet of floor space. (b) This section does not apply to: (1) A grocery store that has an annual gross income of $10,000,000 or less; or (2) A restaurant with: (i) An annual gross income of $1,000,000 or less, exclusive of sales for off-premises consumption; or (ii) A seating capacity of less than 100 individuals. (c) Each owner and operator of a grocery store or restaurant shall: (1) Place an automated external defibrillator in a prominent area, accessible to employees and customers; (2) Maintain the functionality of the automated external defibrillator; and (3) Comply with the applicable requirements of the Public Access Automated External Defibrillator Program provided under Sec. 13-517 of the Education Article. (d) In addition to any other immunities available under statutory or common law: (1) A grocery store or restaurant is not civilly liable for any act or omission in the provision of automated external defibrillation if the grocery store or restaurant has satisfied the requirements under this section; (2) An individual is not civilly liable for any act or omission if: (i) The individual is acting in good faith while rendering automated external defibrillation to another individual who is a victim or reasonably believed by the individual to be a victim of a sudden cardiac arrest; (ii) The assistance or aid is provided in a reasonably prudent manner; and (iii) The automated external defibrillation is provided without fee or other compensation; and (3) A grocery store, restaurant, or individual is not civilly liable for failing to render automated external defibrillation to an individual who is a victim or is reasonably believed to be a victim of a sudden cardiac arrest. (e) The Department and the Maryland Institute for Emergency Medical Services Systems jointly shall adopt regulations that: (1) Establish guidelines for periodic inspections and annual maintenance of the automated external defibrillators; (2) Assist the owner and operator of a grocery store or restaurant in carrying out the provisions of this section; and (3) Require each grocery store and restaurant subject to this section to register with the Maryland Institute for Emergency Medical Services Systems in order to: (i) Make its location publicly available to emergency dispatchers; and (ii) Receive maintenance and recall notices from the Maryland Institute for Emergency Medical Services Systems. #### Section 21-330.4 (a) (1) In this section the following words have the meanings indicated. (2) (i) "Baby food" means food packaged in a jar, pouch, tub, or box sold specifically for babies and children under the age of 2 years. (ii) "Baby food" does not include infant formula, as defined in 21 U.S.C. Sec. 321(z). (3) "Manufacturer" includes a food manufacturer, food processor, and food packer. (4) "Production aggregate" means a quantity of product that is intended to have uniform composition, character, and quality and is produced according to a master manufacturing order. (5) "Proficient laboratory" means a laboratory that: (i) Is accredited under the standards of the International Organization for Standardization/International Electrotechnical Commission 17025:2017; (ii) Uses an analytical method at least as sensitive as the analytical method described in Section 4.7 of the U.S. Food and Drug Administration Elemental Analysis Manual for Food and Related Products; and (iii) Demonstrates proficiency in quantifying each toxic element to at least 6 micrograms of the toxic element to kilogram of food through an independent proficiency test by achieving a z-score that is less than or equal to plus or minus two. (6) "QR code" means a machine-readable code, consisting of an array of squares, used for storing an Internet website in order to access a webpage. (7) "Representative sample" means a sample that consists of a number of units that are drawn based on rational criteria, such as random sampling, and intended to ensure that the sample accurately portrays the material being sampled. (8) "Toxic heavy metal" means arsenic, cadmium, lead, or mercury. (b) (1) Except as provided in paragraph (2) of this subsection, on or after January 1, 2025, a person may not sell, distribute, or offer for sale baby food in the State that contains toxic heavy metals that exceed the limits established by the U.S. Food and Drug Administration. (2) A person may sell, distribute, or offer for sale baby food manufactured before January 1, 2026. (c) (1) Beginning January 1, 2025, each manufacturer of baby food shall test a representative sample of each production aggregate of the manufacturer's final baby food product for each toxic heavy metal. (2) The testing required under paragraph (1) of this subsection shall be conducted by a proficient laboratory at least once per month. (3) A manufacturer may test the final baby food product in accordance with paragraph (1) of this subsection before packaging individual units of baby food for sale or distribution. (d) On the request of the Department, a manufacturer of baby food shall provide the results of the testing conducted under subsection (c) of this section to an authorized agent of the Department. (e) Beginning January 1, 2026, each manufacturer of baby food shall: (1) Make publicly available on the manufacturer's website for each baby food product sold, manufactured, delivered, held, or offered for sale in the State: (i) The name and level of each toxic heavy metal present in the final baby food product as determined by the testing conducted under subsection (c) of this section; (ii) Sufficient information, such as the product name, universal product code, or lot or batch number, to enable consumers to identify the final baby food product; and (iii) A link to the U.S. Food and Drug Administration's website that includes the most recent U.S. Food and Drug Administration guidance and information about the health effects of the toxic heavy metals on children; and (2) If the baby food is tested for a toxic heavy metal subject to an action level, regulatory limit, or tolerance established by the U.S. Food and Drug Administration under 21 C.F.R. Sec. 109, include on the baby food product label: (i) The following statement: "For information about toxic element testing on this product, scan the QR code."; and (ii) A QR code or other machine-readable code that allows consumers to access on the manufacturer's website or the baby food product information page: (1) The test results for the toxic heavy metals; and (2) A link to the webpage on the U.S. Food and Drug Administration website that includes the most recent guidance and information about the health effects of the toxic heavy metal on children. (f) If a consumer believes, based on information gathered through the use of the code included on the baby food product label under subsection (e)(2) of this section, that baby food is being sold in the State with toxic heavy metals that exceed limits established by the U.S. Food and Drug Administration, the consumer shall report the baby food to the Department. #### Section 21-332 The Department shall renew, deny, suspend, or revoke a soft drink registration as provided for the renewal, denial, suspension, or revocation of a license under Sec.Sec. 21-309, 21-311, 21-314, 21-315, 21-316, 21-317, and 21-318 of this subtitle. #### Section 21-333 In this State, a person may not sell a soft drink manufactured outside of this State unless the soft drink has been registered with the Department. #### Section 21-334 (a) This section applies to any container that is used to pack, store, distribute, or sell: (1) A soft drink; or (2) Bottled water. (b) Before putting a soft drink or bottled water in a container, a manufacturer shall clean the container in a manner approved by the Department or shall use clean containers. #### Section 21-335 (a) A person may not sell or offer for sale at retail in this State any metal soft drink container or any composite soft drink container that is designed and constructed with an all metal tab opening device that detaches from the container when the container is opened in a manner which is normally used to empty the contents of the container. (b) The provisions of this section do not prohibit the sale or offer for sale of: (1) A beverage container sealed with a laminated tape seal, even if the seal contains aluminum foil, if the seal is not rigid; (2) Frozen beverage concentrates in all metal containers with detachable metal pull tabs customarily and primarily purchased for dilution and use within the home, or for similar purposes; and (3) Metal beverage containers with pull tabs for milk-based products, soy-based products, or similar products which require sterilization and pressure in the canning process. #### Section 21-336 (a) (1) In this section, "approved source" means a source of water that is: (i) Sampled and found through laboratory analysis to comply with: (1) The microbiological standards adopted by the Department, with testing on a monthly basis; and (2) The chemical and radiological standards adopted by the Department, which shall meet or exceed the standards prescribed by the federal Food and Drug Administration, with testing annually for chemical analyses and once every 4 years for radiological analyses; and (ii) If applicable, constructed and inspected in accordance with regulations adopted by the Department of the Environment under Sec.Sec. 9-204, 9-1305, and 9-1306 of the Environment Article. (2) "Approved source" includes: (i) An artesian well; (ii) A drilled well; (iii) A glacier; (iv) A public water supply; (v) A spring; and (vi) A source of mineral water that complies with the standards specified in paragraph (1) of this subsection but fails to meet the standards with respect to those properties of mineral water related to the limitations on chloride, iron, manganese, sulfate, total dissolved solids, zinc, or any other exemptions listed under 21 C.F.R. 165.110. (3) The Department may approve a source that does not meet standards regulated by the United States Environmental Protection Agency as a secondary standard if the bottler shows by analysis that a particular treatment used reduces the level of contaminants in the bottled water to a level below the maximum contaminant level. (b) The requirements of this section are in addition to any other provision of law. (c) Artesian water, mineral water, natural water, purified water, spring water, well water, and any other type of bottled water shall meet the requirements of the standard of identity for bottled water under 21 C.F.R. 165.110(a). (d) (1) A person may not bottle water unless the person is licensed by the Department under Sec. 21-305 of this subtitle. (2) The Department may not issue a license if the Department determines that the water is: (i) Not from an approved source; or (ii) In any way injurious to the public health. (3) To apply for a license to bottle water, a bottler shall: (i) Submit an application to the Department on the form that the Department requires; (ii) List on the application form the types of bottled water that the applicant proposes to bottle; and (iii) Pay to the Department an annual fee established by the Secretary under Sec. 2-104 of this article. (4) While it is effective, a license to bottle water authorizes a bottler to bottle and sell in the State the types of bottled water identified in the license. (e) (1) (i) A person who is licensed under this section shall submit to the Department the results of: (1) Annual chemical and radiological analyses of a representative sample of the person's source water and bottled water; and (2) A monthly microbiological analysis of a representative sample of the source water and bottled water. (ii) The analyses shall demonstrate that the source water and bottled water comply with the chemical, radiological, and microbiological standards adopted by the Department, which shall meet or exceed the standards prescribed by the federal Food and Drug Administration. (iii) (1) Except as otherwise required by law, mineral water is not subject to the limitations on chloride, iron, manganese, sulfate, total dissolved solids, zinc, or any other exemptions listed under 21 C.F.R. 165.110. (2) Bottled water may not exceed: (A) 10 parts per billion of total trihalomethanes; (B) 5 parts per billion of lead; or (C) 100 parts per billion of chlorine. (2) (i) Analyses required under this subsection may be performed by a laboratory certified by: (1) A state's Laboratory Certification Program in accordance with the United States Environmental Protection Agency's primacy conditions under the Agency's Public Water System Supervision Program; or (2) The United States Environmental Protection Agency. (ii) The Department shall accept analyses performed by any laboratory authorized under subparagraph (i) of this paragraph. (3) A person licensed or registered under this section shall: (i) For at least 2 years, maintain all inspection and sampling records at the person's principal place of business; and (ii) Make inspection and sampling records available to the Department upon request. (4) Notwithstanding the analyses required under paragraph (1) of this subsection, the Department may sample and analyze any bottled water. (5) The provisions of this subsection do not prevent the Department from prohibiting the use or sale of bottled water in the State, if, in the judgment of the Department: (i) The water is shown by analysis to be unfit for drinking; (ii) The water has been misbranded under Sec. 21-210 of this title; or (iii) Its quality is in any way injurious to the public health. (f) Bottled water in individual containers shall be marked on each container with a stencil, stamp, or label that clearly indicates: (1) The identifying batch code for the water; and (2) In compliance with subsection (g) of this section, the type of water and any additional ingredients. (g) Labeling of the type of bottled water and any additional ingredients, as required under subsection (f) of this section, shall conform to the labeling requirements for bottled water under 21 C.F.R. 165.110(a). (h) In accordance with regulations adopted by the Department, a person licensed under this section shall establish written procedures and implement those procedures to: (1) Prevent contamination during the processing, packaging, transportation, or storage of bottled water; and (2) Recall bottled water when the person, the Department, or any other government agency determines that a supply is injurious in any way to the public health. (i) The Department may suspend or revoke a license issued under this section if the licensee: (1) Violates or fails to satisfy any requirement of this title or any regulation adopted under this title; or (2) Fraudulently or deceptively obtains a license. (j) (1) In addition to any other penalty applicable at law, a person who violates any provision of this section shall be liable for a civil penalty of: (i) Not less than $1,000 and not more than $5,000 for a first offense; and (ii) Not less than $5,000 and not more than $10,000 for a second offense within 2 years of the first offense. (2) Each day on which a violation occurs constitutes a separate offense. (k) By October 1, 2008, the Department shall adopt regulations to implement the provisions of this section. (l) (1) The Department shall establish a Bottled Water Advisory Committee to advise and assist the Department in the development and adoption of the regulations required under subsection (k) of this section. (2) The Advisory Committee shall consist of the following representatives: (i) The Secretary of Health or the Secretary's designee, who shall serve as chairman of the Advisory Committee; (ii) The Secretary of the Environment or the Secretary's designee; (iii) A hydrogeologist; (iv) At least two individuals from the bottled water processing industry; (v) At least one individual from the bottled water distribution industry; (vi) At least one individual from the environmental community or consumer advocacy community; and (vii) At least one consumer of bottled water. #### Section 21-336.1 (a) Except as permitted under subsection (b) of this section, bottled water shall: (1) Be obtained from an approved source; and (2) Undergo: (i) Ozonation or an equivalent disinfection process approved by the Department; and (ii) When required by the Department, filtration or any other treatment that is necessary for the water to comply with the standards adopted by the Department under Sec. 21-336(e)(1)(ii) of this subtitle. (b) The Department may grant to a bottler a waiver of the filtration and disinfection treatment required under subsection (a) of this section if the Department is satisfied that the filtration and disinfection treatment are not necessary to assure that a bottled water product will consistently comply with the microbiological standards under this subtitle. (c) (1) Based on the bottler's demonstration of long-term baseline microbiological data that monitors the source and the product, the nature and extent of source monitoring, and source protection and bottling sanitation procedures instituted by the bottler, a waiver may be granted if: (i) The product and source are in compliance with the Codex Alimentarius standard for natural mineral water, CAC/RS 108, as amended, and the requirements under Sec. 21-336(a)(2) and (e) of this subtitle; (ii) The product and source are in compliance with the Code of Hygienic Practice of the Codex Alimentarius, Alinorm 85/13A, as amended, for the collection, processing, and marketing of natural mineral water; and (iii) The bottler has submitted a basic hydrogeological survey of the source, a hydrogeological assessment that demonstrates that the source is not under the direct influence of surface water, and an annual sanitary survey, all of which have been prepared by a professionally qualified hydrogeologist and which demonstrate the integrity of the source. (2) The annual sanitary survey required under paragraph (1)(iii) of this subsection shall include: (i) Watershed surveillance that includes an inspection of those portions of the drainage area necessary to identify and evaluate actual and probable sources of contamination; (ii) Evaluation of source construction and protection, and, when appropriate, intake structures and transmission facilities; and (iii) Evaluation of finished water storage facilities. (d) Once a waiver has been granted under this section: (1) A bottler shall renew the waiver of the filtration and disinfection treatment provided under subsection (b) of this section on an annual basis if a continuation of operations is desired by submitting a letter of compliance with subsection (c) of this section from a representative of the bottler to the Department. (2) The representative of the bottler shall certify under personal knowledge and penalty of perjury that the conditions under subsection (c) of this section on which the waiver was granted have not changed. (3) The representative of the bottler shall have a continuing obligation to notify the Department of any change of a condition under subsection (c) of this section not later than 5 days from the date of the change. (4) The product shall be bottled: (i) In an enclosed filling room or chamber that is under positive pressure of filtered purified air; and (ii) At a facility and with good manufacturing practices that comply with the requirements of 21 C.F.R. Part 129. (e) If a bottled water product is not in compliance with any requirement under subsection (c) or (d) of this section: (1) The Department shall revoke the waiver; and (2) The product shall be subject to the filtration and disinfection treatment requirements under subsection (a) of this section. (f) Except for filtration and disinfection treatment, this section may not be construed to waive any requirement that is applicable under this subtitle to a bottled water product. #### Section 21-339 (a) In this section, "repack crab meat" means to take or remove crab meat from any container or package, when the crab meat has been picked from a crab at another location, and place that crab meat in another container or package. (b) Each container of crab meat shall be marked plainly with the information required by this section. (c) (1) Each container of crab meat shall be marked by: (i) Embossing; (ii) Imprinting; (iii) Lithography; or (iv) Subject to paragraph (2) of this subsection, any other method that the Department approves. (2) Unless approved by the Secretary, a container of crab meat may not be stamped with ink. (d) (1) Each container of crab meat shall be marked with: (i) A description of the product in the container; (ii) Subject to the requirements of paragraph (2) of this subsection, the name and address of the picking plant or the distributor; (iii) If a chemical is added to the crab meat, a statement to that effect; (iv) The license number of the crab meat plant preceded by the State abbreviation applicable to the picking plant; (v) The net weight of the contents of the container; and (vi) Any other information that the Department requires. (2) If a container of crab meat is marked with the name of the distributor, the name of the distributor shall be: (i) Preceded by the words "packed for" or "distributed by"; or (ii) Followed by the word "distributor". (e) A person may not put any false or misleading statement on a container of crab meat. (f) (1) A person may not repack crab meat or change crab meat containers or container lids with the intent to sell the crab meat except as provided by the Department. (2) (i) A person may not possess more than 12 empty crab meat containers or container lids unless the person: (1) Is a manufacturer of containers or lids; (2) Is a licensed crab meat packer and the containers or lids are the same as used by the packer in the ordinary course of business; (3) Has removed the crab meat from the containers and lids for consumption on the premises; or (4) Is in possession of the containers or lids as provided for by the Department. (ii) Possession of empty containers or crab meat container lids in violation of this section shall be presumptive evidence of intent to repack crab meat in violation of this Part VI of this subtitle. (iii) Possession of crab meat containers or crab meat container lids from which the crab meat has been consumed or cooked for consumption and which have been properly disposed of may not constitute presumptive evidence of intent to repack or change crab meat containers for sale. (g) (1) Notwithstanding any other provision of law, each container of crab meat sold in the State containing crab meat picked from a crab, packed, repacked, or processed outside of the United States shall be marked with the words "This product contains crab meat from (name of country of origin)". (2) The marking required by paragraph (1) of this subsection shall be prominently displayed in letters not smaller than 12-point type on the principal display panel of the container so as to be easily read by the consumer. #### Section 21-340 All crab meat sold in this State, whether processed in a crab meat plant in this State or in a crab meat plant outside this State, shall comply with this subtitle and meet the standards set by the regulations adopted under this subtitle. #### Section 21-341 (a) A person may not process, sell, or keep for sale, as crab meat, anything that is not crab meat. (b) A person may not process or sell for human consumption crab meat that: (1) Contains any filthy, putrid, or decomposed substance or is otherwise unfit for human consumption; (2) Has been packed or pasteurized in violation of this subtitle; or (3) Has been packed, prepared, or held under conditions that may have allowed the crab meat to become: (i) Contaminated with filth; or (ii) Injurious to health. (c) (1) A licensee may not possess, with intent to sell for human consumption, any crab meat, the processing or sale of which would be a violation of this section. (2) Possession by a licensee of any crab meat, the processing or selling of which would be a violation of this section, is presumptive evidence of intent to sell the crab meat for human consumption. #### Section 21-343 The Secretary shall seize and condemn any crab meat that does not comply with this subtitle. #### Section 21-346 Except for shellstock that is imported into this State for replanting under the direction of the Department of Natural Resources, or commercially sterile shellfish or shellfish products, a person may not import shellfish into this State unless the shellfish is from a source certified by the appropriate agency responsible for interstate shellfish shipment. #### Section 21-347 (a) Unless the shellfish contained in the food comes from a source certified by the appropriate agency responsible for interstate shellfish shipment, a person may not import into this State any food that contains shellfish. (b) Each processor of food that contains shellfish that is imported into this State shall: (1) Keep on file proof that the shellfish is from a source certified by the appropriate agency responsible for interstate shellfish shipment; and (2) Provide this proof to the Department on request. #### Section 21-348 A person may not process, sell, or keep for sale any shellfish or any food that contains shellfish if the shellfish involved is from an unknown or uncertified source. #### Section 21-349 The Department may: (1) Detain and take any necessary action on any shipment of shellfish or any food that contains shellfish if the shellfish involved is from an unknown or uncertified source; and (2) Condemn and destroy any shellfish or any food that contains shellfish if the shellfish involved is from an uncertified source. #### Section 21-350 (a) (1) Any vehicle that is used to transport, store, or sell shellfish for commercial purposes or processed crabs for commercial purposes shall be capable of maintaining the shellfish or processed crabs at a temperature established by the Department. (2) This subsection does not apply to a licensed harvester of shellfish who delivers the shellfish in a vehicle to a processor, retailer, or wholesaler on the day of harvest. (b) Any shellfish or processed crabs that are transported by, sold from, or stored in any vehicle for commercial purposes shall be maintained at a temperature established by the Department. ### Subtitle 4. Milk Products #### Section 21-401 (a) In this subtitle the following words have the meanings indicated. (b) "Bobtailer" means a person who operates or controls a Grade A milk route and distributes Grade A pasteurized milk products that the person buys from a Grade A distributor or a milk processor. (c) "Bulk milk hauler/sampler" means any person who collects official samples and transports raw milk from a farm or raw milk products or both to or from a milk plant, receiving station, or transfer station and who possesses a permit from any state to sample the milk or raw milk products. (d) "Certified industry dairy farm inspector" means an individual who is certified by the Secretary under Sec. 21-414 of this subtitle. (e) "Dairy farm" means a place where at least 1 cow, goat, or other hooved mammal is kept, and from which the milk is sold or offered for sale. (f) "Departmental inspection area" means the area in which the Department routinely makes inspections under this subtitle. (g) "Farmstead cheese" means cheese made on a dairy farm: (1) Using only the raw milk produced by the herd or flock on the dairy farm; and (2) That meets the definitions and standards of a hard cheese established in 21 C.F.R. 133. (h) "Grade A distribution station" means any place or vehicle where, for redistribution and sale, Grade A pasteurized milk products routinely are received, stored, or transferred. (i) "Grade A distributor" means a person who sells a Grade A pasteurized milk product. (j) (1) "Grade A milk product" means: (i) Grade A milk; (ii) Grade A cream; or (iii) Any other Grade A milk product that the Secretary designates. (2) "Manufactured grade milk product" means: (i) Manufactured grade milk; (ii) Manufactured grade cream; or (iii) Any other manufactured grade milk product that the Secretary designates. (k) "Grade A Pasteurized Milk Ordinance" means the recommended Grade "A" Pasteurized Milk Ordinance published by the federal government. (l) (1) "Milk" means the milk of a cow, goat, or other hooved mammal. (2) "Grade A milk" means the milk of a cow, goat, or other hooved mammal produced, processed, pasteurized, bottled, packaged, or prepared in accordance with the Grade A Pasteurized Milk Ordinance. (3) "Manufactured milk" means the milk of a cow, goat, or other hooved mammal which is not Grade A milk and which is produced, processed, pasteurized, bottled, packaged, or prepared in accordance with "Milk for Manufacturing Purposes and Its Production and Processing: Recommended Requirements". (m) "Milk fat" means the natural fat of milk. (n) "Milk for Manufacturing Purposes and Its Production and Processing: Recommended Requirements" means the Milk for Manufacturing Purposes and Its Production and Processing: Recommended Requirements published by the U.S. Department of Agriculture. (o) (1) "Milk plant" means any place where, for distribution, milk products are: (i) Processed; (ii) Pasteurized; (iii) Bottled or packaged; or (iv) Prepared. (2) "Milk plant" does not include a place where milk products are sold at retail only. (p) "Milk processor" means a person who owns, operates, or controls a milk plant. (q) "Milk producer" means a person who operates a dairy farm. (r) "Milk tank truck" means a truck and its equipment that are used to transport milk products. (s) "Milk transportation company" means a person responsible for a milk tank truck. (t) "Misbranded milk product" means a milk product: (1) That is in a container that bears or is accompanied by any false or misleading written, printed, or graphic material; or (2) That is not labeled in accordance with this subtitle. (u) (1) "Pasteurized" means having undergone the process of uniformly heating each particle of milk product, holding it in the heated state, and cooling it, in approved and properly operated equipment and under the conditions of temperature and time that the Secretary by rule or regulation establishes, to make the milk product safe and free of pathogens. (2) "Pasteurized" includes having undergone any other process that: (i) Is recognized by the appropriate federal authority to be equally as effective as the process described in paragraph (1) of this subsection in making milk products safe and free of pathogens; and (ii) Is approved by the Secretary. (v) "Permit" means a permit issued by the Secretary under this subtitle that authorizes the holder of the permit to do any act that is within the scope of the permit. (w) "Raw milk" means unpasteurized milk. (x) "Receiving station" means any place where, for delivery to a milk plant, raw milk is collected, cooled, and stored. (y) "Transfer station" means a place where milk is transferred directly from a milk tank truck to another milk tank truck for delivery to a milk plant. #### Section 21-402 The General Assembly finds that statewide laws, rules, and regulations are needed to govern the production, processing, labeling, and distribution of milk products in this State. #### Section 21-403 This subtitle applies only to milk products that are intended for sale for immediate or eventual human consumption. #### Section 21-404 (a) A political subdivision may not regulate any milk product that is produced, processed, and manufactured in accordance with this subtitle and the rules and regulations adopted under this subtitle. (b) Any milk product that is produced, processed, and manufactured in accordance with this subtitle and the rules and regulations adopted under this subtitle may be sold anywhere in this State. #### Section 21-405 (a) Except as otherwise provided in this subtitle or by a rule or regulation adopted under this subtitle, this subtitle and the rules and regulations adopted under this subtitle shall be interpreted in accordance with the Grade A Pasteurized Milk Ordinance. (b) For all manufactured milk products and activities, this subtitle and the rules and regulations adopted under this subtitle shall be interpreted in accordance with Milk for Manufacturing Purposes and Its Production and Processing: Recommended Requirements. (c) The Secretary shall keep on file a certified copy of the Grade A Pasteurized Milk Ordinance. (d) The Secretary shall keep on file a certified copy of Milk for Manufacturing Purposes and Its Production and Processing: Recommended Requirements. #### Section 21-406 The Secretary shall adopt rules and regulations to carry out the provisions of this subtitle. #### Section 21-407 The Secretary shall pay all funds collected under this subtitle into the General Fund of this State. #### Section 21-410 (a) Except as otherwise provided in this section, a person shall obtain a permit with a Grade A or a manufactured grade classification from the Secretary before that person may: (1) Bring, send, or receive a milk product into this State for sale; (2) Offer a milk product for sale; (3) Give a milk product away; (4) Store a milk product; or (5) Transport a milk product. (b) A permit is required to: (1) Be a bobtailer; (2) Be a bulk milk hauler/sampler; (3) Be a certified industry dairy farm inspector; (4) Be a milk processor; (5) Be a milk processor - farmstead cheese producer; (6) Be a milk producer; (7) Operate a distribution station; (8) Operate a milk transportation company; (9) Operate a receiving station; or (10) Operate a transfer station. (c) A permit is not required for: (1) A milk producer who is outside the departmental inspection area if the raw milk from that milk producer is processed by a milk processor who holds a permit issued under this subtitle; (2) A bulk milk hauler/sampler who receives raw milk from outside the departmental inspection area; (3) A grocery store, restaurant, soda fountain, or similar establishment where milk products are served or sold at retail if: (i) The establishment complies with all applicable provisions of this subtitle and all applicable rules or regulations adopted under this subtitle; and (ii) The milk product is received from a permit holder; or (4) A bulk milk hauler/sampler who is transporting a sealed tanker and not producers' samples. (d) The Secretary shall designate all permits with one of the following classifications, as required by rules and regulations: (1) Grade A milk; or (2) Manufactured milk. #### Section 21-411 (a) To qualify for a permit, a person shall comply with the requirements of this subtitle and the rules and regulations adopted under this subtitle. (b) In addition to the requirements of subsection (a) of this section, to qualify for a certified industry dairy farm inspector permit or a bulk milk hauler/sampler permit, Grade A classification, the applicant shall meet the requirements of the Grade A Pasteurized Milk Ordinance. (c) In addition to the requirements of subsection (a) of this section, to qualify for a certified industry dairy farm inspector permit or a bulk milk hauler/sampler permit, manufactured milk classification, the applicant shall meet the requirements of Milk for Manufacturing Purposes and Its Production and Processing: Recommended Requirements. #### Section 21-412 An applicant for a permit shall: (1) Submit an application to the Secretary on the form that the Secretary provides; and (2) Pay to the Secretary an annual fee established by the Secretary under Sec. 2-104 of this article. #### Section 21-413 (a) If the property of the applicant is in the departmental inspection area, before issuing a permit, the Secretary shall inspect the property, buildings, and equipment of an applicant for: (1) A bobtailer permit; (2) A distribution station permit; (3) A milk processor permit; (4) A milk processor - farmstead cheese producer permit; (5) A milk producer permit; (6) A milk transportation company permit; (7) A receiving station permit; or (8) A transfer station permit. (b) Each inspection under this section shall be to determine whether the property, buildings, equipment, and their operation conform to the rules and regulations adopted under this subtitle. (c) To ensure continued conformity to the rules and regulations adopted under this subtitle, the Secretary from time to time shall reinspect the property, buildings, and equipment of each permit holder for whom an initial inspection is required under this section. #### Section 21-414 (a) The Secretary shall certify industry personnel as certified industry dairy farm inspectors. (b) Each certified industry dairy farm inspector shall cooperate with the Secretary in carrying out the provisions of this subtitle and the rules and regulations adopted under this subtitle for the supervision of dairy farms. (c) A certified industry dairy farm inspector may inspect a dairy farm to determine whether the dairy farm complies with this subtitle and the rules and regulations adopted under this subtitle for dairy farms. (d) A certified industry dairy farm inspector may not: (1) Take punitive action; or (2) Make an inspection for the issuance or reinstatement of a permit. (e) Each certified industry dairy farm inspector shall send to the Secretary a report of each inspection that the certified industry dairy farm inspector makes. #### Section 21-415 (a) The Secretary shall issue the appropriate permit to any applicant who meets the requirements of this subtitle and the rules and regulations adopted under this subtitle for that permit. (b) A separate permit shall be issued for each place of operation that meets the requirements of this subtitle. #### Section 21-416 (a) While it is effective, a bobtailer permit authorizes the holder, on a Grade A milk route that the holder operates or controls, to distribute Grade A pasteurized milk products that the holder purchased from a Grade A distributor or a Grade A milk processor. (b) While it is effective, a certified industry dairy farm inspector permit authorizes the holder to inspect dairy farms in accordance with this subtitle. (c) While it is effective, a distribution station permit authorizes the holder, for redistribution and sale, whether from a fixed location or from a vehicle: (1) To receive Grade A pasteurized milk products; (2) To store Grade A pasteurized milk products; and (3) To transfer Grade A pasteurized milk products for redistribution and sale. (d) (1) While it is effective, a milk processor permit authorizes the holder: (i) To collect raw milk; (ii) To handle raw milk; (iii) To process raw milk; (iv) To pasteurize raw milk; (v) To store pasteurized milk; (vi) To bottle or package pasteurized milk; (vii) To prepare pasteurized milk for distribution; and (viii) To distribute pasteurized milk. (2) While it is effective, a milk processor - farmstead cheese producer permit authorizes the holder: (i) To perform all the functions set forth in paragraph (1) of this subsection; and (ii) To produce farmstead cheese. (e) While it is effective, a milk producer permit authorizes the holder: (1) To operate a dairy farm; and (2) To sell raw milk from the dairy farm to: (i) A receiving station; (ii) A transfer station; or (iii) A milk plant. (f) While it is effective, a bulk milk hauler/sampler permit authorizes the holder, while operating a milk tank truck: (1) To receive raw milk products from a milk producer, milk plant, receiving station, or transfer station; (2) To transport raw milk products that have been received from a milk producer, milk plant, receiving station, or transfer station; and (3) To deliver raw milk products that have been received from a milk producer, milk plant, receiving station, or transfer station. (g) While it is effective, a receiving station permit authorizes the holder: (1) To collect raw milk; (2) To cool raw milk; (3) To process raw milk; (4) To store raw milk; and (5) To prepare raw milk for delivery to a milk plant. (h) While it is effective, a transfer station permit authorizes the holder to operate a place where raw milk is transferred between milk tank trucks for eventual delivery to a milk plant. (i) A permittee authorized to perform a function under this subtitle shall only exercise that authority as to the classification for which it is designated, except that: (1) Unless otherwise specified in this subtitle, a milk producer permittee with a Grade A classification authorized to perform a function under this subtitle may exercise that authority for manufactured milk; and (2) A milk processor, receiving station, or transfer station with a manufactured milk classification may exercise that authority using Grade A raw milk. (j) While it is effective, a milk transportation company permit authorizes the holder to operate one or more milk tank trucks. #### Section 21-416.1 (a) The Secretary may establish a farmstead cheese program after the Secretary: (1) Adopts regulations to implement the program; and (2) Issues a milk processor - farmstead cheese producer permit to a qualified applicant. (b) Subject to the availability of sufficient inspection and testing staff, equipment, and other resources, the Secretary may issue milk processor - farmstead cheese producer permits under the program. (c) To qualify for a milk processor - farmstead cheese producer permit the applicant shall meet any requirements established by the Department by regulation. #### Section 21-417 (a) (1) Except for a milk producer permit, a permit expires on the first anniversary of its effective date, unless the permit is renewed for a 1-year term as provided in this section. (2) A milk producer permit does not expire. (b) Except for a milk processor - farmstead cheese producer permit, before the permit expires, its holder may renew it for an additional 1-year term, if the holder: (1) Otherwise is entitled to a permit; (2) Pays to the Secretary a renewal fee equal to the fee for an original permit of the same type; and (3) Submits to the Secretary a renewal application on the form that the Secretary requires. (c) (1) Except for a milk processor - farmstead cheese producer permit, the Secretary shall renew the permit of each applicant for renewal who meets the requirements of this section. (2) Subject to the ongoing availability of sufficient inspection and testing staff, equipment, and other resources, the Secretary may renew a milk processor - farmstead cheese producer permit for an additional 1-year term if the holder meets the requirements established by regulation. (d) A permit is not transferable. #### Section 21-418 (a) Subject to the hearing provisions of Sec. 21-419 of this subtitle, the Secretary shall suspend a permit issued under this subtitle if: (1) The holder of the permit has obtained the permit fraudulently or deceptively; (2) The holder of the permit has violated this subtitle or a rule or regulation adopted under this subtitle; (3) A violation of this subtitle or a rule or regulation adopted under this subtitle exists at the place for which the permit has been issued under this subtitle; (4) A health hazard exists at the place for which the permit has been issued or exists as to the individual who holds the permit; or (5) The holder of the permit has interfered with the Secretary in the performance of the Secretary's duties. (b) (1) Except as otherwise provided in this section, before suspending a permit, the Secretary shall give to the holder of the permit notice of intent to suspend. (2) The notice shall: (i) Specify with particularity the condition or violation that the Secretary believes to justify the suspension; and (ii) State that the holder has an opportunity to correct the condition or violation before a time that is: (1) At least 48 hours after the holder receives the notice of intent to suspend; and (2) Agreed on by the parties or set by the Secretary. (c) The Secretary is not required to give notice of intent to suspend a permit if: (1) The violation creates an imminent hazard to public health; or (2) The holder of the permit has willfully refused to permit an authorized inspection. (d) If a permit has been suspended more than once, the Secretary may revoke the permit. #### Section 21-419 (a) Except as otherwise provided in this subtitle and in the Administrative Procedure Act, before the Secretary denies an application for a permit or takes any action under Sec. 21-418 of this subtitle, the Secretary shall give the person against whom the action is contemplated an opportunity for a hearing before the Secretary. (b) Except as otherwise provided in this section, the Secretary shall give notice and hold the hearing in accordance with the Administrative Procedure Act. (c) (1) Within 48 hours after the person receives notice of the Secretary's action, a person whose permit has been suspended or who has received a notice that the Secretary intends to suspend the permit may request a hearing. (2) Within 72 hours after receiving the request for a hearing, the Secretary shall hold the hearing. (d) If after due notice the person for whom the hearing is held fails or refuses to appear, nevertheless the Secretary may hear and determine the matter. (e) A person aggrieved by a final decision of the Secretary in a contested case, as defined by the Administrative Procedure Act, may take a direct judicial appeal. #### Section 21-422 (a) The raw milk that a milk producer sells shall be raw milk that: (1) Is obtained by the complete milking of a healthy cow or goat; (2) Is unadulterated, whole, and unadjusted; and (3) Is practically free of colostrum. (b) The pasteurized milk products that a distributor, bobtailer, or milk processor sells shall: (1) Be pasteurized; and (2) Meet all definitions and standards of identity established by federal law and regulation. #### Section 21-424 After the milk product has been processed, each milk product shall be labeled with: (1) The description of that milk product under this subtitle or the rules and regulations adopted under this subtitle; and (2) Any other information that the Secretary requires by rule or regulation. #### Section 21-425 (a) (1) In this section the following words have the meanings indicated. (2) "Condensed milk" includes sweetened condensed milk and evaporated milk. (3) "Condensed skimmed milk" includes sweetened condensed skimmed milk and evaporated skimmed milk. (4) "Dry milk solids" includes dry buttermilk, dry cream, dry whole milk, and nonfat dry milk solids. (b) (1) Condensed milk: (i) Shall be manufactured from pure and wholesome milk; (ii) Shall contain at least 25.5 percent milk solids and at least 7.5 percent milk fat; (iii) Shall contain, within the limits of good manufacturing practice, at least 25 international units of vitamin D per fluid ounce; and (iv) May contain any optional ingredient that is authorized under federal law. (2) Condensed skimmed milk: (i) Shall be manufactured from pure and wholesome skimmed milk; (ii) Shall contain at least 20 percent milk solids and not more than 0.5 percent fat; (iii) Shall contain, within the limits of good manufacturing practice, at least 25 international units of vitamin D per fluid ounce; and (iv) May contain any optional ingredient that is authorized under federal law. (3) Dry milk solids: (i) Shall be manufactured from pure and wholesome milk, skimmed milk, buttermilk, or cream; and (ii) May not contain any substance foreign to milk. (c) (1) Each package or container in which condensed milk, condensed skimmed milk, or dry milk solids are sold or delivered shall be labeled clearly and accurately to show the exact type of product in the package. (2) The label shall be in letters not smaller or less distinct than any other letters on the package or container except letters used for the brand or trade name. (d) A person may not manufacture, sell, exchange, deliver, advertise, label, or expose for sale, under a distinctive name or otherwise, any milk product for which a standard is set under this section unless the milk product conforms to that standard. #### Section 21-426 (a) In this section, "sell-by period" means the length of time a Grade A milk product may be kept for sale. (b) (1) After a public hearing, the Secretary shall adopt rules and regulations that establish a method for conspicuously marking, on the Grade A milk product container, the last date on which the product may be sold. (2) Each Grade A milk product container shall be marked as required by rules and regulations adopted under this subtitle. (c) The Secretary shall adopt regulations that establish the sell-by period for a Grade A milk product that is cooled to, packaged, and stored at 45 degrees Fahrenheit or less before it is purchased by or delivered to the ultimate consumer. #### Section 21-427 (a) Unless the transfer occurs on a dairy farm or in a receiving station, transfer station, or milk plant, a person may not transfer a milk product from a container or milk tank truck to another. (b) (1) This subsection does not apply to milk for a mixed drink that requires less than 8 ounces of milk. (2) Except as otherwise provided in this subsection, a person may not sell or serve any fluid milk product unless it: (i) Is in the individual, original container that was sealed in the milk plant in which the milk product was pasteurized; or (ii) Is served or sold from a bulk milk dispenser approved by the Secretary. (3) A person may serve cream, whipped cream, or half and half from other than the original container or an approved bulk milk dispenser, if the cream, whipped cream, or half and half: (i) Is served for consumption at the place of sale; or (ii) Is served from an original container of not more than one-half gallon capacity or from a bulk dispenser. (c) (1) In this subsection, "consumer container" means a container that: (i) Contains a milk product; and (ii) Is intended for delivery to the ultimate consumer of the milk product. (2) A person may not store a consumer container in water. (3) A person may not store a consumer container in ice unless the person drains the water from the melting ice properly. (d) Except as approved by the Secretary, a person may not use or permit the use of any apparatus, equipment, utensil, or container that is intended for use in the processing and packaging of a milk product for any other purpose. #### Section 21-428 (a) (1) The Secretary shall impound a milk product that the Secretary determines is a threat to public health. (2) For purposes of this subsection, a threat to public health exists if a milk product intended for consumption: (i) Is handled improperly; (ii) Is not kept at the required temperature; (iii) Is injurious to health if consumed; or (iv) Is otherwise unsafe. (b) If the Secretary impounds a milk product under subsection (a) of this section, the Secretary may issue an order to dispose of the milk product, make the milk product unusable for consumption, or impose a civil monetary penalty in accordance with the health laws and regulations of the State. (c) (1) The owner of the milk product that is disposed of or otherwise made unusable under subsection (b) of this section may bring an action for damages against the Secretary. (2) The Secretary shall have the immunity from liability described in Sec. 5-633 of the Courts Article in any action brought under this subsection. (d) (1) An order of the Secretary that imposes a civil monetary penalty under subsection (b) of this section shall state the basis on which the order is made, the amount of the penalty, and the manner in which the amount of the penalty is calculated as specified by regulations adopted by the Secretary in accordance with paragraph (2) of this subsection. (2) The regulations adopted under paragraph (1) of this subsection shall provide for how the civil money penalty will be adjusted according to the volume of milk found to be unusable for consumption. (3) A person subject to a civil monetary penalty imposed under subsection (b) of this section may appeal the order that imposes the penalty in accordance with Title 10, Subtitle 2 of the State Government Article. (e) Subsections (a), (b), (c), and (d) of this section do not apply to a retail establishment. (f) If a retail establishment repeatedly fails to handle and maintain milk products properly, the Secretary, after due notice, may order that retail establishment to stop selling milk products until the establishment shows that it can and will handle and keep its milk products properly. #### Section 21-429 (a) If a Grade A milk product is from a place outside the departmental inspection area, a person may sell the Grade A milk product in this State if: (1) The person holds a permit issued under this subtitle; and (2) The Grade A milk product: (i) To the extent produced, processed, or pasteurized outside the departmental inspection area, is produced, processed, and pasteurized under requirements that are substantially equivalent to the requirements of this subtitle and of rules and regulations adopted under this subtitle; and (ii) Is from an establishment that has a current individual United States Public Health Service rating of at least 90 from a State milk sanitation rating officer who is certified by the appropriate federal authority and listed in the interstate milk shippers report published by the appropriate federal authority. (b) (1) The Secretary may inspect the property, buildings, or equipment of any permit holder whose Grade A milk product has been produced, processed, or pasteurized outside the departmental inspection area. (2) The person inspected shall pay the cost of the inspection. (3) The Department shall bill and collect the cost of the inspection. (c) A person may not sell in this State any Grade A milk product produced by a dairy farm, milk plant, or frozen dessert manufacturer that is in a jurisdiction that does not authorize milk products or frozen desserts to be imported from this State. #### Section 21-430 (a) In this section, "milk emergency": (1) Means a general and acute shortage of milk from Grade A dairy farms; and (2) Does not include a simple shortage of milk from Grade A dairy farms that affects only a small number of distributors. (b) (1) In a milk emergency, the Secretary may authorize the sale of a pasteurized milk product that has not been certified as Grade A pasteurized milk. (2) A person who sells a milk product under this subsection shall label the milk product as the Secretary requires. #### Section 21-433 A person may not violate any provision of this subtitle or any rule or regulation adopted under this subtitle. #### Section 21-434 Except for sale of raw milk by a holder of a milk producer permit to a holder of a milk processor permit or the sale of a farmstead cheese, a person may not sell raw milk for human consumption. #### Section 21-435 (a) (1) An individual who has a communicable disease or is a carrier of a communicable disease may not work, in any capacity that brings that individual into contact with the production, handling, storage, or transportation of milk products, containers, equipment, or utensils, at: (i) A dairy farm; (ii) A milk plant; (iii) A receiving station; or (iv) A transfer station. (2) A person who operates a dairy farm, transfer station, receiving station, or milk plant may not employ any individual: (i) Who, if employed, would violate paragraph (1) of this subsection; or (ii) Whom the employer reasonably believes would violate paragraph (1) of this subsection if employed. (b) Each holder of a permit for a receiving station, transfer station, or as a distributor, milk processor, or milk producer shall notify the Secretary immediately if: (1) A communicable disease affects any individual on that person's dairy farm, distribution station, receiving station, transfer station, or milk plant; or (2) That person suspects that any employee of that person has contracted a communicable disease or has become a carrier of a communicable disease. (c) An individual who has an infected cut or lesion on a hand or arm may not handle any milk product, milk container, or milk equipment. (d) (1) The Secretary may make or require a reasonable medical and biological examination of an individual who is suspected of having any communicable disease. (2) An examination under this subsection may include examination of the bodily discharges of the individual. #### Section 21-436 (a) In this section, "labeled milk can" means any milk can, cream can, or case that: (1) Belongs to an owner, dealer, or shipper of milk or cream who ships the milk or cream to any place in this State; and (2) Has the name or initials of the owner, dealer, or shipper stamped, marked, or fastened on it. (b) A person may not: (1) Use, sell, dispose of, buy, or traffic in labeled milk cans, without the consent of the owner, dealer, or shipper; (2) Willfully change the name or initials of the owner, dealer, or shipper stamped, marked, or fastened on the labeled milk can without the consent of the owner, dealer, or shipper; or (3) Place in any labeled milk can any substance other than milk or cream, without the consent of the owner, dealer, or shipper. ### Subtitle 8. Frozen Desserts #### Section 21-801 (a) In this subtitle the following words have the meanings indicated. (b) "Frozen dessert" means: (1) Ice cream and frozen custard; (2) Ice milk; (3) Mellorine; (4) Sherbet; (5) Water ice; (6) Goat milk ice cream and goat milk frozen custard; (7) Goat milk ice milk; (8) Quiescently frozen confection; (9) Quiescently frozen dairy confection; or (10) (i) Any frozen food product that is similar in appearance, odor, or taste to any of the products listed in this subsection; (ii) Any frozen food product that is prepared or frozen in the same way as any of the products listed in this subsection; or (iii) The mix that is used in any of the products listed in this subsection. (c) "License" means a license issued by the Secretary to manufacture in this State a frozen dessert or a mix for a frozen dessert. #### Section 21-802 (a) If there is an outside container or wrapper for a frozen dessert or a mix for a frozen dessert, then, in order to comply with any requirement under this subtitle that a word, statement, or any other information appear on the label of the frozen dessert or mix, the word, statement, or other information also shall: (1) Be placed on the outside container or wrapper; or (2) Be legible through the outside container or wrapper. (b) For purposes of the construction and enforcement of this subtitle, an act or omission of any officer, agent, employee, or any other person employed by any corporation, company, or association, shall be considered to be the act or omission of the corporation, company, society, or association, as well as of the person. #### Section 21-803 (a) The Secretary shall provide a copy of this subtitle: (1) To the extent possible, to every person who in this State manufactures or sells, at wholesale or retail, any frozen dessert or mix for a frozen dessert; and (2) To any person who requests it. (b) The Secretary may: (1) Publish summaries of judgments, decrees, or court orders issued under this subtitle; and (2) Otherwise collect, report, or illustrate the results of any investigation conducted under this subtitle. #### Section 21-804 (a) To prevent deception in the sale of frozen desserts and to safeguard the health and welfare of consumers, the Secretary shall adopt rules and regulations that: (1) Provide definitions and set standards of identity for frozen desserts and the mixes used in the manufacture of frozen desserts; (2) Set packaging, labeling, and sanitary requirements for frozen desserts; and (3) Govern any other condition that relates to the manufacture, processing, distribution, or sale of frozen desserts, whether manufactured or processed in a regular manufacturing plant, in a counter freezer, or otherwise. (b) So far as practicable, the Secretary may conform any rule or regulation adopted under this subtitle to the rules and regulations adopted under the federal act. (c) (1) The Secretary may not adopt a rule or regulation under this section unless the requirements of this subsection and the Administrative Procedure Act are met. (2) A public hearing shall be held on any rule or regulation that the Secretary considers under this section. Based on the record of the hearing, the Secretary shall issue a proposed decision on the rule or regulation. (3) The Secretary shall provide any interested party an opportunity to file exceptions to the proposed decision based on the hearing record. (4) When issuing a final decision regarding a rule or regulation, the Secretary also shall: (i) Rule on any exception to the Secretary's proposed decision; and (ii) State the reasons for the ruling. #### Section 21-807 (a) A person shall be licensed by the Secretary before the person may manufacture a frozen dessert or a frozen dessert mix for sale in this State. (b) A separate license is required for each manufacturing plant that a person operates. #### Section 21-808 (a) An applicant for a license shall: (1) Submit an application to the Secretary on the form that the Secretary requires; and (2) Pay to the Secretary an application fee established by the Secretary under Sec. 2-104 of this article. (b) The application fee under this section shall be based on: (1) If the applicant has a manufacturing facility located in this State, the annual production of any frozen dessert or frozen dessert mix in this State; and (2) If the applicant has a manufacturing facility not located in this State, the annual sales of any frozen dessert or frozen dessert mix in this State. (c) For each license for which a person applies, the person shall submit a separate application and pay a separate application fee. (d) The application: (1) Shall be on the form that the Secretary requires; and (2) Shall include: (i) The location of the manufacturing plant at which the frozen dessert or frozen dessert mix is manufactured; and (ii) Any brand name under which the frozen dessert or frozen dessert mix is to be sold. #### Section 21-809 (a) If an application is submitted for a license for a manufacturing plant that is in this State, before issuing the license, the Secretary shall inspect the property, buildings, and equipment of the plant to determine whether the plant meets the requirements for a license. (b) (1) To determine whether the plant meets the requirements for a license, the Secretary may inspect a manufacturing plant that is outside of this State. (2) If the Secretary does not inspect a plant outside of this State, the Secretary may not issue a license for the plant unless the applicant satisfies the Secretary that: (i) The plant and the frozen desserts or frozen dessert mixes produced in the plant conform to the laws of the jurisdiction in which the plant is located; and (ii) Those laws, rules, and regulations are at least as stringent as those that apply under this subtitle. #### Section 21-810 The Secretary shall issue a license to any applicant who meets the requirements of this subtitle. #### Section 21-811 While it is effective, a license authorizes the licensee to manufacture frozen desserts and frozen dessert mixes at the manufacturing plant identified in the license. #### Section 21-812 (a) A license expires on the first anniversary of its effective date, unless the license is renewed for a 1-year term as provided in this section. (b) At least 1 month before the license expires, the Secretary shall send to the licensee, by first-class mail to the last known address of the licensee, a renewal notice that states: (1) The date on which the current license expires; (2) The date by which the renewal application must be received by the Secretary for the renewal to be issued and mailed before the license expires; and (3) The amount of the renewal fee. (c) Before a license expires, the licensee periodically may renew it for an additional 1-year term, if the licensee: (1) Otherwise is entitled to a license; (2) Pays to the Secretary a renewal fee established by the Secretary under Sec. 2-104 of this article; and (3) Submits to the Secretary: (i) A renewal application on the form that the Secretary requires; and (ii) Satisfactory evidence of compliance with the requirements of this section for renewal. (d) The renewal fee under this section shall be based on: (1) If the licensee has a manufacturing facility located in this State, the annual production of any frozen dessert or frozen dessert mix in this State; and (2) If the licensee has a manufacturing facility not located in this State, the annual sales of any frozen dessert or frozen dessert mix in this State. (e) The Secretary shall renew the license of each licensee who meets the requirements of this section. (f) A license is not transferable. #### Section 21-813 (a) If the Secretary finds that a licensee has violated any of the provisions of this subtitle or that a violation has occurred on any premises for which a license has been issued, the Secretary immediately shall give written notice to the licensee. The notice shall set forth the nature of the violation and direct that it be stopped. (b) If a licensee fails to comply with a notice given under this section, the Secretary may suspend or revoke the license of the licensee. #### Section 21-814 (a) Except as otherwise provided in the Administrative Procedure Act, before the Secretary suspends or revokes a license under Sec. 21-813 of this subtitle or denies a license to any applicant, the Secretary shall give the individual against whom the action is contemplated an opportunity for a hearing before the Secretary. (b) The Secretary shall give notice and hold the hearing in accordance with the Administrative Procedure Act. #### Section 21-815 (a) Any applicant who has been denied a license and any licensee aggrieved by the suspension or revocation of a license under Sec. 21-813 of this subtitle may take a judicial appeal. (b) The appeal shall be made in accordance with the provisions for judicial review of final decisions in contested cases in the Administrative Procedure Act. (c) Either party may appeal the decision of the circuit court to the Appellate Court of Maryland. #### Section 21-818 A person may not manufacture for sale in this State a frozen dessert or a frozen dessert mix unless the person holds a license for the plant in which the frozen dessert or mix is manufactured. #### Section 21-819 (a) A person may not manufacture for sale in this State a frozen dessert or a frozen dessert mix: (1) While the license for the plant in which the frozen dessert or mix is manufactured is suspended; or (2) After the license: (i) Has expired; or (ii) Has been revoked. (b) The Secretary may sue to enjoin a person from repeating a violation of this section. #### Section 21-820 (a) A person may not sell any frozen dessert or frozen dessert mix that was manufactured at a plant for which a license was not then held. (b) The Secretary may sue to enjoin a person from repeating a violation of this section. #### Section 21-821 (a) Any frozen dessert manufacturer licensed by the State of Maryland and desiring to sell a product for which a frozen dessert standard has not been set shall file with the Secretary a written request for authorization. (b) Any authorization granted under this section shall not exceed a period of 1 year. ### Subtitle 11. Miscellaneous Drug and Cosmetic Provisions #### Section 21-1110 (a) This section does not apply to cosmetics, infant formula, or baby food if: (1) The cosmetics, infant formula, or baby food are being sold in a single lot at a charity auction; and (2) The total value of the cosmetics, infant formula, or baby food in the lot is $100 or less. (b) A person may not sell any drug, medicine, cosmetic, pharmaceutical preparation, medicinal preparation, or infant formula or baby food that is subject to dating requirements by the United States Food and Drug Administration at any auction sale unless the person notifies the Secretary in writing of the proposed auction at least 7 days before the date of the auction. (c) (1) The Secretary may: (i) Inspect any drugs, medicines, cosmetics, pharmaceutical preparations, medicinal preparations, infant formula, or baby food that a person proposes to sell by auction sale; and (ii) Issue an order that prohibits the sale of any of these if, in the opinion of the Secretary, they are unfit for human use or consumption. (2) A person may not hold an auction sale of any drug, medicine, cosmetic, pharmaceutical preparation, medicinal preparation, infant formula, or baby food in violation of an order issued under this section. #### Section 21-1111 (a) This section does not apply to any: (1) Surgical or dental instrument; (2) Physical therapy equipment; (3) X-ray apparatus; or (4) Component part or accessory of any of these items. (b) A person may not: (1) Sell, distribute, or otherwise dispose of any drug, medicine, pharmaceutical preparation, or medicinal preparation by means of any public exhibition, entertainment, performance, or carnival, commonly known as a "medicine show" or "patent medicine show"; or (2) Put or cause to be put, in any way, any package, parcel, or sample of any drug or medicine: (i) In or on any part of any house, building, or yard without the consent of the owner or occupant; or (ii) On any street or public highway. #### Section 21-1112 (a) (1) In this section the following terms have the meanings indicated. (2) "Authorized prescriber" means a licensed dentist, licensed physician, licensed podiatrist, licensed veterinarian, certified nurse midwife to the extent permitted under Sec. 8-601 of the Health Occupations Article, certified nurse practitioner to the extent permitted under Sec. 8-508 of the Health Occupations Article, or other individual authorized by law to prescribe prescription or nonprescription drugs or devices. (3) "Board" means a health occupation licensing board authorized to issue a permit, license, or certificate under the Health Occupations Article. (4) (i) "Controlled dangerous substance" means a drug, substance, or immediate precursor listed in Schedule I through Schedule V in Title 5 of the Criminal Law Article. (ii) "Controlled dangerous substance" does not include tobacco or a distilled spirit, wine, or malt beverage. (5) "Drug" means a prescription or nonprescription drug. (6) "Nonprescription drug" means a drug which may be sold without a prescription and which is labeled for consumer use in accordance with the requirements of the laws and regulations of this State and the federal government. (7) "Permit holder" means a holder of, or applicant for: (i) A pharmacy permit or distributor's permit issued by the State Board of Pharmacy under Title 12 of the Health Occupations Article; (ii) A dispensing permit issued by a board under the authority of Sec. 12-102(c)(2) of the Health Occupations Article; or (iii) A controlled dangerous substances registration issued by the Office of Controlled Substances Administration under Sec. 5-301(a)(1) of the Criminal Law Article. (8) "Prescription drug" means a drug that under Sec. 21-220 of this title may be dispensed only on the prescription of a health practitioner who is authorized by law to prescribe the drug. (b) (1) The Department may issue an order of impoundment and immediately impound drugs, bulk powders and chemicals, or prescription records of a permit holder or an authorized prescriber if: (i) A permit holder's permit or authorized prescriber's license has expired or has been revoked or suspended; (ii) An application for a permit or license has been denied; (iii) A board has: (1) Determined that the permit holder or authorized prescriber failed to comply with a board order, letter of surrender, or law regarding the disposition of drugs, bulk powders and chemicals, or prescription records; and (2) Requested that the Department impound the drugs, bulk powders and chemicals, or prescription records; (iv) The drugs or bulk powders and chemicals pose an imminent threat to the public health, safety, or welfare; or (v) The confidentiality of the prescription records is in imminent danger of being compromised. (2) The Department may not impound the drugs, bulk powders and chemicals, or prescription records of a permit holder or authorized prescriber who is in compliance with a board order or law specifically providing for the manner of the disposition of drugs, bulk powders and chemicals, or prescription records. (c) (1) Except as otherwise provided in paragraph (2) of this subsection, the Department shall: (i) Attempt to serve written notice of an impoundment on the permit holder or authorized prescriber; (ii) Provide the permit holder or authorized prescriber with an opportunity to avoid impoundment by allowing the permit holder or authorized prescriber to dispose of the drugs, bulk powders and chemicals, or prescription records in a manner acceptable to the Department; (iii) Provide the permit holder or authorized prescriber with an opportunity prior to impoundment to review the nature, type, and amount of information upon which the Department issued the impoundment order; and (iv) Provide the permit holder or authorized prescriber with an opportunity to avoid impoundment by providing the Department with information upon which the Department could reasonably conclude that the impoundment is not warranted. (2) If drugs or bulk powders and chemicals pose an imminent threat to the public health, safety, or welfare, or if the confidentiality of prescription records is in imminent danger of being compromised, the Department may: (i) Issue an impoundment order; and (ii) Immediately impound drugs, bulk powders and chemicals, or prescription records without prior notice to the permit holder or authorized prescriber. (d) An order of impoundment constitutes a final order subject to judicial review under the State Administrative Procedure Act. (e) The Department shall provide the permit holder or authorized prescriber with a list of all drugs, bulk powders and chemicals, and prescription records impounded. (f) The Department may charge reasonable fees to recover the costs of the collection, storage, and disposition of drugs, bulk powders and chemicals, or prescription records. (g) The Department shall adopt regulations governing the disposition of impounded drugs, bulk powders and chemicals, and prescription records. (h) Prior to issuing an order of impoundment, the Department, with the approval of the Board of Pharmacy, shall develop regulations concerning: (1) The nature, type, and amount of information upon which the Department may rely to issue an order of impoundment; (2) The level of investigation the Department must pursue to verify the information upon which the order of impoundment was based under subsection (b)(1)(iv) or (v) or (c)(2) of this section; and (3) The measures the Department must pursue to attempt service on the permit holder or authorized prescriber prior to impoundment under subsection (c) of this section. (i) Prior to destroying or transferring impounded drugs, bulk powders and chemicals, or prescription records, the Department shall publish a notice once a week for 2 consecutive weeks in a newspaper that is circulated locally: (1) Stating the date that the drugs, bulk powders and chemicals, or prescription records will be destroyed or transferred; and (2) Designating a date, time, and location where the drugs, bulk powders and chemicals, or prescription records may be retrieved by the permit holder or authorized prescriber if certain conditions are met. (j) A board shall immediately notify the Office of Controlled Substances Administration of the surrender, suspension, or revocation of a permit holder's permit or an authorized prescriber's license. #### Section 21-1113 In any action brought by the Attorney General under Sec. 11-209 of the Commercial Law Article, a person that sells, distributes, or otherwise disposes of any drug, medicine, cosmetic, food, food additive, or commercial feed, as defined in Sec. 6-101 of the Agriculture Article, or medical device: (1) May not assert as a defense that the person did not deal directly with the person on whose behalf the action is brought; and (2) May prove, as a partial or complete defense against a damage claim, in order to avoid duplicative liability, that all or any part of an alleged overcharge ultimately was passed on to another person by a purchaser or seller in the chain of manufacture, production, or distribution who paid the alleged overcharge. ### Subtitle 12. Penalties #### Section 21-1202 (a) A person who violates any provision of Sec. 21-436 of this title is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $50. (b) Half of any fine collected under this section shall be paid to the school board of the county where the violation occurred. #### Section 21-1203 A person who violates any provision of Subtitle 4, except Sec.Sec. 21-425 and 21-436 of this title is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $100. #### Section 21-1204 (a) A person who violates any provision of Sec. 21-820 of this title is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $100. (b) For purposes of this section, each day that a violation continues constitutes a separate offense. #### Section 21-1205 (a) A person who violates Sec. 21-819 of this title is guilty of a misdemeanor and on conviction is subject to: (1) For a first offense, a fine not exceeding $300; or (2) For a subsequent offense, a fine not exceeding $500. (b) For purposes of this section, each day that a violation continues constitutes a separate offense. #### Section 21-1206 A person who violates any provision of the following sections of this title is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $500: (1) Sec. 21-818 of this title; and (2) Sec. 21-1110 of this title. #### Section 21-1210 A person who violates any provision of Sec. 21-425 of this title is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $100 or imprisonment not exceeding 30 days or both. #### Section 21-1212 A person who violates any provision of Sec. 21-1111 of this title is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $100 or imprisonment not exceeding 1 year or both. #### Section 21-1214 (a) (1) Except as provided in paragraph (2) of this subsection, any person who violates any provision of Subtitle 3 of this title or any rule or regulation adopted under Subtitle 3 of this title is guilty of a misdemeanor and on conviction is subject to: (i) For a first offense, a fine not exceeding $1,000 or imprisonment not exceeding 90 days, or both; and (ii) For a second offense, a fine not exceeding $2,500 or imprisonment not exceeding 1 year, or both. (2) A person who violates Sec. 21-330.1 of this title is not subject to paragraph (1) of this subsection. (b) In addition to any criminal penalties imposed under this section, a person who violates any provision of Subtitle 3 of this title or any rule or regulation adopted under Subtitle 3 of this title or any term, condition, or limitation of any license or registration issued under Subtitle 3 of this title: (1) Is liable for a civil penalty not exceeding $5,000, to be collected in a civil action in the District Court for any county; and (2) May be enjoined from continuing the violation. (c) Each day on which a violation occurs is a separate violation under this section. #### Section 21-1215 (a) This section does not apply to a violation of Sec. 21-220(b)(4), Sec. 21-228, or Sec. 21-259.3 of this title. (b) A person who violates any provision of Subtitle 2 of this title or any regulation adopted under Subtitle 2 of this title is guilty of a misdemeanor and on conviction is subject to: (1) A fine not exceeding $10,000 or imprisonment not exceeding 1 year or both; or (2) If the person has been convicted once of violating Subtitle 2 of this title, a fine not exceeding $25,000 or imprisonment not exceeding 3 years or both. (c) In addition to any criminal penalties imposed under this section, a person who violates any provision of Subtitle 2 of this title, any rule or regulation adopted under Subtitle 2 of this title, or any term, condition, or limitation of any license or registration issued under Subtitle 2 of this title: (1) Is subject to a civil penalty not exceeding $5,000, in an action in any District Court; and (2) May be enjoined from continuing the violation. (d) Each day on which a violation occurs is a separate violation under this section. --- Md. Code Ann., Health-Gen. (as displayed at mgaleg.maryland.gov, October 16, 2026)