In this subtitle the following words have the meanings indicated. “Counterfeit drug” means a drug that: 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 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. “Established name” means, in regard to a drug or an ingredient of a drug: The name designated under the federal act; 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 If a name cannot be determined under item (i) or (ii) of this paragraph, the common or usual name of the drug or ingredient. 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. “New drug” means any drug that: 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 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. “Prescription drug” means a drug that, under § 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. “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.

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. 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.

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: Be placed on the outside container or wrapper; or Be legible through the outside container or wrapper.

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.

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.

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 § 21-208 or § 21-209 of this subtitle apply. A food is adulterated if: It contains any poisonous or otherwise deleterious substance that, in the quantity present, reasonably would be expected to make it injurious to health; It contains any added poisonous or added deleterious substance: That is not a food or color additive; and The particular use of which has not been found safe as provided under § 21-239 of this subtitle; It is or contains any food additive or color additive the particular use of which has not been found safe as provided under § 21-239 of this subtitle; Any part of it is a diseased, contaminated, filthy, putrid, or decomposed substance; It was produced, prepared, packed, or held under unsanitary conditions that reasonably would be expected to have: Contaminated it with filth; or Caused it to be diseased, unwholesome, or injurious to health; 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; 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 § 21-239 of this subtitle; At any time after its manufacturing, processing, or packaging, it was refrozen after having been permitted to thaw from a prior freezing; or It otherwise is unfit as food for human beings.

In addition to any other ground that may be applicable under § 21-207 or § 21-209 of this subtitle, a food is adulterated if: Any part of an important component that normally would be present in the food has been omitted or withdrawn from it; Any substance has been substituted for any part of an important component that normally would be present in the food; Any damage to or inferiority of the food has been concealed in any way; or It has had any substance added, mixed, or packed with it solely for any of the following purposes: To increase its bulk or weight; To reduce its quality or strength below that which normally would be expected of the food; or To mislead the consumer by making the food appear to be better or more valuable than it is.

In addition to any other ground that may be applicable under § 21–207 or § 21–208 of this subtitle, a confectionary food product is adulterated if: It contains any nonnutritive object, except as permitted by the rules and regulations adopted under subsection (b)(1) of this section; or It contains any nonnutritive substance other than a safe substance: That is in or on the confectionery because of some practical functional purpose in the manufacture, packaging, or storing of the confectionery; and The use of which does not promote deception of the consumer or otherwise result in any adulteration or misbranding in violation of this subtitle. 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. To avoid or resolve uncertainty, the Secretary may by rule or regulation: Interpret subsection (a)(2) of this section as that subsection applies to use of a particular nonnutritive substance; and Allow or prohibit the use of the particular nonnutritive substance.

For purposes of this subtitle, a food is considered to be misbranded under any condition specified in this section. A food is misbranded if: Its labeling or packaging is false or misleading in any way; 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; 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; 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: Conspicuous, as compared with other words, statements, designs, or devices on the labeling; and In terms likely to be read and understood by the ordinary individual under customary conditions of purchase and use; 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 § 21-237 of this subtitle and: The food does not conform to the definition or standard; or 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; 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 § 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; It is not subject to item (5) of this subsection and does not bear labeling that clearly gives: The common or usual name of the food, if there is such a name; and 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; 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 § 21-213 of this subtitle to be necessary to inform purchasers fully of its value for those uses; 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; It is a color additive and its packaging and labeling do not conform to the applicable requirements of the federal act; 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; It is a product that: Is intended to be used as an ingredient of another food; and If used according to the directions of the supplier, would result in the final food product being adulterated or misbranded; or It is offered for sale under the name of another food. 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. 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. 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. 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.

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. 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: 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 That the danger imposed by the food normally would not be determinable after the food has entered commerce. 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. 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. 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. 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. 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. The holder of a suspended permit may apply to the Secretary at any time for reinstatement of the permit. On receipt of an application for reinstatement, the Secretary shall hold a hearing and have the establishment inspected. If the Secretary finds that adequate measures have been taken to assure compliance with the permit, the Secretary immediately shall reinstate the permit: As originally issued; or With any amendment that, under the provisions of this section, the Secretary considers proper.

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. Subject to the provisions of § 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. 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: In accordance with the practice of the trade, the food is to be processed, labeled, or repacked at the second establishment; and 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.

Subject to the provisions of § 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. 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.

This subtitle may not be construed to prohibit the addition of alcohol to a food product, including a confectionery and a frozen dessert. A food product that is manufactured or sold that contains more than one–half of one percent of alcohol per volume: May not be sold to individuals under 21 years of age; and Shall state on the label of the food product: That the sale of the product to individuals under 21 years of age is prohibited; That the product contains alcohol; and The product’s alcohol percent per volume. 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.

For purposes of this subtitle, a drug or device is adulterated if the standards in this section apply. A drug or device is adulterated if: Any part of it is a filthy, putrid, or decomposed substance; or It was produced, prepared, packed, or held under unsanitary conditions that reasonably would be expected to have: Contaminated it with filth; or Caused it to be injurious to health. In addition to the grounds specified in subsection (b) of this section, a drug is adulterated if: 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; 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 § 21–239 of this subtitle; The mixing or packing of any substance with the drug has reduced the quality or strength of the drug; Any substance has been substituted for any part of the drug; 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: Meets the requirements of this subtitle as to safety; and Has the identity, strength, quality, and purity that it purports to have; It is purported to be a drug the name of which is recognized in an official compendium and: 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 The difference in strength, quality, or purity is not stated plainly on its label; or 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. 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. 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. 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.

For purposes of this subtitle, a drug or device is misbranded if the standards in this section or in § 21-218 or § 21-220(d) or (e) of this subtitle apply. A drug or device is misbranded if: Its labeling is false or misleading in any way; Its labeling or packaging does not conform with any provision of § 21-248 of this subtitle; 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; 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: Conspicuous as compared with other words, statements, designs, or symbols on the labeling; and In terms likely to be read and understood by the ordinary individual under customary conditions of purchase and use; Its labeling does not include, in whatever manner and form that may be necessary to protect the user of the drug or device: Adequate directions for the use of the drug or device; and Adequate warnings against: The use of the drug or device by anyone suffering from a pathological condition that may cause its use to be dangerous to health; The use of the drug or device by a child if its use by a child may be dangerous; and Unsafe dosages, methods of administration, or duration of administration of the drug or device; 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 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. 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: A rule or regulation adopted under the federal act; or A rule or regulation adopted by the Secretary under this subsection. 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.

In this section, “antibiotic drug” means any drug that: Is intended for use by a human being; Contains any quantity of a chemical substance or the chemically synthesized equivalent of a chemical substance that is produced by microorganisms; and Can inhibit or destroy microorganisms in dilute solution. In addition to any other ground that may apply under § 21–217 or § 21–220 of this subtitle, a drug is misbranded if: 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.”; 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; 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; 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: 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 Printed in this same manner on any labeling of the drug on which any name for the drug or for an ingredient is used; It purports to be a drug whose name is recognized in an official compendium and it is not: Labeled as required by the applicable official compendium; or Packaged as required by: The applicable official compendium; or A consent order granted under the federal act or by the Secretary to modify the packaging requirements of the official compendium; It has been found under the federal act or by the Secretary to be a drug liable to deterioration, and: 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 Its label does not bear a statement of precautions as required by those rules and regulations; 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; Its container is made, formed, or filled in a manner that is misleading; It is an imitation of another drug; It is offered for sale under the name of another drug; 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; 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; 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 § 21–239 of this subtitle; or 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: 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; The formula of the drug showing quantitatively each ingredient of the drug to the extent required for labels under the federal act; and 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. 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. 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. 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. 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. 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. 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. 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. 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.

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. 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.

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 § 5–101 of the Criminal Law Article, or an oral prescription from a health practitioner authorized by law to prescribe the drug: A habit–forming drug to which § 21–218(b)(1) of this subtitle applies. 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. A drug that is limited by an approved application under § 355 of the federal act or § 21–223 of this subtitle to use under the professional supervision of a health practitioner authorized by law to administer such a drug. 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. A pharmacist may not dispense a drug on an oral prescription unless the pharmacist promptly writes out and files the prescription. 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 § 5–101 of the Criminal Law Article. A health practitioner may issue a written or, if authorized by State and federal law, oral prescription for a controlled dangerous substance only if: Electronic prescribing is not available due to temporary technological or electrical failure; The prescription is to be dispensed by a pharmacy located outside the State; The prescription is issued by a health practitioner outside the State; The health practitioner is prescribing and dispensing the controlled dangerous substance directly to the patient; The prescription is being dispensed directly to the patient in accordance with § 12–102(c)(2)(iv) of the Health Occupations Article; The prescription is for an individual who: Resides in a nursing or assisted living facility; Is receiving care through a hospice or palliative care program and the prescription is related to the care provided; Is receiving care at an outpatient renal dialysis facility and the prescription is related to the care provided; or Is detained or confined in a correctional facility, as defined in § 1–101 of the Correctional Services Article; The prescription is issued by a licensed veterinarian; 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; 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; The prescription prescribes a drug under a research protocol; The prescription is issued by a health practitioner who has received a waiver under subsection (d)(1) of this section; 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; 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; 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 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: It would be impracticable for the practitioner to prescribe the drug or device by electronic prescription in a timely manner; and The delay would adversely impact the patient’s medical condition. 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. 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. The Secretary may issue a waiver that applies generally to a group of health practitioners or drugs that meet conditions specified by the Secretary. 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. 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: May not exceed 1 year; and May be granted for the following reasons: Economic hardship; Technological limitations that are not reasonably within the control of the health practitioner; or Any other exceptional circumstances as demonstrated by the health practitioner. The Secretary may adopt regulations on: 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 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. 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. A pharmacist may dispense a drug on a written or oral prescription for a controlled dangerous substance that meets the requirements of this section. 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. 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. 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. A written prescription shall be legible. A pharmacist may not refill and dispense a prescription unless the refilling is authorized by: The health practitioner’s specification in the original prescription as to how many times it may be refilled; or An oral order of the health practitioner that promptly is written out and filed by the pharmacist. The dispensing of a drug without complying with the requirements of this section is the dispensing of a misbranded drug. 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”. 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. The prescription requirements of this section do not apply to any drug that is exempted under a rule or regulation adopted by the Secretary. 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. 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.

A drug that is dispensed under a prescription shall bear a label that states: The name and address of the dispenser; The serial number of the prescription; The date of the prescription or the date that the prescription was filled; The name of the prescriber; and If stated in the prescription: The name of the patient; Any directions for use; and Any cautionary statements. If a drug dispensed under a prescription meets the label requirements of this section, it is exempt from the provisions of: Section 21-217(b)(3) through (7) of this subtitle; and Section 21-218(b)(1) through (4), (7), (8), (13), and (14) of this subtitle. 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.

Nothing in § 21-220 or § 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.

This section does not apply to any drug that: 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 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. A person may not sell, give away, or deliver any new drug: Unless an approved application for the drug is in effect under § 355 of the federal act; or 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. To have an application approved by the Secretary, an applicant shall file with the Secretary an application that sets forth: 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; A full statement of the composition of the drug; A full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of the drug; Any sample of the drug and of any article used as a component of the drug that the Secretary requires; and A specimen of the labeling that is proposed to be used for the drug. 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. 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: The drug has not been tested properly, as required by subsection (d) of this section; Under the conditions specified, recommended, or suggested in the proposed labeling of the drug, it is not safe for or effective in use; 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 Based on a fair evaluation of all material facts, the proposed labeling is false or misleading in any way. 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. The Secretary may revoke an order that disapproved an application and the application then shall be considered approved. 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: The drug may not be safe for or effective in its intended use; or The facilities or controls used in the manufacture, processing, or labeling of the drug may present a hazard to the public health. 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: Keep records; and Submit reports to the Secretary. 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: 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 To submit reports to the Secretary concerning that information. 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. 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.

A new drug is not subject to the requirements of § 21-223 of this subtitle if it is exempted by a rule or regulation adopted under this section. This section does not require any clinical investigator to submit directly to the Secretary any report on the investigational use of a drug. The Secretary shall adopt rules and regulations to exempt from the requirements of § 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: 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; 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: 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 The investigator will not supply the drug to any other investigator, or to any clinic, for administration to a human being; and 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 § 21-223 of this subtitle. 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. 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. Any rule or regulation adopted under § 355(i) of the federal act automatically shall be a rule or regulation of this State, as provided in § 21-241 of this subtitle. 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.

Any person who is required under § 21-223 or § 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.

The manufacturer, packer, or distributor of any prescription drug that is sold or distributed in this State shall: Keep correct copies of any printed matter that is: Required to be included in any package in which the drug is sold or distributed; or Approved under the federal act; and 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. This section does not exempt any person from any labeling requirement imposed under any other provision of this subtitle.

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: Any information that the manufacturer, packer, or distributor has about the biological availability and clinical performance of the drug; and 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.

A person may not sell or offer for sale a natural membrane condom by means of a vending machine or other automatic device.

In Part IV of this subtitle, “hair dye” does not mean eyelash dye or eyebrow dye. For purposes of this subtitle, a cosmetic is considered adulterated if: 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: That are instructed, recommended, or suggested in the labeling or advertisement of the cosmetic; or That are customary or usual for the cosmetic; It contains a filthy, putrid, or decomposed substance; It was produced, prepared, packed, or held under unsanitary conditions that reasonably would be expected to have: Contaminated it with filth; or Caused it to be injurious to health; 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 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 § 21-239 of this subtitle. A coal tar hair dye is not considered adulterated under subsection (b)(1) of this section if it: 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 Has on its labeling adequate directions for the preliminary testing that is referenced on the label.

For purposes of this subtitle, a cosmetic is considered misbranded if: Its labeling or packaging is false or misleading in any way; 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; Any word, statement, or other information required under this subtitle to appear on its labeling is not: Placed prominently on the labeling so that it is conspicuous, as compared with other words, statements, designs, or symbols, on the labeling; and Expressed in terms likely to be read and understood by the ordinary individual under customary conditions of purchase and use; or 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. 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. 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.

The Secretary may adopt rules and regulations to carry out the provisions of this subtitle. 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.

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. The Secretary may adopt for purposes of this subtitle any rule or regulation adopted by the United States Department of Agriculture.

The Secretary shall give notice of and hold any hearing authorized or required by this subtitle in accordance with the Administrative Procedure Act.

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. By rule or regulation, the Secretary may adopt a definition or standard of identity or quality for any food if: A definition or standard has not been adopted for the food under the federal act; and The Secretary finds that the definition or standard will promote honesty and fair dealing in the interest of consumers. 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. For purposes of this subtitle, the standards for the quality, purity, and strength of any drug are the standards set by an official compendium. If a drug is not standardized by an official compendium, then subject to § 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.

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. 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: The Secretary finds that issuance of the permit is in the public interest; and The permit is issued on terms and with safeguards that adequately protect the interests of consumers and potential consumers.

For purposes of §§ 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: A State adopted federal rule or regulation, as provided under subsection (b) of this section; or A rule or regulation adopted by the Secretary under subsection (c) of this section. 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. Subject to the provisions of § 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. 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: As to any added poisonous or otherwise deleterious substance, any food additive, or any color additive: Prohibits its use; or Sets tolerances for its use; or As to any food additive or any color additive: Sets conditions under which it may be used safely; or Provides exemptions for its use for investigational or experimental purposes. 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. 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. 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. The Secretary, in determining whether to adopt a rule or regulation under this section, shall consider: The name of and all pertinent information that concerns the substance or additive, including, if available: Its chemical identity and composition; The conditions of its proposed use, including directions, recommendations, and suggestions; Samples of the proposed labeling for the substance or additive; and 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; 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; 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; 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; The availability of a practicable method of analysis for determining the identity and quantity of: The substance or the additive in or on an article; Any other substance that is formed in or on the article because of the use of the added substance or color additive; and The pure substance or additive and any intermediate or impurity of the substance or additive; Any fact that supports a contention that the proposed use of the substance or additive would serve a useful purpose; and 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.

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. Any person who may be affected adversely by a rule or regulation that is proposed by the Secretary under this subtitle may: File a protest within 30 days after publication of the proposed rule or regulation; and Request a hearing.

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. Any person who may be affected adversely by a State adopted federal rule or regulation may: File a protest against the federal rule or regulation not more than 30 days after its effective date; and Request a hearing. A protest under this section stays the effect of the State adopted federal rule or regulation as a rule or regulation of this State.

If a written protest against a rule or regulation is filed in accordance with § 21-240 or § 21-241 of this subtitle, the Secretary shall hold a public hearing: To receive evidence on the issues raised by the protest; and To hear any interested person.

As soon as practicable after a hearing on a protest to a rule or regulation under § 21-242 of this subtitle, the Secretary shall: Act on the protest by issuing an order; and Send a copy of the order to each protester by certified mail, return receipt requested, bearing a postmark from the United States Postal Service. Each order issued under this section shall be based on substantial evidence in the record of the hearing. An order issued by the Secretary under this section may: Reinstate, rescind, or modify a State adopted federal rule or regulation as a rule or regulation of this State; or As to any other rule or regulation proposed under this subtitle: Withdraw the proposal; Modify the proposal and set an effective date for the modified proposal that is at least 60 days after publication of the order; or Set a new effective date for the original proposal that is at least 60 days after publication of the order.

The Secretary shall provide a copy of this subtitle and Subtitle 1 of this title: 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 To any person who requests it. The Secretary may: Publish summaries of judgments, decrees, or court orders issued under this subtitle; Otherwise collect, report, or illustrate the results of any investigation conducted under this subtitle; and 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.

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.

In addition to any finding that may be made under § 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. If an advertisement for a drug or device is not otherwise considered to be false under § 21-247 of this subtitle, it is not false under this section if: It is disseminated only to members of the medical, dental, or veterinary professions; It appears only in the scientific periodicals of these professions; or 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. 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. 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. 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. 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. 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 § 21-217 of this subtitle.

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: 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 Any vehicle used to transport or hold any food, drug, device, or cosmetic for a commercial purpose. 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. An inspection carried out under this section shall be completed with reasonable promptness. 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. 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: Financial information; Sale information, other than shipment information; Pricing information; Personnel information, other than information as to the qualifications of technical and professional personnel who perform functions subject to this subtitle; or Research information, other than information that: 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 § 355(i) or (k) or § 357(d) or (g) of the federal act; or Relates to any other drug and would be subject to reporting or inspection under rules and regulations adopted under § 355(k) of the federal act. Authority to conduct extended inspections under this subsection does not apply to: 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; 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; 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 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. During any inspection under this section, the Secretary may obtain a sample of any item that is subject to the inspection. 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. On completing an inspection under this section and before leaving the establishment, the Secretary or representative of the Secretary shall: 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: Contains any filthy, putrid, or decomposed substance; or Has been prepared, packed, or held under unsanitary conditions by which it: May have become contaminated with filth; or Otherwise may have been rendered injurious to health; and Give the owner, operator, or agent in charge of the establishment a copy of the report.

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. Any evidence that is obtained under this section may not be used in any criminal prosecution of the person from whom it is obtained. 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.

If, while conducting an inspection under § 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: As to a food sample, whether the food: Is misbranded; Contains any filthy, putrid, or decomposed substance; or Is otherwise adulterated or unfit for food; or As to a drug sample, whether the drug: Is adulterated; or Is misbranded. 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.

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 §§ 21-256 through 21-259 of this subtitle.

Under this section, there is a ground for action against a food, drug, device, or cosmetic if it is: Adulterated; So misbranded that it is dangerous or fraudulent; A food that violates any requirement imposed under § 21-211 of this subtitle; or A drug that violates the provisions on new drugs under § 21-223 of this subtitle. 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 § 21-211 or § 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. 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. 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. If the court finds that there is a valid ground for action against the article, the court may proceed by issuing an order: Of forfeiture for destruction; or To have the article delivered to its claimant and have the violation corrected by proper labeling or processing. 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. 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: Correct the violation under the supervision of a representative of the Secretary; 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 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. 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.

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: Contains any filthy, decomposed, or putrid substance; Is poisonous or otherwise would be injurious to health if consumed; or Is otherwise unsafe. If a food poses an immediate threat, it shall be considered a public nuisance. 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. The owner of a substance that is destroyed or otherwise made unusable under this section may bring a suit for damages against the Secretary. The Secretary shall have the immunity from liability described under § 5–633 of the Courts Article.

Except as otherwise provided in this section, the Secretary shall report to the State’s Attorney any alleged criminal violation of this subtitle. 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. 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.

A person may not: Manufacture or sell any food, drug, device, or cosmetic that is adulterated or misbranded; Adulterate or misbrand any food, drug, device, or cosmetic; 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; Receive in commerce any adulterated or misbranded food, drug, device, or cosmetic; Deliver or offer for delivery any adulterated or misbranded food, drug, device, or cosmetic, whether or not for pay; Disseminate any false advertisement; Sell any food in violation of any requirement imposed under § 21-211 of this subtitle; Fail to comply with § 21-249 or § 21-250 of this subtitle by refusing to permit: An entry or inspection; The taking of a sample; or Access to or copying of any record; Remove or dispose of any article that is detained or restricted under § 21-253 of this subtitle; or 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.

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. A person may not distribute a consumer commodity in commerce if: The commodity is contained in a package that does not conform to a requirement that is imposed under this subtitle; or A label that does not conform to a requirement imposed under this subtitle is attached to the commodity.

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. A person may not: Sell any new drug in violation of § 21-223 of this subtitle; 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 § 21-223 of this subtitle, or that the drug complies with that section; Fail to maintain and to provide to a health practitioner on request printed matter that relates to prescription drugs, as required under § 21-226 of this subtitle; 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; 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: Sell, dispense, or dispose of the drug or device or its container; Cause the drug or device or its container to be sold, dispensed, or disposed of; or Conceal or keep possession, control, or custody of the drug or device or its container with intent to sell, dispense, or dispose of it; Make, sell, or dispose of any counterfeit marking tool; Cause any counterfeit marking tool to be made, sold, or disposed of; Keep possession, control, or custody of any counterfeit marking tool; Conceal any counterfeit marking tool; Cause a drug to be a counterfeit drug; Sell or dispense a counterfeit drug or hold a counterfeit drug for sale or dispensing; Except as permitted under § 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; Prescribe any drug on a written prescription form without clearly identifying the name of the prescriber; Dispense any drug based on a prescription form that lacks the prescriber’s name and signature which: May not be made by use of a rubber stamp; but Except as otherwise required by State law for a controlled dangerous substance, is not required for oral prescription orders; or Fail to provide to the Secretary on request information about prescription drugs, as required under § 21-227 of this subtitle.

A person may not: 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; 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 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: Is acquired under authority of this subtitle; and Concerns any method or process that is entitled to protection as a trade secret.

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: Intends to purchase the item; or Has received from the proprietor authority to open the item. A person who violates this section is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $25. The penalty provisions of Subtitle 12 of this title do not apply to this section.

In this section: “Ingredient” means any single chemical entity or mixture used as a component in the manufacture of a cosmetic product; and “Ingredient” does not include an incidental ingredient, as described in 21 C.F.R. § 701.3(l). 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: Dibutyl phthalate (CAS no. 84–74–2); Diethylhexyl phthalate (CAS no. 117–81–7); Formaldehyde (CAS no. 50–00–0); Paraformaldehyde (CAS no. 30525–89–4); Methylene glycol (CAS no. 463–57–0); Quaternium–15 (CAS no. 51229–78–8); Mercury (CAS no. 7439–97–6); Isobutylparaben (CAS no. 4247–02–3); Isopropylparaben (CAS no. 4191–73–5); m–Phenylenediamine and its salts (CAS no. 108–45–2); o–Phenylenediamine and its salts (CAS no. 95–54–5); Lead (CAS no. 7439–92–1); or The following per– and polyfluoroalkyl substances (PFAS) and their salts: Perfluorooctane sulfonate (PFOS) or heptadecafluorooctane–1–sulfonic acid (CAS no. 1763–23–1); Potassium perfluorooctanesulfonate or potassium heptadecafluorooctane–1–sulfonate (CAS no. 2795–39–3); Diethanolamine perfluorooctane sulfonate (CAS no. 70225–14–8); Ammonium perfluorooctane sulfonate or ammonium heptadecafluorooctanesulfonate (CAS no. 29081–56–9); Lithium perfluorooctane sulfonate or lithium heptadecafluorooctanesulfonate (CAS no. 29457–72–5); Perfluorooctanoic acid (PFOA) (CAS no. 335–67–1); Ammonium pentadecafluorooctanoate (CAS no. 3825–26–1); Nonadecafluorodecanoic acid (CAS no. 335–76–2); Ammonium nonadecafluorodecanoate (CAS no. 3108–42–7); Sodium nonadecafluorodecanoate (CAS no. 3830–45–3); Perfluorononanoic acid (PFNA) (CAS no. 375–95–1); Sodium heptadecafluorononanoate (CAS no. 21049–39–8); or Ammonium perfluorononanoate (CAS no. 4149–60–4). 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: Was manufactured through a process intended to comply with this section; and Contains a technically unavoidable trace quantity of an ingredient listed in subsection (b) of this section due to: An impurity of a natural or synthetic ingredient; The manufacturing process; Storage; or Packaging. 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. 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. In any action brought to enforce this section, a court may award to a prevailing plaintiff: Treble damages; If the violation was willful, punitive damages; and Reasonable attorney’s fees. The Department may investigate any complaint alleging that a person has violated this section. 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. The person may not: 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 Interfere with an inspection under paragraph (2) of this subsection. 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.

In this section the following words have the meanings indicated. “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. “Ingredient” has the meaning stated in 21 C.F.R. § 700.3(e). “Manufacturer” means any person whose name appears on the label of a cosmetic in accordance with the requirements of 21 C.F.R. § 701.12. 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. 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. The provisions of subsection (b) of this section do not apply to animal testing that is: Conducted or contracted to comply with a requirement of a federal or state regulatory agency if: 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; 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 Animal testing is the only method of testing that is accepted for the relevant purpose by the federal or state regulatory agency; Conducted or contracted to comply with the requirement of a regulatory agency of a foreign jurisdiction if: No evidence derived from the testing was relied on to substantiate the safety of a cosmetic sold by the manufacturer within the State; and The testing was not conducted in the State; 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; Conducted or contracted to comply with a requirement of a federal, state, or foreign regulatory agency for purposes unrelated to cosmetics testing if: No evidence derived from the testing was relied on to substantiate the safety of a cosmetic sold by the manufacturer within the State; or Documentary evidence demonstrates that the intent of the test that was performed was unrelated to cosmetics testing; and The ingredient that was the subject of the testing has been used for purposes unrelated to cosmetics for at least 12 months; or Performed on: 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 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. This section may not be construed to prevent a cosmetics manufacturer from reviewing, assessing, or retaining data resulting from animal testing. 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. A person who violates this section is subject to a civil penalty: Not exceeding $5,000 for the first offense; and Not exceeding $1,000 for each subsequent offense. 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. 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. A local law enforcement agency may enforce the provisions of this section. The State’s Attorney for each county may seek appropriate relief for violations of this section. 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. Any testing data reviewed under subparagraph (ii) of this paragraph is entitled to protection as a trade secret.

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. 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: For the purpose of disclosing the possible existence of the violation, the person: Made an inspection, examination, or test; or Received a written report that certified the results of an inspection, examination, or test that was made; 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; The inspection, examination, test, or the written report provided no basis for a belief that the alleged violation existed; and The person did not commit the alleged violation purposely, knowingly, recklessly, or negligently. The provisions of paragraph (1) of this subsection apply to any violation of any of the following provisions of this subtitle: § 21-256(1) of this subtitle, concerning the manufacture or sale of an adulterated or misbranded article; § 21-256(2) of this subtitle, concerning the adulteration or misbranding of any article; § 21-256(4) of this subtitle, concerning the receipt in commerce of any adulterated or misbranded article; § 21-256(5) of this subtitle, concerning the delivery of any adulterated or misbranded article; § 21-258(b)(13) of this subtitle, concerning the failure to identify on a prescription form the name of the prescriber of a drug; § 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 § 21-258(b)(15) of this subtitle, concerning the provision to the Secretary of information about prescription drugs. 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. 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.

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. 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. After a hearing under this section, the Department may affirm, modify, or withdraw the order.

This subtitle may be cited as the “Maryland Food, Drug, and Cosmetic Act”.