This chapter establishes regulations that prohibit the manufacturing, sale, or distribution of child care articles that contain bisphenol-A, also known as BPA. In this chapter, the following terms have the meanings indicated. Terms Defined. “Bisphenol-A (BPA)” means an industrial chemical also known as 2,2-bis (4-hydroxyphenyl) propane used primarily in the manufacture of polycarbonate plastic and epoxy resins. “Child care article” means an empty bottle or cup to be filled with food or liquid that is designed or intended by a manufacturer to be used by a child younger than 4 years old. On or after January 1, 2012, a person may not manufacture, knowingly sell, or distribute in commerce a child care article containing bisphenol-A. A manufacturer of a child care article shall use a safe and legal alternative to BPA when replacing BPA in a child care article. A manufacturer of a child care article may not use in place of BPA a substance determined by the United States Environmental Protection Agency to be a: Group A, B, or C carcinogen; or Reproductive toxicant causing birth defect, reproductive harm, or developmental harm. A person that violates any of the provisions of Health-General Article, §24-304, Annotated Code of Maryland, is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $10,000 for each violation. Health-General Article, §24-304, Annotated Code of Maryland Effective date: November 28, 2011 (38:24 Md. R. 1502) All provisions of 16 Code of Federal Regulations, Parts 1500 and 1505, are incorporated by reference, with the following changes set forth below. 1500.3 Definitions. “Act” means the Maryland Hazardous Substance Act, Health-General Article, §22-502, Annotated Code of Maryland. “Commission” means the Maryland Department of Health. Health-General Article, §22-502, Annotated Code of Maryland Effective date: February 2, 1977 (4:3 Md. R. 145) The Secretary of the Maryland Department of Health recognizes that the public interest requires control over the use of controlled substances in the legitimate manufacturing, distributing, dispensing, storing, and ordering of controlled substances. This chapter applies to every registrant who manufactures, distributes, dispenses, stores, and orders any controlled substances within the State of Maryland, unless exempted from registration by Criminal Law Article, §5-301(d), Annotated Code of Maryland, or 21 CFR §§1301.22 — 1301.24. In the event of conflict between a provision of the Code of Federal Regulations referenced under a provision of this chapter and the provision of this chapter, the registrant shall comply with the more stringent provision. In this chapter, 21 CFR §§1300 —1317, as amended, are incorporated by reference. Applicability to Chapter. In this chapter, the terms defined in §B of this regulation have the meanings indicated. In addition, and unless otherwise provided in this chapter, the definitions appearing in Criminal Law Article, §5-101, Annotated Code of Maryland, shall also apply to this chapter. Terms Defined. “Act” means the Maryland Controlled Dangerous Substances Act, Criminal Law Article, §§5-101—5-1101, Annotated Code of Maryland. “Administrative probable cause” means a valid public interest, sufficient to justify an administrative warrant, allowing the inspection of the area, premises, or building to enforce this chapter. “Agent” means a person who acts on behalf of the Department. “Authorized provider” or “provider” means a: Person licensed, registered, or otherwise allowed to dispense, order, and store controlled substances; Pharmacy, laboratory, hospital, or other institution licensed, registered, or otherwise allowed to manufacture, distribute, dispense, store, and order controlled substances; or Person licensed, registered, or otherwise allowed to conduct research on a controlled substance in the State in the course of professional practice or research. “Board” means the Maryland Boards of Physicians, Podiatry, Dental Examiners, Nursing, and Veterinary Medicine. “Chemical analysis” means the act of decomposing a substance into its constituent elements. “Civil fine” means a fine assessed by the Department against an authorized provider, including establishments. Commercial Container. “Commercial container” means any bottle, jar, tube, ampule, or other receptacle in which a substance is held for distribution or dispensing to an ultimate user. “Commercial container” includes any box or package in which a receptacle is held for distribution or dispensing to an ultimate user. “Commercial container” does not include any package liner, package insert, or other material kept with or within a commercial container, or any carton, crate, drum, or other package in which commercial containers are stored or are used for shipment of controlled substances. Controlled Premises. “Controlled premises” means places where original or other records or documents required under the Act are kept or required to be kept. “Controlled premises” includes factories, warehouses, other establishments, and conveyances, where persons registered under the Act or exempt from registration under the Act may lawfully hold, manufacture, distribute, dispense, administer, or otherwise dispose of controlled substances. “Department” means the Maryland Department of Health. “Disciplinary action” includes but is not limited to a penalty, reprimand, restriction, suspension, or revocation of a license. “Federal Act” means the Controlled Substance Act (84 Stat. 1242; 21 U.S.C. 801) or the Controlled Substance Import and Export Act (84 Stat. 1285; 21 U.S.C. 951). “Fee exempt” means an authorized provider that is required to register with the Department but is not required to pay the registration fee. “In good standing” means having a professional license that is not subject to any form of sanction by the Board or Criminal Law. “Inspector” means an officer or employee of the Department authorized by the Secretary to make inspections under the Act. “Labeling” means all labels and other written, printed, or graphic matter on any controlled substance or any of its commercial containers or wrappers accompanying controlled substances. “License” has the same meaning as State Government Article, §10-226, Annotated Code of Maryland. Manufacture. “Manufacture” means: Producing, preparation, propagation, compounding, or processing of a drug or other substance; Packaging or repackaging of the substance; or Labeling or re-labeling of the commercial container of the substance. “Manufacture” does not include the activities of a provider who, as an incident to the provider’s administration or dispensing the substance in the course of the provider’s professional practice, prepares, compounds, packages, or labels the substance. “Manufacturer” means a person who manufactures a drug or other substance under: A registration as a manufacturer; or Authority of registration as a researcher or chemical analyst. “Office of Controlled Substances Administration (OCSA)” refers to the division within the Maryland Department of Health responsible for administering the enforcement of Criminal Law Article, Title 5, Annotated Code of Maryland. “Penalty” means monetary penalty, including but not limited to a fine. “Person” means: An authorized provider; The responsible party listed on the application licensed by the DEA; or The responsible party listed on the application for an establishment not licensed by the DEA. “Peyote” means the controlled substance in Schedule I under Criminal Law Article, §5-402, Annotated Code of Maryland. This schedule I listing does not apply to the nondrug use of peyote in bona fide religious ceremonies of the Native American Church, and members of the Native American Church using peyote in this manner are exempt from registration. “Pharmacist” means: A pharmacist licensed in the State or otherwise authorized to dispense controlled substances; or An individual, for example, a pharmacist intern, authorized by a state to dispense controlled substances under the supervision of a pharmacist licensed by that state. Prescription. “Prescription” means an order for medication that is dispensed to or for an ultimate user. “Prescription” does not include an order for medication which is dispensed for immediate administration to the ultimate user, such as an order to dispense a drug to a bed patient for immediate administration in a hospital. “Registration” means initial registration or subsequent re-registration with OCSA. “Secretary” means the Secretary of the Maryland Department of Health. “Sufficient application” means an application that is completed in full and has provided all of the information required by the Department. Except for military and federal employees working within the scope of federal employment, a person shall register with the Department and obtain a registration certificate before the person: Manufactures, distributes, dispenses, stores, and orders controlled substances; Conducts research or instructional activities with controlled substances listed in Schedules II through V of Criminal Law Article, §§5-403—5-406, Annotated Code of Maryland; Conducts research or instructional activities with a controlled substance listed in Schedule I of Criminal Law Article, §5-402, Annotated Code of Maryland, with prior registration from the DEA; Conducts a chemical analysis with controlled substances listed in any schedule; Installs and maintains an automated dispensing machine containing controlled substances; or Manufactures peyote for, or distributes peyote to, the Native American Church for bona fide religious ceremonies of the Native American Church. An authorized provider shall: Apply for a registration certificate on a form made available by the Department to: Obtain one registration for all locations that a provider prescribes only and no controlled substances are stored; or Obtain a single registration for each separate location where the provider prescribes, dispenses, orders, and stores controlled substances; Have a professional license in good standing; Be of good moral character; Have no convictions for crimes of moral turpitude; Be 18 years of age or older; Be registered with the Prescription Drug Monitoring Program if the authorized provider is also a prescriber as defined under Health-General Article, §21-2A-04.1, Annotated Code of Maryland; and Except for researchers, have completed 2 continuing education credit hours: Prior to applying for an initial controlled substance registration occurring on or after October 1, 2018; or Prior to the first renewal of a controlled substance registration occurring on or after October 1, 2018. Continuing Education. The continuing education shall: Be accredited by the Accreditation Council for Continuing Medical Education; or Meet the requirements for approval by the authorized providers professional board. The continuing education shall pertain to the prescribing or dispensing of controlled substances. Authorized providers shall meet the requirements of §§B and C of this regulation upon the completion of the 2 credit hours of continuing education. Recent graduates meet the requirements of §§B and C of this regulation upon initial application if two academic course credits were issued relating to controlled substances. An establishment shall: Apply for a registration certificate on a form made available by the Department; Obtain one registration for each separate place of business, professional practice, or location where controlled substances are: Ordered; Purchased; Administered; Delivered to the ultimate user; Stored; Manufactured; or Distributed; and Have a professional or occupational license in good standing to perform any of the following functions related to controlled substances: Manufacture; Distribute; Deliver to the ultimate user; Administer; Store; Order; Prescribe; Package; Label; or Compound. A person shall complete an application to be considered for a registration certificate. The applicant shall: Submit a completed application made available by the Department; Except for fee exempt applicants, pay the appropriate fee as set forth in Regulation .06 of this chapter; Unless exempt from payment of a registration fee, apply for and obtain a registration certificate; Provide an explanation for any not-applicable responses on the applications; Notify the Department of any criminal convictions related to controlled substances; Notify the Department of any actions taken on the applicant’s professional license; Have the application and accompanying documents required for registration signed by the: Applicant, if an individual; General partner, if the applicant is a partnership; or Officer responsible for the applicant, if the applicant is a corporation or other entity; and Provide additional documentation required by the Department pertinent to the registration, to: Clarify application information; and Determine if the applicant meets the requirements of this chapter. New applications that are unable to be processed 6 months from the payment deposit date: May be determined invalid; Will not be issued a refund, unless: The payment is a duplicate; or Approved by the Department; and Will require a new application to be resubmitted. Renewal applications that are unable to be processed 45 days from the payment deposit date: May be determined invalid; Will not be issued a refund, unless: The payment is a duplicate; or Approved by the Department; and Will require a new renewal application to be submitted. An authorized provider or establishment required to obtain and maintain a registration certificate as set forth under this chapter shall pay the appropriate fees as follows: New registration certificate — $120; Renewal registration certificate — $120; Amend a registration certificate — $50; Change of ownership fee — $144; Duplicate registration certificate — $30; and Reinstatement — $50.00. Applicants exempt from registration fees include: Except for contractual positions, an employee of a hospital, clinic, institution, facility, or unit operated by a local or State government agency; An agency, excluding a State agency and its employees, for which the State is responsible for payment of the fee, provided that the exemption is approved by the Secretary; or A person included in 21 CFR §§1301.21. Refunds and Credits. The Secretary may not issue a credit towards or refund any registration fees to an applicant, including but not limited to, an applicant who: Withdraws a registration application; Voluntarily or involuntarily ceases to manufacture, distribute, dispense, order, and store a controlled substances before a registration certificate expires; or Does not complete the application as set forth in Regulation .05 of this chapter. The Secretary, or the Secretary’s designee, shall review the refund request and determine if a refund of any amount is appropriate. A registrant who has lost a registration certificate is required to pay a duplicate registration fee as set forth in §A of this regulation. The Department may not issue a new or a renewed registration certificate until all required fees are paid. The Department-issued registration certificate shall be readily available to any agent or representative of the Secretary within the registered location. Term. The Secretary may issue a registration certificate that is valid for not more than 3 years. Expiration. A registration certificate expires on the date shown on the certificate. The Secretary shall notify the registrant that the registration will expire not less than 30 days before the expiration date shown on the certificate. Renewal. A registration for which a sufficient application for renewal was submitted: Shall be received at least 2 weeks before the expiration; and Will remain in effect until the Department takes a final action. The failure to receive a renewal notice does not excuse a registrant from complying with this chapter. Reinstatement. A registrant whose registration has been surrendered in lieu of further investigation, revoked, suspended, or limited may not be eligible to request reinstatement for a: 2-year period; Specified period designated in a consent order from the Department; or Specified time period determined by the Department. To apply for reinstatement, a registrant shall: Complete and submit an application on a form provided by the Department; and Pay a reinstatement fee shown in Regulation .06 of this chapter. A registration certificate is not transferable. A registration certificate becomes void when the registrant: Dies; Discontinues business or professional practice in the State; or Changes ownership, including when: Partners are added or deleted from the partnership; There is a change in the president or chief executive officer of the corporation; or There is a change in the ownership of 10 percent or more of the outstanding shares in the corporation. A registrant who discontinues business or professional practice in the State shall: Notify the Secretary in writing; Surrender the registrant’s current registration certificate; and Legally transfer or dispose of any controlled substances relative to the registrant’s operation. A registrant who changes ownership of the business or professional practice shall: Notify the Secretary in writing at least 30 days before the change occurs; Complete and submit a change of ownership application to the Department; Pay the change-of-ownership fee in Regulation .06 of this chapter; Surrender the registrant’s current registration certificate after the ownership change is finalized; and Allow the Department to inspect the business or professional practice of the new owners. A registrant who changes the location of a registrant’s place of business or professional practice shall: Notify the Department at least 30 days before there is a change in the location of the registrant’s place of business or professional practice; Apply to amend a current registration certificate; and Pay the fee to amend a certificate in Regulation .06 of this chapter. During the 3-year registration period, the registrant shall notify the Office of Controlled Substances Administration within 30 days of the following: Any criminal convictions; Any disciplinary actions taken against the registrant’s professional or occupational license; or Any disciplinary actions taken against the registrant’s federal Drug Enforcement Agency registration. After an application for registration has been filed, the Secretary may: Inspect the place of business or professional practice described in the application; and Investigate the applicant to determine whether the applicant meets the requirements of this chapter. The registrant shall inform the Office of Controlled Substances Administration prior to any address changes. A registrant shall comply with the provisions of 21 CFR §1302, as amended. Pursuant to Criminal Law Article, §5-306, Annotated Code of Maryland, a registrant shall comply with the provisions of 21 CFR §1304, as amended. Inventories developed under the Federal Act dated May 1, 1971, and subsequent biennial inventory dates are acceptable for purposes of the Maryland Act. On the effective date a substance is added to any schedule of controlled substances pursuant to Criminal Law Article, §5-202, Annotated Code of Maryland, registrants required to keep records, who possess that substance, shall take an inventory of all stocks of that substance on hand. Thereafter, that substance shall be included in each inventory made by the registrant. Reports required in this section shall be accessible to the representative of the Secretary. A registrant shall comply with the provisions of 21 CFR 1305, as amended. Persons Entitled to Issue Prescriptions. A prescription for a controlled substance may be issued only by an authorized provider who is: Authorized to prescribe controlled substances in the State of Maryland; and Either registered or exempted from registration pursuant to 21 CFR §1301.22(c) and 21 CFR §1301.23. A prescription issued by an authorized provider may be communicated to a pharmacist by an employee or agent of the authorized provider. Purpose of Issue of Prescription. A controlled substance prescription shall only be issued for a legitimate medical purpose by a provider. A controlled substance prescription shall be issued by a provider in the usual course of the individual provider’s professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing provider. A pharmacist has a corresponding responsibility to ensure, prior to dispensing, that a controlled substance prescription is issued for a legitimate medical purpose. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of the Maryland Controlled Dangerous Substances Act, Criminal Law Article, §§5-501—5-505, Annotated Code of Maryland. A prescription may not be issued in order for an individual provider to obtain controlled substances for supplying the individual provider for the purpose of general dispensing to patients. A prescription for a Schedule II-V controlled substance shall be dispensed within 120 days from the date of issue. Unless the State has stricter requirements, if a provider has complied with 21 CFR §1306, the provider is deemed to have complied with this chapter. A partial fill of a C-II prescription is permitted if: The pharmacist is unable to fill the full quantity of the prescription, pursuant to 21 CFR §1306.13(a); The prescription is issued for a patient in a long-term care facility or for a patient with a medical diagnosis documenting a terminal illness pursuant to 21 CFR 1306.13(b) or (c); Requested by the patient or the practitioner that wrote the prescription, pursuant to 21 CFR §1306.13(b); or The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed. A prescription for a controlled substance listed in Schedule II may not be refilled. A prescription for a controlled substance listed in Schedule III, IV, or V: May not be refilled more than 6 months after the date on which the prescription was issued; May not be refilled more than five times; and Shall require a new and separate prescription to be issued if additional quantities are deemed necessary by the authorized prescribing provider. The prescribing provider may authorize additional refills of Schedule III, IV, or V substances on the original prescription through an oral refill authorization transmitted to the pharmacist if the following conditions are met: The total quantity authorized, including the amount of the original prescription, does not exceed five refills or extend beyond 6 months from the date of issue of the original prescription; The pharmacist obtaining the oral authorization records on the reverse of the original paper prescription or annotates the electronic prescription record with the date, quantity of refill, and number of additional refills authorized, and initials the paper prescription or annotates the electronic prescription record showing who received the authorization from the prescribing practitioner who issued the original prescription; The quantity of each additional refill authorized is equal to or less than the quantity authorized for the initial filling of the original prescription; and The prescribing practitioner executes a new and separate prescription for any additional quantities beyond the five-refill, 6-month limitation. Required Documentation. Each refilling of a prescription shall be documented on the: Back of the prescription; With Department approval, on another appropriate uniformly maintained, readily retrievable record, such as medication records; or electronic prescription record. The documentation shall indicate the: Number of the prescription; Name of the controlled substance; Dosage form of the controlled substance; Date of each refilling; Quantity dispensed; Identity or initials of the dispensing pharmacist in each refilling; Total number of refills for that prescription; Pharmacist’s initials; and Date by the pharmacist as of the date of dispensing. Each refilling of a prescription shall: State the amount dispensed; or If the amount dispensed is not specifically stated, be deemed to have been dispensed for the full face amount of the prescription. A registrant shall comply with the provisions of 21 CFR §§1301.71—1301.77 as amended. Any registrant in possession of legally obtained controlled substances and desiring or required to dispose of any of these substances may ask the Office of Controlled Substances Administration of the Maryland Department of Health for authority and instructions to dispose of this substance. This does not eliminate the requirement on registrants under federal regulations to report destruction of controlled dangerous substances. Disposal of Medical Waste. A registrant in possession of legally obtained controlled substances deemed medical waste shall render the controlled substances irretrievable by disposing of: Liquid waste in an approved containment unit; or Non-liquid in a receptacle. Two licensed personnel shall keep Waste Destruction Logbooks and maintain the record for 2 years. The Destruction Log shall be readily available upon inspection. Disposal for Registrants Required to Register with the DEA. The Office of Controlled Substances Administration shall authorize and instruct the registrant to dispose of the controlled substance in one of the following manners, provided complete records of the disposition are maintained by the registrant: By transfer to a person registered under the Act and authorized to possess the substance; By destruction in the presence of an agent of the Office of Controlled Substances Administration or another authorized person; By forwarding to the District Office of the Drug Enforcement Administration pursuant to the procedures of that agency; By returning unused controlled substances dispensed by registered hospital pharmacies for administration to in-patients to the pharmacy for appropriate disposition; or By other means that the Secretary may determine to assure that the substance does not become available to unauthorized persons. A registrant that has complied with 21 CFR §1304 is deemed to have complied with this section. If a registrant is required regularly to dispose of controlled substances, the Special Agent in Charge of the Federal Drug Enforcement Administration may authorize the registrant to dispose of these substances, in accordance with 21 CFR §1307. Disposal for Registrants Not required to Register with the DEA. Any registrant who is registered to administer only and is in possession of legally obtained controlled substances shall: List the controlled substance or substances which the registrant desires to dispose of on a drug destruction form provided by the Department; Have two members of the professional staff, limited to an administrator, nurse, or pharmacist, destroy controlled drugs on premises; Dispose per instructions given in §B of this regulation. Forward a copy of the completed drug destruction form to the Office of Controlled Substances Administration within 10 days of destruction; and Keep a copy of the drug disposal form on location for a period of 2 years. Abandoned controlled substances may be: Destroyed in the presence of an agent of the Office of Controlled Substances Administration or another authorized person or persons; Disposed of by other means that the Secretary may determine to assure that the substance does not become available to unauthorized persons; or Impounded under Health-General Article, §21-1113, Annotated Code of Maryland. Aforementioned procedures do not preclude release of medication to discharged patients if ordered in writing by the attending physician. When closing business activities, a registrant shall: Dispose of all controlled dangerous substances in accordance with Regulation .16 of this chapter; and Return the controlled substances registration certificate to the Office of Controlled Substances Administration inspector at the time of the closing inspection. Change of Ownership. A Change of Ownership requires the registrant to notify the Department in writing, Attention to the Office of Controlled Substances Administration. The written notification shall be submitted: In person; By registered mail; or By certified mail with a return receipt request. The written notification must be received 14 days before the transfer occurs. The Secretary has the authority to waive the 14-day time limitation in individual instances. The written notification shall contain the following information: The name; The address; The registration number; and The authorized business activity of the: Registrant-transferor discontinuing the business; and Registrant-transferee acquiring the business; Whether the business activities will be: Continued at the location registered by the person discontinuing business; or Moved to another location and, if so, the address of the new location; and The date on which the transfer of controlled substances will occur. Except for transfer denials by the Secretary, the registrant-transferor may distribute, without being registered to distribute, controlled substances in the registrant-transferor’s possession to the registrant-transferee in accordance with the following procedures, on the date of transfer of the controlled substances: A complete inventory of all controlled substances being transferred shall be taken and serve as the final inventory of the registrant-transferor and the initial inventory of the registrant-transferee; A copy of the inventory shall be included in the records of both the transferor and transferee; A copy of the inventory shall be filed with the Department if requested by the Secretary; Transfers of Schedule I or II controlled substances shall require the use of order forms in accordance with 21 CFR §1305; All transferor-controlled substance records shall be transferred to the transferee; and Pursuant to 21 CFR §1304, transferors are required to make reports, which shall be marked as “Final”. Administrative Inspections. Procedures regarding administrative inspections and warrants pursuant to Criminal Law Article, §§5-305, 5-804, and 5-805, Annotated Code of Maryland, are governed generally by those sections of the Annotated Code and specifically by this regulation. Authority to make inspections is authorized in accordance with Criminal Law Article, §§5-804 and 5-805, Annotated Code of Maryland, to enter controlled premises and conduct administrative inspections for the purpose of the following: Documents required to be kept or made pursuant to 21 CFR §1304, under the Act, or regulations promulgated under the Act may be: Inspected; Copied; Verified for correctness; and Inventoried; Collecting samples of controlled substances or precursors (if samples are collected during an inspection, the inspector shall issue a receipt for these samples to the owner, operator, or agent in charge of the premises); Review of records and information on the distribution of controlled substances by the authorized provider; Reviewing the authorized providers processes; Reviewing the authorized providers controls; and Inspecting the authorized providers facility operations; Entry. An inspection shall be carried out by an inspector. An inspector shall have the right to enter the premises and conduct inspections at reasonable times and in a reasonable manner, upon the following conditions: Stating the inspector’s purpose; and Presenting to the owner, operator, or agent in charge of the premises to be inspected, appropriate credentials and written notice of the inspector’s inspection authority under Criminal Law Article, §5-305, 5-804, or 5-805, Annotated Code of Maryland. Consent to Inspection of Financial Data, Sales Data Other than Shipment Data, or Pricing Data. If inspection is desired of financing, sales, or pricing data, written consent shall first be obtained from the owner, operator, or agent in charge of the premises to be inspected. This written consent shall contain the following information: That the owner, operator, or agent in charge has the right to refuse to consent to an inspection of these items; That anything of an incriminating nature which may be found may be seized and used against the owner, operator, or agent in charge in a criminal prosecution; That the owner, operator, or agent in charge has been presented with a notice of inspection; That the consent is given by the owner, operator, or agent in charge voluntarily and without threats of any kind; and That the owner, operator, or agent in charge may withdraw the owner’s, operator’s, or agent in charge’s consent at any time during the course of inspection. The written consent shall be produced in duplicate and be distributed as follows: The original will be retained by the inspector; and The duplicate will be given to the authorized provider inspected. Administrative Warrants. Probable Cause. If the Department is satisfied that administrative probable cause exists, the Department shall issue an administrative warrant. Execution of Warrants. An administrative inspection warrant shall be executed as required by Criminal Law Article, §5-804(d), Annotated Code of Maryland. Refusal to Allow Inspection with an Administrative Warrant. If an authorized provider or any person subject to the Act refuses to permit execution of an administrative warrant, or impedes the inspector in the execution of that warrant, the authorized provider or person shall be advised that this refusal or action constitutes a violation of Criminal Law Article, §5-902(a)(3), Annotated Code of Maryland. Authority for Enforcement Proceeding. A hearing may be ordered or granted by the Secretary, at the Secretary’s discretion, to permit any person against whom criminal or civil action is contemplated under the Controlled Dangerous Substances Act an opportunity to present the individual’s views and the individual’s proposals for bringing the individual’s alleged violations into compliance with the law. The hearing will also permit the individual to show cause why prosecution should not be instituted, or to present the individual’s views on the contemplated proceeding. The rules of procedure for hearings before the Secretary of the Maryland Department of Health shall be governed by COMAR 10.01.03 and State Government Article, §§10-201—10-226, Annotated Code of Maryland. Administrative Hearings. Procedures for administrative hearings shall be governed by the rules set forth in Criminal Law Article, §5-308, if applicable, Health-General Article, §2-207, and State Government Article, §§10-201—10-226, Annotated Code of Maryland, and COMAR 10.01.03. After a hearing pursuant to Criminal Law Article, §5-308, if applicable, and State Government Article, §§10-201—10-226, Annotated Code of Maryland, and COMAR 10.01.03, the Secretary may impose a sanction or penalty against any registrant that possesses a Maryland-issued controlled substances registration pursuant to Criminal Law Article, Title V, Annotated Code of Maryland, instead of or in addition to: The denial of an application; The refusal to renew a registration; Suspending a registration; Revoking a registration; Placing restrictions on a registration pursuant to Criminal Law Article, §5-307, Annotated Code of Maryland; or Issuing a nonpublic advisory letter. Imposition of Monetary Penalty. After a hearing pursuant to Criminal Law Article, §5-308, Annotated Code of Maryland, the Department may impose a monetary penalty against a controlled substance registration holder pursuant to Criminal Law Article, §5-908, Annotated Code of Maryland. The monetary penalty may be imposed instead of or in addition to the: Suspension of the controlled substances registration; Revocation of the controlled substances registration; or Restrictions placed on the controlled substances registration. The monetary penalty shall be paid within 30 calendar days of the order, unless the order specifies otherwise. Until the imposed fine is paid, the registration may not be: Restored; Reinstated; or Renewed. In its discretion, the Department may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management for collection. Notwithstanding the guidelines set forth in this chapter, in order to resolve a pending disciplinary action, the Department and the registrant may agree to a surrender of a registration, or a consent order with terms, sanction, and penalties agreed to by the Department and the registrant. Nothing in this chapter prohibits the Department from staying any period of non-active suspension. The following substance, also known as a “bath salt”, is added to the Maryland Controlled Dangerous Substances Act, Schedule I of the Criminal Law Article, §5-402, Annotated Code of Maryland: F. 4-Methoxymethcathinone (Methedrone, bk-PMMA, PMMC). The following substances are added to the Maryland Controlled Dangerous Substances Act, Schedule III of the Criminal Law Article, §5-404, Annotated Code of Maryland: Butalbital, Acetaminophen, caffeine C-III Fioricet®; and Opium < or = 100mg per 100Gm or 100ml or not more than 5mg per dosage unit C-III. Criminal Law Article, Title 5; Health-General Article, §21-220; Annotated Code of Maryland Effective date: January 19, 1977 (4:2 Md. R. 87) Regulation .03A amended effective December 17, 1984 (11:25 Md. R. 2134); February 17, 1992 (19:3 Md. R. 304); December 24, 2001 (28:25 Md. R. 2190) Regulation .07E and J amended effective August 17, 1992 (19:16 Md. R. 1474) Regulation .07H amended effective July 12, 1998 (25:14 Md. R. 1132) Regulations .07N, R and .10B amended effective February 10, 1978 (5:3 Md. R. 138) Regulation .08G amended effective March 30, 1992 (19:6 Md. R. 673) Regulation .09A amended effective April 18, 1980 (7:8 Md. R. 771) Chapter revised effective April 26, 2004 (31:8 Md. R. 646) Regulation .03 repealed and new Regulation .03 adopted effective April 24, 2006 (33:8 Md. R. 732) Regulation .03 amended effective January 1, 2016 (42:22 Md. R. 1377) Regulation .13 adopted as an emergency provision effective October 18, 2011 (38:24 Md. R. 1495); adopted permanently effective December 26, 2011 (38:26 Md. R. 1697) Regulations .01—.13 repealed and new Regulations .01—.20 adopted effective October 14, 2024 (51:20 Md. R. 899) This chapter establishes regulations that preserve and improve the health, comfort, and environment of the people of the State by protecting the public and employees from involuntary exposure to environmental smoke in indoor areas open to the public, except for those covered by Health-General Article, §24-205, Annotated Code of Maryland. Nothing in this chapter preempts a county or municipal government from enacting and enforcing more stringent measures to protect the public from involuntary exposure to environmental smoke in indoor areas open to the public. In this chapter, the following terms have the meanings indicated. Terms Defined. “Act” means the Clean Indoor Air Act of 2007, Health-General Article, Title 24, Subtitle 5, Annotated Code of Maryland. “Cannabis” has the meaning stated in the Alcoholic Beverages and Cannabis Article, §1-101, Annotated Code of Maryland. “Club” means a club as defined in Alcoholic Beverages and Cannabis Article, §1-101, Annotated Code of Maryland. “Day care transportation” means the use of a vehicle owned, operated, or contracted for by a licensed day care facility to transport the facility's clients. “Department” means the Maryland Department of Health. “Electronic smoking device” has the meaning stated in Business Regulation Article, §16.7-101, Annotated Code of Maryland. “Environmental smoke” means the complex mixture formed from the: Smoke of a burning tobacco, cannabis, or hemp product, or exhaled by the smoker; or Aerosol of an electronic smoking device or exhaled as electronic smoking device aerosol. “Establishment” means a single physical location where business is conducted or where services are performed. “Health care transportation” means transportation of patients for medical care in a vehicle owned, operated, or contracted for by a licensed health care facility. “Health officer” means the health officer of each of the 23 counties and the Commissioner of Health in Baltimore City, the duly designated representative of the health officer, or both. “Hemp” has the meaning stated in the Agriculture Article, §14-101, Annotated Code of Maryland. “Indoor area” means all space in a structure or building with a ceiling that is enclosed on all sides by any combination of permanent or temporary walls, windows, or doorways, whether open or closed, or other physical barriers extending from floor to the ceiling. “Indoor area open to the public” means: An indoor area or a portion of an indoor area accessible to the public by either invitation or permission; or An indoor area of an establishment licensed or permitted under the Alcoholic Beverages and Cannabis Article, Annotated Code of Maryland, for the sale or possession of alcoholic beverages. “Owner” means an individual or entity having an ownership interest in an establishment or vehicle. “Person in charge” means an owner, operator, manager, or other person who controls, governs, or directs the activities of an establishment. “Public transportation of children” means the transportation of children in a vehicle owned, operated, or contracted for by a government entity or a private educational institution. “Secretary” means the Secretary of Health or the Secretary's designee. “Smoking” means the burning of a lighted cigarette, cigar, pipe, or another matter or substance containing, wholly or in part, tobacco, cannabis, or hemp. “Tobacco product” has the meaning stated in Health-General Article, §13-1001, Annotated Code of Maryland. “Vaping” means the use of: An electronic smoking device; or Any device through which the user inhales aerosol containing tobacco, cannabis, or hemp. This chapter does not apply to: Private homes and residences, including a residence used as a business or place of employment, unless being used by a person who is licensed or registered under Family Law Article, Title 5, Subtitle 5, Annotated Code of Maryland, to provide day care or child care; Private vehicles, unless being used: For the public transportation of children; or As part of health care or day care transportation; A hotel or motel room rented to one or more guests, if the total percent of hotel or motel rooms being rented where smoking or vaping is allowed, does not exceed 25 percent of the guest rooms in the hotel or motel; A retail tobacco business that is a sole proprietorship, limited liability company, corporation, partnership, or other enterprise, in which: The primary activity is the retail sale of tobacco products and accessories; and The sale of other products is incidental; A facility of a manufacturer, importer, wholesaler, or distributor of tobacco-containing products or a tobacco leaf dealer or processor in which employees of the manufacturer, importer, wholesaler, distributor, or processor work or congregate; and A research or educational laboratory for the purpose of conducting scientific research into the health effects of environmental smoke. Except as provided in Regulation .03 of this chapter, an individual may not smoke or vape in: An indoor area open to the public; An indoor place in which a meeting is open to the public in accordance with State Government Article, Title 10, Subtitle 5, Annotated Code of Maryland; An indoor place of employment; A government-owned or government-operated means of mass transportation, including: Buses; Vans; Trains; Taxicabs; and Limousines; A private home or residence that is being used by a person who is licensed or registered under Family Law Article, Title 5, Subtitle 5, Annotated Code of Maryland, to provide day care or child care; and A private vehicle while it is being used: For the public transportation of children; or As part of health care or day care transportation. The owner of a bar, club as defined in Regulation .02B of this chapter, restaurant, pub, tavern, retail establishment, theater, concert hall, athletic facility, financial service institution, government building, educational institution, museum, or library shall: Prohibit smoking or vaping in an indoor area open to the public; and Post a sign indicating where smoking or vaping is prohibited as set forth in Regulation .06A of this chapter. An owner of a hotel or motel shall: Prohibit smoking or vaping in an indoor area open to the public except where smoking or vaping is permitted under Regulation .03C of this chapter; and Post a sign indicating where smoking or vaping is permitted or prohibited, as set forth in Regulation .06B and C of this chapter. An owner of a vehicle listed in Regulation .04D of this chapter shall: Prohibit smoking or vaping in the vehicle; and Post a sign indicating where smoking or vaping is prohibited as set forth in Regulation .06D of this chapter. An owner of an establishment containing an indoor area open to the public not listed in Regulation .05A—C of this chapter shall prohibit smoking or vaping in an indoor area open to the public. An indoor area open to the public and every public entrance to an indoor area open to the public where smoking or vaping is prohibited under Regulation .05A of this chapter shall display conspicuously a “NO SMOKING OR VAPING” sign that conforms to the requirements of Regulation .06E of this chapter. A hotel or motel room in which smoking or vaping is permitted shall display a sign containing the words “SMOKING OR VAPING PERMITTED IN THIS ROOM” conforming to the following requirements: The words “SMOKING OR VAPING PERMITTED IN THIS ROOM” are in capital letters; The background and the print are in contrasting colors; and The letters “SMOKING OR VAPING PERMITTED IN THIS ROOM” on the sign are a minimum of 1 inch in height. An indoor area open to the public and every public entrance to an indoor area open to the public where smoking is prohibited in a hotel or motel shall display conspicuously a “NO SMOKING OR VAPING” sign that conforms to the requirements of Regulation .06E of this chapter. A vehicle where smoking is prohibited under Regulation .04D of this chapter shall display conspicuously a “NO SMOKING OR VAPING” sign that conforms to the requirements of Regulation .06E of this chapter. Sign Requirements. A “NO SMOKING OR VAPING” sign: Shall contain the words “NO SMOKING OR VAPING” composed of letters at least one inch in height; May contain the following symbols: The international symbol for “no smoking”, consisting of a pictorial representation of a burning cigarette enclosed in a circle with a bar across the circle; The international symbol for “no smoking” and pictorial representation of an electronic smoking device enclosed in a circle with a bar across the circle or pictorial representations of an electronic smoking device and a cannabis leaf, enclosed in separate circles, with a bar across each circle; A modified international symbol for “No Smoking”, consisting of a circle with a bar across the circle, with the circle containing pictorial representations of a burning cigarette and an electronic smoking device or electronic smoking device and a cannabis leaf; or Any combination of §E(2)(a)—(c) of this regulation; and May contain additional information, such as: The words, “For information on quitting smoking, call 1-800-QUIT NOW (1-800-784-8669)”; The words “WARNING: TOBACCO SMOKE CAUSES CANCER AND HEART DISEASE AND CAN HARM YOUR CHILD.”; or The words “WARNING: CANNABIS SMOKE CAN HARM LUNG TISSUE AND HAS MANY OF THE SAME CARCINOGENS AS TOBACCO SMOKE.” The owner or person in charge shall ensure that a sign required under this regulation is conspicuously posted and in good condition. A person may register a complaint of a violation of a requirement of this chapter by means of: A written complaint to the health officer in the jurisdiction where the alleged violation took place; or A telephone complaint to the health officer in the jurisdiction where the alleged violation took place. The Department shall make available a complaint form at the Department's website and at a local health department. Upon receipt of a complaint, the health officer or the health officer's designee shall: Record the complaint on the complaint form; and Investigate the complaint. A health officer or the health officer's designee may investigate conditions relative to the enforcement of this chapter. The person in charge of an establishment shall permit a health officer or health officer's designee to enter an establishment during its business hours for the purpose of determining compliance with this chapter. When an investigation is made, the health officer or the health officer's designee shall: Document: The result of the investigation on a report form provided by the Department; and A condition found that is in violation of the provisions of this chapter; Furnish one copy of the report form to the person in charge of the establishment; and Make the completed report form available for public disclosure in accordance with State Government Article, §10-611— 10-628, Annotated Code of Maryland. The health officer or the health officer's designee shall notify the owner of an establishment found in violation of a provision of this chapter or the Act: By certified mail, return receipt requested, bearing a postmark from the United States Postal Service; Of the specific finding and the penalty for the violation as set forth in Regulation .10 of this chapter; Of a specific date by which the owner shall correct the violation; That if the owner fails to correct the violation by the date specified, or is in violation of another provision of this chapter or the Act at another time, the Secretary may impose a subsequent penalty as set forth in Regulation .10 of this chapter; and That the owner is entitled to request a hearing under Regulation .11 of this chapter on a violation and penalty, as set forth in Regulation .10 of this chapter. The owner of an establishment shall submit to the health officer a certification of correction within a time frame provided by the local health department that: Lists a violation; and Includes a description of how the correction was accomplished. A person who violates a provision of this chapter is subject to the following penalties: A written reprimand by the Secretary for the first violation; A civil penalty of $100 for a second violation; A civil penalty of $500 for the third violation; and A civil penalty of $1,000 per violation for each subsequent finding of violation. The Department shall pay a penalty collected under this regulation to the Cigarette Restitution Fund established under State Finance and Procurement Article, §7-317, Annotated Code of Maryland. In order to preserve a right to a hearing on a violation and penalty of this chapter, a person shall submit a written request to the Department for a hearing, if a hearing is desired, within 10 days of receipt of the notice of violation and penalty. In accordance with the Administrative Procedure Act, State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, the Secretary shall provide for a hearing on the violation by referring the matter to the Office of Administrative Hearings. The Office of Administrative Hearings shall: Schedule and conduct the hearing on the violation; and Render a decision and notify the parties of the decision within 30 days after the hearing. Health-General Article, §§24-205 and 24-501 — 24-511, Annotated Code of Maryland Effective date: April 21, 1978 (5:8 Md. R. 594) Regulation .02W-1 adopted as an emergency provision effective March 26, 1979 (6:7 Md. R. 575); adopted permanently effective June 29, 1979 (6:13 Md. R. 1128) Regulation .02PP amended as an emergency provision effective September 11, 1978 (5:9 Md. R. 1442), expired January 20, 1979; adopted permanently effective February 26, 1979 (6:4 Md. R. 277) Regulation .02QQQ amended as an emergency provision effective April 27, 1979 (6:10 Md. R. 839) (Emergency provisions are temporary and not printed in COMAR) Chapter revised effective May 16, 1980 (7:10 Md. R. 952) Chapter revised effective November 23, 1981 (8:23 Md. R. 1856) Chapter, Drug Formulary of Equivalent Drug Products, repealed effective May 16, 1988 (15:10 Md. R. 1202) Chapter, Tobacco Smoking in Retail Stores, adopted effective February 4, 1991 (18:2 Md. R. 149) Chapter, Tobacco Smoking in Retail Stores, repealed, and new Chapter, Prohibition of Smoking in Indoor Areas Open to the Public, adopted effective February 1, 2008 (34:26 Md. R. 2262) Regulation .01 amended effective February 16, 2026 (53:3 Md. R. 122) Regulation .02B amended effective February 16, 2026 (53:3 Md. R. 122) Regulation .03C, D, F amended effective February 16, 2026 (53:3 Md. R. 122) Regulation .04 amended effective February 16, 2026 (53:3 Md. R. 122) Regulation .05 amended effective February 16, 2026 (53:3 Md. R. 122) Regulation .06 amended effective February 16, 2026 (53:3 Md. R. 122) Regulation .12 repealed effective February 16, 2026 (53:3 Md. R. 122) Except for the changes shown in Regulation .02 of this chapter, all provisions of 16 CFR 1602, 1605, 1608, 1609, 1610, 1611, 1615, 1616, and 1632, are incorporated by reference. In the incorporation by reference cited in Regulation .01 of this chapter, the following terms have the meanings indicated. Terms Defined. “Act” means the Maryland Flammable Products Act, Health-General Article, Title 22, Subtitle 4, Annotated Code of Maryland. “Commission” means the Maryland Department of Health. Health-General Article, Title 22, Subtitle 4, Annotated Code of Maryland Effective date: June 30, 1978 (5:13 Md. R. 1063) Regulation .01 amended and recodified to Regulations .01 and .02 effective October 23, 1995 (22:21 Md. R. 1616) All provisions of 16 Code of Federal Regulations, Part 1700, are incorporated by reference, except for the changes shown in §B of this regulation. Definitions (see 16 CFR 1700, §1700.1). “Act” means Child Resistant Packaging of Dangerous Household Substances, Health-General Article, §§22-301 — 22-312, Annotated Code of Maryland. “Commission” means the Maryland Department of Health. “Dietary supplement” means a vitamin or mineral preparation, or both, offered in tablet, capsule, wafer, or other similar uniform unit form; in powder, granule, flake, or liquid form; or in the physical form of a conventional food but which is not a conventional food; and which purports or is represented to be for special dietary use by humans to supplement their diets by increasing the total dietary intake of one or more of the essential vitamins or minerals, or both. Health-General Article, Title 22, Subtitle 3, Annotated Code of Maryland Effective date: November 3, 1978 (5:22 Md. R. 1673) Regulation .01 amended effective January 7, 1991 (17:26 Md. R. 2975) This chapter establishes regulations that prohibit the import, sale, or offering for sale of child care products containing: TCEP, also known as (tris (2-chloroethyl) phosphate); or TDCPP, also known as (tris (1, 3-dichloro-2-propyl) phosphate). This chapter does not apply to the sale or distribution of a child care product that is resold, offered for resale, or distributed by a consumer for consumer use. In this chapter, the following terms have the meanings indicated. Terms Defined. “Child care product” means a consumer product intended for use by a child under the age of 3 years, including a: Baby product; Toy; Car seat; Nursing pillow; Crib mattress; and Stroller. “Secretary” means the Secretary of Health. “TCEP” means an industrial chemical also known as (tris (2-chloroethyl) phosphate). “TDCPP” means an industrial chemical also known as (tris (1, 3-dichloro-2-propyl) phosphate). A person may not import, sell, or offer for sale any child care product containing more than 1/10 of 1 percent of TCEP by mass. On or after October 1, 2014, a person may not import, sell, or offer for sale any child care product containing more than 1/10 of 1 percent of TDCPP by mass. The Secretary may suspend implementation of this chapter if the Secretary determines that the fire safety benefits of TCEP or TDCPP are greater than the known health risks associated with TCEP or TDCPP. A person that violates this chapter is subject to: For a first violation, a civil penalty not exceeding $1,000; and For any subsequent violation, a civil penalty not exceeding $2,500 for each violation. In addition to the civil penalties described in §A of this regulation, a court may also enjoin an action prohibited in Regulation .04 of this chapter. Health-General Article, §§24-306 and 24-306.1, Annotated Code of Maryland Effective date: Regulations .01—.04 adopted as an emergency provision effective October 1, 2013 (40:22 Md. R. 1871); adopted permanently effective January 6, 2014 (40:26 Md. R. 2164) Regulation .01A amended effective January 19, 2015 (42:1 Md. R. 18) Regulation .02B amended effective January 19, 2015 (42:1 Md. R. 18); December 25, 2023 (50:25 Md. R. 1088) Regulation .03 amended effective January 19, 2015 (42:1 Md. R. 18) This chapter establishes regulations that prohibit the import, sale, or offering for sale of juvenile products, mattresses, upholstered furniture, or reupholstered furniture containing more than 0.1 percent of flame-retardant chemical by mass. This chapter does not apply to the sale or distribution of a juvenile product, a mattress, upholstered furniture, or reupholstered furniture that is resold, offered for resale, or distributed by a consumer for consumer use. In this chapter, the following terms have the meanings indicated. Terms Defined. “Adult mattress” means any mattress other than a toddler mattress, a crib mattress, or any other infant sleep product. “Flame-retardant chemical” means a chemical that: Is used to resist or inhibit the spread of fire or act as a synergist to chemicals that resist or inhibit the spread of fire, including any chemical for which the term “flame retardant” appears on a safety data sheet developed in accordance with 29 CFR §1910.1200(g); and Is a nanoscale chemical or has one or more of the following properties: Contains one or more halogen elements, including fluorine, chlorine, bromine, or iodine; Contains one or more carbon elements and one or more phosphorus elements; and Contains one or more carbon elements and one or more nitrogen elements. Juvenile Product. “Juvenile product” means a consumer product intended for use by a child younger than 12 years old. “Juvenile product” includes: A bassinet; A booster seat; A changing pad; A children’s nap mat; A floor playmat; A high chair; A high chair pad; An infant bouncer; An infant carrier; An infant seat; An infant swing; An infant walker; A nursing pad; A nursing pillow; A playpen side pad; A play yard; A portable hook-on chair; and A stroller. “Juvenile product” does not include a: Product that is not primarily intended for use in the home, including a product that is, or is a component part of, a motor vehicle, a watercraft, an aircraft, or any other vehicle; Product regulated under 49 CFR Part 571; Consumer electronic product; or Child care product regulated under Health-General Article, §24-306, Annotated Code of Maryland, or COMAR 10.19.07. “Mattress” has the meaning stated in 16 CFR § 1632.1. “Reupholstered furniture” means furniture for which the original fabric, padding, decking, barrier material, foam, or other resilient filling has been replaced and that has not been sold since the time of replacement. “Upholstered furniture” means furniture that includes filling materials, barrier materials, decking materials, or cover fabrics. This regulation does not apply to: An electronic component, or the casing for an electronic component, of a juvenile product, a mattress, upholstered furniture, or reupholstered furniture; A component of upholstered or reupholstered furniture other than cover fabric, barrier material, resilient filling material, and decking material; Thread or fiber when used for stitching mattress components together; or Except for foam, a component of an adult mattress. A person may not import, sell, or offer for sale any juvenile product, mattress, upholstered furniture, or reupholstered furniture that contains more than 0.1 percent of flame-retardant chemicals by mass. The Secretary or the Secretary’s designee may investigate conditions relative to the enforcement of this chapter. The person in charge of an establishment shall permit the Secretary or the Secretary’s designee to enter an establishment during its business hours for the purpose of determining compliance with this chapter. The person in charge of an establishment shall provide to the Secretary or the Secretary’s designee product safety data sheets, technical specifications, and any information available related to the composition of the juvenile product. If a person willfully violates this chapter, the Secretary may assess a civil penalty: For a first violation after receiving a letter of reprimand, not exceeding $2,500; For a second violation, not exceeding $5,000; For a third violation, not exceeding $7,500; and For any subsequent violation, not exceeding $10,000 for each violation. In determining the amount of a penalty under §A of this regulation, the Secretary shall consider: The nature and severity of the violation; The good faith of the person; The history of violations by the person; The extent to which the person cooperated with any investigation by the Department; and Whether the person has previously been issued a letter of reprimand. For a violation of this chapter, the Secretary shall issue a letter of reprimand. In order to preserve a right to a hearing on a violation and penalty of this chapter, a person shall submit a written request to the Department for a hearing, if a hearing is desired, within 10 days of receipt of the notice of violation and penalty. In accordance with the Administrative Procedure Act, State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, the Secretary shall provide for a hearing on the violation by referring the matter to the Office of Administrative Hearings. The Office of Administrative Hearings shall: Schedule and conduct the hearing on the violation; and Render a decision and notify the parties of the decision within 30 days after the hearing. Health-General Article, §24-306.1, Annotated Code of Maryland Effective date: December 25, 2023 (50:25 Md. R. 1088)