Md. Code Regs. 10.19.03.16

Current through Register Vol. 51, No. 22, November 1, 2024

Section 10.19.03.16 - Controlled Substance Disposal

A. 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.

B. Disposal of Medical Waste.

(1) A registrant in possession of legally obtained controlled substances deemed medical waste shall render the controlled substances irretrievable by disposing of:

(a) Liquid waste in an approved containment unit; or

(b) Non-liquid in a receptacle.

(2) Two licensed personnel shall keep Waste Destruction Logbooks and maintain the record for 2 years. The Destruction Log shall be readily available upon inspection.

C. Disposal for Registrants Required to Register with the DEA.

(1) 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:

(a) By transfer to a person registered under the Act and authorized to possess the substance;

(b) By destruction in the presence of an agent of the Office of Controlled Substances Administration or another authorized person;

(c) By forwarding to the District Office of the Drug Enforcement Administration pursuant to the procedures of that agency;

(d) By returning unused controlled substances dispensed by registered hospital pharmacies for administration to in-patients to the pharmacy for appropriate disposition; or

(e) By other means that the Secretary may determine to assure that the substance does not become available to unauthorized persons.

(2) A registrant that has complied with 21 CFR §1304 is deemed to have complied with this section.

(3) 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.

D. 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:

(1) List the controlled substance or substances which the registrant desires to dispose of on a drug destruction form provided by the Department;

(2) Have two members of the professional staff, limited to an administrator, nurse, or pharmacist, destroy controlled drugs on premises;

(3) Dispose per instructions given in §B of this regulation.

(4) Forward a copy of the completed drug destruction form to the Office of Controlled Substances Administration within 10 days of destruction; and

(5) Keep a copy of the drug disposal form on location for a period of 2 years.

E. Abandoned controlled substances may be:

(1) Destroyed in the presence of an agent of the Office of Controlled Substances Administration or another authorized person or persons;

(2) Disposed of by other means that the Secretary may determine to assure that the substance does not become available to unauthorized persons; or

(3) Impounded under Health-General Article, §21-1113, Annotated Code of Maryland.

F. Aforementioned procedures do not preclude release of medication to discharged patients if ordered in writing by the attending physician.

Md. Code Regs. 10.19.03.16

Regulation .16 adopted effective 51:20 Md. R. 899, eff. 10/14/2024.