D.C. Mun. Regs. tit. 22, r. 22-B409

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 22-B409 - WRITTEN POLICIES AND PROCEDURES

409.1

Licensees shall establish, maintain, and adhere to written policies and procedures for the receipt, security, storage, inventory and distribution of drugs. Written policies shall include the following:

(a) Procedures for identifying, recording, and reporting losses and thefts;

(b) [Reserved]

(c) Procedures whereby the oldest approved stock of a drug product is distributed first. The procedure may permit deviation from this requirement, if such deviation is temporary and appropriate;

(d) Procedures to be followed for handling recalls and withdrawals of drugs. Such procedures shall ensure that all drugs included on the recall and/or withdrawal, are returned for proper disposition due to:

(1) An action initiated at the request of the Food and Drug Administration or other Federal, state, or local law enforcement or other government agency, including the Director;

(2) Any voluntary action by the manufacturer to remove defective or potentially defective drugs from the market; or

(3) Any action undertaken to promote public health and safety by replacing of existing merchandise with an improved product or new package design.

(e) Procedures to ensure that licensees prepare for, protect against, and handle any crisis that affects security or operation of any facility in the event of strike, fire, flood, or other natural disaster, or other situations of local, state or national emergency.

(f) Procedures to ensure that any outdated drugs shall be segregated from other drugs and either returned to the manufacturer or destroyed. This procedure shall provide for written documentation of the disposition of outdated drugs. This documentation shall be maintained for two (2) years after disposition of the outdated drugs.

D.C. Mun. Regs. tit. 22, r. 22-B409

Final Rulemaking published at 39 DCR 7729, 7734 (October 16, 1992)