S.D. Admin. R. 20:67:05:01

Current through Register Vol. 51, page 67, December 16, 2024

Section 20:67:05:01 - Policies and procedures to be established

Wholesale and other drug distributors shall establish, maintain, and adhere to written policies and procedures for the receipt, security, storage, inventory, and distribution of prescription drugs, including policies and procedures for identifying, recording, and reporting losses or thefts and for correcting all errors and inaccuracies in inventories. Wholesale and other drug distributors shall include in their written policies and procedures the following:

(1) A procedure whereby the oldest approved stock of a prescription drug product is distributed first. The procedure may permit deviation from this requirement if the deviation is temporary;

(2) A procedure to be followed for handling recalls and withdrawals of prescription drugs due to:

(a) Any action initiated at the request of the food and drug administration or any other federal, state, or local law enforcement or governmental agency, including the board;

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

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

(3) A procedure to ensure that wholesale and other drug distributors 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;

(4) A procedure to ensure that any outdated prescription drugs are segregated from other drugs and either returned to the manufacturer or destroyed. This procedure shall provide for written documentation of the disposition of outdated prescription drugs;

(5) A procedure to keep access from outside the premises to a minimum and well controlled; and

(6) A procedure to limit entry into areas where prescription drugs are held to authorized personnel only.

S.D. Admin. R. 20:67:05:01

18 SDR 95, effective 11/25/1991; 45 SDR 086, effective 12/24/2018

General Authority: SDCL 36-11A-14(7),(10),(12).

Law Implemented: SDCL 36-11A-7.