La. Admin. Code tit. 46 § XXXIV-313

Current through Register Vol. 50, No. 11, November 20, 2024

Section XXXIV-313 - Policy and Procedures

A. Drug or device distributors shall establish, maintain, and adhere to written policies and procedures, which shall be followed for the receipt, security, storage, inventory, and distribution of drugs or devices, including policies and procedures for identifying, recording, and reporting losses or thefts, and for correcting all errors and inaccuracies in inventories including contraband or counterfeit drug or device information. Drug or device distributors shall include in their written policies and procedures the following:

1. a procedure whereby the oldest approved stock of a drug or device is distributed first. The procedure may permit deviation from this requirement if such deviation is temporary and appropriate;

2. a procedure to be followed for handling recalls and withdrawals of drugs or devices. Such procedure shall be adequate to deal with recalls and withdrawals due to:

a. 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 board;

b. any voluntary action by the manufacturer to remove defective or potentially defective drugs or devices from the market; or

c. any action undertaken to promote public health and safety by replacing of existing merchandise with an improved product or new package design;

3. a procedure to ensure that drug or device 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 a procedure to ensure that any outdated drugs or devices shall be segregated from other drugs or devices and either returned to the manufacturer or destroyed. This procedure shall provide for written documentation of the disposition of outdated drugs or devices. This documentation shall be maintained for three years after disposition of the outdated drugs;

5. a procedure to validate customer licenses, to review excessive or suspicious purchases, to inspect all incoming and outgoing shipments, and to monitor and record the temperature of product storage;

6. a procedure to notify the board, in writing, within three business days of discovering, or being in a position to have acquired such knowledge, of any theft or diversion of a drug or device;

7. a procedure to notify the board, in writing, within 24 hours of discovery, or being in a position to have acquired such knowledge, of any contraband, counterfeit, or misbranded drug or device in his possession, whether actual or constructive.

La. Admin. Code tit. 46, § XXXIV-313

Promulgated by the Department of Health and Hospitals, Board of Wholesale Drug Distributors, LR 18:384 (April 1992), amended LR 29:1480 (August 2003), LR 32:400 (March 2006), LR 39:91 (January 2013), amended by the Department of Health, Board of Drug and Device Distributors, LR 42:2186 (December 2016).

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:3461-3482.