Louisiana Administrative Code
Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS
Part XCI - Drug and Device Distributors
Chapter 3 - Drug and Device Distributors
Section XCI-313 - Policy and Procedures
Universal Citation: LA Admin Code XCI-313
Current through Register Vol. 50, No. 3, March 20, 2024
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ensure that any outdated drugs or devices shall be segregated from other drugs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shall provide for written documentation of the disposition of outdated drugs or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disposition of the outdated drugs;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.
AUTHORITY NOTE: Promulgated in accordance with R.S. 37:3461-3482.
Disclaimer: These regulations may not be the most recent version. Louisiana may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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