Wyoming Administrative Code
Agency 059 - Pharmacy, Board of
Sub-Agency 0001 - Pharmacy, Board of
Chapter 8 - WHOLESALE DISTRIBUTOR REGULATIONS
Section 8-16 - Policies and Procedures

Universal Citation: WY Code of Rules 8-16

Current through September 21, 2024

All entities shall establish, maintain and adhere to written policies and procedures, which shall be followed for the receipt, security, storage, inventory, transport, shipping and wholesale 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. Policies and procedures shall include the following:

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

(i) Any action initiated at the request of the FDA or any other federal, state or local law enforcement or other governmental agency, including the board of pharmacy; or

(ii) Any volunteer action by the manufacturer to remove defective or potentially defective prescription drugs from the market.

(b) A procedure to ensure that all entities prepare for, protect against, and handle any crisis that affects security or operation of any facility in the event of a strike, fire, flood, natural disaster, or other situations of local, state or national emergency;

(c) A procedure to ensure that any outdated prescription drugs shall be segregated from other prescription drugs and either returned to the manufacturer or third party return processor or destroyed in accordance with federal and state laws, including all necessary documentation and the appropriate witnessing. This procedure shall provide for written documentation of the disposition of outdated prescription drugs. This documentation shall be maintained for two (2) years after disposition of the outdated prescription drugs;

(d) A procedure for the disposing and destruction of containers, labels and packaging to ensure that the containers, labels and packaging cannot be used in counterfeiting activities, including all necessary documentation, maintained for a minimum of two (2) years, and the appropriate witnessing of the destruction of any labels, packaging, immediate containers or containers in accordance with all applicable federal and state requirements;

(e) A procedure for identifying, investigating and reporting significant prescription drug inventory discrepancies involving suspect products, in the inventory and reporting of such discrepancies within ten (10) business days to the Board and appropriate federal or state agency upon discovery of such discrepancies;

(f) A procedure for reporting criminal or suspected criminal activities involving the inventory of prescription drugs to the board, FDA and, if applicable, DEA, within three (3) business days; and

(g) A procedure for verifying security provisions of common carriers.

Disclaimer: These regulations may not be the most recent version. Wyoming 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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