NAC639.601. Prescription drugs: Separation and disposal of certain drugs.

     1. A prescription drug that is outdated, damaged, deteriorated, misbranded or adulterated must be separated from other prescription drugs until it is destroyed or returned to the supplier.

     2. A prescription drug whose immediate or sealed outer or secondary container has been opened or used must be identified as such and separated from other prescription drugs until it is destroyed or returned to the supplier.

     3. If a prescription drug is returned to a wholesaler by a purchaser or purchasing wholesaler under conditions which cast doubt on the prescription drug’s safety, identity, strength, quality or purity, the wholesaler shall destroy the prescription drug or return it to the supplier unless, after conducting an examination, testing or other investigation, the wholesaler determines that the prescription drug complies with the appropriate standards of safety, identity, strength, quality and purity as prescribed in the package insert as approved by the Food and Drug Administration or in the United States Pharmacopeia - National Formulary, as adopted by reference in paragraph (c) of subsection 1 of NAC 639.670. The wholesaler shall keep a record of any examination, testing or other investigation conducted and make any records available for inspection by the Board.

     4. Unless the reason a prescription drug must be destroyed or returned to the supplier is related to the expiration date of the prescription drug, a wholesaler that is required to destroy a prescription drug or return it to the supplier pursuant to subsection 3 shall provide to the Board a written notice that includes:

     (a) The name of the prescription drug;

     (b) The lot number and expiration date of the prescription drug;

     (c) The quantity of the prescription drug;

     (d) The name and address of the business that returned the prescription drug to the wholesaler;

     (e) Whether the wholesaler will:

          (1) Return the prescription drug to the supplier; or

          (2) Destroy the prescription drug; and

     (f) The reason for the action taken by the wholesaler.

     5. Within 48 hours after receipt by the Board of a notice required pursuant to subsection 4, a member of the staff of the Board shall inspect the prescription drug at the facility of the wholesaler and may impound or remove the prescription drug. If the member of the staff of the Board does not impound or remove the prescription drug, the wholesaler may return the prescription drug to the supplier or destroy the prescription drug.

     (Added to NAC by Bd. of Pharmacy, eff. 7-16-92; A by R049-04, 2-28-2005; R035-06, 9-18-2008)