Current through June 11, 2024
Section 639.605 - Establishment and maintenance of policies and procedures regarding prescription drugs1. Each wholesaler shall establish written policies and procedures for the receipt, security, storage, inventory and distribution of prescription drugs.2. The written policies and procedures must include: (a) A procedure for identifying, recording and reporting any losses or thefts of prescription drugs.(b) A procedure for correcting any errors or inaccuracies concerning the wholesaler's inventory.(c) A procedure that requires the oldest approved stock of a prescription drug to be distributed first. The procedure may allow deviation from that requirement if the deviation is temporary and appropriate.(d) A procedure relating to the recall or withdrawal of a prescription drug because of: (1) Any action taken at the request of the Food and Drug Administration or other federal agency or state or local law enforcement agency or other governmental agency, including the Board;(2) Any voluntary action taken by a manufacturer to remove defective or potentially defective drugs from the market; or(3) Any action taken by a manufacturer to promote public health and safety by the replacement of existing prescription drugs with an improved product or new design of a package.(e) A procedure for the operation of a facility in the event of a strike, fire, flood or other natural disaster or emergency.(f) A procedure to ensure that any outdated prescription drug is separated from other drugs that are not outdated and is destroyed or returned to the manufacturer. The procedure must provide for the establishment and maintenance of written records of the disposition of each outdated prescription drug. The wholesaler shall keep the records for 3 years after the disposition of the prescription drug.(g) A procedure to gather, make and maintain all records required pursuant to NRS 639.234 and NAC 639.585 to 639.607, inclusive, and sections 2, 3 and 4 of this regulation, including a procedure to make records readily retrievable, as applicable.(h) A procedure to ensure that all prescription drugs received are examined pursuant to NAC 639.599 and 639.601.(i) A procedure to ensure that the prescription drugs are not contraband drugs or counterfeit drugs.3. As used in this section: (a) "Contraband drug" means a prescription drug that is offered for sale by a purchaser to a wholesaler in violation of an agreement to which the purchaser is a party or is otherwise in privity of contract that would prohibit or otherwise disallow such a sale or resale.(b) "Counterfeit drug" means a prescription drug that is adulterated, mislabeled or misbranded pursuant to chapter 585 of NRS.Nev. Admin. Code § 639.605
Added to NAC by Bd. of Pharmacy, eff. 7-16-92; A by R049-04, 2-28-2005; A by R040-20A, eff. 8/26/2020