Oregon Administrative Rules › Chapter 855 - BOARD OF PHARMACY › Division 65 - WHOLESALE DRUG OUTLETS › Section 855-065-0010 - Minimum Requirements for Reporting, Record Keeping and Inventory Management

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A
			 Wholesale distributor must establish and maintain inventories and records of
			 all transactions regarding the receipt and distribution or other disposition of
			 drugs. These records must comply with all federal drug laws and regulations
			 unless exempted.
(2) Inventories
			 and records required by this rule must be made available for inspection and
			 copying by any authorized official of the Drug Enforcement Agency, the Food and
			 Drug Administration, the Department of Agriculture, law enforcement agencies,
			 and this Board.
(3) Inventories
			 and records required under these rules must be maintained for a minimum of
			 three years following disposition of the drugs.
(4) Records described in this section that
			 are less than 13 months old must be kept at the inspection site or be
			 immediately retrievable by computer or other electronic means, and must be
			 immediately available for inspection. All other records required by this rule
			 must be made available for inspection within three business days of a request.
(5) A wholesale distributor must
			 establish, maintain, and adhere to written policies and procedures for the
			 receipt, security, storage, inventory, transport, shipping and distribution of
			 drugs, including policies and procedures for identifying, recording, and
			 reporting any loss, theft, counterfeiting or diversion of any drug and for
			 correcting all errors and inaccuracies in inventories. A wholesale distributor
			 must include in its written policies and procedures the following:
(a) A procedure whereby the oldest approved
			 stock of a drug is distributed first. The procedure may permit deviation from
			 this requirement if such deviation is temporary and appropriate.
(b) A procedure to be followed for handling a
			 recall or withdrawal of a drug. Such procedure must be adequate to deal with a
			 recall or withdrawal due to:
(A) Any 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 a defective or potentially defective drug from the
			 market; or
(C) Any action
			 undertaken to promote public health and safety by replacing an existing drug
			 with an improved product or new package design.
(c) A procedure to prepare for, protect
			 against, and handle any crisis that affects the security or operation of the
			 facility in the event of strike, fire, flood, or other natural disaster, or
			 other local, state, or national emergencies.
(d) A procedure to ensure that any outdated
			 drug is segregated from other drugs and either returned to the manufacturer or
			 destroyed. This procedure must provide for written documentation of the
			 disposition of an outdated drug. This documentation must be maintained for
			 three years after disposition of the outdated drug.
(e) Disposition and destruction of
			 containers, labels, and packaging to ensure that the containers, labels, and
			 packaging are not used in counterfeiting activities, including necessary
			 documentation and witnessing in accordance with state and federal law.
(f) Investigation of discrepancies
			 in the inventory involving counterfeit, suspected counterfeit, contraband, or
			 suspected contraband drugs and reporting of discrepancies within three business
			 days to the Board and any other appropriate state or federal agency.
(g) Reporting of criminal or suspected
			 criminal activities involving the inventory of drugs to the Board within three
			 business days.
(h) Conducting for
			 cause authentication as required under section (7) of this rule.
(i) Procedures for accurately documenting the
			 temperature and humidity conditions of the storage facility.