Or. Admin. Code § 855-065-0010

Current through Register Vol. 63, No. 12, December 1, 2024

Section 855-065-0010 - Minimum Requirements for Reporting, Record Keeping and Inventory Management

(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.

(6) A wholesale distributor must maintain and adhere to written policies and procedures for all incoming and outgoing product shipments, including but not limited to the following:

(a) Upon receipt, visual examination of each shipping container sufficient to identify the drugs in the container and to determine whether the drugs may be outdated, adulterated, misbranded, contaminated, contraband, counterfeit, damaged, or otherwise unfit for distribution.

(b) Upon receipt, review of records for accuracy and completeness, considering the:

(A) Total facts and circumstances surrounding each transaction involving the drugs; and

(B) Wholesale distributors involved.

(c) Quarantine of a drug considered to be outdated, adulterated, misbranded, contaminated, contraband, counterfeit, damaged, or otherwise unfit for distribution until:

(A) Examination and a determination is made that the drug is fit for distribution; or

(B) The drug is destroyed or returned to the manufacturer or wholesale distributor from which the drug was acquired.

(d) If the wholesale distributor identifies a suspect product, the wholesale distributor must quarantine the product and promptly conduct an investigation to determine whether the suspect product is illegitimate. If it is determined to be an illegitimate product the wholesale distributor must provide notice to the Board, the Food and Drug Administration, and the trading partners involved in the transaction, within 24 hours.

(e) If the immediate or sealed outer or secondary container or labeling of a drug is adulterated, misbranded, counterfeit, or suspected counterfeit, the wholesale distributor must:

(A) Quarantine the drug until the drug is destroyed or returned to the manufacturer or wholesale distributor from which the drug was acquired; and

(B) Provide notice of the adulteration, misbranding, counterfeiting, or suspected counterfeiting to the Board, the Food and Drug Administration, and the manufacturer or wholesale distributor from which the drug was acquired, within 24 hours.

(f) A drug that is not adulterated, misbranded, counterfeit, or suspected counterfeit, but has been opened or used, is identified as such and quarantined until the drug is destroyed or returned to the manufacturer or wholesale distributor from which the drug was acquired.

(g) A drug that will be returned to a manufacturer or wholesale distributor is stored, handled and transported under proper conditions before the return, and documentation showing that proper conditions were maintained must be provided to the manufacturer or wholesale distributor to which the drug is returned.

(h) Inspection of each outgoing shipment to verify the identity of each drug and to ensure that each drug has not been damaged in storage or held under improper conditions.

(i) Contraband, counterfeit, or suspected counterfeit drugs, other evidence of criminal activity, and accompanying documentation are retained until a disposition is authorized by the Board or the Food and Drug Administration.

(j) Any sealed outer or secondary shipping container or labeling, and accompanying documentation, for a drug that is suspected to be counterfeit or fraudulent, is retained until a disposition is authorized by the Board and the Food and Drug Administration.

(k) Operations comply with all state and federal laws, rules and regulations applicable to wholesale drug distribution.

(l) All confidential information is stored in an area with restricted access and in such a way as to protect the integrity and confidentiality of the information.

(7) A wholesale distributor must maintain pedigree records for a minimum of three years.

(8) If the wholesale distributor is involved in the distribution of controlled substances, the distributor must register with the Drug Enforcement Administration and the Board, and comply with all laws related to the storage, handling, transport, shipment, and distribution of controlled substances including, but not limited to, the isolation of controlled substances from non-controlled substances and storage of the controlled substances in a secure area in accordance with Drug Enforcement Administration security requirements and standards.

(9) A wholesale distributer must notify the Board in writing of suspicious orders of controlled substances to be distributed within Oregon upon discovery. Suspicious orders include, but are not limited to orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.

Or. Admin. Code § 855-065-0010

1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; PB 3-1992, f. & cert. ef. 3-26-92 (and corrected 4-8-92); BP 12-2006, f. & cert. ef. 12-19-06; BP 4-2015, f. & cert. ef. 7/1/2015; BP 2-2017, f. 6-30-17, cert. ef. 7/1/2017

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155, 689.315, 689.325 & 689.765