Current through Register Vol. 63, No. 3, March 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.
(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.
Stat. Auth.: ORS
689.205
Stats. Implemented: ORS
689.155,
689.315,
689.325 &
689.765