Oregon Administrative Rules
Chapter 855 - BOARD OF PHARMACY
Division 65 - WHOLESALE DRUG OUTLETS
Section 855-065-0013 - Prohibited Practices
Universal Citation: OR Admin Rules 855-065-0013
Current through Register Vol. 63, No. 3, March 1, 2024
(1) The following practices are expressly prohibited:
(a) A wholesale distributor may not purchase
drugs from a closed-door pharmacy.
(b) A wholesale distributor may not sell,
distribute or transfer a drug to a person who is required by the laws and rules
of Oregon to be registered with the Oregon Board of Pharmacy and who is not
appropriately registered by the Board. Before furnishing a drug to any person
not known to the wholesale distributor, the wholesale distributor must verify
that the person is legally authorized to receive the drug.
(c) A wholesale distributor may not purchase
any drug from a person who is required by the laws and rules of Oregon to be
registered with the Oregon Board of Pharmacy and who is not appropriately
registered by the Board. Before purchasing a drug from any person not known to
the wholesale distributor, the wholesale distributor must verify that the
person is legally authorized to sell the drug.
(d) A Class 1 Wholesaler who is classified as
a "Specialty Wholesaler Distributor" as defined in OAR 855-065-005(20) may not:
(A) Sell, distribute or transfer a
prescription drug to a pharmacy or to a practitioner who is licensed to
prescribe the prescription drug, without providing a complete pedigree for the
prescription drug, unless the prescription drug was purchased directly from the
manufacturer or from the manufacturer's authorized distributor of record.
(B) Sell, distribute or transfer a
prescription drug to a wholesale distributor, without providing a complete
pedigree for the prescription drug.
(2) A wholesaler may not perform, cause the performance of, or aid the performance of any of the following:
(a) The manufacture, repackaging, sale,
delivery, holding, or offering for sale of a drug that is adulterated,
misbranded, counterfeit, suspected counterfeit, or is otherwise unfit for
distribution.
(b) The
adulteration, misbranding, or counterfeiting of a drug.
(c) The intentional receipt of a drug that is
adulterated, misbranded, stolen, obtained by fraud or deceit, counterfeit, or
suspected product, and the delivery or proffered delivery of the drug for pay
or otherwise.
(d) The alteration,
mutilation, destruction, obliteration, or removal of the whole or a part of the
labeling of a drug or the commission of another act with respect to a drug that
results in the drug being misbranded.
(e) The forging, counterfeiting, simulating,
or falsely representing a drug using a mark, stamp, tag, label, or other
identification device without the authorization of the manufacturer.
(f) The purchase or receipt of a drug from a
person that is not registered to distribute drugs to the purchaser or
recipient.
(g) The sale or
transfer of a drug to a person that is not authorized under the law of the
jurisdiction in which the person receives the drug, to purchase or receive
drugs from the person selling or transferring the drug.
(h) The failure to maintain or provide
records as required under these rules.
(i) Providing the Board, a representative of
the Board, or a state or federal official with false or fraudulent records or
making false or fraudulent statements regarding a matter related to these
rules.
(j) Participating in the
wholesale distribution of a drug that was:
(A) Purchased by a public or private hospital
or other health care entity under the terms of an "own-use" contract; or
(B) Donated or supplied at a
reduced price to a charitable organization; or
(C) Stolen or obtained by fraud or deceit; or
(D) Illegally imported into the
USA.
(k) Obtaining or
attempting to obtain a drug by fraud, deceit, misrepresentation, or engaging in
fraud, deceit, or misrepresentation in the distribution of a drug.
(l) Failing to maintain required pedigree
records.
(m) Receiving a
prescription drug through wholesale distribution without receiving a required
pedigree attested to as accurate and complete by the wholesale distributor.
(n) Distributing a drug that was
previously dispensed by a retail pharmacy or a practitioner.
(o) Failing to report an act prohibited by
any of the rules in OAR 855.065 to the appropriate state or federal
authorities.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155, 689.305, 689.315 & 689.527
Disclaimer: These regulations may not be the most recent version. Oregon may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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