Current through Register Vol. 63, No. 3, March 1, 2024
(1) "Affiliate"
means a business entity that has a relationship, or is an authorized trading
partner, with a second business entity if, directly or indirectly:
(a) One business entity controls, or has the
power to control, the other business entity; or
(b) A third party controls, or has the power
to control, both of the business entities.
(2) "Authorized Distributor of Record" means
a wholesale distributor with whom a manufacturer has established an ongoing
relationship to distribute the manufacturer's prescription drug. An ongoing
relationship is deemed to exist between such wholesale distributor and a
manufacturer when the wholesale distributor, including any affiliated group of
the wholesale distributor, as defined in Section 1504 of the Internal Revenue
Code, complies with either or both of the following:
(a) The wholesale distributor has a written
agreement currently in effect with the manufacturer evidencing such ongoing
relationship; or
(b) The wholesale
distributor is listed on the manufacturer's current list of authorized
distributors of record, which is updated by the manufacturer no less than
monthly.
(3) "Broker"
means a person engaged in the marketing, offering, or contracting for wholesale
distribution and sale of a drug into, within, or out of Oregon and who does not
take physical possession of the brokered substance.
(4) "Chain Pharmacy Warehouse" means a
physical location for drugs that acts as a central warehouse and performs intra
company sales or transfers of drugs to a group of chain pharmacies that have
the same common ownership and control.
(5) "Closed Door Pharmacy" means a pharmacy
that provides pharmaceutical services to a defined and exclusive group of
patients and is not open for dispensing to the general patient population and
cannot be registered as a wholesale distributor.
(6) "Co-Manufacturing Partner" means a
pharmaceutical manufacturer that has entered into an agreement with another
pharmaceutical manufacturer to engage in a business activity or occupation
related to the manufacture or distribution of a prescription drug.
(7) "Designated Representative" means an
individual designated by each wholesale distributor registered by the board who
will serve as the primary contact person for the wholesale distributor with the
board and who is responsible for managing the company's operations at that
registered location.
(8) "Drug
Sample" means a unit of a drug that is intended to promote the sale of the
drug, but which is not itself for sale.
(9) "Illegitimate Product" means a product
for which credible evidence shows that the product is:
(a) Counterfeit, diverted, or
stolen;
(b) Intentionally
adulterated such that the product would result in serious adverse health
consequences or death to humans;
(c) The subject of a fraudulent transaction;
or
(d) Otherwise unfit for
distribution such that the product would be reasonably likely to result in
serious adverse health consequences or death.
(10) "Intra Company Transfer" means the
transfer of any drug between a division, subsidiary, parent, and an affiliated
or related company under the common ownership and control of a corporate
entity.
(11) "Manufacturer" means
anyone, including a manufacturer's co-manufacturing partner, who is engaged in
manufacturing, preparing, propagating, compounding, processing, packaging,
repackaging, or labeling of a drug, except when the process is part of a shared
pharmacy service agreement as defined in OAR 855-006-0005.
(12) "Pedigree" for the purpose of this
Division consists of:
(a) "Transaction
History," which means a statement in paper or electronic form, including the
transaction information for each prior transaction going back to the
manufacturer of the product.
(b)
"Transaction Information," which must include, but is not limited to:
(A) The proprietary or established name or
names of the product;
(B) The
strength and dosage form of the product;
(C) The National Drug Code number of the
product;
(D) The container
size;
(E) The number of
containers;
(F) The lot number of
the product;
(G) The date of the
transaction;
(H) The date of the
shipment, if more than 24 hours after the date of the transaction;
(I) The business name and address of the
person from whom ownership is being transferred; and
(J) The business name and address of the
person to whom ownership is being transferred.
(c) "Transaction Statement," which is a
statement, in paper or electronic form, that the entity transferring ownership
in a transaction is compliant with Food and Drug Administration (FDA)
regulations set forth by the Drug Quality and Security Act and includes but is
not limited to:
(A) Confirmation that the
entity is authorized or registered as required under the Drug Supply Chain
Security Act;
(B) Acknowledgement
that product is received from an authorized or registered entity, as required
under the Drug Supply Chain Security Act;
(C) Confirmation of receipt of transaction
information and of transaction statement from the prior owner of the product,
as required under the Drug Supply Chain Security Act;
(D) Verification that a suspect or
illegitimate product was not knowingly shipped;
(E) Confirmation that systems and processes
are in place to comply with verification requirements under the Drug Supply
Chain Security Act;
(F)
Confirmation that false transaction information was not knowingly provided;
and
(G) Confirmation that
transaction history was not knowingly altered.
(13) "Prescription Drug" means any drug
required by law to be dispensed only by a prescription.
(14) "Quarantine" means the storage or
identification of a product, to prevent distribution or transfer of the
product, in a physically separate area clearly identified for such use or
through other procedures.
(15)
"Suspect Product" means a product for which there is no reason to believe that
such product is:
(a) Potentially counterfeit,
diverted, or stolen;
(b)
Potentially intentionally adulterated such that the product would result in
serious adverse health consequences or death to humans;
(c) Potentially the subject of a fraudulent
transaction; or
(d) Otherwise unfit
for distribution such that the product would result in serious adverse health
consequences or death.
(16) "Trading Partner" means:
(a) A manufacturer, repackager, wholesale
distributor, or dispenser from whom a manufacturer, repackager, wholesale
distributor, or dispenser accepts direct ownership of a product or to whom a
manufacturer, repackager, wholesale distributor, or dispenser transfers direct
ownership of a product; or
(b) A
third-party logistics provider from whom a manufacturer, repackager, wholesale
distributor, or dispenser accepts direct possession of a product or to whom a
manufacturer, repackager, wholesale distributor, or dispenser transfers direct
possession of a product.
(17) "Validate" means to verify that each
transaction listed on the pedigree and other accompanying documentation has
occurred and is accurately recorded.
(18) "Wholesale Distribution" means
distribution of a drug to a person other than a consumer or patient, but does
not include:
(a) Delivery by a retail pharmacy
of a prescription drug to a patient or patient's agent pursuant to the lawful
order of a licensed practitioner.
(b) The sale of minimal quantities of a
prescription drug by retail or institutional pharmacies to licensed
practitioners for office use.
(c)
The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade
a drug which may include:
(A) Emergency
medical reasons;
(B) Drug or
devices used during a federal or state declared emergency; or
(C) The transfer of a drug by a pharmacy to
another pharmacy to alleviate a temporary shortage.
(d) Intra company transfer of drugs as
defined in these rules.
(e) The
lawful distribution of a drug sample by a manufacturer's or a distributor's
representative.
(f) The
distribution of a drug or an offer to distribute a drug by a charitable
organization to a non-profit affiliate of the organization to the extent
permitted by law.
(g) The purchase
or acquisition of a drug by a hospital or other health care entity that is a
member of a group purchasing organization, for the hospital's or health care
entity's own use, from the group purchasing organization or from other
hospitals or health care entities that are members of the organization or under
common control.
(h) The transfer of
a prescription drug between pharmacies pursuant to a shared pharmacy service
agreement as defined in OAR 855-006-0005.
(i) The distribution by a manufacturer, as
part of a prescription assistance program, of a drug intended for a specific
patient, to a person authorized to prescribe, administer or dispense
prescription drugs.
(j) The sale,
purchase, or trade of blood and blood components intended for
transfusion.
(k) Drug returns, when
conducted in accordance with state and federal laws and regulations. A drug
return includes the sale or transfer from a dispenser, retail pharmacy, or
chain pharmacy warehouse of expired, damaged, returned or recalled drugs to the
original manufacturer, wholesale distributor, or to a reverse wholesaler, and
the returns of saleable drugs to the original manufacturer or
wholesaler.
(l) The sale, transfer,
merger or consolidation of all or part of the business of a pharmacy from or
with another pharmacy.
(m) The
distribution of drugs by a manufacturer registered under OAR 855-065 division
of this chapter of rules of its own products to a person other than a
patient.
(19) "Wholesale
Distributor" means any entity engaged in the wholesale distribution of drugs.
The term "Wholesale Distributor" includes but is not limited to, own-label
distributors; private-label distributors; warehouses, including manufacturers'
and distributors' warehouses; drug wholesalers or distributors; retail
pharmacies that conduct wholesale distribution; and chain pharmacy warehouses
that conduct wholesale distribution.
(20) "Wholesaler" means any wholesale
distributor:
(a) "Class I Wholesaler" for the
purpose of these rules means any person operating or maintaining a wholesale
distribution center, wholesale business or any other business in which
prescription drugs, including controlled drugs, devices containing prescription
drugs, medicinal chemicals, or poisons are sold, dispensed, stocked, exposed or
offered for sale at wholesale to a pharmacy or other legally licensed drug
outlets or persons and is required to comply with all pedigree
requirements;
(b) "Class II
Wholesaler" means any person operating or maintaining a wholesale distribution
center, wholesale business or any other business in which any non-prescription
drugs are stored, or offered for sale or distribution at wholesale to a drug
outlet or practitioner legally authorized to resell, distribute, dispense or
administer.
(c) "Class III
Wholesaler" means any person operating or maintaining a wholesale distribution
center, wholesale business or any other business in which any of the products
in paragraphs (A)-(F) below are stored, or offered for sale or distribution at
wholesale to a drug outlet or practitioner legally authorized to resell,
distribute, dispense or administer and is exempted from Federal recordkeeping
requirements:
(A) Drugs distributed
exclusively for veterinary use. If any prescription drugs not intended for
veterinary use are offered for sale, the wholesaler must register as a Class I
wholesaler;
(B) Prescription
devices that do not contain a prescription drug;
(C) Drugs or devices possessed by a state or
local government agency, or non-profit relief organization approved by the
board;
(D) Oxygen USP and medical
gases;
(E) Intravenous drugs; by
which formulation, are intended for the replenishment of fluids, electrolytes
or calories;
(F) Medical
convenience kits which includes any non-controlled drug product or biological
product, assembled in kit form.
Statutory/Other Authority: ORS
689.205
Statutes/Other Implemented: ORS
689.155