Oregon Administrative Rules
Chapter 855 - BOARD OF PHARMACY
Division 62 - DRUG DISTRIBUTION AGENT
Section 855-062-0005 - Definitions
Current through Register Vol. 63, No. 3, March 1, 2024
(1) "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 drug.
(2) "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.
(3) "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.
(4)"Common Carrier" means an organization that is available to the public to transport a product or service using its facilities, or those of other carriers.
(5) "Drug": In this Division of rules, the term "drug" shall mean any drug and any prescription device as these terms are defined in ORS 689.005.
(6) "Illegitimate Product" means a product for which credible evidence shows that the product is:
(7) "Manufacturer" means any person, including a manufacturer's co-manufacturing partner, that is engaged in the manufacture of a drug, is responsible or otherwise accountable to the Food and Drug Administration (FDA) for the manufacture of the drug, or is the private label manufacturer or distributor of product bearing its NDC number that is intended for sale, distribution, dispensing or administration in Oregon, and who holds one or more of the following registrations or licenses with the FDA:
(8) "Manufacture" means the preparation, propagation, compounding, or processing of a drug or device intended for human or animal use. Manufacture includes repackaging or otherwise changing the container, wrapper, or labeling of any drug package in furtherance of the distribution of the drug from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer or user, except when the process is part of a shared pharmacy service agreement as defined in OAR 855-006-0005.
(9)"Pedigree" for the purpose of this Division consists of:
(10) "Person" means individual, corporation, partnership, association, joint-stock company, business trust or unincorporated organization.
(11) "Suspect Product" means a product for which there is reason to believe that such product is:
(12) "Third-Party Logistics Provider" means an entity that provides or coordinates warehousing, or other logistics services of a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product, but does not take ownership of the product, and not have responsibility to direct the sale or disposition of the product.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155