Or. Admin. Code § 855-062-0005

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

Section 855-062-0005 - Definitions

(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:

(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.

(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:

(a) A New Drug Application number (NDA);

(b) An Abbreviated New Drug application number (ANDA);

(c) A Labeler Code number (LC) or National Drug Code Number (NDC);

(d) An FDA Central File Number (CFN);

(e) An FDA Establishment Identifier number (FEI);

(f) A Biologic License Application (BLA);

(g) An Outsourcing Facility.

(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:

(a) "Transaction History" 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" 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" is a statement, in paper or electronic form, that the entity transferring ownership in a transaction is compliant with 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.

(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:

(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 to humans.

(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.

Or. Admin. Code § 855-062-0005

BP 2-2009(Temp), f. 6-22-09, cert. ef. 6-26-09 thru 12-23-09; BP 5-2009, f. & cert. ef. 12-24-09; BP 4-2015, f. & cert. ef. 7/1/2015

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155