Or. Admin. R. 855-060-0002 - Definitions

(1) "Affiliate" means a business entity that has a relationship 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) "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.

(3) "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.

(4) "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.

(5)"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 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.

(6) "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.

Notes

Or. Admin. R. 855-060-0002

BP 4-2015, f. & cert. ef. 7/1/2015

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155