Or. Admin. Code § 855-062-0003 - Application

(1) The following persons must register as a Drug Distribution Agent under this Division of rules:

(a) A broker;

(b) An import broker;

(c) An agent for a foreign manufacturer who is registered with the Food and Drug Administration (FDA);

(d) Sales and marketing office for a drug;

(e) A Drug Order Contractor;

(f) A Third-Party Logistics Provider; and

(g) A person registered with the FDA as the holder of a New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA) that contracts with a third-party for the manufacture of a drug but does not take physical possession of the drug, does not have its name on the label and is not accountable to the FDA for the purity and integrity of the drug.

(2) Any person who would otherwise be required to register as a Wholesaler under Division 65 of this Chapter of rules but who does not at any time have possession of a drug intended for distribution must register as a Drug Distribution Agent under this Division of rules.

(3) A person whose sole purpose is the marketing, brokering or arranging the initial distribution of drugs manufactured by a registered manufacturer, but does not take physical possession of a product must register as a Drug Distribution Agent.

Notes

Or. Admin. Code § 855-062-0003

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