Drug Outlet, Drug Distribution Agent
Last updated 07/21/2025
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Fees
License Fee |
Description |
Exemptions |
$560.00 |
|
None
|
$560.00 |
|
None
|
Description
The following persons must register as a Drug Distribution Agent: a broker; an import broker; an agent for a foreign manufacturer who is registered with the Food and Drug Administration (FDA); a Sales and marketing office for a drug; a Drug Order Contractor; a Third-Party Logistics Provider; and 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.
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.
Any person who would otherwise be required to register as a Wholesaler under OAR 855-065 but who does not at any time have possession of a drug intended for distribution must register as a Drug Distribution Agent.
Duration
Expires 9/30 annually
Renewal Information
Expires 9/30 - Annual renewal required
Duplicate License Requirements
None
Prerequisites and Requirements
Prerequisites
None
Required Documentation
Submission of an application on the form prescribed by the State Board of Pharmacy and applicable fees as required in OAR 855-110. See application for detailed list of required documents, which includes a copy of resident state license/registration and verification for all non-resident applicants. Registration with the Oregon Secretary of State's Business registry is also required.
Examination Information
None
Continuing Education Requirements
None
Bonding Requirements
None
Insurance Requirements
None
Other Information
None
Statutes, Administrative Rules, Ordinances
Other Detail Information
None
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