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A facility that holds, or has applied for, a Delaware Distributor (Pharmacy Wholesale) license must also hold a Delaware Outsourcing Facility permit when the facility:
The facility must comply with the requirements of Section 503B, Registration of Outsourcing Facilities and Reporting of Drugs, of the federal Food, Drug, and Cosmetics Act.
Submit an application when you are applying for an initial Outsourcing Facility permit or
re-applying when a previous Outsourcing Facility permit has lapsed and is no longer renewable.
The facility must hold a current Delaware Pharmacy Wholesale license before submitting an application for an Outsourcing Facility permit.
Since Outsourcing Facility permits are not transferable, you must also file this application to report when an Outsourcing Facility already licensed in Delaware:
An Outsourcing Facility permit terminates automatically when the:
All applications are submitted through our online system, DELPROS.
DELPROS allows you to save your incomplete application and return to it later to finish the process. You only have six (6) months to submit your application once you begin.
You may check the status of your application online throughout the entire application process by using the “View Application Status” feature in DELPROS on your e-License dashboard.
The requirements for this license type are provided in the following section(s).
Note: This Delaware inspection is in addition to the required federal outsourcing facility inspection.
Related Topics: Board of Pharmacy, Department of State, Division of Professional Regulation, DPR, Outsourcing Facility Permit, State of Delaware