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A facility that holds, or has applied for, a Delaware In-State or Non-Resident Pharmacy license or a Delaware Distributor 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 In-State Pharmacy, Non-Resident Pharmacy or Distributor license or apply for one of these licenses concurrently with the 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 our online system DELPROS. We no longer accept paper applications.
In order to apply for a license or submit a service request, you must first have a DELPROS user account. To LOG IN or CREATE a DELPROS (Delaware Professional Regulation Online Services) user account:
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.
On the ATTACHMENTS page of your application, you may be instructed to:
The requirements for this license type are provided in the following section(s).
In addition to submitting the application and fee in DELPROS, you must submit:
In addition to meeting the requirements above, an inspector representing the Delaware Board of Pharmacy must inspect an outsourcing facility physically located in Delaware before the facility begins compounding operations. A representative of the facility must notify the Board office when the facility is ready for inspection. When the facility passes the final inspection, the Board office will issue the license. This Delaware inspection does not apply to facilities that are compounding at a location outside Delaware.
Note: This Delaware inspection is in addition to the required federal outsourcing facility inspection.