SEARCHING FOR AN OUTSOURCING FACILITY?
Click Outsourcing Facility. Choose Pharmacy as the Profession and Outsourcing Facility as the License Type—then click Search.
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.
File the application when
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:
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.