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Division of
Professional Regulation

Outsourcing Facility Permit



SEARCHING FOR AN OUTSOURCING FACILITY?

Click Outsourcing Facility. Choose Pharmacy as the Profession and Outsourcing Facility as the License Type—then click Search.

 

When to File Application

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:

  • compounds sterile drugs without a prescription, and
  • distributes the compounded drugs to Delaware.

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

  • 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:

  • changes ownership (controlling interest), or
  • relocates.

An Outsourcing Facility permit terminates automatically when the:

  • facility’s Delaware In-State Pharmacy, Non-Resident Pharmacy or Distributor license terminates for any reason, or
  • controlling interest in the facility changes, or
  • facility’s legal existence ends, or
  • business ceases to operate (24 Del. C. §2540 (d)).

 

Requirements for All Applicants

  • Enclose the non-refundable processing fee by check or money order made payable to the “State of Delaware.”
  • If the facility has registered with the Food and Drug Administration or Drug Enforcement Administration, enclose results of the most recent Good Manufacturing Practice (GMP) inspection.

 

Inspection Requirement

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.


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