Delaware Board of Pharmacy New Rules and application for all who compound sterile drugs without a prescription and distribute the compounded drugs to Delaware to have a Delaware Outsourcing Facility Permit

APPLICATION FOR OUTSOURCING FACILITY PERMIT



INSTRUCTION SHEET

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 this form to apply for an initial Outsourcing Facility permit OR to re-apply 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 this application for the 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

Please read and follow instructions carefully. Failure to follow instructions may delay your application.

Submit completed, signed and notarized Application for Outsourcing Facility Permit.



 Applications that are incomplete, unsigned or not notarized will be rejected.

Enclose 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 for In-State Pharmacies and Distributors

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 beginning 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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