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Division of
Professional Regulation

Outsourcing Facility Permit



When to Apply

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.

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:

  • 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)).


Information on How to Apply for a License in DELPROS

All applications are submitted our online system DELPROS. We no longer accept paper applications.


PRIOR TO APPLYING

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:

  1. Go to: https://delpros.delaware.gov/OH_HomePage.
  2. Click GO on the Apply/Manage a License and Service Requests tile.
  3. If you do not have a DELPROS user account, click the REGISTER button on the left side of page for NEW USERS.
  4. If you already have a DELPROS user account, enter your email address and password on the right side for EXISTING USERS and click the LOGIN button.

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.

  • If you do not submit your application within six months of starting it, you will be required to restart the entire online application again.

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.


KNOW YOUR REQUIREMENTS AND COLLECT YOUR DOCUMENTS

  1. Know the requirements for the license you are pursuing.
  2. Request and gather all documents required to upload on the Attachments page. All information and forms are located on your profession’s webpages.


ATTACHING AND ACKNOWLEDGING DOCUMENTS

On the ATTACHMENTS page of your application, you may be instructed to:

  • either “attach” or “upload” the required document(s) directly to your application. This means you will find the document(s) saved on your computer or device and upload it to your application.
  • click “acknowledge.”  This means you will either have to mail the documents yourself or request the “third-party” mail the document(s) directly to the Board office.
    • Examples of “third-party forms” are transcripts from schools, employment verifications from a supervisor, and license verifications from another state.
  • Forms requiring a supervisor signature, seal, or notary may have to be MAILED to the Board office directly UNLESS the document specifically indicates to UPLOAD the document.

The requirements for this license type are provided in the following section(s).


Requirement

In addition to submitting the application and fee in DELPROS, you must submit:

  • The results of the most recent Good Manufacturing Practice (GMP) inspection if the facility has registered with the Food and Drug Administration or Drug Enforcement Administration.


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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