Expiration dates for renewable licenses expiring on 8/31/20 have been extended until 9/30/20. If you are unable to reach us by phone, submit your inquiry via email at customerservice.dpr@delaware.gov. Please read the important COVID-19 information from the Division of Professional Regulation. More Info

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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

Applications are processed in DELPROS (Delaware Professional Regulation Online Services). The online license application process is simple and provides you with clear instructions throughout each stage of the application process. We strongly recommend that you understand what the requirements are for the license you are pursuing. Then, request and gather the documents you need before you begin the application process. Most of the information and forms are on this website. For further clarification of requirements, refer to your profession’s License Law and the Rules and Regulations.

In order to apply for a license or service request, you must have a DELPROS account. To create a new account or log into an existing DELPROS account, follow the instructions at the beginning of the application process. As part of the final steps of the application process, DELPROS instructs you to either “attach” or “upload” the required documents directly to your application and/or to “acknowledge” that you will either send them in yourself or make arrangements for “third-party” documents/forms to be sent to the Board office. Examples of “third-party forms” are transcripts from schools, employment verifications from a supervisor, and license verifications from another state. These forms usually require a signature, seal, or notary, therefore, must be mailed into the Board office directly. All documents received by mail are scanned and attached to the appropriate license records.

In DELPROS, you have the ability to save your application and return to it to edit/update information or upload documents for up to six months. However, if you do not submit your application within six months, you will have to restart your online application process. The Board office begins processing applications shortly after submission in the portal. You may check the status of your application in the DELPROS system throughout the whole process and we will correspond with you by email. 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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