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

Manufacturer License



When to Apply

Manufacturers are facilities that manufacture or package drugs, toilet preparations, dentifrices, or cosmetics in Delaware.

Submit an application for a Pharmacy-Manufacturer license when:

  • applying for an initial license.
  • re-applying when a previous Delaware license has lapsed and is no longer renewable.
  • you need to report that your Delaware-licensed manufacturer:
    • changes ownership (controlling interest), or
    • relocates.

A Pharmacy-Manufacturer permit terminates automatically when the controlling interest in the facility changes, the facility’s legal existence ends, or the business ceases to operate.


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).


Requirements

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

  • The results of last GMP inspection if the firm is registered with the Food and Drug Administration or Drug Enforcement Administration.
  • A Manufacturer Permit–Information about Ownership forms for all of the following:
    • Designated Representative (DR) or most senior person responsible for facility operations, purchasing, and inventory control
    • Supervisor of the DR or most senior person responsible for facility operations, purchasing and inventory control
    • If the distributor is not a publicly held company, all principals and owners who directly or indirectly own more than 10% interest in the company
  • Each person who is required to complete a Manufacturer Permit – Information_About_Ownership form must also complete a Criminal History Record Check Authorizationform to request State of Delaware and Federal Bureau of Investigation criminal background checks.


Inspection Requirement

In addition to meeting the requirements above, the facility must be inspected before opening. A representative of the manufacturer 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.


Reporting a Manufacturer Name Change

If the facility’s name changes, but there is no change in ownership nor in location, submit a Name Change Service Request in DELPROS. The license number will not change. When completed, you will be notified and you may print the updated license.


Controlled Substances Registration

IMPORTANT: The facility also manufacturers controlled substances, you must submit a separate Controlled Substances – Facility application in the DELPROS online portal.

 


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