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 firstname.lastname@example.org. Please read the important COVID-19 information from the Division of Professional Regulation. More Info
Manufacturers are facilities that manufacture or package drugs, toilet preparations, dentifrices, or cosmetics in Delaware.
Submit an application for a Pharmacy-Manufacturer license when:
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.
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).
In addition to submitting the application and fee in DELPROS, you must submit:
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.
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.
IMPORTANT: The facility also manufacturers controlled substances, you must submit a separate Controlled Substances – Facility application in the DELPROS online portal.