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.
File this application for a Pharmacy-Manufacturer license when applying for an initial license OR re-applying when a previous Delaware license has lapsed and is no longer renewable. Since these licenses are not transferable, you must also file this application to report when a manufacturer already licensed in Delaware:
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.
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 neither ownership nor location has changed, it is not necessary to submit an Application for Pharmacy-Manufacturer Permit. Instead, submit:
The duplicate license will show the new name, but the license number will not change.
If the facility also manufactures controlled substances, a separate Application for Facility Controlled Substance Registration application is required.