When to File Application
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:
- Changes ownership (controlling interest), or
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.
How to Apply
- Enclose non-refundable processing fee by check or money order made payable to the “State of Delaware.”
- If the firm is registered with the Food and Drug Administration or Drug Enforcement Administration,enclose results of last GMP inspection.
Enclose 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 Authorization form to request State of Delaware and Federal Bureau of Investigation criminal background checks.
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, it is not necessary to submit an Application for Pharmacy-Manufacturer Permit . Instead, submit:
- Letter notifying the Board of the change that includes the manufacturer’s old name and new name, license number and effective date of the change.
The duplicate license will show the new name, but the license number will not change.
Controlled Substances Registration
If the facility also manufactures controlled substances, a separate Controlled Substances Application for Facilities application is required.