When to File Application
Distributors include facilities that distribute on a wholesale basis:
- Drugs, toilet preparations, dentifrices, and cosmetics to persons other than the ultimate consumer (24 Del. C. §§2540)
- Medical gases to other facilities authorized to possess medical gases.
Note: If you are a facility that sells medical gases directly to patients in Delaware, the correct application form is Application for Medical Gas License.
File the application for a Pharmacy-Wholesale 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 distributor already licensed in Delaware:
- Changes ownership (controlling interest), or
A Pharmacy-Wholesale permit terminates automatically when the controlling interest in the facility changes, the facility's legal existence ends, or the business ceases to operate.
Requirements for All Applications
- Enclose non-refundable processing fee by check or money order made payable to the “State of Delaware.”
- Enclose Distributor 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 Distributor 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.
- If the facility is not located in Delaware, arrange for the Board office to receive a License Verification forDistributors form from the licensing agency for the state where the facility is located.
- Enclose a drawn plan and full description of this distributor’s site—including each area utilized for drug storage, distribution, or both—at this location. The description should include:
- square footage
- security and alarm system descriptions
- terms of lease or ownership
- quarantined area for damaged, outdated, deteriorated, misbranded, or adulterated drugs
- temperature and humidity controls.
- Enclose a copy of the deed or lease for the property on which the wholesale distributor’s establishment is located. If leased, the lease must be for an original term of not less than one calendar year.
- If the distributor is a repackager or manufacturer with the Food and Drug Administration,enclose a copy of the regulatory letter.
Reporting a Distributor 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 Distributor (Pharmacy-Wholesale) Permit . Instead, submit:
- Letter notifying the Board of the change that includes the distributor’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 distributes controlled substances, a separate Controlled Substances Application for Facilities application is required.
A distributor must have a Delaware Distributor (Pharmacy-Wholesale) permit, Delaware controlled substance registration and federal DEA permit before storing and/or distributing controlled substances in Delaware.