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 this 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
• Relocates.

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.

How to Apply

• Submit completed, signed and notarized Application for Distributor (Pharmacy-Wholesale) Permit . All auxiliary forms needed are included with the application packet.

• 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

• Arrange for the Board office to receive a federal and state criminal background check for each person who is required to submit the Distributor Permit–Information About Ownership form. Each of these persons must complete an Authorization to Release Information form and follow the instructions on the form to submit his or her fingerprints. The background checks must be sent directly from the State Bureau of Identification to the Board office.

• 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. See Instruction Sheet on the application form for a complete list of the items that the description should include.

• 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.

• Duplicate license fee by check or money order made payable to the “State of Delaware.”

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.