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 customerservice.dpr@delaware.gov. Please read the important COVID-19 information from the Division of Professional Regulation. More Info

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Division of
Professional Regulation

Distributor License (Pharmacy-Wholesale)



When to Apply

The application for a Pharmacy-Wholesale Permit is for facilities that:

  • distribute the following on a wholesale basis:
    • drugs, toilet preparations, dentifrices, and cosmetics to persons other than the ultimate consumer (24 Del. C. §§2540), OR
    • medical gases to other facilities authorized to possess medical gases, OR
  • provide or coordinate warehousing or other logistics service for dangerous drugs or devices in intrastate or interstate commerce.

You must submit an application for a Pharmacy-Wholesale license when:

  • applying for an initial license.
  • re-applying when a previous Delaware license has expired and is no longer renewable.
  • a Delaware-licensed distributor changes ownership (controlling interest) or relocates.

 
A Pharmacy-Wholesale permit automatically terminates when the controlling interest in the facility changes, the facility’s legal existence ends, or the business ceases to operate (24 Del. C. §2540 (d)). Therefore, you must apply for a new license.

If the facility sells medical gases directly to patients in Delaware, apply for a Medical Gas Dispenser License.

 

IMPORTANT:
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.


Information on How to Apply for a License in DELPROS

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).
Requirements

In addition to submitting the application and fee in DELPROS, you must submit:

  • A Distributor Permit–Information About Ownership form(s) 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.
  • A State of Delaware and Federal Bureau of Investigation criminal background checks (CBC)from each person who is required to complete a Distributor Permit-Information about Ownership form. Follow the instructions on the Criminal History Record Check Authorization form to arrange to be fingerprinted. Submit the forms and payment to the State Bureau of Identification (SBI). Do not send these forms to the Board office.
    • Allow at least four weeks for the SBI to send criminal history records to the Board office.
    • A new criminal background check is required even if the person recently had a criminal background check done for some other reason.
  • A License Verification for Distributors form from the licensing agency for the state where the facility is located if not located in Delaware.
  • 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.
  • 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.
  • A copy of the regulatory letter if the distributor is a re-packager or manufacturer with the Food and Drug Administration.


Reporting a Distributor Name Change

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.


Controlled Substances Registration

IMPORTANT: The facility also distributes controlled substances, you must submit a separate Controlled Substances – Facility application in the DELPROS online portal.

 


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