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.
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
All applications are submitted our online system DELPROS. We no longer accept paper applications.
PRIOR TO APPLYING
In order to apply for a license or submit a service request, you must first have a DELPROS user account. To LOG IN or CREATE a DELPROS (Delaware Professional Regulation Online Services) user account:
- Go to: https://delpros.delaware.gov/OH_HomePage.
- Click GO on the Apply/Manage a License and Service Requests tile.
- If you do not have a DELPROS user account, click the REGISTER button on the left side of page for NEW USERS.
- If you already have a DELPROS user account, enter your email address and password on the right side for EXISTING USERS and click the LOGIN button.
DELPROS allows you to save your incomplete application and return to it later to finish the process. You only have six (6) months to submit your application once you begin.
- If you do not submit your application within six months of starting it, you will be required to restart the entire online application again.
You may check the status of your application online throughout the entire application process by using the “View Application Status” feature in DELPROS on your e-License dashboard.
KNOW YOUR REQUIREMENTS AND COLLECT YOUR DOCUMENTS
- Know the requirements for the license you are pursuing.
- Request and gather all documents required to upload on the Attachments page. All information and forms are located on your profession’s webpages.
ATTACHING AND ACKNOWLEDGING DOCUMENTS
On the ATTACHMENTS page of your application, you may be instructed to:
- either “attach” or “upload” the required document(s) directly to your application. This means you will find the document(s) saved on your computer or device and upload it to your application.
- click “acknowledge.” This means you will either have to mail the documents yourself or request the “third-party” mail the document(s) directly to the Board office.
- Examples of “third-party forms” are transcripts from schools, employment verifications from a supervisor, and license verifications from another state.
- Forms requiring a supervisor signature, seal, or notary may have to be MAILED to the Board office directly UNLESS the document specifically indicates to UPLOAD the document.
The requirements for this license type are provided in the following section(s).
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.