Wholesale Distributor of Prescription Drugs
Understand the requirements of this profession to be a credential holder in WI.
Credential Statute: Wis. Stat. Sec 450
Credential Code: Chapter Phar
Disclaimer: Please review WI statute for full professional requirements.
Related Boards: Pharmacy Examining Board
Overview
This page contains all information required for the Wholesale Distributor of Prescription Drugs credential. Each way to apply has a special subsite denoting specific requirements. Renewal information, forms, and legal information can be found on this page.
Application Methods
General Licensure
For applicants who are applying for a Whole Distributor of Prescription Drugs license for the first time.
Change in Location
For applicants who are obtaining licensure for a Wholesale Distributor of Prescription Drugs license due to a change in location.
Change in Ownership
For applicants who are obtaining licensure for a Wholesale Distributor of Prescription Drugs license due to a change in ownership.
Renewal and Continuing Education Information
Renewal Information
For a list of renewal dates please see: Renewal Date Page
To Renew:
You will be able to renew your credential approximately 4 weeks prior to your license expiring. You will receive an email to the email address on file with instructions on how to renew.
Online Log In: Go to LicensE
Select "Renew My License"
Complete the application
Upload any required documents
Submit payment
See fees list here: Credential Fees
Wholesale Distributor of Prescription Drugs licenses must be renewed by May 31 of even years for a $74 renewal fee. Wholesale Distributor of Prescription Drugs licenses renewed after May 31 of even years must pay $99, which includes the $74 renewal fee and a late fee of $25.
Note: If you receive your initial credential in the months leading up to this date, you are still required to renew your license by May 31 of even years.
There is no continuing education (CE) requirement for this credential.
Requirements for Licensure
A distributor's license authorizes a facility to sell prescription drugs or devices to pharmacists, pharmacies, researchers, hospitals, authorized agents of the federal government and other distributors. A distributor’s license does not permit a facility to give prescription drugs directly to patients based on a prescriber’s order. Dispensing directly to patients under a prescription order requires a pharmacy license.
Out-of-state or in-state wholesale distributors of prescription drugs are required to obtain a distributor's license in Wisconsin for each facility that distributes prescription drugs.
Prescription Medical Device Distributors
No longer need a wholesale distributor of prescription drug license to ship medical device products into Wisconsin. Print this web page for your records verifying no license is needed.
Prescription Medical Device or Drug Manufacturers
Need to hold a WI Drug or Device Manufacturer license only if your facility is physically located in the state of Wisconsin. Print this web page for your records verifying no license is needed.
No longer need to hold the Wholesale Distributor of Prescription Drug license. Print this web page for your records verifying no license is needed.
Manufacturers must maintain a list of distributors of record and update the list monthly.
Inspection Requirements
Wholesale distributors are advised that they must have an inspection completed before the application is filed.
An approved inspection must be completed and passed within three years prior to the application date.
Approved inspections include:
National Association of Boards of Pharmacy (NABP) Drug Distributor Accreditation (DDA). See the NABP’s website or call the NABP at (847) 391-4406 for more information.
Inspections completed by another State Board of Pharmacy.
Inspections completed by the Wisconsin Department of Safety and Professional Services (for facilities physically located in Wisconsin only).
For wholesale distributors of prescription drugs physically located in Wisconsin, inspection requests of the Department of Safety and Professional Services should be submitted as soon as possible to allow time to plan for an inspection.
Completion of inspections will depend on when the inspection request is received, availability of Department staff, and the Department’s inspection schedule. Department staff will contact you to schedule an inspection. If you have questions regarding inspections, please contact the Department by submitting a support ticket through the Request Support feature at LicensE. Please note that we do not conduct inspections of currently licensed Wisconsin facilities for that facility to obtain out-of-state licensure.
Other inspections approved by the Board. Distributors must comply with any applicable federal tract and trace pedigree system after July 1, 2011, unless an earlier federal law is mandated and supersedes state law (emergency rule pending).
Please note that distributors may experience delays in completing inspections by the deadline date. Within 45 days of filing for renewal of an existing license or filing an application for original licensure, a distributor must submit proof to the Department that an approved inspection has been scheduled or the National Association of the Boards of Pharmacy (NABP) Drug Distribution Accreditation process has been initiated. Failure to provide timely notification to the Department may result in the distributor being required to discontinue doing business in Wisconsin pending completion of the credentialing process.
Procedure for Reporting Theft or Loss of Controlled Substances
The Designated Representative is responsible for reporting any theft or loss of controlled substances to the U.S. Department of Justice, DEA Kluczynski Building, Suite. 1200, 230 S. Dearborn Street, Chicago, IL 60604 (312-353-7875, or 800-882-9539 toll free), and to the Pharmacy Examining Board, P.O. Box 8935, Madison, WI 53708-8935, (608-266-2112). Report the theft or loss on Form DEA-106, Report of Theft or Loss of Controlled Substances, obtainable from Drug Enforcement Administration’s (DEA) website. Make four (4) copies. Send the original and one copy to the DEA office, one copy to the Pharmacy Examining Board, and one copy should be kept with the biennial inventory in the Pharmacy.
All thefts or significant losses must be reported to DEA officials. In any instance that a pharmacy, practitioner, or other DEA registrant authorized to possess controlled substances is required to file with the DEA a Report of Theft or Loss of Controlled Substances, the pharmacy, practitioner, or other DEA registrant shall also send a copy to the Board the same day of the DEA filing.
Procedure for Destroying Controlled Substances
Contact the Drug Enforcement Administration (DEA) Diversion Group, 4725 West Electric Avenue, West Milwaukee, WI 53219, (414) 336-7370, or see the DEA’s website for the proper forms and procedures.
Approved Prescription Drug Products and Code of Federal Regulations
These publications are obtainable from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20401, or available at the U.S. Government Publishing Office’s website
Frequently Asked Questions (FAQ)
How does a Wholesale Distributor notify the Pharmacy Examining Board of a change in their DBA name?
Please create a support ticket through your organization’s LicensE account using the Request Support feature. You must include in the ticket the FEIN for the Wholesale Distributor and confirm that this is a name change only and change of ownership has not occurred. Include your current and new name with your WI license number.
How does a Wholesale Distributor notify the Pharmacy Examining Board of a change in Designated Representative?
When a change in designated representative occurs for a Wisconsin licensed wholesale distributor of prescription drugs, a new Form 2812 must be completed and submitted with Forms 2822 and 2687. Form 2687 is also required for all newly listed Designated Representatives. The Designated Representative listed must meet all requirements of Wisconsin Statute section 450.071(3)(c).
Please note: This change will not be approved until the required fingerprint check has been cleared and Form 2812 has been submitted and approved. If applicant is accredited by the National Association of Boards of Pharmacy’s Drug Distributor Accreditation (DDA) program the designated representative will not need to provide fingerprints.
How does a Wholesale Distributor notify the Pharmacy Examining Board of a facility closure?
Please submit a letter to the board requesting closure. Indicate your facility name, license number, reason for closure, and the date of closure.
Payment Information
You can pay all fees associated with your credential by going to LicensE.
You will be asked to pay automatically at the end of your application.
You can pay with a credit or debit card, or via an automated clearing house or (ACH) payment.
Please note, using an ACH payment can increase credential processing times by 3-5 business days.
You can view a list of fees for initial credentials and renewing your credential here:
Predetermination & Legal Information
The term credential is used universally to mean license, certification, permit, registration, enrollment and authorization.
Applicants with convictions, who do not already have a credential, may apply for a predetermination. Predetermination is an optional, first step that happens before you would submit an initial credential application while meeting all credentialing requirements (e.g., education, training, examination, etc.)
To apply for a predetermination, log into LicensE.
If you have not created an account, you will first need to register.
After creating your account, log in, and select “Apply for a Pre-Determination.”
Select the type of credential you would like to apply for.
Follow all application instructions and upload all required documents.
If the Department decides your record would not disqualify you, you can then apply for the actual credential and meet all the typical requirements like education, training, and exams.
You may skip the predetermination process and submit your initial application for your credential. You must complete all steps to meet the credentialing requirements such as education, training, exams, and disclose your conviction record on your application. Convictions and pending charges will be reviewed as part of the application process.
Some applications require review by Department Legal staff.
This can be for a number of reasons, including but not limited to disclosure of convictions or pending charges, professional discipline, malpractice, termination, medical condition, supervised experience and application via reciprocity/endorsement.
Applications that require legal review will require additional processing time.
An application in the status “Legal File Preparation” is with DSPS and under review.
Wisconsin State Statute and Administrative Code
Contact Us
Support Ticket
Submit a support ticket on LicensE and click "request support." Please provide as much detail as possible regarding your concern so we can work to answer your question with a one touch resolution.
Call
608-266-2112
Email
dsps@wisconsin.gov
Office Hours
7:45am-4:30pm
Department of Safety and Professional Services
4822 Madison Yards Way
Madison, WI, 53705
Note: The in-person office does not process same day.
LicensE
LicensE at (license.wi.gov) is a self-guided online system where you can manage your professional credential from start to finish.
You will still need to review the requirements for the credential you are applying to. These can be found on the A-Z profession page.
With LicensE you can:
Apply for a credential for the first time, with steps guiding you to upload your application documents, and pay all required fees.
Renew an existing credential when it is time, to keep your credential active.
View or download your credential for your records or verification.
Update your personal information, including your phone number, email, and mailing address
Submit support tickets and receive responses to your email from our staff experts.
Allow third parties to review and upload required documents on your behalf
Check the status of someone's credential using the public LicensE look up.
If you have never held a credential, you will need to create an account the first time you are on LicensE.
To create an account, visit LicensE. You will then select “register for an individual” if you are applying for a license held by an individual, or “register for an organization” if you are applying for a license held by an organization.
If you are not sure if the license you are applying for is an individual or organization license, please visit our A-Z professions page and review the profession page for more information.
When you create an account, please be sure to use an email you will always have access to.
For more information on LicensE, please see link to LicensE "How To" Page.
How To Guide
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Apply
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Application Status Look Up
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