License Information
Per
Wisconsin State Statutes 440.08 (2), the required renewal date for the Wholesale Distributor of Prescription Drugs credential is 05/31/even years. Should you receive your initial credential in the months leading up to this date, you are still required to renew your license by the statutorily defined date.
Requirements for Licensure
Application Process
- A designated representative must be identified on the application.
- All designated representatives must be fingerprinted as described in the application materials.
- All distributors are required to submit a surety bond (Form #2819) or irrevocable letter of credit (Form #2824) with the application in the amount of $5,000.
-
Meet Inspection Requirements. (See below.)
- Distributors must comply with any applicable federal track and trace pedigree system.
- Register with the
Drug Enforcement Administration (if applicable).
- Determination to grant credential.
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 WI. 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
- Whole sale 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) Verified-Accredited Wholesale Distributors (VAWD). Go to:
http://www.nabp.net and click on Accreditation Programs, then VAWD, or call the NABP at (847) 391-4406.Inspections completed by another state.
- 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. Contact Shelby Braatz to schedule an inspection at (608) 267-0391 or email Shelby.Braatz@wisconsin.gov.
- 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).
Note: 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 VAWD certification process has been initiated. Failure to timely provide notification to the Department may result in the distributor being required to discontinue doing business in Wisconsin pending completion of the credentialing process.
Application for Licensure
| Form | Description |
|---|
| 2814 | Application for Wholesale Distributor of Prescription Drugs License
May not conduct business in WI until the new application and all required documents have been approved. |
| 2812 | Designated Representative Form
This form is required. |
| 2687 | Authorization for Release of FBI Information Form
This form is required for all Designated Representatives. This includes VAWD Certification. |
| 2819 | Bond of Prescription Drug Wholesale Distributor Form
This form must be used. There are no exceptions or modifications to this form that will be approved. |
| 2824 | Irrevocable Letter of Credit of Prescription Drug Wholesale Distributor Form
This form must be used. There are no exceptions or modifications to this form that will be approved. |
| 2252 | Convictions and Pending Charges |
Profession Forms
| Form | Description |
|---|
| 2822 | Change in Designated Representative for Wholesale Distributor of Prescription Drugs
Whenever a change occurs, complete and return this form along with Forms #2687 and 2812. |
| 2691 | Division of Enforcement Supplemental DEA Form for Reporting of Theft or Loss of Controlled Substances |
