Wholesale Distributor of Prescription Drugs

Pursuant to 2017 Wisconsin Act 278, beginning August 1, 2018, prior to submitting an application for a credential, an individual may apply to the Department for a determination of whether the individual would be disqualified from obtaining the credential due to his or her conviction record.  To apply for a predetermination, please fill out Form #3085 and submit all required documentation specified on the form.  Pursuant to Wis. Stat. § 111.335(4)(e), the offenses or kinds of offenses that may result in a refusal, bar, or termination of licensure are published under Additional Resources on the left side of this page.


License Information

Fee Reduction

Pursuant to 2017 Wisconsin Act 319, beginning August 1, 2018, an applicant for an initial credential may apply for a reduction of the initial credential fee that is equal to 10% of the initial fee.  Qualification is based on the federal adjusted gross income being at or below 180% of the federal poverty guideline prescribed for the applicant's family household size by the United States Department of Health and Human Services. To determine eligibility please visit the United States Department of Health and Human Services website at https://aspe.hhs.gov/poverty-guidelines, prior to submitting Form 3217.

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

  • 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 authorize a facility to dispense prescription drugs directly to patients pursuant to a prescriber's prescription 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 from which the prescription drugs are distributed.
  • A prescription device distributor does not need to be registered with the Food and Drug Administration, if it is not a manufacturer or initial importer and distributes a device from the original location of the manufacturer to the person who is making the final delivery or sale of the device to the ultimate consumer and/or user.  A Wisconsin prescription device distributor license is still needed.
  • Submit Wholesale Distributor of Prescription Drugs Application, including required documentation and fee(s). 

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. Department staff will contact you to schedule an inspection. If you have questions regarding inspections, please contact Kyle Heller at (608) 266-3622 or email Kyle.Heller@wisconsin.gov. Please note that we do not conduct inspections of currently licensed Wisconsin facilities in order 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).

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

FormDescription
2814Application for Wholesale Distributor of Prescription Drugs License
May not conduct business in WI until the new application and all required documents have been approved.
​3217

Application for Fee Reduction (This form must accompany the application for the credential)

2812Designated 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.
​3085​Application for Predetermination
2252​Convictions and Pending Charges

Profession Forms

FormDescription
​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.
2691Division of Enforcement Supplemental DEA Form for Reporting of Theft or Loss of Controlled Substances

Renewal Information

Requirements

  • FEE (See Renewal Dates and Fees)

Renewal Methods

  • Online Log In: License Renewal Online
  • Request a Paper Renewal Form: (888) 506‑4239 or (608) 261‑4460 for the Madison area
FormDescription
RDAFRenewal Dates and Fees