Drug or Device Manufacturer

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 Wis. Stat. § 440.08 (2), the required renewal date for the Drug or Device Manufacturer 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

  • Drug or device manufacturing facilities, which are located within the state of Wisconsin, are required to obtain a manufacturer's license from the Board.
  • A corporate headquarters for a drug manufacturer, located in this state, does not need to be licensed as a manufacturer if the headquarters is not a facility where manufacturing occurs.
  • A drug manufacturer may retain title to prescription drugs distributed to pharmacies until the medications are actually sold to a consumer pursuant to a prescription order.  The pharmacy laws in this state do not prohibit the business arrangement proposed.
  • No distributor's license would be required for an out-of-state manufacturing facility that engages in the wholesale distribution of prescription drugs in this state from that manufacturing facility.

Application

  • If applicable, register with Food and Drug Administration (FDA) or Drug Enforcement Administration (DEA).
  • Complete and submit Application for Drug or Device Manufacturer including all required documentation and fee(s).
  • Review of application.  If the establishment has not been inspected by the FDA or DEA, it must be inspected by the Department prior to licensure.
  • Determination to grant credential.

Application for Licensure

FormDescription
611Application for In-State Drug or Device Manufacturer License
​3217​Application for Fee Reduction (This form must accompany the application for the credential)
2599Drug or Device Manufacturer Self-Inspection Report
​3085​Application for Predetermination
2252​Convictions and Pending Charges
3071​Fax Payment Form

Procedures for Reporting DEA Theft or Loss of Controlled Substances

FormDescription
2691Division of Enforcement Supplemental DEA Form for Reporting of Theft or Loss of Controlled Substances
2821Procedures for Reporting Theft or Loss of Controlled Substances (You will also need to contact the DEA and complete the DEA Form for Reporting a 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