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Title: Drug Manufacturer License
Alternate Title:
Description: Minnesota Board of Pharmacy
Subject: Drugs
Pharmaceuticals
Pharmacies
Creation Date: 9/11/2008 2:12:35 PM
Modification Date: 12/24/2024 1:04:57 PM
Agency Name: Pharmacy, Minnesota Board of
Agency URL: https://mn.gov/boards/pharmacy/
Agency Description: The Minnesota Board of Pharmacy exists to promote, preserve, and protect the public health, safety, and welfare by fostering the safe distribution of pharmaceuticals and the provision of quality pharmaceutical care to the citizens of Minnesota.
Agency Phone: 651-201-2825
Agency Fax: 612-617-2262
Agency URL: https://mn.gov/boards/pharmacy/
Agency Address:
335 Randolph Ave., Suite 230

St. Paul
MN
55102
Division Name: Email
Division URL:
Division Description:
Division Phone: Division Fax: Division URL:
Audience: Hold Application URL:
Renewal URL: https://pha.hlb.state.mn.us/#/Login
Versa URL:
Requirements:

Review Manufacturer


Rules: 6800.0100 - .1460

Statutes: 151.01
151.361
152.101

Forms:
Application for a New Manufacturer License
       - Use this application to apply for a new manufacturer license. Complete the form 60 days prior to opening.

Additional Forms

Facility Category Change Notification
        - Use this notification to change the categories of the facility.

Officer Reporting Form
  • Use this form to report the officers of the facility
Officer Change Form
  • Use this form to report any change to the officers of the facility. Officer changes must be reported to the Board within 30 days of the change.
License Closure Form
  • Submit this form 14 days prior to the date the facility closes or will no longer conduct business in Minnesota.
Change of Ownership Form
  • Licenses and registrations granted by the Board are not transferable. When a change of ownership of the licensee occurs, a new application must be submitted to the Board.
    • For a non-resident facility, it is recommended the new application and supporting documentation be submitted no later than 30 days after the change has occurred.
  • Upon approval of the application, a new license will be issued.
  • All application payments are non-refundable.
The following are some examples of ownership changes that require you to report a change of ownership.
  • Sale to another individual;
  • Major stock change (if 20% or more of the stock changes hands since the incorporation);
  • Sole owner to partnership;
  • The addition of one or more partners to a partnership; or
  • One partner buying out the other partner.
Facility Name Change Form
  • Name changes should be submitted 30 days prior to the change for facilities located in Minnesota. Non-resident facilities must report the name change of the facility on the notification form and include the license issued by the home state regulatory agency showing the new facility name.
Relocation Form
  • It is recommended that resident facilities (those facilities that are located in the state of Minnesota) submit the relocation application to the Board a minimum of 60 days prior to the date that the physical relocation takes place.
  • Non-resident facilities must submit a relocation application after their home state regulatory agency has issued a license showing the new address and an inspection has been conducted of the new location. It is recommended the application and supporting documentation be submitted to the Board no later than 30 days after the change has occurred.
  • In each case, in accordance with Minnesota Statute section 151.065, a new license is issued upon approval of the application. All application payments are non-refundable.
 
Renewal Information
Renewal Applications and Instructions

The Board of Pharmacy migrated to an online licensing/registration platform. Renewals for manufacturers are now available

Tip Sheet: Informational Sheet for Licensees


Renewal Applications and Instructions


The Board of Pharmacy recently migrated to an online licensing/registration platform. Renewals for manufacturers are now available

Tip Sheet: Informational Sheet for Licensees

 Applications are available at Manufacturer


Fees:

New - $5,500

Renewal - $5,500 

Late fee - $ 2,750 

New Opiate - $55,500 for first facility, $5,500 for each additional [per Minn .Stat. §151.252, subd. 1. (g)] 

Renewal Opiate $55,500 for first facility, $5,500 for each additional [per Minn .Stat. §151.252, subd. 1. (g)]

Late fee - $27,750

Medical Gas Manufacturer $5,500 for first facility, $500 for each additional

Review Licensure Fees


Period of Issuance:

June 1 - May 31 annually


Length of Determination:
Approximately 60 days.

Other Info:
Activity: Drugs (Human and Veterinary)
License Detail URL:
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