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    Manufacturer

    Includes 503B Outsourcing Facility | Medical Gas Manufacturer

    A Minnesota Board of Pharmacy-issued manufacturer license is a six-digit number that begins with a “4”. If your current license begins with any other number, please refer back to the license menu to find the appropriate license for your facility.
    Facilities engaged in the production, preparation, propagation, conversion, or processing of a drug, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis need to hold a drug manufacturer license. Manufacturing includes the packaging or repackaging of a drug, or the labeling or relabeling of the container of a drug, for resale by pharmacies, practitioners, or other persons in the state of Minnesota. This includes, but is not limited to, virtual manufacturers, contract manufacturers, repackagers, and labelers. The exception is if the manufacturer is located outside of the United States or its Territories. (MN Statute § 151.01 Subd. 14)

    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

    Please note, Minnesota’s licensing fees were revised effective 7/1/2023. The updated fees are available in statute and on our website.

    All fees are non-refundable.

    To avoid late fees, renewal applications, supporting documentation, and correct payment must be received as a complete packet by the Board, prior to the expiration date. Any payment received without an application will not be processed. Licenses are mailed to the facility’s physical address.

     

    Types of Manufacturers

    Virtual manufacturer. Virtual manufacturers own the approved New Drug Application (NDA) or the Abbreviated New Drug Application (ANDA) for a drug and contracts with a contract manufacturing organization (CMO) for the physical manufacture of the drug on the behalf of the owner(s). Virtual manufacturers of legend and/or OTC drugs are required to be licensed as a manufacturer (MN Stats. § 151.252).

    Outsourcing facility. An outsourcing facility must be registered by the United States Food and Drug Administration pursuant to United States Code, title 21, section 353b. Outsourcing facilities must also be licensed as wholesalers in Minnesota. Outsourcing facilities dispensing patient specific prescriptions must also be licensed as a pharmacy.

    Opiate manufacturers and outsourcing facilities that manufacture opiates. A manufacturer or outsourcing facility engaged in the manufacturing of any opiate-containing controlled substance listed in MN Stats. § 152.02, subd. 3-6, that is distributed, delivered, sold, or dispensed into or within this state is subject to an opiate product registration fee (MN Stats. § 151.066).

    Labeler/Repackager. Are considered manufacturers and need to hold a drug manufacturer license. (MN Stats. § 151.252)

    Contract manufacturer. A company that serves other companies in the pharmaceutical industry on a contract basis to provide one or more manufacturing services need to hold a drug manufacturer license. (MN Stats. § 151.252)

    Medical gas manufacturer. A medical gas manufacturer license allows a facility to manufacture medical gases, distribute them at wholesale, and dispense them to patients. Therefore, licensed medical gas manufacturing facilities do not also need wholesaler licenses or dispenser registrations. If this applies, complete the Medical Gas Manufacturer Renewal Form. Note: medical gas manufacturers produce medical gases only. If the facility manufactures anything other than medical gases, they are considered a drug manufacturer. 

    New Application

    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 of licensee to another individual or person;
    • If cumulative 20% or more of the stock (ownership interest in licensee) changes hands since original license issued;
    • A change in business structure (Ex. – Inc. to LLC.) for either licensee or parent;
    • 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.

    General Information

    Do drug manufacturers also need to be licensed as drug wholesalers?

    No, not if they only engage in the wholesale distribution of their own drug products. Manufacturers who distribute the drugs of other manufacturers do need to be licensed as drug wholesalers. Any manufacturer that only distributes its own products and that still also holds a drug wholesaler license can drop the wholesaler license (or simply not renew it when it is up for renewal in May 2020).

    Laws and Rules Regarding Manufacturers:
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