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)
License renewal payments are due May 1 of each year, and licenses expire May 31 of each year. Payments must accompany the renewal form and be submitted in the form of a check or money order, payable to the Minnesota Board of Pharmacy. Renewals cannot be paid online at this time.
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.
Renewal Applications and Instructions
Manufacturer/Outsourcer Renewal Application
Medical Gas Manufacturer Renewal Application
- The Board will continue to allow persons with power of attorney to sign applications on behalf of the applicant.
- There is an area on the renewal form where the facility contact person can be listed, if this is a new contact, the record will be updated to reflect the change.
- Inspections required for outsourcing facilities which are over 24 months old will not be accepted.
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.
Application for a New Manufacturer License
Facility Category Change Notification
- Use this application to apply for a new manufacturer license. Complete the form 60 days prior to opening.
Officer Reporting Form
- Use this notification to change the categories of the facility.
Officer Change Form
- Use this form to report the officers of the facility
License Closure 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.
Change of Ownership Form
- Submit this form 14 days prior to the date the facility closes or will no longer conduct business in Minnesota.
- A change of ownership requires a change of ownership application to be submitted to the Board 30 days prior to the effective date of the change. A new license is not issued for the change and there is not a fee.
The following are some examples of ownership changes that require you to report a change of ownership.
Facility Name Change Form
- Sale to another individual;
- Incorporation (from sole owner to corporation, from partnership to corporation);
- 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.
- 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.
- A relocation application and required documents must be submitted to the Board 30 days prior the relocation date for facilities located in Minnesota. Non-resident facilities must apply for a new license after your home state regulatory agency has issued a license, showing the new address, and an inspection has been conducted of the new location. A new license is issued upon approval, and a fee is charged.
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: