Minnesota Healthcare and Pharmaceutical Licensing

Application for a New Manufacturer License

$5,500 for non-opiate manufacturers and $55,500 for opiate manufacturers.

4 weeks

Online

$5,500 for non-opiate manufacturers and $55,500 for opiate manufacturers.

License renewal payment is due May 1 of each year, and licenses expire annually on May 31.

Application for Registration as a Medical Gas Distributor

$400

Renewal Application

$400

Renewals are due November 1 of each year, and licenses expire December 1 of each year.

A $200 late fee will be imposed for renewals submitted after November 30

Application for Registration as a Pharmacy

$450

• The following must be submitted to the Board at least 60 days prior to the planned opening date.
• The Board shall not issue an initial or renewed license for a pharmacy located outside of the state unless the
  applicant discloses and certifies:
  • The location, names, and titles of all principal corporate officers and all pharmacists who are involved in
    dispensing drugs to residents of this state.
  • That it maintains its records of drugs dispensed to residents of this state so that the records are readily
    retrievable from the records of other drugs dispensed.
  • That it agrees to cooperate with and provide information to, the board concerning matters related to
    dispensing drugs to residents of this state.
  • That, during its regular hours of operation, but no less than six days per week, for a minimum of 40 hours per week, a toll-free telephone service is provided to facilitate communication between patients in this state and a pharmacist at the pharmacy who has access to the patients' records; the toll-free number must
    be disclosed on the label affixed to each container of drugs dispensed to residents of this state.
  • That, upon request of a resident of a long-term care facility located in this state, the resident's authorized representative, or a contract pharmacy or licensed health care facility acting on behalf of the resident, the pharmacy will dispense medications prescribed for the resident in unit-dose packaging or, alternatively, comply with section 151.415, subdivision 5.

• Out of state pharmacies attach a copy of:
  • Your current license or registration from the state in which your facility is located
  • Per MN Statute §151.19, subd. 1(f), the board shall not issue a license unless the pharmacy passed an inspection conducted by an authorized representative of the board. You must attach a copy of an inspection report issued by the appropriate regulatory authority for your state, and any related documents. The inspection must have occurred within the 24 months immediately preceding receipt of the initial application, and must be appropriate for the services provided by the pharmacy. You must also submit any FDA inspection reports issued for the pharmacy. All applicants must submit evidence that any deficiencies noted in any inspection or investigatory report have been corrected, including any documents that you have provided to state agencies or the FDA in response to inspections or investigations. 
  • Copy of the license from the state that the pharmacy is located in.
  • A copy of your last inspection report from the state your facility is located in.
  • Articles of Incorporation, if a corporation or limited liability corporation or partnership papers, if a partnership or a limited liability partnership. (If the time period from your date of application until your
    date of opening spans two licensing periods, July 1- June 30, then it will be necessary to submit two fees,
    or a total of $520.00, for both the opening fee and the renewal fee.)
  • Review Minnesota Statutes Section 152.126, which requires dispensers (pharmacies) licensed by the MN
    Board of Pharmacy to report daily to the Prescription Monitoring Program (PMP) the dispensing of all
    schedule II-V controlled substances, butalbital, and gabapentin. Information regarding the submission of
    data can be found on the PMP website under "PMP Data Uploader" section.

Online

$450

Annually by June 1.