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    Pharmacy


    Use of Temporary Satellite Locations for the Storage and Use of Medications During the COVID-19 Pandemic

    In order to support surge planning and expand treatment capacity during the COVID-19 outbreak, the Minnesota Board of Pharmacy is providing the following guidance for the temporary off-site storage of drugs. This guidance is for the utilization of emergency temporary sites and satellite locations to treat COVID-19 patients and to treat patients when existing capacity is limited due to COVID-19.

    A pharmacy licensed by the Board and located in Minnesota may maintain possession, custody, or control of drugs for the treatment of patients at a temporary site or satellite location other than or in addition to its actual licensed location during the COVID-19 crisis if the facility complies with the following:
    1. The in-state licensed pharmacy must submit a Satellite Registration Form. The use of a pharmacy satellite location does not require an approval from the Board, but the form must be submitted prior to the off-site storage and use of drugs.
      NOTE: The Board will be reviewing submissions for completeness and forms will be subject to a review process.
    2. The pharmacy maintaining drugs at an off-site satellite location is responsible for the following:
      • Implementing policies and procedures to ensure that drugs removed from the licensed pharmacy and stored at a temporary site or satellite location are maintained under the supervision and control of licensed healthcare personnel.
        • For controlled and non-controlled substances, supervision is under licensed practitioners (i.e. – licensed prescribers), pharmacists, and nurses
      • The drugs shall be physically secured in a manner to prevent unauthorized access.
      • Reasonable efforts shall be made to store the drugs at temperatures and conditions which will ensure the integrity of the drugs prior to their use as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling.
      • Maintaining required records of receipt, administration, dispensing and disposal.
    3. If intending to maintain controlled substances at an off-site satellite location, the licensee is required to obtain a temporary registration from the Drug Enforcement Administration (DEA) and follow all applicable regulations and guidance from the DEA. For more information on this process visit the Drug Diversion website.
      Important: The temporary or satellite location may only possess controlled substances if the licensed pharmacy is registered with the DEA.
    4. The licensed pharmacy must maintain a record of all drugs transferred to the temporary site or satellite location, to include, at a minimum, the following: name, strength, dosage form, and quantity of the drugs transferred, the address of the location where the drugs were transferred, and the date of transfer.
    5. Both the temporary site or satellite location and its parent licensed pharmacy location are subject to the same disciplinary measures set forth in MN Statute 151.06, should the Board be presented with clear and convincing evidence of a danger of immediate and serious harm to others.
    This guidance will remain in effect until withdrawn by the Board.

    Renewal

    Renewals are due June 1 of each year.

    Pharmacy Renewal Application Form and Instructions

    New/Change Application

    Pharmacy License Application

    Use this form to apply for a new pharmacy license, to request a name change, notify the Board of an upcoming relocation, or if your pharmacy has had a change in ownership. If you are a RESIDENT pharmacy and plan to remodel, you must also complete this form and submit it to the Board. (See the “Sterile Compounding Area Remodel Guidance – Pharmacy” in the Guidance Documents on the Board’s website for additional information.) For category changes and closure notifications, see appropriate forms below.

    Forms


    General Information

    Checklists:

    Fee Increases Effective July 1, 2019

    Legislation enacted during the 2019 Regular and Special Sessions contained many provisions that will have an impact on the Board’s licensees and registrants. The increase affects all licensees of the Board of Pharmacy. We have an updated Fee Chart on the License and Registration home page that summarizes all fee increases with the exception of the opioid product registration fees. In addition, the application and renewal registration fees for most drug manufacturers, medical gas manufacturers, drug wholesalers, and medical gas wholesalers, and medical gas distributors will increase to at least $5,260 effective July 1, 2019. The Board believes that the Legislature may reconsider the increase in fees for medical gas manufacturers, wholesalers, and distributors during the 2020 Session.
    • All drug and medical gas wholesalers: $5,260
    • Drug manufacturers (except for opioid manufacturers) and medical gas manufacturers: $5,260
    • Medical gas distributors: $5,260
    • Opioid drug manufacturers: $55,260 (Reduced to $5,260 if the sunset provision kicks in).
    • Opioid manufacturers with sales within Minnesota of over 2,000,000 units per year will also have to pay an annual opiate product registration fee of $250,000.

    The Definition of a Pharmacy

    A Pharmacy is a place of business in which prescription drugs are prepared, compounded or dispensed by or under the supervision of a pharmacist and from which related clinical pharmacy services are delivered.

    Any establishment that falls under this definition needs to be licensed by the state of Minnesota as a pharmacy. Our computer records for pharmacies only accept the DBA name and the facility's physical address.
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