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Pharmacy Licensing Guide and FAQs

Pharmacy Licensing Guide and FAQs

OVERVIEW:
The pharmacy license type allows a licensee to dispense prescription drugs or prepare prescription drugs for delivery or distribution.

NOTE:   The content contained below is a general overview of licensing requirements.  Links to access the Public Health Code and Administrative Rules for this profession can be found at the end of this guide.

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LICENSURE REQUIREMENTS CHECKLIST

APPLICATION AND FEES

  • Online Application for a Pharmacy License - Complete all fields, answer all questions, and upload any supporting documentation.

  • Online applications can be completed by visiting www.michigan.gov/miplus

  • Application Fee + 2 year license fee: (Must be paid by Visa, Mastercard, American Express, or Discover credit or debit card)

    Pharmacy License – $178.50
    Controlled Substance License – $176.40

THE FOLLOWING REQUIREMENTS APPLY TO ALL APPLICANTS

  • Criminal Background Check – Once the online application is completed and submitted you will be emailed an Application Confirmation letter containing instructions to complete the Criminal Background Check. 

    The individuals listed below for a pharmacy license are required to undergo a Criminal Background Check
    (CBC):
    • An individual, if the person applying is an individual.
    • All partners and any individual who will manage the day-to-day operations, if the person applying is a partnership.
    • An individual who will manage the day-to-day operations, if the person applying is a privately held corporation. This subdivision only applies to a privately held corporation that in the aggregate owns fewer than 75 pharmacies, manufacturers, wholesale distributors, or wholesale distributor-brokers on the date the corporation submits its license application.

      An individual is not required to obtain a CBC if one has been obtained for the individuals within the 2 years preceding the date of application for a new pharmacy, manufacturer, wholesale distributor or wholesale distributor-broker license. If fingerprints have been obtained within the two years preceding the date of the application, the individuals must submit proof of the previous criminal history check with the application for a pharmacy license.  Relicensure applications lapsed 3 years or less are also not required to obtain a CBC.

  • Criminal/Disciplinary History Questions – Criminal conviction and/or disciplinary documentation will be required if you answer “yes” to either question.

  • Verification of Licensure – If your pharmacy holds a current pharmacy license or ever held a pharmacy profession license, verification of licensure must be sent directly to our office by the licensing agency of any state of the United States or country in which you hold or ever held a license.  The verification must show that disciplinary proceedings are not pending against the applicant and sanctions are not in force at the time of application. Verification can be emailed to bpldata@michigan.gov or mailed to the Bureau of Professional Licensing, PO Box 30670, Lansing, MI 48909.

  • If your pharmacy is a partnership, corporation, or is operating under an assumed name, you must submit business documentation showing the business ownership structure, including FEIN certificate, certified copies of articles of incorporation or certificates of partnership and assumed name certificates, list of partners, owners, officers, and members of the board of directors.

  • A licensed pharmacy must have a pharmacist in charge (PIC) licensed in Michigan.  You must provide the Michigan license number of the PIC or the pharmacist application number of the PIC if the PIC has not yet obtained Michigan licensure. If your pharmacy will be distributing or dispensing controlled substances in Michigan, the PIC and the pharmacy must have a controlled substance license.

  • If your pharmacy has an NABP E-Profile Identification Number, you may enter it on the application.

  • If your pharmacy is not located in Michigan and you will not be shipping sterile compounded products into Michigan, you must submit an inspection report from your resident state board of pharmacy or from the National Association of Boards of Pharmacy Verified Pharmacy Program (NABP-VPP) performed within the last 2 years.

  • If your pharmacy is a governmental entity, an individual shall be designated as the licensee.  The licensee and the pharmacist on duty are responsible for complying with all federal and state laws regulating the practice of pharmacy and the dispensing of prescription drugs.

  • You may apply for a controlled substance license by completing the controlled substance license fields on the application.  Be sure that the controlled substance license address matches the pharmacy address.  If you do not apply for a controlled substance license on your initial application, you must wait for the pharmacy license to be issued before applying for a controlled substance license.
 

 

ADDITIONAL REQUIREMENTS FOR STERILE COMPOUNDING PHARMACIES

  • Sterile compounding pharmacy applicants must upload a copy of a current accreditation certificate (if applicable) OR an inspection report completed within the last 18 months showing compliance with USP standards in a manner approved by the Michigan Board of Pharmacy.  Approved entities include:
    • Accreditation Commission for Health Care (ACHC)
    • CPS Solutions, LLC
    • Gates Healthcare Associates, Inc. 
    • Joint Commission Home Care Accreditation Program
    • Joint Commission Medication Compounding Certification Program
    • National Association of Boards of Pharmacy Verified Pharmacy Program (NABP-VPP)
    • National Association of Boards of Pharmacy – Multistate Pharmacy Inspection Blueprint Program
    • Pharmacy Compounding Accreditation Board (PCAB)
    • The Compliance Team, Inc.

  • If the application is for an outsourcing facility, you must upload a copy of an inspection report completed within the last 18 months that demonstrates compliance with the current and as amended good manufacturing practice for finished pharmaceuticals set forth in CFR part 211 in a manner approved by the Michigan Board of Pharmacy. Approved entities include: FDA; Gates Healthcare Associates, Inc. FDA documentation may include the FDA-483 form and the plan of corrections, and the biannual report it provided to the FDA that identifies the drugs compounded in the previous 6-month period, including a drug’s active ingredients, strength, and dosage form.
 

 

ADDITIONAL REQUIREMENTS FOR THOSE APPLYING FOR RELICENSURE
(These are in addition to the requirements stated above that apply to All applicants)

  • Online application can be completed by visiting www.michigan.gov/miplus and selecting MiPLUS Login. Once logged in, click on Modification” next to your pharmacy license number and this will start the relicensure process.

  • 2 year Pharmacy Relicensure Application and Fee (Must be paid by Visa, Mastercard, American Express or Discover credit or debit card)
    • Pharmacy Relicensure – $198.50
    • Controlled Substance License – $176.40

 

ADDITIONAL REQUIREMENTS FOR THOSE APPLYING FOR RELOCATION

  • A pharmacy with a current Michigan pharmacy license that is moving the pharmacy to a new address must complete the Online Application For a Pharmacy License – Complete all fields, answer all questions, and upload any supporting documentation.  Online application can be completed by visiting www.michigan.gov/miplus.

  • Be sure to select “yes” to the question “Is this an existing Michigan licensed facility that is changing location?” and provide the current Michigan facility license number and proposed date of relocation.

ADDITIONAL REQUIREMENTS FOR LICENSE MODIFICATIONS
(CHANGING PHARMACIST-IN-CHARGE, CHANGING FACILITY OWNERSHIP, OR CHANGING COMPANY INFORMATION)

 
  • A pharmacy must notify the department of a change in pharmacist-in-charge within 30 days of the change.  This can be done by visiting www.michigan.gov/miplus and submitting a modification to the pharmacy license.  Choose the Pharmacy PIC Change option.  Please note that your pharmacist-in-charge must have a Michigan pharmacist license and if you will be dispensing controlled substances, the PIC must also have a Michigan controlled substance license.

     

  • A pharmacy that has changed ownership must notify the department within 30 days of the change.  In order to notify the department, the new owner must submit a Pharmacy Facility Change of Ownership application by visiting www.michigan.gov/miplus. 

     

  • A pharmacy may change their organization name, DBA name, or Federal Employer Identification Number (FEIN) by visiting www.michigan.gov/miplus and submitting a modification to the pharmacy license.  Choose the Company Information Change option.

RENEWAL REQUIREMENTS CHECKLIST

  • Online Application for a Pharmacy Renewal – Must be completed by visiting www.michigan.gov/miplus no sooner than 90 days prior to the expiration date of current license.

  • Renewal Application Fee (Must be paid by Visa, Mastercard, American Express or Discover credit or debit card):
    • Pharmacy Renewal: $102.00
    • Controlled Substance Renewal: $165.40

  • Renewal Cycle: 2 years

  • Your controlled substance license and any controlled substance automated device licenses will renew along with the pharmacy license unless you uncheck the “renew cs” box on the renewal application.

  • Disciplinary Question – Documentation will be required if you answer “yes” to having sanctions imposed against you by a similar licensure, registration, certification, or disciplinary board of another state or country you have not previously reported to the department.

  • Sterile compounding pharmacies located in Michigan and pharmacies located outside of Michigan that ship sterile compounded products into Michigan must, prior to the end of the renewal period, upload a copy of a current accreditation certificate (if applicable) OR an inspection report completed within the last 18 months showing compliance with USP standards in a manner approved by the Michigan Board of Pharmacy. Approved entities include:
    • Accreditation Commission for Health Care (ACHC)
    • CPS Solutions, LLC
    • Gates Healthcare Associates, Inc.
    • Joint Commission Home Care Accreditation Program
    • Joint Commission Medication Compounding Certification Program
    • National Association of Boards of Pharmacy Verified Pharmacy Program (NABP-VPP)
    • National Association of Boards of Pharmacy – Multistate Pharmacy Inspection Blueprint Program
    • Pharmacy Compounding Accreditation Board (PCAB)
    • The Compliance Team, Inc.

  • Outsourcing facilities must upload a copy of an inspection report completed within the last 18 months that demonstrates compliance with the current and as amended good manufacturing practice for finished pharmaceuticals set forth in CFR part 211 in a manner approved by the Michigan Board of Pharmacy. Approved entities include: FDA; Gates Healthcare Associates, Inc. FDA documentation may include the FDA-483 form and the plan of corrections, and the biannual report it provided to the FDA that identifies the drugs compounded in the previous 6-month period, including a drug’s active ingredients, strength, and dosage form.

HELPFUL RESOURCES AND FORMS

By visiting www.michigan.gov/healthlicense and clicking on the pharmacy link you can access the following helpful resources and forms:

Resources:

FREQUENTLY ASKED QUESTIONS

  • How can I contact the Board of Pharmacy, Licensing Division?

    Email (Questions): BPLHelp@michigan.gov
    Email (Submit Documents): BPLData@michigan.gov
    Phone: (517) 241-0199
    Mailing Address:   Bureau of Professional Licensing
                                     Board of Pharmacy
                                     PO Box 30670
                                     Lansing, MI 48909

  • How long are Pharmacy license types valid?

    Pharmacy licenses are valid for 2 years.


  • How do I verify my Michigan Pharmacy license?

    Certified license verification requests must be obtained from the Michigan Board of Pharmacy. You must submit your request via the MiPLUS system at www.michigan.gov/miplus. There is a $15.00 fee for certification processing for each address you list. Please note, if you submit both a USPS mailing adddress and an email address for the same recipient, you will be charged $30.00 since you have requested your certification to go to two different addresses. Normal processing time for verifications being sent by email is the same day, verifications being mailed are sent the next business day.

    Licenses may also be verified online on the Bureau’s License Verification website free of charge. You may need to confirm with the recipient if verifying a license on this website is acceptable or if a certified license verification is needed.

  • How will I know when I need to renew? Can I renew my license early?

    You will be sent a renewal notification to both your mailing and email address on record approximately 90 days prior to the expiration date of your license.  You will not be able to renew before that time. It is your responsibility as a licensed health professional to renew your license on time. Failure to receive the renewal postcard, email notification, or to notify the Department of an address change does not exempt you from renewing your license on time.


  • Is there a grace period for my renewal?

    Yes, there is a 60-day grace period in which you may renew your license without having to go through the relicensure process. However, if you renew during the 60-day grace period, there is an additional $20.00 late fee for each license type when you renew your license(s).


  • What happens if my license expires?

    If your license is not renewed within the 60-day grace period after your expiration date, your license will lapse. The expiration date will reflect the original expiration date – it will not include the grace period. For example: If your license expires January 31, you have until April 1 to pay your renewal fee. If you do not renew by April 1, the end of the 60-day grace period, your license is considered lapsed as of January 31.


  • How long will you keep my licensure application on file?

    Your application and fee are valid for two years. If you fail to meet the licensure requirements within that time period, your application and fees are no longer valid.


  • If the pharmacy is licensed in more than one state, Canada or in another country, do you need verification from all locations in which the pharmacy holds or ever held a license in?

    Yes, we need verification from any state of the United States, Canada or country in which the pharmacy holds or has ever held a license. The verification must show that disciplinary proceedings are not pending against the applicant and sanctions are not in force at the time of application.


  • How long does it take to process my application for licensure? Once processed, how long before I receive my license?

    Applications are reviewed in the order by date received. The average time to receive a new license is 4 to 6 weeks and could be sooner if all required documents are received with the application. Once all the required information is submitted and accepted your license will be issued. If all licensure requirements are not met upon application review, you will receive an email requesting any outstanding items needed to complete your application. Once you are approved for licensure, it takes approximately 7 to 10 business days to receive the license by mail, if requested. Immediately upon license issuance a PDF of the license will also be sent to the email address provided on the application.

  • Will the pharmacy be subject to a pre-licensure inspection? Once assigned to an inspector, how long before an inspection is completed?

    Once we are in receipt of the required documentation the application file will be forwarded to our Pharmacy and Drug Monitoring Section (PDMS) for inspection and/or review. Inspections are scheduled to be completed within 30 days once the application file has been assigned to an inspector.


  • How do I apply for a (Drug Enforcement Administration) DEA registration?

    The State of Michigan and the DEA are two separate entities. The DEA is federally administered and regulated. If you have any questions concerning your DEA registration, you should visit their website at www.dea.gov or contact them directly at (800) 882-9539.

    You must obtain a Michigan controlled substance license prior to a DEA registration, if applicable.

  • Do I need to notify the department that my pharmacy is closing?

    A pharmacy that is ceasing operations shall provide the department with written notification of all the following not less than 15 days before closing:

    1. The effective date of closing.
    2. How controlled substances will be disposed.
    3. How non-controlled substances will be disposed.
    4. The location where records and prescription files will be stored.

    A pharmacy shall comply with all applicable federal requirements for discontinuing operation as a pharmacy that dispenses controlled substances.

    Records must be maintained for the same amount of time that is required if the pharmacy remained open.

  • How do I file a complaint against a health care professional?

    Visit the Bureau of Professional Licensing’s website at www.michigan.gov/bpl for information on how to File a Complaint Against a Health Care Licensee.