LARA: New Pharma Rules

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The Bureau of Professional Licensing (BPL) within the Department of Licensing and Regulatory Affairs (LARA) would like to inform you that the new Pharmacy Administrative Rules were effective as of February 29, 2024. A list of the notable changes is below. This is not intended to provide a comprehensive listing of all changes or current requirements. Licensees should review the rules and statute for a complete understanding of all applicable requirements.

The summary of changes is below:

For Pharmacy Services in Medical Institutions: Updates were made indicate that the limited number of medications may be stocked in patient care areas if pharmacist review and interpretation of the order before the administration of the first dose would adversely affect the patient’s medical condition.

For Pharmacist Licenses:

An individual participating in an unconventional internship is required to annually submit an affidavit from the internship supervisor including the type of activities performed and the number of hours completed.
A graduate from a program outside the United States may petition the board for approval of a maximum of 1,400 internship hours if the hours are not obtained through an approved educational program or under the personal charge of a Michigan-licensed pharmacist.
An internship preceptor is required to submit an affidavit including the number of internship hours completed by the intern in the practice of pharmacy, unless the hours are completed in an educational program.
The Multistate Pharmacy Jurisprudence Examination requirement is eliminated and replaced with an attestation that the applicant has sufficient knowledge of the Public Health Code and the Board of Pharmacy’s rules to competently practice pharmacy in Michigan.
For Pharmacy Licenses:

If a pharmacist in charge (PIC) is unable to fulfil their duties for 120 consecutive days, the pharmacy shall appoint a new PIC and notify the department.
The 2023 revisions of USP Chapters 795 and 797 are adopted, with the exception of flavoring; inspection requirements are modified, including a 2-step inspection process for an in-state pharmacy that will compound sterile products and requiring out-of-state pharmacies that will not ship compounded sterile products into Michigan to submit inspections from their resident state boards of pharmacy or the National Association of Boards of Pharmacy (NABP) Verified Pharmacy Program.
Requirements for a pharmacy’s access to pharmacy laws and rules and reference texts are clarified.
A pharmacy that dispenses drugs is required to maintain a sink with running water, a refrigerator for the exclusive use of prescription drugs, and a telephone.
For Manufacturer Licenses:

If a PIC or facility manager is unable to fulfil their duties for 120 consecutive days, the pharmacy shall appoint a new PIC or facility manager and notify the department.
Inspection and accreditation requirements were modified to provide the option of submitting an inspection from the United States Food and Drug Administration, the manufacturer’s resident state board of pharmacy, or NABP drug distributor accreditation.
For Wholesale Distributor and Wholesale Distributor-Broker Licenses:

If a PIC or facility manager is unable to fulfil their duties for 120 consecutive days, the pharmacy shall appoint a new PIC or facility manager and notify the department.
For the Practice of Pharmacy:

If a pharmacy intern completes final product verification under the supervision of a pharmacist, initials of both the pharmacy intern and the delegating pharmacist are required; modifies the locations where a pharmacy may operate an automated device; requires pharmacist review of orders and authorization of further dispensing within 48 hours when an automatic device is used as an after-hours cabinet, emergency kit, or when the system is accessed to treat the emergent needs of a patient;
The requirements for automated devices used in non-inpatient settings and in medical institutions were clarified.
A pharmacist may remotely access a pharmacy database as well as any other necessary databases that are routinely accessed to perform their functions and requires the pharmacist to provide adequate security.
The requirements for a pharmacist to dispense an emergency supply of insulin.
Please click HERE to view the revised Pharmacy rules.

Our office is diligently working on updating relative information on our website to reflect the revisions of the revised rules. For more information, please visit our website at www.michigan.gov/bpl.

Please send questions about the revised rules to BPLHELP@michigan.gov.