Department of Licensing and Regulatory Affairs
Bureau of Professional Licensing
Administrative Rules for Pharmacy - General Rules
Rule Set 2020-128 LR
NOTICE OF PUBLIC HEARING
Tuesday, September 21, 2021
01:00 PM
G. Mennen Williams Building Auditorium
525 W. Ottawa Street, Lansing, Michigan
The Department of Licensing and Regulatory Affairs will hold a public hearing to receive public
comments on proposed changes to the Pharmacy - General Rules rule set.
The proposed revisions to the rules will: require preceptors to report internship hours; require an
applicant who has failed the NAPLEX or the MPJE to review the material in a preparation course or with
an instructor; clarify that an applicant who has completed the FPGEC certification has met the English
proficiency requirement; allow an applicant for licensure by endorsement to obtain a license in this state
if he or she either holds a license in another state or holds a license in Canada and meets additional
requirements; add requirements for relicensure; establish the requirements for a remote pharmacy
license; provide a waiver process from the 10 mile requirement for remote pharmacies; require any
pharmacy that will provide sterile compounding in this state to submit an onsite physical inspection and
report completed no more than 18 months before the application; clarify that a pharmacy that starts or
resumes sterile compounding must apply to the Department and submit the required inspection report;
require a pharmacy, manufacturer, wholesale distributor, and wholesale distributor-broker that is closing
to maintain records; clarify the process for renewal versus relicensure; add the requirements for a facility
manager for a manufacturer; adopt the federal exclusions to the definition of wholesale distribution; add
the licensure and record keeping requirements for a wholesale distributor-broker; reduce the time from 3
years to 2 years before a prescription may be electronically duplicated; provide the requirements for
electronic transmission of prescriptions; provide the process for a waiver from the mandate to
electronically transmit a prescription; and clarify that if final product verification is delegated, then both
the pharmacist and technician must record their initials.
By authority conferred on the Department of Licensing and Regulatory Affairs, Bureau of Professional
Licensing in consultation with the Board of Pharmacy pursuant to MCL 333.16141, MCL 333.16145, MCL
333.16148, MCL 333.16174, MCL 333.16175, MCL 333.16178, MCL 333.16182, MCL 333.16186, MCL
333.16201, MCL 333.16204, MCL 333.16204e, MCL 333.16205, MCL 333.16215, MCL 333.16287, MCL
333.17707, MCL 333.17721, MCL 333.17722, MCL 333.17731, MCL 333.17737, MCL 333.17739, MCL
333.17742a, MCL 333.17742b, MCL 333.17746, MCL 333.17748, MCL 333.17748a, MCL 333.17748b,
MCL 333.17748e, MCL 333.17751, MCL 333.17753, MCL 333.17754a, MCL 333.17757, MCL
333.17760, MCL 333.17767, MCL 333.17775, and Executive Reorganization Order Nos. 1991-9, 1996-2,
2003-1, and 2011-4, MCL 338.3501, 445.2001, 445.2011, and 445.2030.
The proposed rules will take effect immediately after filing with the Secretary of State. The proposed
Michigan Register in the 9/15/2021 issue. Copies of these proposed rules may also be obtained by mail
or electronic transmission at the following address: BPL_BoardSupport@michigan.gov.
Comments on these proposed rules may be made at the hearing or by mail or electronic mail at the
following address until 9/21/2021 at 05:00PM.
Department of Licensing and Regulatory Affairs, Bureau of Professional Licensing – Boards and
Committees, Attention: Policy Analyst