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may be sold, adoption by reference of a federal regulation on good manufacturing practices for
finished pharmaceuticals, closure of a manufacturer, and relicensure.
Part 5 of the proposed pharmacy rules pertains to a wholesale distributor license. This part includes
the determination of a pharmacy as a wholesale distributor, the licensure requirements for
wholesale distributors of drugs and devices, persons to whom drugs or devices may be sold,
wholesale distributor practices, recordkeeping and policy requirements for wholesale distributors,
facility requirements, examination of drugs and devices, closure of a wholesale distributor, and
Part 6 of the proposed pharmacy rules pertains to the practice of pharmacy. This part includes
pharmacy services by medical institutions, prescription drug labeling and dispensing, prescription
drug receipts, noncontrolled prescriptions, a customized patient medication packages, prescription
records, prescription refill records, automated devices, professional responsibility of a pharmacist,
and a hospice emergency drug box.
5. Cite the specific rule promulgation authority (i.e. agency director, commission, board, etc.,
listing all applicable statutory references. If the rule(s) are mandated by any applicable
constitutional or statutory provision, please explain.
MCL 333.16145(2); MCL 333.16145(3); MCL 333.16148; MCL 333.17721; Executive
Reorganization Order No. 1991-9, MCL 338.3501; Executive Reorganization Order No. 1996-2,
MCL 445.2001; Executive Reorganization Order No. 2003-1, MCL 445.2011, and Executive
Reorganization Order No. 2011-4, MCL 445.2030.
6. Describe the extent to which the rule(s) conflict with, duplicate, or exceed similar regulations,
compliance requirements, or other standards adopted at the state, regional, or federal level.
Include applicable public act and statutory references.
Each state establishes its own requirements with respect to the licensing requirements of a
pharmacy. There is no federal rule or standard set by a national or state agency that the proposed
rules duplicate or are against. The rules adopt the sterile compounding standards of the United
States Pharmacopeia (USP), published by the United States Pharmacopeial Convention.
7. Is the subject matter of the rule(s) currently contained in any guideline, manual, handbook,
instructional bulletin, form with instructions, or operational memo?
No. The subject matter of these rules is not currently contained in any guideline, handbook,
manual, instructional bulletin, form with instructions, or operational memoranda.
8. Explain whether the rule(s) will be promulgated under Sections 44 or 48 of the APA or the full
These rules will be promulgated using the full rulemaking process.
9. Do the rule(s) incorporate the recommendations of any Advisory Rules Committee formed
pursuant to Executive Order 2011-5? If yes, explain.
The proposed rules do not incorporate any recommendation of any Advisory Rules Committee.
10. Is there an applicable decision record as defined in Section 3(6) and required by Section 39(2) of
the APA? If so, please attach the decision record.
The Michigan Board of Pharmacy voted to open the rules at the regularly scheduled board meeting
on October 11, 2017. Please see attached copy of the minutes from that meeting.
Revised: January 4, 2018