State Budget Office  
Office of Regulatory Reinvention  
111 S. Capitol Avenue; 8th Floor, Romney Building,  
Lansing, MI 48933  
Phone: (517) 335-8658 FAX: (517) 335-9512  
Under the Administrative Procedures Act (APA), 1969 PA 306, the agency that has the statutory authority  
to promulgate rules must electronically file a RFR with the Office of Regulatory Reinvention (ORR)  
before initiating any changes or additions to the rules. Submit copy to the ORR at  
1. Agency Information  
Agency name: Department of Licensing and Regulatory Affairs  
Division/Bureau/Office: Legal Affairs/Enforcement Division/Bureau of Professional Licensing  
Agency contact person name, e-mail, and phone: Andria M. Ditschman  
2. Rule Set Information  
Title of proposed rule set: Board of Pharmacy – General Rules  
Rule number(s) or range of numbers: R 338.471 – R 338.590  
Included in agency’s annual regulatory plan as rule to be processed in current year? Yes.  
3. Estimated timetable for completion, or statutory deadline, if applicable:  
1 year  
4. Describe the general purpose of these rules, including any problem(s) the changes are intended to  
The current Pharmacy – General Rules are incomplete, disorganized, and difficult to use. The draft  
rules have been reorganized and substantially rewritten to provide for rules that encompass all the  
necessary requirements for licensing and regulating the practice for pharmacists, pharmacies, and  
manufacturers and wholesale distributors of drugs and devices. The draft rules include parts for  
general provisions, pharmacist licenses, pharmacy licenses, manufacturer licenses, wholesale  
distributor licenses, and the practice of pharmacy.  
Part 1 of the proposed pharmacy rules pertains to definitions, resale of drugs and devices, and  
inspections of applicants and licensees.  
Part 2 of the proposed pharmacy rules pertains to licensure of pharmacists. This part includes the  
rules pertaining to training for identifying victims of human trafficking, educational limited  
licenses, internship requirements, preceptor licenses, examinations, pharmacist licensure by  
examination and endorsement, and relicensure.  
Part 3 of the proposed pharmacy rules pertains to pharmacy licenses. This part includes the  
application requirements for pharmacies, sterile compounding services and the adoption by  
reference of standards that apply to these services, inspections, discontinuance and resumption of  
sterile compounding services, housing of a pharmacy, professional and technical equipment and  
supplies, closure of a pharmacy, and relicensure.  
Part 4 of the proposed pharmacy rules pertains to a manufacturer license. This part includes  
licensure requirements for manufacturers of drugs and devices, persons to whom drugs or devices  
Revised: January 4, 2018  
MCL 24.239  
RFR – Page 2  
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  
rulemaking process:  
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  
MCL 24.239  
RFR – Page 3  
11. Reviewed by the following Departmental Regulatory Affairs Officer:  
Liz Arasim  
Department of Licensing and Regulatory Affairs  
To be completed by the ORR ↓  
Date RFR received:5-29-2018  
Based on the information in this RFR, the ORR concludes that there are sufficient policy and  
legal bases for approving the RFR.  
ORR assigned rule set number: 2018-039 LR  
Date of approval:  
Based on the information in this RFR, the ORR is not approving the RFR at this time.  
Date of disapproval:  
Revised: January 4, 2018  
MCL 24.239