Michigan Office of Administrative Hearings and Rules  
Administrative Rules Division (ARD)  
611 W. Ottawa Street  
Lansing, MI 48909  
Phone: 517-335-8658 Fax: 517-335-9512  
REQUEST FOR RULEMAKING (RFR)  
1. Department:  
Licensing and Regulatory Affairs  
2. Bureau:  
Bureau of Professional Licensing  
3. Promulgation type:  
Full Process  
4. Title of proposed rule set:  
Pharmacy - General Rules  
5. Rule numbers or rule set range of numbers:  
R 338.471 – R 338.590  
6. Estimated time frame:  
12 months  
Name of person filling out RFR:  
Andria Ditschman  
E-mail of person filling out RFR:  
DitschmanA@michigan.gov  
Phone number of person filling out RFR:  
517-290-3361  
Address of person filling out RFR:  
611 West Ottawa Street #rd Floor  
7. Describe the general purpose of these rules, including any problems the changes are intended  
to address.  
The purpose of the Pharmacy – General Rules is to encompass all the necessary requirements for  
licensing and regulating the practice for pharmacists, pharmacies, and manufacturers and  
wholesale distributors of drugs and devices. The rules include parts for general provisions,  
pharmacist licenses, pharmacy licenses, manufacturer licenses, wholesale distributor licenses, and  
the practice of pharmacy.  
The purpose of the proposed rules is to: establish any additional licensure requirements for a  
remote pharmacy and provide a procedure to request a waiver from the 10 mile rule for a remote  
pharmacy, pursuant to PA 4 of 2020; modify the requirements in the rules to require mandatory  
electronic transmission of a prescription and add the criteria for a waiver from electronic  
transmission, pursuant to PA 134 of 2020; establish licensure requirements for a wholesale  
distributor-broker and modify the activities allowed by an out-of-state pharmacy that is not  
licensed as a pharmacy in this state, pursuant to PA 142 of 2020; update rules affected by any  
other modified Public Health Code (Code) provisions; review practical experience requirements  
and limited licensure; review pharmacy ownership and licensure requirements; review the need for  
telehealth regulations; sanitation regulations; licensure reciprocity; and update definitions.  
MCL 24.239  
RFR-Page 2  
8. Please cite the specific promulgation authority for the rules (i.e. department director,  
commission, board, etc.).  
MCL 333.16141 authorized the Department to promulgate rules to promote the effective and  
consistent administration of Article 15 of the Public Health Code. MCL 333.16145 authorizes a  
Board to promulgate rules necessary or appropriate to fulfill its functions as prescribed in Article  
15. MCL 333.17742a authorizes the Department, in consultation with the Board, to establish  
requirements for licensure for remote pharmacies. MCL 333.17748a authorizes the Department, in  
consultation with the Board, to promulgate rules regarding conditions and facilities for the  
compounding of nonsterile and sterile pharmaceuticals. MCL 333.17748e authorizes the  
Department, in consultation with the Board, to establish requirements for licensure as a wholesale  
distributor-broker. MCL 333.17754a authorizes the Department to establish by rule the  
requirements for obtaining a waiver from electronically transmitting a prescription, as well  
authorizing the Department, in consultation with the Board, to promulgate rules to implement  
MCL 333.17754a; MCL 333.17767 authorizes the Board to promulgate rules necessary or  
appropriate to the licensing of pharmacists, drugs, dispensers, manufacturers, wholesale  
distributors, and wholesale distributor-brokers.  
A. Please list all applicable statutory references (MCLs, Executive Orders, etc.).  
MCL 333.16141; MCL 333.16145; MCL 333.16148; 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 333.17731; MCL 333.17737; MCL 333.17739; MCL 333.17742a; MCL  
333.17742b; MCL 333.17746; MCL 333.17748a; MCL 333.17748b; MCL 333.17748e; MCL  
333.17754a; MCL 333.17757; MCL 333.17767; MCL 333.17775; 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.  
B. Are the rules mandated by any applicable constitutional or statutory provision? If so, please  
explain.  
The proposed rules are required by sections 16287, 17722, 17731, 17737, 17742a, 17748e, and  
17754a of the Code, MCL 333.16287, MCL 333.17722, MCL 333.17731, MCL 333.17737, MCL  
333.17742a, MCL 333.17748e, and MCL 333.17754a. The rules are not federally mandated.  
9. Please describe the extent to which the rules conflict with or duplicate similar rules,  
compliance requirements, or other standards adopted at the state, regional, or federal level.  
There are no other laws, rules or other legal requirements that conflict with the proposed rules.  
Each state establishes its own requirements with respect to the licensing requirements of  
pharmacists, pharmacies, manufacturers, and wholesale distributors. In addition to state laws and  
rules, federal laws regulate the practice of pharmacy with respect to controlled substances and  
chemicals used in the manufacture of controlled substances.  
The proposed rules are being modified pursuant to additions to the Code.  
10. Is the subject matter of the rules currently contained in any guideline, handbook, manual,  
instructional bulletin, form with instructions, or operational memoranda?  
No. The subject matter of these rules is not currently contained in any guideline, handbook,  
manual, instructional bulletin, form with instructions, or operational memoranda.  
11. Are the rules listed on the department’s annual regulatory plan as rules to be processed  
for the current year?  
Yes.  
MCL 24.239  
RFR-Page 3  
12. Will the proposed rules be promulgated under Section 44 of the Administrative Procedures  
Act, 1969 PA 306, MCL 24.244, or under the full rulemaking process?  
Full Process  
13. Please describe the extent to which the rules exceed similar regulations, compliance  
requirements, or other standards adopted at the state, regional, or federal level.  
Although there are similar provisions to some of the proposed rules at the federal level and other  
states, the proposed rules are not expected to exceed similar regulations, compliance requirements,  
or other standards adopted at the state, regional, or federal level.  
The proposed rules are consistent with the standards required by the Code and are expected to be  
largely consistent with the requirements of other states in the Great Lakes region.  
14. Do the rules incorporate the recommendations received from the public regarding any  
complaints or comments regarding the rules? If yes, please explain.  
The Department will work with associations, related businesses, and lobbyists in preparing the  
proposed rules.  
15. If amending an existing rule set, please provide the date of the last evaluation of the rules  
and the degree, if any, to which technology, economic conditions, or other factors have changed  
the regulatory activity covered by the rules since the last evaluation.  
The rules were last promulgated on December 22, 2020. There have been no technological factors,  
economic conditions or other factors that would necessitate amendment of the rules.  
16. Are there any changes or developments since implementation that demonstrate there is no  
continued need for the rules, or any portion of the rules?  
No, there are no changes or developments since implementation of the rules that demonstrate there  
is no continued need for the rules, or any portion of the rules.  
17. Is there an applicable decision record (as defined in MCL 24.203(6) and required by MCL  
24.239(2))? If so, please attach the decision record.  
Yes  
MCL 24.239  
;