Michigan Office of Administrative Hearings and Rules  
Administrative Rules Division (ARD)  
MOAHR-Rules@michigan.gov  
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 338.592  
6. Estimated time frame:  
12 months  
Name of person filling out RFR:  
Jennifer Shaltry  
Email of person filling out RFR:  
ShaltryJ1@michigan.gov  
Phone number of person filling out RFR:  
517-241-3085  
Address of person filling out RFR:  
611 West Ottawa Street, 3rd Floor  
P.O. Box 30670  
Lansing, MI 48909  
7. Describe the general purpose of these rules, including any problems the changes are intended  
to address.  
The Pharmacy – General Rules pertain to pharmacy services in medical institutions, definitions, the  
return or exchange of prescription drugs and devices, inspections, telehealth, pharmacist licenses,  
pharmacy licenses, manufacturer licenses, wholesale distributor and wholesale distributor-broker  
licenses, and the practice of pharmacy.  
The rules will be reviewed and amended to supply necessary revisions on pharmacy services in  
medical institutions, definitions, the return or exchange of prescription drugs and devices, inspections,  
telehealth, pharmacist licenses, pharmacy licenses, manufacturer licenses, wholesale distributor and  
wholesale distributor-broker licenses, and the practice of pharmacy.  
8. Please cite the specific promulgation authority for the rules (i.e., department director,  
commission, board, etc.).  
The department has the authority to promulgate the rules in consultation with the board.  
A. Please list all applicable statutory references (MCLs, Executive Orders, etc.).  
MCL 333.16141; MCL 333.16145; MCL 333.16148; MCL 333.16174; MCL 333.16175; MCL  
333.16178; MCL 333.16182; MCL 333.16184; MCL 333.16186; MCL 333.16201; MCL  
333.16204; MCL 333.16205; MCL 333.16215; MCL 333.16287; MCL 333.17707; MCL  
333.17722; MCL 333.17724; MCL 333.17724a; MCL 333.17744g; MCL 333.17731; MCL  
333.17737; MCL 333.17739; MCL 333.17742a; MCL 333.17742b; MCL 333.17744f; MCL  
333.17746; MCL 333.17748; MCL 333.17748a; MCL 333.17748b; MCL 333.17748e; MCL  
MCL 24.239  
RFR-Page 2  
333.17751; MCL 333.17753; MCL 333.17754a; MCL 333.17757; MCL 333.17760; MCL  
333.17761; 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 16148, 16204, 16287, 17724, 17724a, 17744g,  
17731, 17737, 17744f, 17748e, 17754a of the Public Health Code, MCL 333.16148, MCL  
333.16204, MCL 333.16287, MCL 333.17724, MCL 333.17724a, MCL 333.17744g, MCL  
333.17731, MCL 333.17737, MCL 333.17744f, MCL 333.17748e, MCL 333.17754a.  
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.  
The Drug Supply Chain Security Act, (DSCSA) Public Law 113-54 and corresponding federal  
regulations include requirements to develop and enhance drug supply chain security. They establish  
a federal system for tracing prescription drug products through the pharmaceutical distribution supply  
chain and include product tracing requirements for entities in the drug supply chain, including  
manufacturers, repackagers, wholesale drug distributors, and pharmacies. They also require the  
Food and Drug Administration (FDA) to establish federal standards for licensing of wholesale drug  
distributors and third-party logistics providers. States may not regulate tracing that is inconsistent  
with, more stringent than, or in addition to the federal requirements. States are also preempted from  
establishing licensure requirements that are inconsistent with or below the minimum standards  
established by federal law for wholesale distributors and third-party logistics providers. The DSCSA  
and federal regulations require a wholesale drug distributor and third-party logistics provider to  
maintain licensure in the state from which the drug is distributed and in most cases the state into  
which the drug is distributed if those states have a licensure process. State licensure information  
including significant discipline must be reported to the FDA on an annual basis.  
The rules adopt the pharmaceutical compounding standards of the United States Pharmacopeia  
(USP), published by the United States Pharmacopeial Convention, and the regulations regarding  
good manufacturing practices for finished pharmaceuticals set forth in 21 CFR sections 211.1 to  
211.208. Some aspects of the practice of pharmacy, such as the labeling of prescription drugs, are  
regulated by the Federal Food, Drug, and Cosmetic Act of 2016, 21 USC sections 351 to 399g and  
have been adopted by the rules.  
The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients  
and Communities (SUPPORT) Act and corresponding Code of Federal Regulations, 42 CFR 423,  
require electronic prescribing under Medicare Part D for Schedule II to V controlled substances and  
provide for exceptions to this requirement. Section 17754a of the Public Health Code, MCL  
333.17754a, requires the Department to establish by rule the requirements for obtaining a waiver  
from electronically transmitting all prescriptions, including controlled substances. The rules provide for  
a waiver from electronic prescribing in certain circumstances. Most, but not all of the circumstances  
are consistent with the SUPPORT Act.  
Under the Controlled Substances Act, (CSA), 21 USC 801 et seq., the federal government regulates  
the practice of pharmacy with respect to controlled substances and chemicals used in the  
manufacture of controlled substances and requires pharmacies to register or self-certify with the Drug  
Enforcement Administration (DEA). A pharmacy must maintain a state license to obtain a DEA  
registration.  
Under the Public Readiness and Emergency Preparedness (PREP) Act, 42 USC 247d-6d, the  
Secretary of Health and Human Services is authorized to issue a declaration to provide liability  
immunity to certain individuals and entities related to medical countermeasures. Currently, the 12th  
Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for  
Medical Countermeasures Against COVID-19, 89 Fed. Reg. 99875 (Dec. 11, 2024) (Declaration),  
effective until December 31, 2029, provides liability immunity to state-licensed pharmacists who order  
MCL 24.239  
RFR-Page 3  
and administer certain vaccines, as well a pharmacy interns and qualified pharmacy technicians who  
administer certain vaccines. The Declaration also provides liability immunity to pharmacists,  
pharmacy interns, and qualified pharmacy technicians to administer COVID-19 tests, and to state-  
licensed pharmacists to order and administer, and pharmacy interns or qualified pharmacy  
technicians who administer, FDA-authorized, approved, or licensed COVID-19 therapeutics. The  
Declaration specifies training requirements for a pharmacist, pharmacy intern, and qualified pharmacy  
technician to perform the vaccine and testing functions described above. Section 17724 of the Public  
Health Code authorizes pharmacists to order and administer qualified immunizations. Section 17724a  
of the Public Health Code authorizes pharmacists to order and administer tests, and to dispense,  
without a prescription, an antiviral drug to treat, COVID-19, influenza, and respiratory infections,  
pursuant to protocols established by the Centers for Disease Control and Prevention or the  
Department of Health and Human Services. Sections 17724 and 17724a each require the  
department, in consultation with the board, to make rules requiring training for pharmacists who order  
and administer qualified vaccines or who order and administer tests and dispense, without a  
prescription, an antiviral drug to treat COVID-19, influenza, or a respiratory infection.  
Taking into consideration the federal laws and regulations referenced above, each state establishes  
its own requirements with respect to the licensing requirements of pharmacists, pharmacies,  
manufacturers of prescription drugs and devices (manufacturer), wholesale distributors of prescription  
drugs and devices (wholesale distributor), and wholesale distributor-brokers of prescription drugs and  
devices (wholesale distributor-broker). There are no other known laws, rules or other legal  
requirements that conflict with or duplicate the proposed rules.  
10. Is the subject matter of the rules currently contained in any guideline, handbook, manual,  
instructional bulletin, form with instructions, or operational memoranda?  
No.  
11. Are the rules listed on the department’s annual regulatory plan as rules to be processed for  
the current year?  
Yes.  
12. Will the proposed rules be promulgated under Section 44 of the administrative procedures act  
of 1969, 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.  
The rules are not expected to exceed similar regulations, compliance requirements, or other  
standards adopted at the state, regional, or federal level.  
14. Do the rules incorporate the recommendations received from the public regarding any  
complaints or comments regarding the rules? If yes, please explain.  
Yes. The Department works with various associations, pharmacies, lobbyists, and members of the  
public 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 amended on March 12, 2026. 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.  
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  
RFR-Page 4  
Based on the information provided in this RFR, MOAHR concludes that there are sufficient policy and legal  
bases for approving the RFR. The RFR satisfies the requirements of the administrative procedures act of  
1969, 1969 PA 306, MCL 24.201 to 24.328, and Executive Reorganization Order No. 2019-1, MCL 324.99923.  
MCL 24.239  
;