Michigan Office of Administrative Hearings and Rules

Administrative Rules Division (ARD)

MOAHR-Rules@michigan.gov

AGENCY REPORT TO THE

JOINT COMMITTEE ON ADMINISTRATIVE RULES (JCAR)

AGENCY INFORMATION:

Agency name:

Licensing and Regulatory Affairs

Division/Bureau/Office:

Bureau of Professional Licensing

Name of person completing this form:

Jennifer Shaltry

Phone number of person completing this form:

517-241-3085

Email of person completing this form:

ShaltryJ1@michigan.gov

Name of Department Regulatory Affairs Officer reviewing this form:

Elizabeth Arasim

RULE SET INFORMATION:

MOAHR assigned rule set number:

2025-28 LR

Title of the proposed rule set:

Pharmacy - General Rules

1. Purpose of the proposed rules and background:

The Pharmacy – General Rules provide the licensing requirements and regulate the practice of pharmacists,

pharmacies, manufacturers, wholesale distributors, and wholesale distributor-brokers.

The rules will be amended to implement Sections 17724, 17724a, and 17744g of the Public Health Code, MCL

333.17724, MCL 333.17724a, and MCL 333.17744g, concerning pharmacists ordering and administering qualified

immunizing agents, ordering qualified laboratory tests and dispensing medications based on the results, and

prescribing hormonal contraceptives. Further, all rules will be reviewed, updated, and revised for clarity as needed.

2. Summary of the proposed rules:

The proposed revisions include updates to improve ease of reading and comply with current drafting standards, new

definitions, the removal of outdated language concerning training required to renew a controlled substance license,

establishing a process for the board to approve entities to inspect pharmacies that compound under good

manufacturing practice for finished pharmaceuticals, updates to the adopted United States Pharmacopeia Convention

standards, and clarification of inspection requirements for pharmacies that engage in compounding. New rules are

proposed concerning telehealth services; a pharmacist ordering and administering qualified immunizations; a

pharmacist ordering and administering qualified laboratory tests and dispensing, without a prescription, an antiviral

drug based on the test result; and a pharmacist prescribing a hormonal contraceptive patch, a self-administered

hormonal contraceptive, an emergency contraceptive, or a vaginal ring hormonal contraceptive.

3. List names of newspapers in which the notice of public hearing was published and publication

dates:

The Escanaba Daily Press, August 28, 2025

The Flint Journal, August 28, 2025

The Grand Rapids Press, August 28, 2025

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Agency Report to JCAR -Page 2

4. Date of publication of the proposed rules and notice of public hearing in the Michigan Register:

9/1/2025

5. Date, time, and location of the public hearing:

9/10/2025 09:00 AM at G. Mennen Williams Building Auditorium, 525 W. Ottawa Street, Lansing, MI

6. Provide the link the agency used to post the regulatory impact statement and cost-benefit analysis

on its website:

https://ARS.apps.lara.state.mi.us/Transaction/RFRTransaction?TransactionID=1601

7. List of the name and title of agency representative(s) who attended the public hearing:

Jennifer Shaltry, Departmental Specialist, Bureau of Professional Licensing

Kerry Przybylo, Manager, Bureau of Professional Licensing

8. Persons submitting comments of support:

Eric Roath, Leang Mey Tao

9. Persons submitting comments of opposition:

Joseph Paul Pacis Javier, Obioma Opara, Arian Shaska, Micaiah Whitaker, Maria Young

10. Persons submitting other comments:

Kennyle Johnson, Eric Roath, Krupa, Chris Munden, Michelle Kelly, Susan Davis, Brittany Stewart, Lynette Moser,

Sally Rafie, Hsin Wang, Leang Mey Tao

11. Identify any changes made to the proposed rules based on comments received during the public

comment period:

Name &

Comments Made at Written Comments

Agency Rationale for Rule Rule Number &

Organization Public Hearing

Change & Description of

Change(s) Made

Citation

Changed

Eric Roath,

Michigan

Pharmacists

Association

An agent of a licensed The Board agrees with the

R 338.507(1) and

health professional,

rather than the health staff working with licensees

professional to obtain consent and keep

proposal to permit unlicensed (2).

themselves, may obtain proof of consent in the

consent and document patient’s medical record.

consent according to

proposed subrules (1) to keep “health professional”

and (2) – (i.e. a and add “or delegate of the

pharmacy technician or health professional.” The

However, the Board prefers

an unlicensed

Department agrees.

pharmacy clerk). The

commenter proposed

changing “health

professional” in R

338.507(1) and (2) to

“pharmacist, pharmacy

technician, or agent of

the pharmacist.”

Eric Roath,

Michigan

Pharmacists

Association

Entities that provide CE The Board and Department R 338.581

or certificate programs agree with the comment.

accredited by ACPE

are not, themselves,

“accredited.” Rather,

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Agency Report to JCAR -Page 3

they are organizations

that provide courses

which are accredited by

ACPE. This distinction

is important for

ensuring that common

certificate programs

utilized by practicing

professionals are

recognized (e.g. the

APhA Immunization

Certification

Program). ꢀThe

commenter

recommended adding

“or course” after

“entity”.

Eric Roath,

Michigan

Entities that provide

training, CE, or

The Board and Department R 338.581b

agree with the comment.

Pharmacists

Association

certificate programs

accredited by ACPE

are not, themselves,

“accredited.” Rather,

they are organizations

that provide courses

which are accredited by

ACPE. This distinction

is important for

ensuring that common

certificate programs

utilized by practicing

professionals are

recognized. The

commenter

recommended adding

“or course” after

“entity”.

Susan Davis,

Brittany

Stewart and

Lynette Moser,

Wayne State

University

Excessive referral

requirements: Rule 81c patient for a physical

mandating referral for a examination cannot be

physical exam if one

hasn’t occurred in 12

months is not

The requirement to refer the R 338.581c(b)(iii)

completely eliminated

because MCL 333.17744g

mandates referrals under

certain circumstances.

consistent with CDC

guidance, which does However, the Board agreed

not require a physical that the proposed rule

before safely initiating contained too many referral

most hormonal

contraceptives.

requirements. The Board

decided to remove R

According to the CDC, 338.581c(b)(iii) from the

the goals of the proposed rule because

recommendations are referrals for patients who do

to remove unnecessary not receive a prescription are

medical barriers to

accessing and using

contraception and to

support providing

person-centered

not mandatory under MCL

333.17744g. The Department

agrees.

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Agency Report to JCAR -Page 4

contraceptive

counseling and

services in a

noncoercive manner. ꢀ

Recommendation:

eliminate the

mandatory physical

exam requirement.

Suggested alternative

can be based on that

used in Oregon: “The

Pharmacist is

responsible for

recognizing limits of

knowledge and

experience for

resolving situations

beyond their expertise

by consulting with or

referring patients to

another health care

provider.”

Eric Roath,

Michigan

The commenter

proposed modifications 338.581(c)(iii) was stricken,

Because the former R

R 338.581c(b)(iv)

Pharmacists

Association

including adding

second sentence

stating that a

this paragraph was

renumbered as R

338.581c(b)(iii). The Board

prescription receipt or and Department agree that

note in an electronic

health record or

the written record may

include electronic records.

pharmacy management The commenter’s sentence

system shall be

sufficient to comply

was rewritten to use simpler

language and to include all

with this subrule. The types of electronic records.

commenter wrote this

change would

accomplish the goals of

the proposed language

while recognizing the

realities of current

workflow and health

communication

practices.

Eric Roath,

Michigan

Pharmacists

Association

The commenter

proposed simpler

language.

The Board and Department R 338.581c(b)(v)

agree with the comment.

12. Date report completed:

5/7/2026

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