Michigan Office of Administrative Hearings and Rules

MOAHR-Rules@michigan.gov

AGENCY REPORT TO THE

JOINT COMMITEE ON ADMNINISTRATIVE RULES (JCAR)

1. 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

E-mail of person completing this form:

ShaltryJ1@michigan.gov

Name of Department Regulatory Affairs Officer reviewing this form:

Elizabeth Arasim

2. Rule Set Information

MOAHR assigned rule set number:

2025-28 LR

Title of proposed rule set:

Pharmacy - General Rules

3. Purpose for 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.

4. Summary of proposed rules:

MCL 24.242 and 24.245

Agency Report to JCAR-Page 2

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standards, new definitions, the removal of outdated language concerning training required to renew a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.

5. 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

6. Date of publication of rules and notice of public hearing in Michigan Register:

9/1/2025

7. Date, time, and location of public hearing:

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

MI

8. 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

9. 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

10. Persons submitting comments of support:

Eric Roath, Leang Mey Tao

11. Persons submitting comments of opposition:

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

12. 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

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

public comment period:

MCL 24.242 and 24.245

Agency Report to JCAR-Page 3

Name &

Organization public hearing

Comments made at Written

Agency Rationale Rule number

for Rule Change & citation

and Description changed

of Change(s)

Comments

Made

1

Eric Roath,

Michigan

Pharmacists

Association

An agent of a

licensed health

professional,

rather than the

health

The Board agrees R 338.507(1)

with the proposal and (2).

to permit

unlicensed staff

working with

professional

licensees to obtain

themselves, may consent and keep

obtain consent

and document

proof of consent in

the patient’s

consent according medical record.

to proposed However, the

subrules (1) and Board prefers to

(2) – (i.e. a

pharmacy

keep “health

professional” and

technician or an add “or delegate of

unlicensed the health

pharmacy clerk). professional.” The

The commenter Department

proposed

agrees.

changing “health

professional” in

R 338.507(1) and

(2) to

“pharmacist,

pharmacy

technician, or

agent of the

pharmacist.”

MCL 24.242 and 24.245

Agency Report to JCAR-Page 4

2

Eric Roath,

Michigan

Pharmacists

Association

Entities that

provide CE or

certificate

The Board and

Department agree

with the comment.

R 338.581

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 (e.g.

the APhA

Immunization

Certification

Program).

The commenter

recommended

adding “or

course” after

“entity”.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 5

Entities that

3

Eric Roath,

Michigan

Pharmacists

Association

The Board and

R 338.581b

provide training, Department agree

CE, or certificate with the comment.

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”.

4

Susan Davis,

Brittany

Stewart and

Lynette Moser,

Wayne State

University

Excessive referral The requirement R 338.581c

requirements:

Rule 81c

to refer the patient (b)(iii)

for a physical

mandating

referral for a

examination

cannot be

physical exam if completely

one hasn’t

eliminated because

occurred in 12

months is not

consistent with

MCL 333.17744g

mandates referrals

under certain

CDC guidance, circumstances.

which does not However, the

require a physical Board agreed that

before safely

initiating most

hormonal

the proposed rule

contained too

many referral

contraceptives.

requirements. The

According to the Board decided to

MCL 24.242 and 24.245

Agency Report to JCAR-Page 6

CDC, the goals of remove R

the 338.581c(b)(iii)

recommendations from the proposed

are to remove

unnecessary

rule because

referrals for

medical barriers patients who do

to accessing and not receive a

using

contraception and not mandatory

to support under MCL

providing person- 333.17744g. The

prescription are

centered

Department

agrees.

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.”

MCL 24.242 and 24.245

Agency Report to JCAR-Page 7

5

Eric Roath,

Michigan

Pharmacists

Association

The commenter Because the

proposed

modifications

including adding stricken, this

second sentence paragraph was

R 338.581c

former R 338.581 (b)(iv)

(c)(iii) was

stating that a

prescription

renumbered as R

338.581c(b)(iii).

receipt or note in The Board and

an electronic Department agree

health record or that the written

pharmacy

record may

management

system shall be

sufficient to

include electronic

records. The

commenter’s

comply with this sentence was

subrule. The rewritten to use

commenter wrote simpler language

this change

would

accomplish the

goals of the

proposed

and to include all

types of electronic

records.

language while

recognizing the

realities of

current workflow

and health

communication

practices.

6

Eric Roath,

Michigan

Pharmacists

Association

The commenter The Board and

proposed simpler Department agree (b)(v)

language. with the comment.

R 338.581c

14.Date report completed:

12/2/2025

MCL 24.242 and 24.245