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:

2022-8 LR

Title of proposed rule set:

Pharmacy-General Rules

3. Purpose for the proposed rules and background:

The purpose of the Pharmacy – General Rules is to encompass all the necessary requirements for

licensing and regulating the practice for pharmacists, pharmacies, manufacturers, wholesale

distributors, and wholesale distributor-brokers. The rules include parts for general provisions,

pharmacist licenses, pharmacy licenses, manufacturer licenses, wholesale distributor licenses,

wholesale distributor-broker licenses, and the practice of pharmacy.

The purpose of the proposed rules is to: implement section 17744f of the Public Health Code (Code),

MCL 333.17744f, regarding dispensing emergency supplies of insulin, pursuant to PA 36 of 2021;

clarify the internship requirements; clarify the regulations regarding compounding accreditation,

inspections, and applicable standards; update rules affected by any other modified Code provisions or

federal regulations; review refill requirements; review the professional and technical equipment and

supply requirements; review licensure requirements including the necessity of the Multistate

Pharmacy Jurisprudence Examination; review the need for telehealth regulations; and update

definitions.

4. Summary of proposed rules:

MCL 24.242 and 24.245

Agency Report to JCAR-Page 2

The proposed rules will be modified as follows: except for disciplinary inspections, inspections at the

direction of the department will not involve purchasing data, other than shipment data and the current

and historical selling price of the drug, or some research data; applicants will only be able to submit

intern hours that are acquired through an educational program, under the personal charge of a

preceptor, through a preapproved unconventional internship, or through an educational program

outside of the United States; graduates of programs outside of the United States will be able to submit

up to 1400 hours earned in an educational program experience if the hours are not completed through

an approved educational program or under the person charge of a preceptor licensed in this state;

preceptors in an educational program will not have to submit annual affidavits of hours; applicants for

licensure by endorsement will no longer have to take the MPJE and instead will submit knowledge of

the laws and rules affidavit; a PIC or facility manager who is unable to fulfill their duties for 120

consecutive days will appoint a new PIC or facility manager; an out-of-state pharmacy that will not

compound sterile pharmaceutical products in this state may submit an inspection from NABP-VPP or

a resident state board of pharmacy; an in-state pharmacy that will compound sterile pharmaceutical

products will have a two-step inspection process that requires an inspection from the department and,

within 6 months, an inspection to assess USP compliance or accreditation; a pharmacy that dispenses

drugs will have a sink with running water, a refrigerator for drugs, and a telephone; a manufacturer

will have the option of submitting an inspection from the FDA, the manufacturer’s resident state

board of pharmacy, or NABP drug distributor accreditation; a pharmacy intern who provides final

product verification will record both the initials of the intern and supervising pharmacist; a pharmacy

may locate an automated device as an extension of a pharmacy in additional locations with

limitations; a pharmacy may locate a non-dispensing storage and pick-up device on the premises of

the pharmacy; and a pharmacist may dispense an emergency supply of insulin.

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

publication dates:

The Flint Journal: April 30, 2023.

The Grand Rapids Press: April 30, 2023.

The Mining Journal: May 16, 2023.

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

6/1/2023

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

6/2/2023 09:00 AM at Location: G. Mennen Williams Building Auditorium , 525 W. Ottawa Street,

Lansing, Michigan

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=1367

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

Andria Ditschman, Departmental Specialist, Bureau of Professional Licensing.

Stephanie Wysack, Departmental Technician, Bureau of Professional Licensing.

10. Persons submitting comments of support:

There were no comments submitted of support.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 3

11. Persons submitting comments of opposition:

The following individuals submitted comments in opposition with suggested changes:

Douglas Apple, Ascension Michigan; Rose Baran; Todd Belding, Sparrow; Ryan Bickel, Ascension

Borgess;Gary Blake; Randy Burke; Alisha Cottrell, Ascension Michigan; Michelle Dehoorne; Deeb

Eid, CVS Health; Rony Foumia; Denise Frank, Gates Healthcare Associates, Inc.; Mark Guzzardo;

Lisa Herz; Lee King, Sparrow Health System; Bradley McCloskey, University Compounding

Pharmacy; David Medina; Jasmine Mehta; David Miller, Keystone Pharmacy; Jessica Morris; Eric

Roath, Michigan Pharmacists Association; Colleen Ryan; Renee Smiddy, Michigan Health &

Hospital Association; Jamie Tharp, Pharmacy-Compounding Compliance, University of Michigan

Health; Jeffrey Thomas, Ascension Rx; Chad Whitefield, University Compounding Pharmacy; and

Maria Young, University Pharmacy.

12. Persons submitting other comments:

There were no other comments submitted in addition to those mentioned above.

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

public comment period:

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

Baran

There is no rule The Board agrees R 338.486

338.588c in this that 338.588c is

rule set or the

not the correct rule

current rule set. citation and R

Delete 338.588c. 338.486(4)(d)

should be

modified to

specify R

338.588b.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 4

2

Baran

Individual in this The Board agrees R 338.501(1)

section (x) should with the comment (w)

be changed to

“person”.

that “individual”

should be changed

to “person” as a

virtual

manufacturer may

be a company.

Subdivision (x) in

the draft that went

to public hearing

defined “virtual

manufacturer” but

due to

renumbering in the

draft due to other

changes, “virtual

manufacturer” is

now (w).

3

Baran

Rule 338.7004

requires an

individual

The Board agrees R 338.513(6)

to add “and rule

338.7004” to

applying for

licensure or

clarify for

applicants that

registration under they must attend

article 15 of the the implicit bias

code, MCL

333.16101 to

333.18838,

training to receive

an educational

limited license.

except those

seeking to be

licensed under

part 188 of the

code to obtain

Implicit Bias

Training.

Add at the end of

(6): and rule

338.7004.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 5

4

Morris

Remove adoption The Board agrees R 338.519(2),

of MPJE. with the comments (3), (5) and

to remove

(8)

adoption of the

MPJE as the

requirements to

take the MPJE is

being deleted in

the rules.

Removing the

adoption of the

MPJE in section

(2) results in:

deleting section

(2), (5), and (8);

renumbering the

sections in the

rule; and making

additional changes

to the language in

section (3).

MCL 24.242 and 24.245

Agency Report to JCAR-Page 6

5

Morris

Remove the

MPJE

requirement.

The Board agrees R 338.521(2)

with the comments (f)

to remove the

MPJE requirement

for the reasons

stated in the

comments.

For consistency

with the licensure

by endorsement

rule, where the

Board has

proposed deletion

of passing the

MPJE and instead

is requiring an

attestation from

the applicant, this

same requirement

should be added to

this rule if the

MPJE requirement

is deleted.

Because the

will be deleted

based on another

comment, a new

subdivision (2)(f)

will be added

requiring the

applicant to

submit an

attestation to the

department that

the applicant has

sufficient

knowledge of the

code and the

board’s rules to

competently

practice pharmacy

in this state.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 7

6

Ryan

Allow licensure The Board agrees R 338.521

by examination with the comment

by new grads

with a score

transfer even

to allow initial

licensure by score

transfer if the

though they may applicant has been

be licensed in

another state.

licensed in another

state for 1 year or

less. Therefore, (2)

(a) and (2)(a)(iii)

must be modified

to allow score

transfer as an

option.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 8

7

Morris

Delete MPJE

requirement.

The Board agrees R 338.525

with the comments

to remove the

MPJE requirement

for the reasons

stated in the

comments.

For consistency

with section (4) of

this rule and other

licensure rules,

where the Board

has proposed

deletion of passing

the MPJE and

instead is

requiring an

attestation from

the applicant, this

same requirement

should be added to

this rule if the

MPJE requirement

is deleted.

Subdivision (1)(e)

will be modified to

require the

applicant to

submit an

attestation to the

department that

the applicant has

sufficient

knowledge of the

code and the

board’s rules to

competently

practice pharmacy

in this state

MCL 24.242 and 24.245

Agency Report to JCAR-Page 9

8

Young

Delete reference Although the

R 338.521(2)

to English

comment refers to (f) and R

language

requirement as

R 338.525(1)(f)

and (4)(g), it is

338.523(2)(g)

this should only clear from the

be required with content of the

initial licensure. rules and the

comment that the

comment is

intended to

address R 338.521

(2)(f) and R

338.523(2)(g)

concerning the

English language

requirement.

The Board agrees

to delete the

English language

requirement as it is

only required for

initial licensure.

9

Young

Apple

Adopt updated

versions of USP recommends

with the

exception of

flavoring.

The Board

R 338.533(1)

adopting the 2023

version of 795 and

797 with the

exception of

flavoring.

The Board agrees R 338.533(1)

to remove the

10

Remove “not

limited to.”

language “ not

limited to.”

MCL 24.242 and 24.245

Agency Report to JCAR-Page 10

11

Tharp

USP no longer

provides free

copies of

The Board agrees R 338.533(2)

that the rule

should state that

compounding

chapters.

there is a cost

associated with

Pharmacies and obtaining the USP

licensees must

purchase or

and that the

Department can’t

subscribe to USP provide copies to

to gain access the the public as

chapters.

pharmacies and

licensees must

purchase or

subscribe to USP

to gain access to

the chapters.

12

Tharp

The use of the

phrase “current

The Board agrees R 338.533(3)

with the comment

standards” is in to delete the

conflict with the language that

proposed fixed

references

versions of USP “current

being proposed in standards” as well

subrule (1) of this as “applicable”

rule.

and instead will

refer to the

standards adopted

above in the same

rule.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 11

13

Tharp

Consider aligning The Board agrees R 338.533(4)

this standard with with the comment and (5)

the Sterile

Compounding

Pharmacy

that there is a need

for a two-step

process for

Licensing

licensing

requirement in R outsourcing

338.534a (2), An facilities that

applicant for an practice in this

in-state pharmacy state. Therefore,

license that

intends to

the two-step

process suggested

compound sterile in the comments is

pharmaceutical

products shall

adopted in (5).

complete both of The changes in (5)

the following:

(a) Obtain an

that apply to only

outsourcing

inspection from facilities located in

the department or this state, requires

its designee for

the purpose of

meeting R

changing (4) to

apply to out-of-

state outsourcing

facilities. This

338.536 and R

338.537 for initial change

licensure.

differentiates

(b) Within 6

months after

between the

process for an in-

initial licensure state facility,

under this

which needs a two

subrule, a

pharmacy shall

obtain, and

provide to the

department, a

subsequent

-step process, and

an out-of-state

facility, which

does not require

the two-step

process.

inspection to

assess adherence

to cGMP.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 12

14

Tharp

Recommend that The Board agrees R 338.533(6)

revisions to with the comment (b)

cGMP standards to delete the year

be allowed for

outsourcing

facilities.

in the citation and

simply adopt the

current version.

Suggest deleting

a fixed reference

date (year) to

cGMP standards:

(b) Compound

drugs pursuant to

current good

manufacturing

practices for

finished

pharmaceuticals

set forth in 21

CFR 211.1 to

211.208.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 13

15

Young

Update (1)(b):

Most recent

printed, and or

unabridged

The Board agrees R 338.537(1)

that the language (b)

should be updated

to include

computerized

versions of the

Michigan

“unabridged

computerized

versions” of

pharmacy laws

reference

and rules, plus at materials, and

least 2

comprehensive

pharmaceutical

include “or other

information

necessary for the

reference text(s). delivery of safe

Which will

encompass the

and effective

practice of

general practice pharmacy”.

of pharmacy that

pertains to

pharmacology,

drug interactions,

drug

composition, or

other information

necessary for the

delivery of safe

and effective

practice of

pharmacy.

16

Foumia

Pharmacies are

The Board agrees R 338.538(1)

now allowed to with the comment

print and

that the license

download copies does not need to

of their pharmacy be returned to the

licenses. I don't Department.

think it is

necessary to have

closed

pharmacies return

these licenses as

many times they

are not even

originally printed

by the

department.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 14

17

Baran

It places a burden The Board agrees R 338.583a

on pharmacies

that sell non-

with the comment (1)

to delete non-

prescription drugs prescription.

that it doesn’t

place on other

retailers that sell

non-prescription

drugs that are not

a pharmacy. It

doesn’t require

the retailer to

keep the records

for non-

prescription drugs

as it does the

pharmacy. This

will increase cost

for pharmacies.

Delete “and non-

prescription”

from (1).

MCL 24.242 and 24.245

Agency Report to JCAR-Page 15

Additionally, The Board agrees R 338.588a

18

Roath

MPA advocates with the comment (1)(b)

for removing the to allow an

limitation

prohibiting a

automated device

at a remote

remote pharmacy pharmacy if

from operating an consistent with the

automated device Code.

in subsection (1)

(b). If a

pharmacist is

available, as

required by

subsection (1)(c),

and a pharmacist

may be available

for real-time

consult in

subsection (1)(f),

then a remote

pharmacy should

be permitted to

operate an

automated

device. Further,

the added safety

features

implemented by

an automated

device stocked

and maintained

by a pharmacist

will enhance the

safe delivery of

medications in a

remote pharmacy.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 16

19

Smiddy

The MHA

suggests

The Board agrees R 338.588a

with the comment (1)(c)-(h)

combining (f) and to combine (f) and

(c) subsections. (c) to simplify the

rule.

Combining (c) and

(f) resulted in the

revision of (d)

through (g) and

the removal of (h).

20

Eid

We recommend The Board agrees R 338.588a

simplifying (2)

by adding the

with the comments (2) and (2)(a)

to simplify the and (2)(b)

word “inside of” provision as

after “device” as suggested by Eid.

shown below and

deleting the word The changes

“on”, along with require deletion of

letter (b) for

clarity and

“pharmacy meets

both of the

simplification.

following:” from

subrule (2) and

“(a) The". Then,

the remaining

language from (2)

(a) was

incorporated into

subrule (2).

21

Smiddy

The suggested

modifications

The Board agrees R 338.588b

with the comments (1), (1)(a),

attempt to reduce to simplify the

confusion related rule.

if the pharmacist

is the default

and (1)(b)

standard for

stocking the

automated

device, since

there is not an

explicit language

referencing

stocking by a

pharmacist.

Above statements

reference

MCL 24.242 and 24.245

Agency Report to JCAR-Page 17

‘controlled by a

pharmacy’, not

controlled by a

pharmacist.

In her written

statement, Ms.

Smiddy

suggested

revising R

338.588b as

follows: (1) An

automated device

used by staff to

administer store

medications to

registered

patients intended

for patient

administration in

any hospital,

county medical

care facility,

nursing home,

hospice, or

another skilled

nursing facility,

as defined in

section 20109(4)

of the code, MCL

333.20109, must

comply with all

of the following:

(a) The

automated device

must be supplied

stocked,

maintained, and

controlled by a

pharmacy that is

licensed in this

state.

(b) If a

pharmacist

delegates the

stocking of the

MCL 24.242 and 24.245

Agency Report to JCAR-Page 18

automated device

is performed by

non pharmacist

personnel, then

technologies must

be in place and

utilized to ensure

that the correct

drugs are stocked

in their

appropriate

assignment

utilizing bar-

coding or another

board-approved

error-prevention

technology that

complies with R

338.3154.

22

Baran

Add to (5)

“Pharmacist

The Board agrees R 338.589(5)

that there are

delegation of

acts, tasks, or

situations in

addition to R

functions shall be 338.486 where a

in compliance

pharmacist

must comply with delegates without

section 16215 of personal charge

the code, MCL

and those rule and

333.16215, and code sections

be under the

should be added to

personal charge this rule.

of the delegating

pharmacist,

except as

provided in R

338.486 and

17742b of the

code MCL

333.17742b.”

MCL 24.242 and 24.245

Agency Report to JCAR-Page 19

MPA

23

Roath

The Board agrees R 338.591

recommends the to add the

addition of

language to

clarify that

although an

emergency

proposed language

to (1)(c).

Subdivision (c)

was revised as a

supply of insulin result of Mr.

may only be

dispensed once

per qualified

Roath’s comment,

but a new

subdivision wasn’t

prescription, this added.

does not change

the ability of a

pharmacy to issue

three such

emergency

supplies per

patient per year

(MCL

333.17744f (2)).

24

Young

Add ability for

the licensed

Pharmacist to

The Board agrees R 338.589

that a pharmacist

may access a

access pharmacy pharmacy database

database from

home or other

and other

necessary

remote location databases that a

for remote order pharmacist uses

entry verification with the added

including

security to protect

the confidentiality

and integrity of a

patient’s protected

health

performing a

drug regimen

review. If the

pharmacy

establishes

controls to

protect the

privacy and

security of

confidential

records.

information.

Subrule (7) was

added in response

to Ms. Young’s

statement.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 20

25

Morris

Delete MPJE

definition if

The Board agrees R 338.501(1)

to delete the

(q)-(x)

delete the MPJE requirement to

M. Morris’

as a requirement. take the MPJE in comments to

R 338.519, R

338.521, and R

338,523 in

delete the

MPJE

requirement

as noted in

response to

comments about this JCAR

deleting this

requirement as

Report results

in deleting the

noted later in this MPJE

JCAR Report

Therefore, the

reference to the

MPJE in the

definition in

R 338.501.

definitions should

be deleted.

14.Date report completed:

10/31/2023

MCL 24.242 and 24.245