Michigan Office of Administrative Hearings and Rules

611 W. Ottawa Street

Lansing, MI 48909

Phone: 517-335-8658 Fax: 517-335-9512

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:

Andria Ditschman

Phone number of person completing this form:

517-290-3361

E-mail of person completing this form:

DitschmanA@michigan.gov

Name of Department Regulatory Affairs Officer reviewing this form:

Elizabeth Arasim

2. Rule Set Information

MOAHR assigned rule set number:

2020-128 LR

Title of proposed rule set:

Pharmacy - General Rules

3. Purpose for the proposed rules and background:

MCL 24.242 and 24.245

Agency Report to JCAR-Page 2

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.

4. Summary of proposed rules:

The proposed revisions to the rules will: require preceptors to report internship hours; require an

applicant who has failed the NAPLEX or the MPJE to review the material in a preparation course or

with an instructor; clarify that an applicant who has completed the FPGEC certification has met the

English proficiency requirement; allow an applicant for licensure by endorsement to obtain a license

in this state if he or she either holds a license in another state or holds a license in Canada and meets

additional requirements; add requirements for relicensure; establish the requirements for a remote

pharmacy license; provide a waiver process from the 10 mile requirement for remote pharmacies;

require any pharmacy that will provide sterile compounding in this state to submit an onsite physical

inspection and report completed no more than 18 months before the application; clarify that a

pharmacy that starts or resumes sterile compounding must apply to the Department and submit the

required inspection report; require a pharmacy, manufacturer, wholesale distributor, and wholesale

distributor-broker that is closing to maintain records; clarify the process for renewal versus

relicensure; add the requirements for a facility manager for a manufacturer; adopt the federal

exclusions to the definition of wholesale distribution; add the licensure and record keeping

requirements for a wholesale distributor-broker; reduce the time from 3 years to 2 years before a

prescription may be electronically duplicated; provide the requirements for electronic transmission of

prescriptions; provide the process for a waiver from the mandate to electronically transmit a

prescription; and clarify that if final product verification is delegated, then both the pharmacist and

technician must record their initials.

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

publication dates:

Marquette Mining Journal – August 31, 2021; Flint Journal – August 31, 2021; Grand Rapids Press –

August 31, 2021

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

9/15/2021

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

MCL 24.242 and 24.245

Agency Report to JCAR-Page 3

9/21/2021 01:00 PM at 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=1254

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

Kerry Przybylo, Manager; Andria Ditschman, Senior Policy Analyst; and LeAnn Payne, Board

Support.

10. Persons submitting comments of support:

Deeb D. Eid, PharmD, RPh, Advisor, Pharmacy Regulatory Affairs, CVS Health submitted a

comment in support.

11. Persons submitting comments of opposition:

The following persons sent comments in writing:

Rose M. Baran, PharmD

Deeb D. Eid, PharmD, RPh, Advisor, Pharmacy Regulatory Affairs, CVS Health

Charlie Mollien

Julie L. Novak, Chief Executive Officer, Michigan State Medical Society (MSMS)

Jon Pritchett, PharmD., RPh., BCSCP, Pharmacy Program Director, Accreditation Commission for

Health Care (ACHC)

Brian Sapita, Director of Government Affairs, Michigan Pharmacists Association (MPA)

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

public comment period:

Name &

Comments made at Written

Agency Rationale Rule number

Organization public hearing

Comments

for change

& citation

changed

1

Mollien

“Written” is used The Board agrees R 338.501(1)

throughout the

rules without a

with the comment (l)

that the term

definition. Add a “written” should

definition making be added to the

it clear that

“written” allows clarification that

for paper or the term allows for

definitions with

electronic forms. paper or electronic

forms.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 4

2

Sapita/MPA

Regarding R

338.505

The Board agrees R 338.505(2)

with the comment

subsection 2

that subrules (1)

which specifies and (2) are

“prelicensure

inspection”.

inconsistent with

the addition of

Subsection 1

references both

applicants and

license holders

“prelicensure” in

(2) and, therefore,

“prelicensure”

should be deleted

but subsection 2 as in the original

now excludes

inspections of

language, and

additional

license holders. language should

We suggest

removing this

language and

keeping the

be added to (2),

“Inspections in

provision (1) must

not extend to any

original language. of the following

information,

however, the

information is

subject to a

disciplinary

investigation.”

MCL 24.242 and 24.245

Agency Report to JCAR-Page 5

Add “and The Board agrees R 338.531a

3

Eid/CVS

Health

explanation” and with the comment (2)(b)

“or otherwise not to modify (b) as it

readily available will ensure the

to patients” to (b) Department/Board

to strengthen the has a clearer

outcome of the

rule.

understanding of

the services that

will be offered

rather than just a

“list”.

The addition of

“or otherwise not

readily available

to patients” to 2(b)

ensures the

application is

inclusive of

services that may

not be readily

available to

patients currently.

The Board agrees R 338.534(3)

4

Pritchett/ACHC

Requiring an

inspection within with the comment

18 months of

application

presents a

that the rule

should be

modified to allow

problem with the for virtual

previously

inspections by

approved PCAB deleting “onsite”

process.

Accreditations

and “physical”

from (a) as a

with ACHC are virtual inspection

provided on a 36- can cover the same

month cycle,

issues as an in-

which aligns with person inspection

accreditation

programs

with the bulk of

the inspection

provided in other being conducted

areas of the

healthcare

by review of

documents.

industry as well

as requirements The Board agrees

issued by the

Centers for

that a pharmacy

that has been

Medicare and

accredited should

MCL 24.242 and 24.245

Agency Report to JCAR-Page 6

Medicaid

not have to submit

Services (CMS). an inspection

A survey occurs within 18 months

prior to each new before the date of

accreditation

cycle, thus a

survey roughly

an application.

The Board will

add the following

every 36 months. language to (3)

This creates a

misalignment

with the

“unless accredited

by a national

accrediting

Michigan

organization,

licensure

schedule of

recognized by the

board, an … .

renewal every 2

years; some

pharmacies,

depending on

where they are in

their accreditation

cycle, will not be

scheduled for a

survey within the

18 months

preceding

renewal of their

licensure. ACHC

requests that the

rule be returned

to requiring either

evidence on a

current

accreditation or a

physical

inspection and

corresponding

report completed

within 18 months

of application.

We would also

like to see

clarification

about acceptance

of the use of

virtual surveys

during a public

MCL 24.242 and 24.245

Agency Report to JCAR-Page 7

health emergency,

as the issues

surrounding

COVID-19

appear to be

ongoing.

5

Mollien

Clarify if the

FDA certification comment to delete (h)

requirement is

In response to the R 338.563(2)

(h), add “if

necessary and if it required by the

is necessary

FDA” to the rule.

whether it should

only apply to

distributions of

blood and blood

products.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 8

6

Mollien

Add “board” to To address the

(6). safety concern in and (8)

These rules create the comment, the

a significant Board adds the

public health and proposed language

R 338.569(6)

safety gap that

allows

introduction of

counterfeit

to (6) and as (8)

requires additional

record

requirements, (8)

medications into must be referenced

the closed

in (6).

distribution

supply chain. To

close this gap,

clarify in this rule

that any

purchasing

pharmacy using a

wholesale

distributor-broker

to facilitate a

transaction from

a pharmacy not

licensed in

Michigan shall

request the

transaction

history,

transaction

statement, or

transaction

information for

the drugs

supplied.

7

Mollien

The rules are

missing the

The Board agrees R 338.583a

with the comment

record retention that for

requirements

applicable to

pharmacies

consistency with

the controlled

substances rules, a

rule regarding

related to non-

control drug and pharmacy

device acquisition acquisition and

and distribution distribution

records.

ADD

records should be

added.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 9

Pharmacy

Acquisition and

Distribution

Records

(1) A pharmacy

must keep and

make available

for inspection all

acquisition and

distribution

records for

prescription and

non-prescription

drugs and

devices, such as

invoices, packing

slips or receipts,

for 5 years. All

records, which

may be

electronic, must

be readily

retrievable within

48 hours.

(2) Acquisition

and distribution

records must

include the

following

information:

(a) The source of

the prescription

drugs or devices,

including the

name and

principal address

of the seller or

transferor and the

address from

which the

prescription drugs

or devices were

shipped.

(b) The identity

and quantity of

the prescription

MCL 24.242 and 24.245

Agency Report to JCAR-Page 10

drugs or devices

received, if

applicable, and

distributed or

disposed of.

(c) The dates of

receipt, if

applicable, and

distribution of the

prescription drugs

or devices.

8

Baran

Change 338.584 The Board will

R 338.584(1)

(g)

(1)(g) to “Issue

date of the

replace

“dispensed” with

“issued.”

Novak/MSMS

prescription.”

The prescriber

will not know the

date the

prescription was

dispensed when

issuing a

prescription.

Align the

Pharmacy

9

Mollien

CMS waiver is

automatic state

R 338.584a

(4)(a)

General rule with waiver/Section (4)

the CS rule

regarding

electronic

transmission of

prescriptions.

(a):

The Code requires

that if a CMS

waiver is granted

then the

Department shall

also grant a

waiver. Subrule

(4) will be

modified to allow

for a waiver

without meeting

other requirements

if the CMS waiver

has been granted.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 11

10

Novak/MSMS

Amend to

recognize the

The rule will

recognize the

R 338.584a

(3)

exceptions to the exceptions to

mandate by electronic

adding, “unless transmissions

an exception

under section

17754 of the

Code, MCL

333.17754a,

applies, …”

permitted by MCL

333.17754a.

11

Novak/MSMS

Recommends the The Public Health R 338.584a

effective dates Code mandates (1) and (3)

between the rules electronic

sets and the Code transmission of

be consistent.

prescriptions as of

October 1, 2021

but requires that

the Department

delay the

implementation

date of the

mandate to the

date established by

the Federal

Centers for

Medicare and

Medicaid Services

for electronic

transmission of

prescription for

controlled

substances.

Therefore, the

effective/enforced

date will be the

date the mandate

is enforced by the

Federal Centers

for Medicare and

Medicaid

Services.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 12

12

Novak/MSMS

Identify examples Exceptional

of qualifying

“exceptional

R 338.584a

circumstances will (4)(b)(iii)

be further clarified

circumstances” as by adding

follows:

circumstances

(iii) The

suggested in (B)

and (C). However,

(A) will not be

added as this basis

is really a claim

for economic

prescriber

demonstrates

attests to

exceptional

circumstances

including, but not hardship, which is

limited to, the

following:

already in the rule.

A. Prescribing

fewer than “X”

The rule will read

prescriptions per “The prescriber

year.

demonstrates by

attesting to

exceptional

circumstances

including, but not

limited to, the

B. Intention to

cease practice

within the next

twelve months.

C. Limited

practice due to an following: …”

illness or other

unforeseen event.

Clarify that the

prescriber may

declare or

formally certify

in writing such as

with an

attestation as to

the exceptional

circumstances,

instead of using

the word

“demonstrate.”

MCL 24.242 and 24.245

Agency Report to JCAR-Page 13

We believe the

13

Sapita/MPA

“On site” will be R 338.587(4)

(e)

use of “on site” is deleted in (e).

confusing since

after 2 years the

prescription

information can

be kept

electronically. We

suggest that “on

site” be removed

from this

subsection

entirely.

14

Eid/CVS

Health

Add in clarifying The comment will R 338.588(3)

language to allow be added as it

for use of

automated

clarifies that a

pharmacy may use

devices as patient an automated

pick-up options device within the

within the

premises of a

licensed

pharmacy. The

following changes

also need to be

pharmacy. Add made: delete “and

this language: A if a pharmacy is

secured, lockable, closed;” add

and privacy

enabled

“only” and “non-

controlled;” and

automated device modify “used” to

located on the

premise of the

licensed

“under control.”

pharmacy may be

utilized as a

means for

patient’s or an

agent of the

patient to pick up

prescription

medications when

and if a pharmacy

is closed.

13.Date report completed:

10/7/2021

MCL 24.242 and 24.245