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:

517-241-9255

E-mail of person completing this form:

DitschmanA@michigan.gov

Name of Department Regulatory Affairs Officer reviewing this form:

Deidre O'Berry

2. Rule Set Information

MOAHR assigned rule set number:

2018-39 LR

Title of proposed rule set:

Board of Pharmacy - General Rules

3. Purpose for the proposed rules and background:

MCL 24.242 and 24.245

Agency Report to JCAR-Page 2

The current Pharmacy – General Rules are incomplete, disorganized, and difficult to use. The draft

rules have been reorganized and substantially rewritten to provide for rules that encompass all the

necessary requirements for licensing and regulating the practice for pharmacists, pharmacies, and

manufacturers and wholesale distributors of drugs and devices. The draft rules include parts for

general provisions, pharmacist licenses, pharmacy licenses, manufacturer licenses, wholesale

distributor licenses, and the practice of pharmacy. Part 1 of the proposed pharmacy rules pertains to

definitions, resale of drugs and devices, and inspections of applicants and licensees. Part 2 of the

proposed pharmacy rules pertains to licensure of pharmacists. This part includes the rules pertaining

to training for identifying victims of human trafficking, educational limited licenses, internship

requirements, preceptor licenses, examinations, pharmacist licensure by examination and

endorsement, and relicensure. Part 3 of the proposed pharmacy rules pertains to pharmacy licenses.

This part includes the application requirements for pharmacies, sterile compounding services and the

adoption by reference of standards that apply to these services, inspections, discontinuance and

resumption of sterile compounding services, housing of a pharmacy, professional and technical

equipment and supplies, closure of a pharmacy, and relicensure. Part 4 of the proposed pharmacy

rules pertains to a manufacturer license. This part includes licensure requirements for manufacturers

of drugs and devices, persons to whom drugs or devices may be sold, adoption by reference of a

federal regulation on good manufacturing practices for finished pharmaceuticals, closure of a

manufacturer, and relicensure. Part 5 of the proposed pharmacy rules pertains to a wholesale

distributor license. This part includes the determination of a pharmacy as a wholesale distributor, the

licensure requirements for wholesale distributors of drugs and devices, persons to whom drugs or

devices may be sold, wholesale distributor practices, recordkeeping and policy requirements for

wholesale distributors, facility requirements, examination of drugs and devices, closure of a

wholesale distributor, and relicensure. Part 6 of the proposed pharmacy rules pertains to the practice

of pharmacy. This part includes pharmacy services by medical institutions, prescription drug labeling

and dispensing, prescription drug receipts, noncontrolled prescriptions, a customized patient

medication packages, prescription records, prescription refill records, automated devices, professional

responsibility of a pharmacist, and a hospice emergency drug box.

4. Summary of proposed rules:

The current Pharmacy – General Rules will be substantially rewritten and reorganized to provide for

rules that encompass all the necessary requirements for licensing and regulating the practice for

pharmacists, interns, preceptors, pharmacies, manufacturers, and wholesale distributors. The

proposed revisions modify the parts pertaining to general provisions, pharmacist licenses, pharmacy

licenses, manufacturer licenses, wholesale distributor licenses, and the practice of pharmacy.

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

publication dates:

Marquette Mining Journal – September 18, 2019; Flint Journal – September 19, 2019; Grand Rapids

Press – September 19, 2019.

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

10/4/2019

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

10/4/2019 09:00 AM at G. Mennen Williams Building - Auditorium , 525 W. Ottawa Street, Lansing,

MI

MCL 24.242 and 24.245

Agency Report to JCAR-Page 3

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=56

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

Kerry Przybylo, Manager; Andria Ditschman, Senior Policy Analyst; Weston MacIntosh, Senior

Policy Analyst; Dena Marks, Senior Policy Analyst; Kimberly Catlin, Board Support; LeAnn Payne,

Board Support; and Stephanie Wysack, Board Support.

10. Persons submitting comments of support:

There were no comments in support.

11. Persons submitting comments of opposition:

The following persons submitted public comments: Rose M. Baran, PharmD, MA, Assistant

Professor, College of Pharmacy, Ferris State University; Alyssa R. Baskerville, PharmD Candidate;

Adam Carlson, Senior Director, Government & Political Affairs, Michigan Health & Hospital

Association (MHA); Thomas R. Clark, RPh, MHS, BCGP, Senior Director, Board of Pharmacy

Specialties (bps); Maher Daman, PharmD, Ferris State University; Deeb D. Eid, PharmD, Assistant

Profession, Ferris State University; Justin Kuhns, PharmD, Lab Director, Portage Pharmacy; Joel

Kurzman, Director, State Government Affairs, National Association of Chain Drug Stores (NACDS);

Bradley McCloskey, PharmD, President/CEO; Neal Mehta, Pharm D; Ned Milenkovich, PharmD, JD,

Much Shelist, P.C.; Joseph C. Osborne, PharmD, Candidate, Ferris State University; Scott Popyk,

Health Dimensions/member MPA and International Academy of Compound Pharmacists; Eric Roath,

PharmD, MBA, Clinical Care Coordinator, SpartanNash; Brian Sapita, Government Affairs Manager,

Michigan Pharmacists Association (MPA); Tom Sullivan, Michigan Surgical Hospital and Insight for

Neurosurgery and Neurological Sciences; Larry Wagenknecht, Pharmacist, FMPA, FAPhA, Chief

Executive Officer, MPA; and Neal Watson, Member Liaison, National Association of Boards of

Pharmacy (NABP).

12. 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 4

Name &

Comments made at Written

Agency Rationale Rule number

Organization public hearing

Comments

for change

& citation

changed

1

Rose M. Baran

Removing “who The Board agrees R 338.486(3)

is on the

with the comments

to not remove

premises” does

not allow the

technicians to

remain in the

pharmacy

“who is on the

premises” as it

would negate the

original intent of

the provision to

working while

the pharmacist is allow the

at meeting in the pharmacist to be in

hospital or on the the hospital but

floor. This

not in the

negates the

pharmacy.

original intent to

allow the

pharmacist to be

in the hospital but

not in the

pharmacy and let

the technicians

remain to

continue drug

preparation for

the pharmacist

review. This

allows the

pharmacist of

small hospitals to

attend meetings

and other issues

outside of the

pharmacy but on

the hospital

premises. This

would enable

small hospitals to

stay open and

serve the public

health of the

community.

2

Ned

Milenkovich,

PharmD, JD,

USP has

indicated they

intend to classify to exclude

The Board agrees R 338.501(1)

with the comment (e)(iv)

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Agency Report to JCAR-Page 5

Much Shelist,

P.C.

all flavorings of flavoring agents as

conventionally

manufactured

medications as

nonsterile

an exception to the

compounding rule

as long as there is

no other product

manipulation.

compounding.

Fourteen state

boards of

pharmacy have

language on their

books excluding

flavoring from

the definition of

compounding.

The request is to

implement a

regulation

excepting the safe

administration of

flavorings added

to conventionally

manufactured

medications from

the definition of

compounding.

The Board can

achieve this by

narrowing the use

of flavoring

agents to

conventionally

manufactured and

commercially

available liquid

medications and

by setting

conditions to

ensure safe

administration of

flavorings

(flavoring agents

must be

nonallergenic and

inert, not

exceeding 5% of

a drug product’s

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Agency Report to JCAR-Page 6

total volume).

3

Rose M. Baran

Add to this rule The Board agrees R 338.503(2)

the return of

drugs for a

with the comment (d)

to add the

manufacturer

recall that is

down to the

patient level or

language

recommended to

(d). The addition

of this language

when the wrong will allow the

medication was return of drugs in

dispensed to the 2 additional

patient. This then circumstances that

would align with are not currently in

21 CFR part

1317. Add: (d)

the rules, subject

to any controlled

The provisions of substances

subsection (1) exceptions or

shall not apply to limitations.

drugs returned

when the wrong

medication was

dispensed to the

patient or in the

instance of a drug

recall. In no

instance may

returned drugs be

reused or

returned to active

stock.

4

Brian Sapita,

Government

Affairs

Manager,

Michigan

The rule as

The Board agrees R 338.511(3)

written is not

consistent with

the continuing

education (CE)

with the comment

that the dates in

this rule and the

dates in the

Pharmacists

Association

(MPA)

rules – consider pharmacist CE

same verbiage.

rules should be

consistent.

5

6

Brian Sapita,

Government

Affairs

Remove “90

The Board agrees R 338.513(1)

days” and replace with the comment (a) and (2)(a)

with “180 days.” to replace “90

Ninety days is not days” with “180

Manager, MPA

enough time.

days” as more

time is necessary.

Brian Sapita,

Government

Replace with “An The Board agrees R 338.513(4)

educational with the comments

MCL 24.242 and 24.245

Agency Report to JCAR-Page 7

Affairs

limited licensee that the rules

Manager, MPA

And

must engage in

the practice of

should be clarified

to indicate that a

Eric Roath,

PharmD, MBA,

Clinical Care

Coordinator,

SpartanNash

pharmacy under licensee may

the supervision of engage in the

a pharmacist

preceptor as

practice of

pharmacy only

defined in section under the personal

17708(1) of the charge of a

code and only

under the

pharmacist.

However, if the

personal charge licensee wants to

of a pharmacist.” count the hours

In the context of towards the

the Proposed

Rule 13, this

required internship

they must also be

subrule seems to acting under a

require that an

educational

preceptor. The

Board does not

limited licensee agree with the

(pharmacy intern) specific proposed

only practice

changes in either

under the direct comment to (4).

personal

supervision of a

pharmacist

licensed as a

preceptor.

Previously, this

requirement only

extended to

pharmacy interns

working towards

the intern hours

required to obtain

their full

pharmacist

license. The

language, as

proposed, would

create a barrier

for pharmacy

interns seeking to

gain additional

experience

through paid

MCL 24.242 and 24.245

Agency Report to JCAR-Page 8

internships aside

from what is

required by their

academic

programs. Also,

this seems to

conflict with Rule

15 (3) which

creates provisions

for a pharmacy

intern to submit

hours that were

not conducted

under the

personal charge

of a preceptor

licensed in the

state. As such, we

recommend that

Rule 13, Subrule

(4) be removed

from the rules as

proposed.

7

8

Rose M. Baran

Need to add the The Board agrees R 338.513(6)

human trafficking with the comment

requirement.

to add the

requirement of the

human trafficking

training.

Adam Carlson,

Senior Director,

Government &

Political

Under the

“Practice of

Pharmacy”

The Board agrees R 338.519(4)

with the comment

to modify (4) to

Section, the new “within 3

Affairs,

North American attempts” not 1

Michigan

Health &

Pharmacist

Licensure

attempt, as

requiring

Hospital

Examination

retraining after

Association

(MHA)

(NAPLEX) and only 1 attempt is

Michigan

too strict.

Multistate

Pharmacy

Jurisprudence

Examination

The Board also

has added (8) to

separate the MPJE

(MPJE) passing test from the

requirements

raised some

NAPLEX which

allows an

MCL 24.242 and 24.245

Agency Report to JCAR-Page 9

apprehension

among hospital

membership.

applicant that fails

the MPJE more

than 5 times to

While we respect take a pharmacy

the proposal to

safeguard

law course. The

commenter

competent

pharmacists to

enter the

suggested that the

applicant

satisfactorily

workforce, the

MHA wants to

complete courses.

The Board agrees

ensure qualified that for the MPJE

candidates are not repeating an entire

inadvertently

program would

vetted out. Other not be the most

variables,

including

beneficial to

passing an

education, prior examination on

employment,

internships,

rules and the law.

residencies and

skills which are

valuable to

hospitals are not

defined by exams

alone.

Additionally, one

day of poor

performance

during a test can

happen, and

students deserve

another try before

they are required

to provide

satisfactorily

completed

courses

information to the

Board.

Modify to:

(4) If an applicant

for licensure fails

to pass either of

these

examinations

MCL 24.242 and 24.245

Agency Report to JCAR-Page 10

within 3 attempts,

he or she shall

provide the

board, after the

third failed

attempt and prior

to retesting,

certification from

an approved

education

program

certifying that he

or she

satisfactorily

completed

courses that

provide a

thorough review

of the area or

areas that he or

she failed in the

most recent

examination.

This section as

9

Rose M. Baran

The Board agrees R 338.519(7)

currently written to delete the

would require the reference to the

applicant to foreign pharmacy

completely redo graduate

the pharmacy

degree yet a

equivalency

examination

foreign graduate certification

would not have to program, as a

do so.

foreign graduate

should be held to

the same standard

if they are failing

the examinations.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 11

10

Adam Carlson,

Senior Director,

Government &

Political

Remove

“Canadian

council for

The Board agrees R 338.521(2)

with the comment (i)

to delete the

accreditation of reference to the

Affairs, MHA

And Brian

pharmacy

programs.” The for Accreditation

Canadian Council

Sapita,

Canadian

of Pharmacy

Government

Affairs

Manager, MPA

Healthcare

System is

significantly

Programs as it is

not equivalent to

Accreditation

different than that Council of

of the United Pharmacy

States and should Education

be removed from (ACPE).

the rules. Under

the “Pharmacist

licensure by

examination”

section, it is

important to note

that Canadian

Council for

Accreditation of

Pharmacy

Programs uses

different criteria

than the

Accreditation

Council for

Pharmacy

Education.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 12

11

Neal Watson,

Member

Mirror the license The Board agrees R 338.523(2)

by exam rules to with the suggested (a)

Liaison,

National

require the

Foreign

change to require

passing the

Association of

Boards of

Pharmacy

(NABP)

Pharmacy

Graduate

examination and

obtaining the

FPGEC certificate

from NABP.

Examination

CommitteeTM

(FPGEC®) under

the License by

Endorsement as

follows:

That he or she

has successfully

passed the

foreign pharmacy

graduate

equivalency

examination

administered by

the National

Association of

Boards of

Pharmacy

(NABP) Foreign

Pharmacy

Graduate

Examination

Committee, 1600

Feehanville Dr.,

Mount Prospect,

IL 60056,

https://nabp.phar

macy/programs/f

pgec/

AND:

A foreign

pharmacy

graduate

examination

committee

certificate

administered by

the NABP.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 13

12

Deeb D. Eid,

PharmD,

Assistant

Profession,

Ferris State

University

The commenter The Board agrees R 338.525(1)

asked how CE with the comment (d) and (4)(d)

requirements will to clarify that

(1)(e) and (4)

(e)

be handled in

processing

relicensure will

not be granted

applications for until the

relicensure as continuing

well as requesting education

that the 1-time

trainings be

required.

requirements are

met, and that to

meet relicensure

an applicant must

meet the 1-time

training

requirements.

13

14

Rose M. Baran

Add USP Chapter The Board agrees R 338.531(4)

797 for with adding USP

consistency with 797 for

Rule 338.533(1). consistency.

Delete “and 800”. The Board agrees R 338.531(4)

with the comments

Justin Kuhns,

PharmD, Lab

Director,

to delete USP 800

Portage

from the rule until

Pharmacy

it is published in

the compendium.

15

Eric Roath,

The adoption of Pursuant to the

R 338.531(2)

(g) and (i)

PharmD, MBA,

Clinical Care

Coordinator,

SpartanNash

these reference

standards in

commenter’s

concern, it is

conjunction with necessary to delete

the clause in (4) “sterile” to clarify

(b) seems to

imply that the

standards are

that the rules apply

to both sterile and

non-sterile

only applicable to compounding.

pharmacies

providing

As the Board

compounding

agrees with the

services, though comments to R

this is not

338.532 and R

explicit.

338.533 to delete

the term “sterile”

as the rules should

regulate sterile and

Additionally,

some of the

guidance in the

standards extend non-sterile

to practices

beyond

compounding, for

consistency,

MCL 24.242 and 24.245

Agency Report to JCAR-Page 14

compounding and “sterile” will also

it is unclear as to be deleted from R

whether

338.531.

pharmacies

operating under

the purview of

these standards

would be

required to

comply with the

full reference

standard, or just

the areas that

apply to

compounding

practices.

Additionally,

recent comments

at the NABP

Annual meeting

by a USP

representative

suggest that the

USP’s intent

regarding general

chapter 800

indicate that this

guidance was

intended to apply

to compounding

activities only. To

provide

additional

clarification, we

recommend that

Rule 31, Subrule

(4)(b) be

modified to read:

“A pharmacy that

provides

compounding

services shall

comply with all

standards adopted

in subrule (4) of

this rule as they

MCL 24.242 and 24.245

Agency Report to JCAR-Page 15

apply to

compounding

services as

defined in

Michigan law.”

16

Justin Kuhns,

PharmD, Lab

Director,

Portage

Pharmacy

The commenter The Board agrees R 338.532(1)

has requested to with the comment

delete the term

“sterile.”

to delete the term

“sterile” from R

338.532 and R

338.533, as both

rules should

regulate sterile and

non-sterile

compounding. For

consistency

“sterile” will also

be deleted from R

338.531.

17

Deeb D. Eid,

PharmD,

Assistant

Profession,

Ferris State

University

The commenter The Board agrees R 338.532(3)

asked that the with the comment (e) and (f)

rules clarify how that the results of a

often an pharmacy

inspection should inspection should

be submitted and be required to be

whether the

shared with the

Department and

does not agree that

the rule should

include a set

expiration date of

a certain amount

of years for

details of the

inspection are

required to be

shared with the

Department.

accreditation

approvals. The

inspection entity

should submit the

length of their

accreditation

approvals with

their application as

an approval entity.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 16

18

Justin Kuhns,

PharmD, Lab

Director,

Portage

Pharmacy

The commenter The Board agrees R 338.533(3),

has requested to with the comment (4), (6)(c), (6)

delete the term

“sterile.”

to delete the term (e)

“sterile” from R

338.532 and R

338.533, as the

rules should

regulate sterile and

non-sterile

compounding. For

consistency

“sterile” will also

be deleted from R

338.531.

19

Justin Kuhns,

PharmD, Lab

Director,

The commenter The Board agrees R 338.533(4)

suggested the

following

with further

expanding the

Portage

Pharmacy

language for (4): term distributes”

An outsourcing to “dispenses,

facility located in provides,

this state or that distributes, or

dispenses,

otherwise

provides,

furnishes.”

distributes, or

otherwise

furnishes sterile

compounded

pharmaceuticals

in this state must

shall be inspected

and registered as

an outsourcing

facility by the

United States

Food and Drug

Administration

(FDA) prior to

applying for a

pharmacy license

in this state.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 17

20

Justin Kuhns,

PharmD, Lab

Director,

The commenter The Board agrees R 338.533(5)

requested the

deletion of (5)

with the comment

that only the FDA

Portage

which allows an should inspect an

Pharmacy

outsourcing

facility to

undergo an

outsourcing

facility that

handles

inspection by the compounded

board or a third pharmaceuticals in

party recognized this state which is

by the board

instead of only

the FDA

providing the

inspections.

registered as an

outsourcing

facility by the

FDA and,

therefore, deletes

(5).

21

22

Rose M. Baran

The commenter The Board accepts R 338.533(6)

requested to

reference the

Federal Food,

Drug, and

Cosmetic Act

503B(10) and

rule 338.582.

the comment to

reference R

338.582 and

patient specific

drugs to the rule.

(d)

Justin Kuhns,

PharmD, Lab

Director,

The commenter The Rules

R 338.533(8)

requested this

language be

added, “An

Committee agrees

with adding the

language to (10).

Portage

Pharmacy

outsourcing

facility may

compound drugs

using bulk drug

substances that

appear on a list

established by the

Secretary

identifying bulk

drug substances

for which there is

a clinical need.”

MCL 24.242 and 24.245

Agency Report to JCAR-Page 18

23

Brian Sapita,

Government

Affairs

Remove “the

NABP-VPP”

replace with “a

The Board agrees R 338.534

with the comment

to replace the

Manager, MPA

board approved existing language

accrediting

with “a board

organization.”

approved

accrediting

organization”

instead of listing

each organization

in the rule as the

rule would require

modification every

time a change was

made.

24

Justin Kuhns,

PharmD, Lab

Director,

Portage

Pharmacy

Add “or

The Board agrees R 338 535(1)

with the proposed

change as it

clarifies that an

outsourcing

facility must

notify the

Department if it

ceases to provide

sterile

outsourcing

facility” to (1):

“A sterile

compounding

pharmacy or

outsourcing

facility … .”

compounding.

The Board agrees R 338.535(4)

with the proposed

25

Justin Kuhns,

PharmD, Lab

Director,

Add the

following:

“An outsourcing change to clarify

facility shall not that an

Portage

Pharmacy

resume providing outsourcing

sterile

facility must

notify the

Department if it

desires to resume

sterile

compounding

services in this

state until the

outsourcing

facility is

compounding.

approved by the

department and

verifies that it is

compliant by an

organization

satisfying the

requirements of R

338.533(4-10).”

MCL 24.242 and 24.245

Agency Report to JCAR-Page 19

MPA believes The Board agrees R 338.551(4)

26

Brian Sapita,

Government

Affairs

that R 338.493a that prior R

(3), proposed R 338.493a(3),

Manager, MPA

338.561(b),

should not be

deleted and

proposed R

338.561(b), should

not be deleted

should read, “if entirely from the

the total number rules. However,

of dosage units of the Board moves

all prescription

drugs that are

prepared or

R 338.561(b) to R

338.551(4) as the

provision applies

compounded by a to a manufacturer

pharmacy for

license not

resale,

wholesale license.

compounding, or

dispensing by

another person, as

defined in section

1106 of the code,

during any

consecutive 12-

month period is

more than 5% of

the total number

of dosage units of

prescription drugs

prepared by the

pharmacy during

the 12-month

period, then the

pharmacy is a

manufacturer as

defined in section

17706(1) of the

code.”

MCL 24.242 and 24.245

Agency Report to JCAR-Page 20

Delete (b)

27

Rose M. Baran

The Board does

R 338.561(b)

entirely as (b) is not agree with

in violation of

333.17748a(7)

and the Drug

Quality and

deleting (b) from

the rules, but

instead

recommends

Security Act

section 503A.

moving (b) to R

338.551(4) as it

applies to a

manufacturer

license and clarify

(a) to make it

consistent with the

Drug Quality and

Security Act.

28

Rose M. Baran

Delete “or the

reference

"G.Eq.,"

"generic," or

"generic

The Board agrees R 338.582(3)

with the comment

to delete "G.Eq.,"

"generic," or

"generic

equivalent" in the equivalent" in the

case of multi-

ingredient

case of multi-

ingredient

products” from

products” from the

the rule. The rule rule, but does not

was created agree with

before computer deleting the rule in

software was its entirety as the

standard practice use of generic

in pharmacy over needs to be

30 years ago.

disclosed if being

This terminology used.

is no longer used

on prescription

labels because

computers made

it obsolete.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 21

29

Rose M. Baran

Change the first The Board agrees R 338.585(2)

sentence to: “A with the comment (b)

CPMP must be as it clarifies the

accompanied by provision.

any mandated

patient

information

required under

federal law.”

This would cover

any medication

guides required.

30

31

Brian Sapita,

Government

Affairs

Manager, MPA

Eric Roath,

Subrule (2)

should be

Subrule (2) will be R 338.587(6)

added back in as it

included in this was deleted by

section. error.

Statutory changes The Board agrees R 338.588(2)

PharmD, MBA,

Clinical Care

Coordinator,

SpartanNash

that have

occurred since

the original rules language “a

regarding the use pharmacy, or at the

with the comment

to add the

of automated

devices in

healthcare

same physical

address as the

pharmacy

settings, as well provided that the

as the addition of location of the

Subrule (2)(h) in device is owned

these proposed

and operated by

rules, creates the the same legal

potential for

automated

entity as the

pharmacy.”

devices to be

used in locations

outside a

pharmacy but at

the same physical

address of the

pharmacy.

However, this is

currently limited

only to hospital

settings. Given

that hospital

pharmacies do

not have any

differentiation in

MCL 24.242 and 24.245

Agency Report to JCAR-Page 22

license

classification and,

in some

circumstances,

have the ability to

operate as

outpatient

facilities, this

creates an

environment

where certain

outpatient

pharmacies are

able to use these

devices in

capacities that are

denied to

pharmacies in the

community

practice setting.

To address this

discrepancy, we

recommend that

Rule 88, Subrule

(2)(a) be

modified to read

“a pharmacy, or

at the same

physical address

as the pharmacy

provided that the

location of the

device is owned

and operated by

the same legal

entity as the

pharmacy.”

32

Eric Roath,

The current

definition

“automated

device” in the

Michigan Public with a change of

Health Code and the term “patient”

The Board agrees R 338.588(3)

with the comment

from Roath as this

PharmD, MBA,

Clinical Care

Coordinator,

SpartanNash

is current practice

in the rules as

proposed

to “ultimate user.”

encompasses

MCL 24.242 and 24.245

Agency Report to JCAR-Page 23

several devices

that may be used

in workflow for

tasks other than

the delivery of a

medication to

patient or other

healthcare

provider (e.g.,

counting

machines and

packaging

devices operated

by pharmacy staff

as part of the

dispensing

process). We feel

that to register

each of these

devices with the

department goes

beyond the intent

of the Board and

the Department

and will cause

devices that do

not require

department

oversight to be

erroneously

registered with

the Department.

To correct this,

we recommend

that Rule 88,

Subrule (3) be

modified to read:

“A pharmacy that

operates an

automated device

under this section

to deliver a drug

or device directly

to a patient or

other healthcare

provider shall

MCL 24.242 and 24.245

Agency Report to JCAR-Page 24

notify the

department of the

automated

device’s location

on a form

provided by the

department …”

33

Brian Sapita,

Government

Affairs

Remove “unless Although the

the prescriber’s Board does not

office is affiliate agree with the

R 338.588(4)

Manager, MPA

with a hospital

consisted with

commenter’s

suggestion to

section 17760 of delete MCL

code, MCL 333.17760

333.17760.” This because the

is not relevant to statutory provision

this section.

it an exception to

the rule, a

reference to (2)(h)

which details the

circumstances that

amount to the

exception, is being

added for

clarification.

34

Rose M. Baran

Rule 338.3154

The Board agrees R 338.588(5)

does not identify with the comment

what is “board- to delete the

approved error- reference to R

prevention

338.3154 for the

technology” and reasons noted by

refers back to rule the commenter.

338.490 which is

being rescinded

by the new draft

rules. 338.3154

and 338.490 go

around in a circle

without ever

defining “board-

approved error-

prevention

technology”.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 25

35

36

Brian Sapita,

Government

Affairs

Manager, MPA

Rose M. Baran

After “pharmacy” The Board agrees R 338.588(7)

add “or

with the comments (b)

to provision (7).

dispensing

prescriber.”

There is no

longer an

exception in R

338.486(3).

The Board does

not agree with the

comment that

R 338.589(5)

there is no longer

an exception in R

338.486.

However, as there

are multiple

exceptions in this

rule there is a

typographical

error and the (3)

should be deleted.

The Board agrees R 338.590

with the comment

37

Brian Sapita,

Government

Affairs

After

“prescriptions”

add issued by an to update the

Manager, MPA

appropriate

prescriber” and

remove “of the

attending

language.

physician.”

13.Date report completed:

7/22/2020

MCL 24.242 and 24.245