Subject: Ascension Michigan Comment Letter

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Attachments:

Administrative Rules for Pharmacy-General Rules Comment Letter.pdf ;

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Hi Andria,

Please let me know if this works for you.

Thanks!

Alisha

--

Alisha Cottrell

Chief Advocacy Officer

Ascension Michigan

110 W. Michigan Ave., Suite 1000 | Lansing, MI 48933

Office: 517-482-1422

Mobile: 517-392-5304

Executive Assistant: Laurie Piekarski

Ascension Michigan

Administration - Corporate Services Building

ascension.org/Michigan

T: (586) 753-0662

Located in Eastern Time Zone

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Archived: Thursday, June 22, 2023 11:36:11 AM

Sent: Friday, June 2, 2023 1:06:22 PM

Subject: FW: Administrative Rules for Pharmacy-General Rules Comment Letter

Response requested: No

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Hi Andria,

Please see below.

From: Alisha Cottrell <alisha.cottrell@ascension.org>

Sent: Friday, June 2, 2023 12:11 PM

To: BPL-BoardSupport <BPL-BoardSupport@michigan.gov>

Cc: Jeffrey Thomas <jeffrey.thomas@ascension.org>; Gary Blake <gary.blake@ascension.org>; Douglas Apple

<douglas.apple@ascension.org>

Subject: Administrative Rules for Pharmacy-General Rules Comment Letter

CAUTION: This is an External email. Please send suspicious emails to abuse@michigan.gov

Dear Department Specialist:

Please see the attached letter submitted on behalf of Ascension Michigan as our official comment letter for the

Administrative Rules for Pharmacy-General Rules. Thank you for your time and consideration in this matter.

Sincerely,

Alisha

--

Admini s tr a tive Rules for Pharmacy-General Rule s ...

Alisha Cottrell

Chief Advocacy Officer

Ascension Michigan

110 W. Michigan Ave., Suite 1000 | Lansing, MI 48933

Office: 517-482-1422

Mobile: 517-392-5304

Executive Assistant: Laurie Piekarski

Ascension Michigan

Administration - Corporate Services Building

ascension.org/M i c higan

T: (586) 753-0662

Located in Eastern Time Zone

CONFIDENTIALITY NOTICE:

This email message and any accompanying data or files is confidential and may contain privileged

information intended only for the named recipient(s). If you are not the intended recipient(s), you are

hereby notified that the dissemination, distribution, and or copying of this message is strictly prohibited.

If you receive this message in error, or are not the named recipient(s), please notify the sender at the

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immediately. Receipt by anyone other than the named recipient(s) is not a waiver of any attorney-

client, work product, or other applicable privilege.

®

This message was secured byZix .

Archived: Thursday, June 22, 2023 11:27:38 AM

From: Alisha Cottrell

Sent: Tuesday, June 6, 2023 10:10:33 AM

Subject: Ascension Michigan Comment Letter

Sensitivity: Normal

Attachments:

Administrative Rules for Pharmacy-General Rules Comment Letter.pdf ;

CAUTION: This is an External email. Please send suspicious emails to abuse@michigan.gov

Hi Andria,

Please let me know if this works for you.

Thanks!

Alisha

--

Alisha Cottrell

Chief Advocacy Officer

Ascension Michigan

110 W. Michigan Ave., Suite 1000 | Lansing, MI 48933

Office: 517-482-1422

Mobile: 517-392-5304

Executive Assistant: Laurie Piekarski

Ascension Michigan

Administration - Corporate Services Building

ascension.org/Michigan

T: (586) 753-0662

Located in Eastern Time Zone

CONFIDENTIALITY NOTICE:

This email message and any accompanying data or files is confidential and may contain

privileged information intended only for the named recipient(s). If you are not the intended

recipient(s), you are hereby notified that the dissemination, distribution, and or copying of

this message is strictly prohibited. If you receive this message in error, or are not the named

recipient(s), please notify the sender at the email address above, delete this email from

your computer, and destroy any copies in any form immediately. Receipt by anyone other

than the named recipient(s) is not a waiver of any attorney-client, work product, or other

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June 2, 2023

Department of Licensing and Regulatory Affairs

Bureau of Professional Licensing

Administrative Rules for Pharmacy-General Rules

2022-8 LR

Submitted via BPL-BoardSupport@michigan.gov

Dear Department Specialist:

Thank you for the opportunity to provide comments on the proposed changes to the

Administrative Rules for Pharmacy-General Rules. Ascension Michigan has the following

concerns identiﬁed below.

R 338.533 Compounding standards and requirements; outsourcing facilities;

requirements.

Rule 33. (1) The board approves and adopts by reference the compounding standards of the

United States Pharmacopeia (USP), published by the United States Pharmacopeial Convention,

12601 Twinbrook Parkway, Rockville, Maryland, 20852-1790. This includes, but is not limited to,

USP Chapters 795 (revised 2014) and 797 (revised 2008).

(2) The standards adopted by reference in subrule (1) of this rule are available at no cost at

http://www.usp.org/compounding, or at a cost of 10 cents per page from the Board of

Pharmacy, Bureau of Professional Licensing, Michigan Department of Licensing and Regulatory

Affairs, Ottawa Building, 611 West Ottawa, P.O. Box 30670, Lansing, Michigan, 48909.

(3) A pharmacy that provides compounding services shall comply with all applicable current

standards adopted in subrule (1) of this rule.

(4) An outsourcing facility located in this state or that dispenses, provides, distributes, or

otherwise furnishes compounded pharmaceuticals in this state shall must be inspected and

registered as an outsourcing facility by the United States Food and Drug Administration (FDA)

prior to before applying for a pharmacy license in this state.

Suggestion: Delete the phrase “not limited to” and remove the reference to chapter version

dates from USP 795 and 797. Update this section to adopt “current compendial chapters of

USP 795 and 797”.

Rationale: It is anticipated that other regulatory and accrediting bodies (e.g. Joint Commission)

will utilize the revised USP standards when evaluating Michigan pharmacies. This would result

in state licensed pharmacies having to adopt the strict requirements in the updated chapters

without realizing any of the corresponding beneﬁts (e.g. extended BUDs) and leading to

increased operational costs and waste. Also, the new standards are more in alignment with the

FDA deﬁnition of compounding. For multi-state health-systems (like Ascension) attempting to

standardize practice, state-speciﬁc compounding policies and metrics would need to be

established for MI sites. Also, for MI pharmacies licensed outside of the state (e.g. home

infusion), other states may not accept sterile products from MI pharmacies, which would result

in a loss of business. Most recognized training programs (e.g. ASHP) will update their training

and resources to reﬂect current USP standards, which will result in confusion for pharmacists

licensed in the state of Michigan and both in-state and out-of-state pharmacy

students/residents being trained at MI facilities.

R 338.591 Dispensing emergency supply of insulin.

Rule 91. (1) A pharmacist may dispense an emergency supply of insulin to an individual if the

pharmacist complies with all of the following:

(a) The requirements in section 17744f of the code, MCL 333.17744f.

(b) An emergency supply of insulin may only be dispensed from a pharmacy with real time

access to the qualiﬁed prescription for insulin.

(c) Only 1 emergency supply, as that term is deﬁned in MCL 333.17744f, may be dispensed per

qualiﬁed prescription.0

(2) If the smallest single package of insulin available exceeds a 30-day supply, dispensing the

package of insulin that is available complies with this rule and section 17744f of the code, MCL

333.17744f.

Suggestion: Change to also include insulin analogs

Rationale: Since many patients are prescribed insulin analogs (e.g. lispro, as part), adding this

language would clarify that the emergency supply also pertains to these agents.

Again, thank you for your time and consideration. Should you have any further questions or

concerns, please contact me at (586) 753-1120 or douglas.apple@ascension.org.

Sincerely,

Douglas J. Apple, MD, MS, FHM

Chief Clinical Oﬃcer, Ascension Michigan

Archived: Thursday, June 22, 2023 11:45:58 AM

Sent: Wednesday, May 31, 2023 9:24:49 AM

Subject: FW: Comments on Pharmacy General Rules (MOAHR #2022-8 LR)

Response requested: No

Sensitivity: Normal

Attachments:

PharmacyGeneralRulesComment.docx ;

From: Rose M Baran <RoseBaran@ferris.edu>

Sent: Wednesday, May 31, 2023 9:11 AM

To: BPL-BoardSupport <BPL-BoardSupport@michigan.gov>

Subject: Comments on Pharmacy General Rules (MOAHR #2022-8 LR)

CAUTION: This is an External email. Please send suspicious emails to abuse@michigan.gov

Attention: Departmental Specialist

Please find attached comments on the Pharmacy General Rules (MOAHR #2022-8 LR) for the public hearing on these Rules

scheduled for June 2, 2023 at 9:00 AM.

Sincerely,

Rose Baran Pharm.D.

Rose Baran

This email message and any attachments are for the confidential use of the intended recipient. Please notify me if you have

received this message by mistake and delete this message and any attachments.

Comments on Administrative Rules for Pharmacy-General Rules

Rule Set 2022-8 LR

Rose Baran Pharm.D.

Rule 338.486

(d) Furnishing medications There is no rule 338.588c in

for administration to this rule set or the current rule

Issue

Suggested change

Delete 338.588c.

registered patients under R set.

338.588 and 338.588c.

Delegating the stocking of an

automated device.

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.

Rule 338.501

Issue

Suggested change

Individual in this section (x)

should be changed to

“person”.

(x)(k) “Virtual manufacturer” Individual means a natural

means an individual person

who engages in the

person (333.1105(1)) while

person is defined in

manufacture of prescription

333.1106(4) as “(4) "Person"

drugs or devices and meets all means an individual,

of the following:

(i) Owns either of the

following:

(A) The new prescription

drug application or

partnership, cooperative,

association, private

corporation, personal

representative, receiver,

trustee, assignee, or other

abbreviated new prescription legal entity. Person does not

drug application number.

(B) The unique device

identification number, as

available, for a prescription

device.

(ii) Contracts with a

contract manufacturing

organization for the physical

manufacture of the drugs or

devices.

include a governmental entity

unless specifically provided.”

Using individual would

restrict this to only a natural

person and would not allow a

partnership, cooperative,

association, private

corporation, personal

representative, receiver,

trustee, assignee, or other

legal entity to be a virtual

manufacturer.

(iii) Is not involved in the

physical manufacture of the

drugs or devices.

1

(iv) At no time takes

physical possession of or

stores the drugs or devices.

(v) Sells or offers for sale

to other individuals persons,

for resale, compounding, or

dispensing of, drugs or

devices, salable on

prescription only.

Rule 338.511

Issue

Suggested change

Rule 338.511 lacks a time

period the licensee needs to

hold the documentation of

completing the training for

identifying the victims of

human trafficking.

The current status of this rule Add (3) A licensee or

would mean the licensee

would have to retain

registrant shall retain

documentation of meeting the

documentation for as long as requirements of this rule for a

they are licensed in Michigan. period of 6 years after the

date of applying for licensure,

registration, or renewal.

Rule 338.513

Issue

Suggested change

Add at the end of (6) and rule

338.7004

(6) An applicant for an

educational limited license

shall meet the requirements

of R 338.511.

Rule 338.7004 requires an

individual applying for

licensure or registration under

article 15 of the code, MCL

333.16101 to 333.18838,

except those seeking to be

licensed under part 188 of the

code to obtain Implicit Bias

Training.

Rule 338.517

Issue

Suggested change

In (3)(b) and (3)(c) it quotes

rule 338.501(ju).

(u) is the definition for PIC,

perhaps the u should be v the

definition for practical

experience.

Change the u to v

Rule 338.523

Issue

Suggested change

338.523(2)(b) Pass the MPJE A pharmacist needs

Leave the language as is in

338.523(2)(b) Pass the MPJE

as required under R 338.519.

as required under R

knowledge of both state and

338.519Provide an

federal regulations to

attestation to the

competently practice in this

state as identified in the

department that the

applicant has sufficient

knowledge of the code and

the board’s rules to

competently practice

pharmacy in this state.

competency statements of the

MPJE exam. This would

allow an applicant who failed

the Michigan MPJE to obtain

a license in another state and

then by endorsement get

licensed in Michigan if they

attest to the department that

2

they have sufficient

knowledge of the code and

the board’s rules even though

they failed the MPJE. Also,

there is no attestation here

that the applicant is attesting

to sufficient knowledge of the

laws of the United States

Code and Code of Federal

Regulations relevant to the

practice of pharmacy.

Rule 338.525(4)

Issue

Suggested change

(f) Examination: retake and

pass the MPJE as provided in knowledge of both state and

R 338.519519Provide 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.

Rule 338.532

A pharmacist needs

Add this to 338.525(4)(f)

Must also attest to sufficient

knowledge of the laws of the

United States Code and Code

of Federal Regulations

federal regulations to

competently practice in this

state as identified in the

competency statements of the relevant to the practice of

MPJE exam.

pharmacy.

Issue

Suggested change

(5) The board may rescind

approval of an organization

upon just cause. The

Need timely notice when the Add to 338.532(5) (a) If the

board the rescinds approval

of a sterile compounding

Board rescinds approval, the

Board must indicate on the

rescission will not

accrediting organization. This website that it has, with an

immediately affect the

compliance of a pharmacy

using the accreditation.

Within 12 months of after the obtain accreditation from an

rescission date or by the next approved organization.

licensure renewal date,

will give notice to the

pharmacies involved so they

may plan accordingly to

effective date.

(b) If the Board rescinds

approval the accrediting

organization or inspection

entity must notify the

pharmacies involved.

whichever is later, the

accreditation is void, and a

pharmacy shall obtain

accreditation or an inspection

from an organization that

satisfies subrule (1) of this

rule.

Rule 338.537

Issue

Suggested change

(2) In addition to subrule

(1) of this rule, a pharmacy regarding the sink as

that dispenses drugs shall proposed a bucket could be

maintain, at a minimum, all used to collect the effluent

of the following equipment: draining from the sink.

The rule needs clarification

Change (2) to: (2) In addition

to subrule (1) of this rule, a

pharmacy that dispenses

drugs shall maintain, at a

3

(a) A sink with running

water.

(b) A refrigerator for the

exclusive use of prescription pharmaceuticals, including

drugs. Personal or food

items must not be stored in counter drugs. Vaccine

Most pharmacies now have

frozen vaccines in inventory

as well as refrigerated

minimum, all of the following

equipment:

(a) A functioning sink of

adequate capacity, connected

both prescription and over the to running cold and hot

water, with sanitary drainage.

the

storage practice standards are (b) A purpose-built or

refrigerator. Refrigeration given by the Centers for

pharmaceutical-grade unit

designed to either refrigerate

must be capable of

Disease Control (CDC) as

maintaining temperature

within a range compatible

with the proper storage of

drugs requiring

well as Michigan Department or freeze, if frozen drugs are

of Health and Human

in the pharmacies inventory.

Personal or food items must

not be stored in the

Service, Division of

Immunization.

refrigeration or

Telephone needs further

clarification. Is the phone

requirement a separate land

line with the capacity to

accept fax prescriptions, or

can it be a cell phone that is

carried by the pharmacist?

refrigerator or freezer. The

units must be capable of

maintaining temperature

within a range compatible

with the proper storage of

drugs requiring refrigeration

or freezing. Temperatures

freezing. Temperatures

must be monitored at all

times for out-of-range

temperatures during

business closure.

(c) A telephone.

Should there be a requirement must be monitored at all

for a type of telephone system times.

(VoIP system, PBX, or multi- (c) A telephone or telephone

line system).

system that is HIPAA

compliant for the exclusive

use of the pharmacy.

Suggested change

Rule 338.569

Issue

Rule lacks the requirement to Records required to be kept.

maintain information required

by the drug supply chain

Add to 338.569(1) a (d) All

information required under

the drug supply chain

security act, Public Law 113-

54.

security act.

Rule 338.583a(1)

Issue

Suggested change

(1) A pharmacy must shall

keep and make available for

It places a burden on

pharmacies that sell non-

Delete “and non-prescription”

from (1).

inspection all acquisition and prescription drugs that it

distribution records for

prescription and non-

doesn’t place on other

retailers that sell non-

prescription drugs and

devices, such asincluding

invoices, packing slips or

receipts, for 5 years. All

records, which may be

electronic, must be readily

retrievable within 48 hours.

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.

4

Rule 338.583a(1)

Issue

Suggested change

(1) A pharmacy must shall

keep and make available for

inspection all acquisition and substance rule 338.3153(k).

distribution records for

prescription and non-

prescription drugs and

devices, such asincluding

invoices, packing slips or

receipts, for 5 years. All

records, which may be

electronic, must be readily

retrievable within 48 hours.

Also, rule 383.583a conflicts

Change rule 338.583a(1) to

with the Pharmacy controlled read “Except for

prescriptions, aA pharmacy

The controlled substance rule must shall keep and make

states “Except for controlled

substance prescriptions

pursuant to subdivision (h) of records for prescription and

this rule, a licensee shall

maintain controlled

substances records for 2

years.” Also conflicts with

Rule 338.3154(5) “If a

controlled substance is

available for inspection all

acquisition and distribution

non-prescription drugs and

devices, such asincluding

invoices, packing slips or

receipts, for 2 5 years. All

records, which may be

electronic, must be readily

dispensed from an automated retrievable within 48 hours.

device, then documentation

of all of the following must

be maintained on-site in the

pharmacy responsible for the

automated device for 2 years

for review by the department,

an agency, or the board:” So

this would mean

noncontrolled acquisition and

distribution records would

have to be kept for 5 years

whereas controlled substance

records, other than

prescriptions need only be

retained for 2 years.” This

will cause confusion and

uncertainty.

Rule 338.588

Issue

Suggested change

Rule 338.588 states “(73)

Records and electronic data

kept maintained by

Rule 338.3154 states “(5) If a These two rules are

controlled substance is

inconsistent on how long to

dispensed from an automated maintain the records. Rule

automated devices must meet device, then documentation

338.3154 is undergoing

revision, recommend

changing the time period in

all of the following

of all of the following must

be maintained on-site in the

requirements:

(a) All events involving

access to the contents of the

automated devices must be

recorded electronically.

(b) Records must be

pharmacy responsible for the Rule 338.3154 to 5 years to

automated device for 2 years maintain consistency

for review by the department,

an agency, or the board:….”

maintained for 5 years by the

pharmacy or dispensing

5

prescriber and must be

retrievable on demand for

review by an agent of the

board. The records must

include all of the following

information:……..

These two rules are

inconsistent on how long to

maintain the records.

Rule 338.589

Issue

Suggested change

(5) “Pharmacist delegation of A technician at a remote

acts, tasks, or functions shall pharmacy is not under the

Add to (5) Pharmacist

delegation of acts, tasks, or

functions shall be in

be in compliance must

personal charge of a

comply with section 16215 of pharmacist.

the code, MCL 333.16215,

and be under the personal

charge of the delegating

pharmacist, except as

provided in R 338.486. A

pharmacist who that

delegates acts, tasks, or

functions to a licensed or

unlicensed individual person

shall do all of the

compliance must comply

with section 16215 of the

code, MCL 333.16215, and

be under the personal charge

of the delegating pharmacist,

except as provided in R

338.486 and 17742b of the

code MCL 333.17742b. A

pharmacist who that

delegates acts, tasks, or

functions to a licensed or

unlicensed individual person

shall do all of the

following:…..”

following:……..

Rule 338.591(1)(c)

Issue

Suggested change

Delete 0.

(c) Only 1 emergency

supply, as that term is

defined in MCL 333.17744f,

may be dispensed per

qualified prescription.0

Typo at end of sentence.

6

Archived: Thursday, June 22, 2023 11:32:28 AM

Sent: Friday, June 2, 2023 2:45:02 PM

Subject: FW: 23_Pharmacy proposed rules comment

Response requested: No

Sensitivity: Normal

Attachments:

23_Pharmacy proposed rules comment.docx ;

From: Belding, Todd <Todd.Belding@sparrow.org>

Sent: Friday, June 2, 2023 1:46 PM

To: BPL-BoardSupport <BPL-BoardSupport@michigan.gov>

Cc: Shaski, John <John.Shaski@sparrow.org>

Subject: FW: 23_Pharmacy proposed rules comment

CAUTION: This is an External email. Please send suspicious emails to abuse@michigan.gov

Pharmacy proposed rules comments

Todd Belding, PharmD.

Director of Pharmacy

Sparrow Health System

1215 E Michigan Ave.

Lansing, MI 48912

(517)253-2376

June 2, 2023

Michigan Department of Licensing and Regulatory Affairs

Bureau of Professional Licensing– Boards and Committees Section

Attention: Departmental Specialist

P.O. Box 30670

Lansing, MI 48909-8170

Submitted electronically to: BPL-BoardSupport@michigan.gov

Thank you for the opportunity to submit comments on the proposed revisions to the pharmacy

general rules.

Related to section R 338.533 Compounding standards and requirements; outsourcing

facilities.

The current rule mandates compliance with United States Pharmacopeia (USP) 795 and 797 to

versions revised in 2014 and 2008, respectively. We understand there is a new version of USP

effective November 2023. USP needed to update the chapters because there are inconsistencies

between the existing chapters and other chapters they have been updated. For example, we are

required to follow USP to handle hazardous medications and several conflicts exist between

chapters 800 and 797. The Joint Commission will require compliance with the new standards, and

it will be impossible to be compliant with both the old and the new standards simultaneously.

Related to section R 338.534a In-state initial pharmacy license inspections.

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. We believe the second inspection is

redundant as we are required to have all rooms and hoods certified semi-annually as well as

conducting monthly testing for surface growth. The standards for an IV room are far stricter than

other sterile areas, like surgery.

We appreciate this opportunity, and we appreciate revisions to the specific sections referenced.

Sincerely yours,

Todd Belding, PharmD

Director of Pharmacy

Archived: Thursday, June 22, 2023 11:36:49 AM

Sent: Friday, June 2, 2023 1:05:57 PM

Subject: FW: Comment on Proposed Revisions to Pharmacy General Rules

Response requested: No

Sensitivity: Normal

Attachments:

MI BOP Proposed Rule- Comment 6-1-23.pdf ;

Hi Andria,

Please see below.

From: Ryan Bickel <ryan.bickel@ascension.org>

Sent: Friday, June 2, 2023 12:58 PM

To: BPL-BoardSupport <BPL-BoardSupport@michigan.gov>

Cc: Ryan Bickel <rjbickel@hotmail.com>

Subject: Comment on Proposed Revisions to Pharmacy General Rules

CAUTION: This is an External email. Please send suspicious emails to abuse@michigan.gov

R yan.Bickel@Ascension.org

Departmental Specialist,

I have attached a letter, which shares my comments regarding one of the proposed changes to the Pharmacy General Rules.

Please let me know if you have any questions or wish to discuss this further.

Sincerely,

--

Ryan J. Bickel, Pharm.D., MHA, FASHP

Director, Pharmacy Services

Ascension Borgess

Ascension.org/Michigan

Phone: 269-226-6645

Fax: 269-226-8173

CONFIDENTIALITY NOTICE:

This email message and any accompanying data or files is confidential and may contain privileged

information intended only for the named recipient(s). If you are not the intended recipient(s), you are

hereby notified that the dissemination, distribution, and or copying of this message is strictly prohibited.

If you receive this message in error, or are not the named recipient(s), please notify the sender at the

email address above, delete this email from your computer, and destroy any copies in any form

immediately. Receipt by anyone other than the named recipient(s) is not a waiver of any attorney-

client, work product, or other applicable privilege.

®

This message was secured byZix .

June 2, 2023

Department of Licensing and Regulatory Affairs

Bureau of Professional Licensing– Boards and Committees Section

P.O. Box 30670 Lansing, MI 48909-8170

Dear Departmental Specialist,

Thank you for the opportunity to provide comments on the proposed change to the

Administrative Rules for Pharmacy - General Rules. As a Michigan-licensed Registered

Pharmacist, I have identified a couple of concerns below.

R 338.533 Compounding standards and requirements; outsourcing facilities;

requirements.

Rule 33. (1) The board approves and adopts by reference the compounding standards of

the United States Pharmacopeia (USP), published by the United States Pharmacopeial

Convention, 12601 Twinbrook Parkway, Rockville, Maryland, 20852-1790. This

includes, but is not limited to, USP Chapters 795 (revised 2014) and 797 (revised 2008).

(2) The standards adopted by reference in subrule (1) of this rule are available at no cost

at http://www.usp.org/compounding, or at a cost of 10 cents per page from the Board of

Pharmacy, Bureau of Professional Licensing, Michigan Department of Licensing and

Regulatory Affairs, Ottawa Building, 611 West Ottawa, P.O. Box 30670, Lansing,

Michigan, 48909.

Suggestion 1: Delete the phrase “not limited to” and remove the reference to chapter version

dates from USP 795 and 797 in subrule (1). Update this section to adopt “current compendial

chapters of USP Chapter 795 and 797.”

Rationale: It is anticipated that most regulatory and accrediting bodies (e.g. The Joint

Commission) will adopt the most current compendial chapters when evaluating Michigan

hospitals and pharmacies. This would result in state licensed pharmacies having to adopt the

strict requirements in the updated USP chapters without appreciating any of the benefits (e.g.

extended beyond use dating) and lead to increased operational costs and waste. This rule also

creates obstacles for MI pharmacies, who dispense medications to patients in neighboring

states, thus resulting in a loss of business. Conversely, some out-of-state pharmacies (e.g.

503B pharmacies) may not be able to send compounded medications to MI customers. This

may result in exacerbating medication shortages for health-systems and, potentially, adversely

impact patient care. Finally, most national professional pharmacy organizations (e.g. ASHP)

accept the current compendial standards of the USP and base their training programs on them,

which will result in confusion for pharmacists license in the State of Michigan and both in-state

and out-of-state pharmacy students and residents training at MI facilities.

Suggestion 2: Strike “at no cost” in subrule (2).

Rationale: The United States Pharmacopeia (USP) no longer provides copies of these

chapters for free of charge, as they have transitioned to an online platform.

Thank you for your time and consideration. Please feel free to contact me should you have any

further questions or concerns.

Sincerely,

Ryan J. Bickel, PharmD, MHA, FASHP

rjbickel@hotmail.com

C: (269) 303-1664

Archived: Thursday, June 22, 2023 11:34:04 AM

Sent: Friday, June 2, 2023 1:08:06 PM

Subject: FW: Comment on Proposed Revisions to Pharmacy General Rules

Response requested: No

Sensitivity: Normal

Hi Andria,

Please see below.

From: GARY BLAKE <gdb42@aol.com>

Sent: Friday, June 2, 2023 11:32 AM

To: BPL-BoardSupport <BPL-BoardSupport@michigan.gov>

Subject: Comment on Proposed Revisions to Pharmacy General Rules

CAUTION: This is an External email. Please send suspicious emails to abuse@michigan.gov

Department of Licensing and Regulatory Affairs

Bureau of Professional Licensing

Thank you for the opportunity to comment on the proposed revisions to the Pharmacy General Rules.

I would like to comment on 2 of the proposed rules changes:

Michigan BOP Proposed Revision

R 338.533 Compounding standards and requirements; outsourcing facilities;

requirements.

Rule 33. (1) The board approves and adopts by reference the compounding standards of the United States Pharmacopeia (USP),

published by the United States Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland, 20852-1790. This includes,

but is not limited to, USP Chapters 795 (revised2014) and 797 (revised2008).

(2) The standards adopted by reference in subrule (1) of this rule are available at no cost at http://www.usp.org/co m p ounding, or at a

cost of 10 cents per page fromthe Board of Pharmacy, Bureau of Professional Licensing, Michigan Department of Licensing and

Regulatory Affairs, Ottawa Building, 611 West Ottawa, P.O. Box30670, Lansing, Michigan, 48909.

(3) A pharmacy that provides compounding services shall comply with all applicable current standards adopted in subrule (1) of this rule.

(4) An outsourcing facility located in this state or that dispenses, provides, distributes, or otherwise

furnishes compounded pharmaceuticals in this state shall must be inspected and registered as an outsourcing facility by the United

States Food and Drug Administration (FDA) prior to before applying for a pharmacy license in this state.

Comment/Response

Suggestion: Delete the phrase “not limited to” and remove the reference to chapter version dates from USP 795 and 797. Update

this section to adopt “current compendial chapters of USP 795 and 797”.

Rationale: It is anticipated that other regulatory and accrediting bodies (e.g. Joint Commission) will utilize the revised USP

standards when evaluating Michigan pharmacies. This would result in state licensed pharmacies having to adopt the strict

requirements in the updated chapters without realizing any of the corresponding benefits (e.g. extended BUDs) and leading to

increased operational costs and waste. Also, the new standards are more in alignment with the FDA definition of compounding.

For multi-state health-systems (like Ascension) attempting to standardize practice, state-specific compounding policies and

metrics would need to be established for MI sites. Also, for MI pharmacies licensed outside of the state (e.g. home infusion),

other states may not accept sterile products from MI pharmacies, which would result in a loss of business. Most recognized

training programs (e.g. ASHP) will update their training and resources to reflect current USP standards, which will result in

confusion for pharmacists licensed in the state of Michigan and both in-state and out-of-state pharmacy students/residents being

trained at MI facilities.

Michigan BOP Proposed Revision

R 338.591 Dispensing emergency supply of insulin.

Rule 91. (1) A pharmacist may dispense an emergency supply of insulin to an individual if the pharmacist complies with all of the

following:

(a) The requirements in section 17744f of the code, MCL 333.17744f.

(b) An emergency supply of insulin may only be dispensedfrom a pharmacy with real time access to the qualifiedprescription for

insulin.

(c) Only 1 emergency supply, as that term is definedin MCL 333.17744f, may be dispensedper qualifiedprescription.0

(2) If the smallest single package of insulin available exceeds a 30-day supply, dispensing the package of insulin that is available

complies with this rule andsection 17744f of the code, MCL 333.17744f.

Comment/Response

Suggestion: Change to also include insulin analogs

Rationale: Since many patients are prescribed insulin analogs (e.g. lispro, aspart), adding this language would clarify that the

emergency supply also pertains to these agents.

Thank you, again, for the opportunity to comment.

Gary Blake, R.Ph.

Michigan Registered Pharmacist

Archived: Thursday, June 22, 2023 11:46:28 AM

Sent: Tuesday, May 30, 2023 7:05:11 AM

Subject: FW: Michigan Board of Pharmacy General Rules Public Comments

Response requested: No

Sensitivity: Normal

From: Randy Burke <burke.randy88@gmail.com>

Sent: Tuesday, May 30, 2023 7:00 AM

To: BPL-BoardSupport <BPL-BoardSupport@michigan.gov>

Subject: Michigan Board of Pharmacy General Rules Public Comments

CAUTION: This is an External email. Please send suspicious emails to abuse@michigan.gov

To: Michigan Board of Pharmacy Members

From: Randy Burke

Subject: Public Comments for MIPharmacy Rules

Dear MIBOP,

The rules Iam writing to comment publicly on are 338.519 (Rule 19) through 523 (Rule 23).

The main topic is to suggest removal of the MPJE law exam requirement from the rules governing pharmacy

licensure. I, along with many others in the state and outside of the state believe removing this exam would

simplify the licensing process and maintain patient safety.

Iwould like the Board to consider the following points to remove the MPJE requirement:

Schools of pharmacy are required to have a law course and students are required to memorize, practice,

and pass multiple assessments. This has been required for some time now in all states, including

Michigan.

Our technology has become so advanced and will continue to advance. Even programs such as ChatGPT

have shown the ability to pass standardized tests. Pharmacies have technology in place these days that

help with ensuring laws/rules are generally followed and pharmacists are healthcare professionals who are

held to a high standard. They can look things up in a split second as needed these days.

The exam is expensive and costs students who take on an average of $170,000 of debt for pharmacy

school yet another expense. NABP is really who profits and gets the financial gain from making students

take this meaningless test.

If NABP submits comments, there is a direct conflict of interest as they have financial gains from keeping

the test as a state requirement (so those should not be considered by the board to be fair).

Doctors, nurses, PAs, and almost all other healthcare professionals do not require a law exam to become

licensed. Why are they not held to the same "standard" if the exam is so important for patient safety and to

truly protect patients?

Even Colleges of Pharmacy are calling for removal of the law exam at the national conferences.

Furthermore, I would like to bring your attention to a published literature article titled "The Impact of

Jurisprudence Exams on Pharmacy Licensure and Patient Safety". The article underscores the need to reassess

the role of law exams in pharmacy licensure, focusing on competency assessment and meaningful measures of

patient care. It provides great examples of how a state like Idaho logically thought through the process and

provides rationale and level headed insights as to why.

In light of successful examples set by other states, such as Idaho and Vermont, which have removed the MPJE

requirement without compromising patient safety, I am asking the Michigan BOP to consider this change.

Thank you for your attention to this matter. I hope you will consider my points in your discussions, as well as

the insights provided by the literature.

Sincerely,

Randy

Archived: Thursday, June 22, 2023 11:30:27 AM

Sent: Monday, June 5, 2023 7:04:26 AM

To: Ditschman, Andria (LARA); BPL-BoardSupport

Subject: FW: feedback on the Administrative Rules for Pharmacy-General Rules.

Response requested: No

Sensitivity: Normal

From: Michelle Dehoorne <dehoornesmith@gmail.com>

Sent: Friday, June 2, 2023 4:57 PM

To: BPL-BoardSupport <BPL-BoardSupport@michigan.gov>

Subject: feedback on the Administrative Rules for Pharmacy-General Rules.

CAUTION: This is an External email. Please send suspicious emails to abuse@michigan.gov

June 2, 2023

Department of Licensing and Regulatory Affairs

Bureau of Professional Licensing

Administrative Rules for Pharmacy-General Rules

2022-8 LR

Submitted via BPL-BoardSupport@michigan.gov

Dear Department Specialist:

As a pharmacist who practices in the role of a Director at a hospital, I appreciate the opportunity to provide feedback on

the Administrative Rules for Pharmacy-General Rules. Thank you for the opportunity to provide comments on the

proposed changes.

1. R 338.533 Compounding standards and requirements; outsourcing facilities;

requirements.

Rule 33. (1) The board approves and adopts by reference the compounding standards of the

United States Pharmacopeia (USP), published by the United States Pharmacopeial Convention,

12601 Twinbrook Parkway, Rockville, Maryland, 20852-1790. This includes, but is not limited to,

USP Chapters 795 (revised 2014) and 797 (revised 2008).

(2) The standards adopted by reference in subrule (1) of this rule are available at no cost at

http://www.usp.org/compounding, or at a cost of 10 cents per page from the Board of

Pharmacy, Bureau of Professional Licensing, Michigan Department of Licensing and Regulatory

Affairs, Ottawa Building, 611 West Ottawa, P.O. Box 30670, Lansing, Michigan, 48909.

(3) A pharmacy that provides compounding services shall comply with all applicable current

standards adopted in subrule (1) of this rule.

(4) An outsourcing facility located in this state or that dispenses, provides, distributes, or

otherwise furnishes compounded pharmaceuticals in this state shall must be inspected and

registered as an outsourcing facility by the United States Food and Drug Administration (FDA)

prior to before applying for a pharmacy license in this state.

Recommedation:

Remove the phrase “not limited to”

Remove the reference to chapter version dates from USP 795 and 797

Update this section to adopt “current compendial chapters of USP 795 and 797”.

Rationale: The administrative rules going foward would encourage utilizattion of the most current and up to date USP

standards. This likely will establish standards that align with other accreditating bodies such as the Joint Commission.

Lastly, this will decrease confusion for Michigan pharmacies and promote best practice.

2. R 338.591 Dispensing emergency supply of insulin.

Rule 91. (1) A pharmacist may dispense an emergency supply of insulin to an individual if the

pharmacist complies with all of the following:

(a) The requirements in section 17744f of the code, MCL 333.17744f.

(b) An emergency supply of insulin may only be dispensed from a pharmacy with real time

access to the qualified prescription for insulin.

(c) Only 1 emergency supply, as that term is defined in MCL 333.17744f, may be dispensed per

qualified prescription.0

(2) If the smallest single package of insulin available exceeds a 30-day supply, dispensing the

package of insulin that is available complies with this rule and section 17744f of the code, MCL

333.17744f.

Recommendation;

Expand definition of insulin to include insulin analogs such as lispro and aspart.

Rationale: Many patients are prescribed insulin analogs (e.g. lispro, as part) and are a standard of care. By clarifying the

scope of insulin to include insulin analogs, we would improve patient safety and accessibility resulting in improved

patient care. .

3 R 338.588a Automated devices in non-inpatient settings.

Recommendation:

Remove(a) The automated device may only deliver non-controlled drugs.

Remove(b) the restriction that automated devices can only be used to deliver non-narcotics

Remove limitation prohibiting a remote pharmacy from operating an automated device as long as a pharmacist is

available

4. R 338.588b Automated devices in medical institutions.

Rule 88b. (1) An automated device used by staff to administer1 store medications to registered

patients1 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 delegates3 the stocking of the automated device is performed 4 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.

Recommendation:

¹Remove administer from "to administer store medications"

2Remove "to registered patients" and adjust to intended for patient administration

3 Remove a pharmacy delegates

3 Add is performed by non-pharmacist personnel

Rational: currently there is confusion as to who stocking may be delegated to.

Respectfully Submitted,

Michelle Dehoorne, PharmD, BSPharm

Archived: Thursday, June 22, 2023 11:31:21 AM

From: Eid, Deeb D

Sent: Friday, June 2, 2023 4:57:54 PM

Subject: RE: Public Comments for MI General Rules (Pharmacy)

Sensitivity: Normal

Attachments:

CVS Health Comments on General Rules-MI 2023.pdf ;

CAUTION: This is an External email. Please send suspicious emails to abuse@michigan.gov

Andria,

Please see the attached pdf for public comments from CVS Health on the Pharmacy General Rules. Thanks so much!

Thank you for your time!

Upcoming PTO: I will be out of the office with no access to work email and phone from 5/24 to 6/4 .

Deeb D. Eid, PharmD, RPh | One CVS Drive | Mail Code 2325 | Woonsocket, RI 02895 | T: 616-490-7398

May 30^th, 2023

Andria Ditschman, JD

Senior Policy Analyst

Bureau of Professional Licensing, Michigan Department of Licensing and Regulatory Affairs (LARA)

611 W. Ottawa St. PO Box 30670 Lansing, MI 48909

Telephone: 517-241-9255

DitschmanA@michigan.gov

Re: CVS Health Comments Rules Public Hearing for Pharmacy General Rules (2022-8 LR)

Dear Andria and Board Members:

I am writing to you in my capacity as Senior Advisor of Regulatory Affairs for CVS Health and its family of pharmacies.

CVS Health, the largest pharmacy health care provider in the United States, is uniquely positioned to provide diverse

access points of care to patients in Michigan through our integrated offerings across the spectrum of pharmacy care.

CVS Health appreciates the opportunity to submit comments on the proposed rules for Pharmacy General Rules. We

would also like to thank the Department and Board for their vigilance to continuously improve the laws and

regulations that guide pharmacists, pharmacy interns, and pharmacy technicians serving Michigan’s patients.

After review, CVS Health has comments for the Department and Board to consider strengthening and better align

with national trends, improve patient safety, and overall outcomes. These recommended changes are in the

Appendix section below which highlights the rules, comments, proposed language, and any citations or additional

information or questions to consider.

CVS Health appreciates the opportunity to submit comments for the Board’s review. Please contact me directly at

616-490-7398 if you have any questions.

Sincerely,

Deeb D. Eid, PharmD, RPh

Sr. Advisor, Pharmacy Regulatory Affairs

CVS Health

deeb.eid@cvshealth.com

Deeb D. Eid, PharmD, RPh | One CVS Drive | Mail Code 2325 | Woonsocket, RI 02895 | T: 616-490-7398

Appendix

1. Suggested Rule Language Changes:

Rule 88a

R338.588a

(2) A pharmacy licensee may locate a non-dispensing storage and pick up device inside of on the premises of the

pharmacy that is used for a patient or agent of the patient to pick up prescription medication if the pharmacy

meets both of the following:

(a) The automated device is secured, lockable, and privacy enabled.

(b) The automated device is located on the inside of the premises of the licensed pharmacy.

Comments: CVS Health supports the Board’s efforts to simplify and create access to care for non-dispensing storage

and pick up devices. These efforts will continue to allow Michigan patients to access medications and join along 29

other states that have had jurisdictional successes in allowing this type of access. Furthermore, we recommend

simplifying (2) by adding the word “inside of” after “device” as shown above and deleting the word “on”, along with

letter (b) for clarity and simplification.

Archived: Thursday, June 22, 2023 11:32:00 AM

Sent: Friday, June 2, 2023 3:46:07 PM

To: Ditschman, Andria (LARA) Ditschman, Andria (LARA)

Subject: FW: Public Comment - General Rules

Response requested: No

Sensitivity: Normal

From: Rony Foumia <ronyfoumia10@gmail.com>

Sent: Friday, June 2, 2023 3:40 PM

To: BPL-BoardSupport <BPL-BoardSupport@michigan.gov>

Cc: Rony Foumia <ronyfoumia10@gmail.com>

Subject: Public Comment - General Rules

CAUTION: This is an External email. Please send suspicious emails to abuse@michigan.gov

Good Afternoon - My name is Rony Foumia and I am a pharmacist in the State of Michigan. Even though I am a regional leader for

a pharmacy chain and a Michigan Board of Pharmacy Member, my comments are those of my own and don't represent the views

of my organization or the BOP.

1. R 338.531 Pharmacy license; remote pharmacy license; applications; requirements.

Rule 31. (1) An applicant for a pharmacy license or a remote pharmacy license shall submit to the department a completed

application on a form provided by the department together with the requisite fee.

(2) An applicant shall submit all of the following information:

(a) Certified copies of articles of incorporation or partnership certificates and certified copies of assumed name certificates, if

applicable.

(b) Submission of fingerprints for the purpose of a criminal history background check required under section 17748(6) of the

code, MCL 333.17748.

(c) A federal employer identification number (FEIN) certificate.

(d) The name and license number of the pharmacist in this state designated as the pharmacist in charge (PIC) pursuant tounder

section 17748(2) of the code, MCL 333.17748, who must have a valid and unrestricted license. If a PIC is unable to fulfill

his or her duties for 120 consecutive days, the pharmacy shall appoint a new PIC and notify the department as

required in section 17748(4) of the code, MCL 333.17748.

Comment: We also require that a PIC works on average 8 hours a week in a pharmacy to be compliant as a PIC. Are

we saying that if a pharmacist in charge goes on a leave of absence i.e., are we forgoing the requirement for them to

maintain the 8 hours a week average?

R 338.533 Compounding standards and requirements; outsourcing facilities;

requirements.

Rule 33. (1) The board approves and adopts by reference the compounding standards of the United States Pharmacopeia

(USP), published by the United States Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland, 20852-

1790. This includes, but is not limited to, USP Chapters 795 (revised 2014) and 797 (revised 2008).

(2) The standards adopted by reference in subrule (1) of this rule are available at no cost at http://www.usp.org/compounding,

or at a cost of 10 cents per page from the Board of Pharmacy, Bureau of Professional Licensing, Michigan Department of

Licensing and Regulatory Affairs, Ottawa Building, 611 West Ottawa, P.O. Box 30670, Lansing, Michigan, 48909.

Comment: USP 795 and 797 (2022 revisions are set to be implemented on 11-1-23, has this been taken into account?

Furthermore, I am hearing that the rule website listed above (USP.org) is no longer free to obtain.

\

R 338.588a Automated devices in non-inpatient settings.

Rule 88a. (1) A pharmacy that operates an automated device to deliver prescription medication directly to an

ultimate user that is not included in R 338.588(2)(a) to (h) shall comply with all of the following requirements:

(a) The automated device may only deliver non-controlled drugs.

Comment: Have we added a definition of an "Automated Device"? I think we need to clearly define what that is.

R 338.538 Closing pharmacy.

Rule 38. (1) A pharmacy that is ceasing operations shall return to the department the pharmacy license and the controlled

substance license, if applicable, and provide the department with written notification of all of the following at leastnot less than

15 days prior to before closing:

Comment: Pharmacies are now allowed to print and download copies of their pharmacy licenses. I don't think it is

necessary to have closed pharmacies return these licenses as many times they are not even originally printed by the

department.

Archived: Thursday, June 22, 2023 11:42:55 AM

From: Ditschman, Andria (LARA) Ditschman, Andria (LARA)

Sent: Thursday, June 1, 2023 4:05:51 PM

Subject: FW: FW: State of Michigan Board of Pharmacy National Accrediting Organization Approval List

Response requested: No

Sensitivity: Normal

Attachments:

compendial-applicability-of-usp-800.pdf ;

For Pharmacy General Rules Comments.

Andria M. Ditschman, JD

Department Specialist

Boards and Committees Section

From: Denise Frank <denise.frank@gatesconsult.com>

Sent: Thursday, June 1, 2023 2:47 PM

To: Ditschman, Andria (LARA) <DitschmanA@michigan.gov>

Cc: Dan Parisi <dan.parisi@gatesconsult.com>

Subject: Re: FW: State of Michigan Board of Pharmacy National Accrediting Organization Approval List

CAUTION: This is an External email. Please send suspicious emails to abuse@michigan.gov

Sure!

When the revised USP Chapters 795 and 797 become official on November 1, 2023, because they reference USP 800, then USP

800 will become compendially required (and enforceable) for compounding. I don't know if you will need to specifically

reference USP Chapter 800, (although it would be prudent to specifically point out that it is now required!!) because you do

not also point out and specifically approve all the other chapters referenced in USP 795 and 797 when the compounding

chapters say you must perform an activity according to another chapter of USP. An example would be USP 797 references USP

Chapter 71, Sterility Tests and USP 795 references Chapter 51, Antimicrobial Effectiveness Testing.

And, would you want to adopt USP 800 in its entirety (not limited to only those pharmacies only when they are compounding)

to protect all pharmacy personnel? I would think, in the spirit of protecting the public, that this would make sense!

For reference:

I included the information from USP about applicability of 800 when the new 795 and 797 that reference 800 are made official

in the email above.

This is an excerpt directly from the USP document that addresses USP 800 from this

link: https://www.usp.org/sites/default/files/usp/document/our-work/compounding/compendial-applicability-of-usp-

800.pdf

You could supply them with the document itself (it's a PDF). I have also attached a copy to this email.

This is the excerpt:

" On December 1, 2019, USP’s standard on the safe handling of hazardous drugs, General Chapter <800>,

became official. General Chapter <800> is informational and not compendially applicable. USP General

Chapter <800> Hazardous Drugs – Handling in Healthcare Settings describes practice and quality standards

for handling hazardous drugs. USP is committed to maintaining patient access to medicines, while

supporting patient safety, healthcare worker safety, and environmental protection when handling HDs

(hazardous drugs) in healthcare facilities."

"USP General Chapters, monographs, and related programs are intended to help protect and improve the

health of people, in part by facilitating access to high quality, safe, and beneficial medicines. A general

chapter numbered below 1000 becomes compendially applicable and thus is considered a required

standard only when:

1. the chapter is referenced in a monograph;

2. the chapter is referenced in another General Chapter below 1000; or

3. the chapter is referenced in General Notices.

General Chapter <800> is informational and not compendially applicable because it is not referenced in

General Notices, a monograph, or another applicable general chapter numbered below <1000>.

Revisions to General Chapters <795> Pharmaceutical Compounding—Nonsterile Preparations and <797>

Pharmaceutical Compounding—Sterile Preparations, published on June 1, 2019, include cross-references

to <800>. This would have made <800> compendially applicable for facilities that are required to

implement <795> and <797>. Due to the appeals received on certain provisions in revised USP <795> and

<797>, the chapters have been remanded to the Compounding Expert Committee with the

recommendation for further engagement on the issues raised in the appeals (see Compounding

Appeals).

This means that the currently official chapters of <795> (last revised in 2014) and <797> (last revised in

2008) remain official. These currently official compounding chapters do not reference USP <800>.

In the future, if the revised USP <795> and <797> contain reference to USP <800>, <800> would be

applicable and compendially required only to the extent to which USP General Chapters <795> and <797>

apply. For hazardous drugs, this means only when a practitioner is “compounding” (as that term is defined

in USP <795> and <797>) <800> would be applicable and compendially required. Since administration is out

of scope of USP <795> and <797>, General Chapter <800> would not be applicable or compendially

required in this context."

Warm regards,

Denise

(she/her/hers)

Denise M. Frank, RPh, FACA, FAPC

Senior Associate

Gates Healthcare Associates, Inc.

Innovative Healthcare Solutions

1 Central Street, Suite 201, Middleton, MA 01949

Phone: 978-646-0091

Cell: 612-860-1705

P

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Role and Applicability of

USP General Chapter <800>

Related to Safe Handling of

Hazardous Drugs

Summary

On December 1, 2019, USP’s standard on the safe handling of hazardous drugs, General Chapter <800>, became oﬀicial. General

Chapter <800> is informational and not compendially applicable. USP General Chapter <800> Hazardous Drugs – Handling in

Healthcare Settings describes practice and quality standards for handling hazardous drugs. USP is committed to maintaining

patient access to medicines, while supporting patient safety, healthcare worker safety, and environmental protection when

handling HDs (hazardous drugs) in healthcare facilities.

Compendial Applicability

USP General Chapters, monographs, and related programs are intended to help protect and improve the health of people, in

part by facilitating access to high quality, safe, and beneficial medicines.

A general chapter numbered below 1000 becomes compendially applicable and thus is considered a required standard only when:

1. the chapter is referenced in a monograph;

2. the chapter is referenced in another General Chapter below 1000; or

3. the chapter is referenced in General Notices.

General Chapter <800> is informational and not compendially applicable because it is not referenced in General Notices, a

monograph, or another applicable general chapter numbered below <1000>.

Revisions to General Chapters <795> Pharmaceutical Compounding—Nonsterile Preparations and <797> Pharmaceutical

Compounding—Sterile Preparations, published on June 1, 2019, include cross-references to <800>. This would have made

<800> compendially applicable for facilities that are required to implement <795> and <797>. Due to the appeals received on

certain provisions in revised USP <795> and <797>, the chapters have been remanded to the Compounding Expert Committee

with the recommendation for further engagement on the issues raised in the appeals (see Compounding Appeals). This means

that the currently oﬀicial chapters of <795> (last revised in 2014) and <797> (last revised in 2008) remain oﬀicial. These currently

oﬀicial compounding chapters do not reference USP <800>.

In the future, if the revised USP <795> and <797> contain reference to USP <800>, <800> would be applicable and compendially

required only to the extent to which USP General Chapters <795> and <797> apply. For hazardous drugs, this means only

when a practitioner is “compounding” (as that term is defined in USP <795> and <797>) <800> would be applicable and

compendially required. Since administration is out of scope of USP <795> and <797>, General Chapter <800> would not be

applicable or compendially required in this context.

March 12, 2020

Role and Applicability of USP General Chapter <800>

Related to Safe Handling of Hazardous Drugs

Enforcement

State agencies (e.g., State Boards of Pharmacy), other regulators (e.g., Occupational Safety and Health Administration), and

oversight organizations (e.g., The Joint Commission) may make their own determinations regarding the applicability and

enforceability of <800> for entities within their jurisdiction. USP continues to engage and inform regulators, accreditation

organizations, and stakeholders about the compendial status of the chapter. USP plays no role in enforcement.

USP Standards for the Handling and Compounding of Hazardous Drugs

The known risks associated with hazardous drug exposure present a compelling public health challenge. General Chapter

<800> was developed based on public health need and potential exposure of approximately 8 million U.S. healthcare workers

to hazardous drugs each year. There were also published reports of adverse eﬀects in healthcare personnel from occupational

exposure to hazardous drugs. Although General Chapters <795> and <797> contained some information on handling of

hazardous drugs, there was no public standard aimed to minimize the potential risk of exposure. To meet this need, the

Compounding Expert Committee sought to expand on the principles of hazardous drug compounding established in USP

<795> and <797> and to develop a general chapter specific to the handling of hazardous drugs through the development of USP

<800>. USP is committed to maintaining patient access to medicines, while supporting patient safety, healthcare worker safety,

and environmental protection when handling HDs (hazardous drugs) in healthcare facilities.

Additional Resources

For additional information on General Chapter <800>, see:

` USP <800> FAQs

` FAQs on the Compounding Appeals

March 12, 2020

Archived: Thursday, June 22, 2023 11:32:51 AM

Sent: Friday, June 2, 2023 2:44:37 PM

Subject: FW: Comments for proposed Pharmacy General Rules

Response requested: No

Sensitivity: Normal

Attachments:

Comment MI BOP Proposed Revisions 6.2.23.pdf ;

From: Marc Guzzardo <marc.guzzardo@ascension.org>

Sent: Friday, June 2, 2023 2:32 PM

To: BPL-BoardSupport <BPL-BoardSupport@michigan.gov>

Subject: Comments for proposed Pharmacy General Rules

CAUTION: This is an External email. Please send suspicious emails to abuse@michigan.gov

Please accept these comments to the proposed revisions to the Pharmacy General Rules.

Thank you

--

Marc Guzzardo

t: 810-606-6095

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Comment : Proposed Revisions to Michigan Pharmacy General Rules

Michigan BOP Proposed Revision

Proposed Ascension Michigan Response

Suggestion: Delete the phrase “not limited to” and remove the reference to chapter

version dates from USP 795 and 797. Update this section to adopt “current

compendial chapters of USP 795 and 797”.

R 338.533 Compounding standards and requirements; outsourcing facilities;

requirements.

Rule 33. (1) The board approves and adopts by reference the compounding standards of the United States Pharmacopeia (USP), published by the

United States Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland, 20852-1790. This includes, but is not limited to, USP

Chapters 795 (revised 2014) and 797 (revised 2008).

(2) The standards adopted by reference in subrule (1) of this rule are available at no cost at http://www.usp.org/compounding, or at a cost of 10

cents per page from the Board of Pharmacy, Bureau of Professional Licensing, Michigan Department of Licensing and Regulatory Affairs, Ottawa

Building, 611 West Ottawa, P.O. Box 30670, Lansing, Michigan, 48909.

(3) A pharmacy that provides compounding services shall comply with all applicable current standards adopted in subrule (1) of this rule.

(4) An outsourcing facility located in this state or that dispenses, provides, distributes, or otherwise furnishes compounded pharmaceuticals in this

state shall must be inspected and registered as an outsourcing facility by the United States Food and Drug Administration (FDA) prior to before

applying for a pharmacy license in this state.

Rationale: It is anticipated that other regulatory and accrediting bodies (e.g. Joint

Commission) will utilize the revised USP standards when evaluating Michigan

pharmacies. This would result in state licensed pharmacies having to adopt the strict

requirements in the updated chapters without realizing any of the corresponding

beneﬁts (e.g. extended BUDs) and leading to increased operational costs and waste.

Also, the new standards are more in alignment with the FDA deﬁnition of

compounding. For multi-state health-systems (like Ascension) attempting to

standardize practice, state-speciﬁc compounding policies and metrics would need to

be established for MI sites. Also, for MI pharmacies licensed outside of the state

(e.g. home infusion), other states may not accept sterile products from MI

pharmacies, which would result in a loss of business. Most recognized training

programs (e.g. ASHP) will update their training and resources to reﬂect current USP

standards, which will result in confusion for pharmacists licensed in the state of

Michigan and both in-state and out-of-state pharmacy students/residents being

trained at MI facilities.

Suggestion: Change to also include insulin analogs

R 338.591 Dispensing emergency supply of insulin.

Rule 91. (1) A pharmacist may dispense an emergency supply of insulin to an individual if the pharmacist complies with all of the

following:

(a) The requirements in section 17744f of the code, MCL 333.17744f.

(b) An emergency supply of insulin may only be dispensed from a pharmacy with real time access to the qualified prescription for insulin.

(c) Only 1 emergency supply, as that term is defined in MCL 333.17744f, may be dispensed per qualified prescription.0

(2) If the smallest single package of insulin available exceeds a 30-day supply, dispensing the package of insulin that is available complies

with this rule and section 17744f of the code, MCL 333.17744f.

Rationale: Since many patients are prescribed insulin analogs (e.g. lispro, aspart),

adding this language would clarify that the emergency supply also pertains to these

agents.

1

Archived: Thursday, June 22, 2023 11:45:29 AM

Sent: Thursday, June 1, 2023 6:42:07 AM

Subject: FW: Comment Submission for April 2023 Pharmacy General Rules

Response requested: No

Sensitivity: Normal

Attachments:

UMH Comments on BOP General Rules Revisions 2023 copy.docx ;

From: Lisa Herz <lisamarieherz@gmail.com>

Sent: Wednesday, May 31, 2023 3:45 PM

To: BPL-BoardSupport <BPL-BoardSupport@michigan.gov>

Subject: Comment Submission for April 2023 Pharmacy General Rules

CAUTION: This is an External email. Please send suspicious emails to abuse@michigan.gov

Hello,

I am a Board Certified Sterile Compounding Pharmacist and have been a Compounding Supervisor for over 10 years at an

acute care hospital in Michigan.

I support the general and specific comments submitted by Jamie Tharp on May 26, 2023. Please review and revise as

described in the attached document.

Thank you,

Lisa Herz, PharmD, BCSCP

586-524-3039

Archived: Thursday, June 22, 2023 11:44:48 AM

Sent: Thursday, June 1, 2023 1:41:25 PM

Subject: FW: Public comment on proposed revisions to Pharmacy General Rules

Response requested: No

Sensitivity: Normal

From: King, Lee <Lee.King@Sparrow.Org>

Sent: Thursday, June 1, 2023 1:00 PM

To: BPL-BoardSupport <BPL-BoardSupport@michigan.gov>

Subject: Public comment on proposed revisions to Pharmacy General Rules

CAUTION: This is an External email. Please send suspicious emails to abuse@michigan.gov

Questioning the undue burden and redundancy that would be caused by enforcement of the two proposed changes:

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.

- We all understand that there is not complete alignment in rules between the State of Michigan and USP

compliance. In the many areas that rules are conflicting, which source would prevail? In any situation

where the expectation that the State of Michigan rule were to be followed as opposed to USP, any Joint

Commission accreditation would be in immediate noncompliance for not conforming with USP standards.

- Additional burden of record keeping and standard compliance with having to maintain two separate

sterile compounding surveys

- From a safety perspective, Iwould suggest that compliance with the USP standards are sufficient to

attain sterile compounding compliance.

- A suggestion would be to consider the dual inspection for any site that previously failed inspection by the

accrediting body as the first path back towards compliance with sterile compounding standards.

Mandates compliance with USP 795 and 797 to versions revised in 2014 and 2008, respectively.

- Iwould question if the recommendation to hold pharmacies accountable to both the 2008 and 2014

versions of USP 795 and 797 came from USP themselves? What is the purpose in enforcing both

versions simultaneously?

- There is significant overlap and even contradicting standards between the 2008 and 2014 versions. It

will be extremely difficult to enforce both versions at the same time.

- Having to maintain compliance with two separate versions of USP puts our patients at risk when there

are standards that are in disagreement.

I have no other additional feedback on other public comment changes at this time.

Thank you for your time and consideration.

Regards,

Lee M. King, PharmD

Medication Safety Officer | Sparrow Health System | lee.king@sparrow.org |Phone: 517/ 364-5564

“Quality’s core is Safety. Safety’s core is reliability. Reliability’s core is culture. Culture’s core is fairness, justice,

teamwork and transparency.” – Barbara Balik

Archived: Thursday, June 22, 2023 11:43:54 AM

Sent: Thursday, June 1, 2023 2:51:52 PM

Subject: FW: Comments for Proposed Rules for 6/2/23 Public Hearing

Response requested: No

Sensitivity: Normal

From: Bradley McCloskey <brad@univrx.com>

Sent: Thursday, June 1, 2023 2:51 PM

To: BPL-BoardSupport <BPL-BoardSupport@michigan.gov>

Subject: Comments for Proposed Rules for 6/2/23 Public Hearing

CAUTION: This is an External email. Please send suspicious emails to abuse@michigan.gov

Hello, please find my comments below regarding the Proposed Draft Rule Language and our Requests for Change. I agree

with proposed changes suggested by the MPA

Proposed Language

Comment

R 338.533 (1) The board approves and adopts by reference the

compounding standards of the United States Pharmacopeia (USP),

published by the United States Pharmacopeial Convention, 12601

Twinbrook Parkway, Rockville, Maryland, 20852-1790. This

includes, but is not limited to, USP Chapters 795 (revised 2014) and

797 (revised 2008).

MPA opposes the addition of dates to this rule language. We

second this opposition. The proposed language creates a situation

in which pharmacies are required to comply with outdated

standards rather than the most current versions. Pharmacies may

also be put in a situation where they might need to comply with the

latest versions under federal law or for the purpose of

accreditation by a non-governmental entity. This may not be

possible as revised standards may conflict sufficiently with older

versions that simultaneous compliance with both old and new

versions is not feasible. Additionally, adding these dates punishes

pharmacies that have sought to become compliant with upcoming

versions of the standards in advance of official publication.

Suggested Revision:

R 338.555 (1) The board approves and adopts by reference the

current good manufacturing practice for finished pharmaceuticals

regulations set forth in 21 CFR 211.1 to 211.208 (20212022).

Do not specify the revision dates for USP 795 and 797 in R

338.533(1).

Remove the 2021 revision date for cGMP in R 338.555 (1), but do

not replace it with the 2022 date.

Thank you,

Brad McCloskey, PharmD

President/CEO

University Compounding Pharmacy

6054 Livernois Rd.

Troy, MI 48098

Phone: 877-531-1147

Fax: 866-531-1826

www.univrx.com

Helping one patient at a time live their best life

The documents in this correspondence may contain confidential health information that is privileged and legally protected from disclosure by federal law, the Health Insurance Portability and

Accountability Act (HIPAA). This information is intended only for use of the individual or entity named above. If you are not the intended recipient, you are hereby notified that reading,

disseminating, disclosing, distributing, copying, acting upon or otherwise using the information contained in this email is strictly prohibited. If you have received this information in error, please

notify the sender immediately and delete.

Archived: Thursday, June 22, 2023 11:46:55 AM

Sent: Monday, May 29, 2023 8:20:17 PM

Subject: FW: Comment regarding your USP law language

Response requested: No

Sensitivity: Normal

From: David Medina <dmedinarph@gmail.com>

Sent: Monday, May 29, 2023 9:44 AM

To: BPL-BoardSupport <BPL-BoardSupport@michigan.gov>

Subject: Comment regarding your USP law language

CAUTION: This is an External email. Please send suspicious emails to abuse@michigan.gov

Good morning,

I am a NYS pharmacist and I became aware of your recent updates to your pharmacy law via a post on LinkedIn from a

Michigan based based pharmacist. Upon reading the language in the law, as it's written, professionally speaking, you are

putting your patient population, and even the livelihood of your Compunding pharmacists on the line.

If you are specifically stating in law that your standards for compounding will be based on the old rules, as a Board of

Pharmacy you are willfully stating that increased protection for the public as a whole is not a vital concern.

For years now stakeholders have been meeting to discuss the revisions to USP 797. These revisions are now final and serve as

the benchmark for any compounding pharmacist in the country as a gold standard.

If you are going to hold your pharmacies to an outdated standard, what will happen to them when they pursue JCAHO, ACHC,

or URAC accreditation? Failing those could mean loss of business. That aside, if you hold pharmacies to less than the standard,

what will the board be saying to the public at large should harm come to them as a result of this? What would happen to the

business or Pharmacist in charge if the FDA decides to come into a 503a pharmacy and sees way less than they should be

seeing as a result of this law?

I urge you as a Board of Pharmacy to reconsider your language on this. Remove your specificity to the old years and just state

the the Board will uphold the mist current revisions to the USP standards as they come. Not doing this could have dramatic

consequences for your pharmacists and your people.

Sincerely

David Medina R.ph

Archived: Thursday, June 22, 2023 11:45:06 AM

Sent: Thursday, June 1, 2023 1:41:14 PM

Subject: FW: Board of Pharmacy Comments on Rules

Response requested: No

Sensitivity: Normal

From: Jasmin Mehta <jasminmehta43@gmail.com>

Sent: Thursday, June 1, 2023 12:30 PM

To: BPL-BoardSupport <BPL-BoardSupport@michigan.gov>

Subject: Board of Pharmacy Comments on Rules

CAUTION: This is an External email. Please send suspicious emails to abuse@michigan.gov

Hello Michigan Board,

My name is Jasmin and I am writing to you about the pharmacy rules that are open for public comments. I have been reading

your meeting minutes over the past year as part of a project I am working on and noticed you have had many discussions on

the topic of removing the state law exam or MPJE.

In looking at your proposed rules, I am suggesting you look at rule 19, 21, 23 and any others that mention the MPJE or law

exam as a requirement. My comment is to remove the law exam as a requirement for licensure.

You all have had some great discussions based on your meeting minutes in the past on this topic. Don't let the opinion of just

1 or 2 board members change your minds and you had some great arguments for why to remove this exam.

Other states have removed the exam and talked about this based on researching the topic.

Please consider removal of the exam from your rules as it is a pointless exam that is outdated.

Best,

Jasmin Mehta

Sent from my iphone

Archived: Thursday, June 22, 2023 11:37:40 AM

Sent: Friday, June 2, 2023 7:07:55 AM

jPritchett@revpharmacorp.com

Subject: FW: Comments to proposed changes to R338.533(1)

Response requested: No

Sensitivity: Normal

Attachments:

smime.p7s ;

From: Dr. Dave <drdave@keystonepharm.com>

Sent: Thursday, June 1, 2023 7:06 PM

To: BPL-BoardSupport <BPL-BoardSupport@michigan.gov>

Cc: Eric Roath <eroath@michiganpharmacists.org>; Lawrence Curtis <lcurtis@centerforcompounds.com>;

Subject: Comments to proposed changes to R338.533(1)

CAUTION: This is an External email. Please send suspicious emails to abuse@michigan.gov

Dear board of pharmacy members,

I oppose the addition of dates to this rule language. The 2014 and 2008 revisions for USP<795> and USP<797> respectively are antiquated

and about to officially change on November 1, 2023. The proposed language creates a situation in which pharmacies are required to comply

with outdated standards rather than the most current versions. This will put compounding pharmacies at odds with accrediting bodies.

Public Act 280 of 2014 requires pharmacies to receive PCAB, or equivalent accreditation for sterile compounding. Accreditation cannot be

obtained unless the most current chapters of USP are followed. This revision will also put compounding pharmacies at odds with the Food

and Drug Administration who will require the most current revisions of the USP chapters to be followed. Additionally, adding these dates

punishes pharmacies that have sought to become compliant with upcoming versions of the standards in advance of official publication.

Suggested Revision:

Do not specify the revision dates for USP 795 and 797 in R 338.533(1). Simply state:

R 338.533 (1) The board approves and adopts by reference the compounding standards of the United States Pharmacopeia (USP), published by

the United States Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland, 20852-1790. This includes, but is not limited to,

USP Chapters 795 and 797.

Thank you for considering my comments when considering the proposed revisions.

David J Miller, RPh, PhD, FAPC, FACA

Keystone Pharmacy

4021 Cascade Rd SE, STE 50

Grand Rapids, MI 49546

616-974-9792

616-464-3469 fax

www.ke y s t oner x .com

This email may contain certain privileged content. This content is intended for the listed recipient(s) and cannot be forwarded or copied with the express written permission of the original owner. If

you are not the intended receiver of this information, you must delete this email immediately and notify the sender of this error using the contact information provided.

From: Jessica Morris

Mail received time: Wed, 24 May 2023 03:35:47

Sent: Tuesday, May 23, 2023 11:35:47 PM

To: BPL-BoardSupport

Cc: Ditschman, Andria (LARA)

Subject: Michigan General Rules Pharmacy Public Comments

Importance: Normal

Sensitivity: None

Archived: Wednesday, May 24, 2023 10:57:14 AM

___________________________________

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Dear Members of the Michigan Board of Pharmacy,

I hope this letter finds you well. This letter is in relation to the

Pharmacy General Rules you have open for public comments. On behalf of

myself, I am writing to respectfully request the removal of the MPJE

(Multistate Pharmacy Jurisprudence Examination) law exam requirement

from the rules governing pharmacy licensure in Michigan. After careful

consideration and review of the relevant statutes and regulations, I

believe that eliminating this exam would be a progressive step towards

streamlining the licensing process without compromising patient

safety. Your Board has also discussed this topic in the past and has

had ample and colorful discussions on why the exam is baseless and no

longer relevant.

Upon conducting an in-depth analysis of the existing laws and

regulations, it is evident that there is no explicit requirement for

the MPJE in the statutes pertaining to pharmacy licensure in Michigan.

Therefore, I present the following arguments in favor of removing the

MPJE requirement within your current proposed rules. Relevant rules

are: R338.519, R 338.521, R 338.523 and anywhere else in these rules

that require this exam.

Pharmacy is among a minority of health professions that impose a

jurisprudence exam as a prerequisite for licensure. It is worth

considering which other health professions require a similar exam and

if it is truly necessary for ensuring public safety. What evidence or

published literature shows that an individual passing this exam one

time improves patient safety or outcomes? There are none to my

knowledge. When asked, even NABP can not produce an answer to this

day-old question.

Some arguments in favor of a law exam may stem from conflicts of

interest, such as individuals or entities that benefit financially

from creating study materials (such as state associations or

colleges), generating exam questions, or providing educational content

related to the exam. It is important to question the motivations

behind such arguments and consider whether they truly contribute to

public safety or simply serve vested interests. In addition, NABP has

a vested financial interest in making this exam a requirement to

ensure they are receiving revenue each year from students and

licensees who are taking the test in multiple states.

The historical belief that a law exam is required due to the

complexity of pharmacy laws may not be entirely applicable today.

Technological advancements and electronic pharmacy dispensing systems

have greatly facilitated adherence to professional practice standards.

Many of the specific details, such as information on prescription

labels or permissible refills, are now automatically checked and

enforced by these systems, alleviating the burden on pharmacists to

memorize every minute aspect of the laws.

It is worth noting that there are currently no published articles

demonstrating a direct correlation between jurisprudence competence

exams and patient safety. Without concrete evidence that passing such

an exam leads to safer care provided by pharmacists, the burden of

cost and time associated with the MPJE becomes difficult to justify.

The COVID-19 pandemic serves as a poignant example of how additional

examinations can exacerbate delays in equipping the pharmacy workforce

and addressing staffing shortages. Executive orders were required to

waive regulations and increase access to pharmacists during this

critical time. By removing the MPJE requirement, Michigan can ensure a

more efficient and timely process for licensing pharmacists.

To address potential counterarguments, I offer the following responses:

The argument that pharmacists need to know the law when other

healthcare professionals may not overlooks the fact that each

profession has its own set of laws and rules that its members must

adhere to. If passing an exam directly equates to comprehensive

knowledge of the laws and rules, then why don't other health

professions impose a similar requirement?

Technological advancements have significantly improved compliance with

laws and regulations. Many aspects of pharmacy practice that

previously required manual vigilance are now automated and integrated

into computer software and systems. This reduces the reliance on

individual pharmacists to memorize every detail, as the technology

itself enforces compliance.

Removing the MPJE requirement does not necessarily lower the bar for

licensure or allow anyone to become a pharmacist. On the contrary, it

could attract highly qualified candidates who are seeking a more

efficient pathway to licensure and practice. Incompetence exists in

every profession, and passing an exam does not guarantee competence. A

comprehensive evaluation of candidates' qualifications, including

their educational background and performance in pharmacy school,

remains critical in ensuring the competency of licensed pharmacists.

Concerns about NABP's opinion and potential loss of support should not

overshadow the primary objective of protecting public safety. While

NABP may experience financial losses due to the removal of the exam,

it is the responsibility of the Board of Pharmacy to prioritize

patient safety and outcomes over financial considerations. If patient

safety remains unaffected by the removal of this administrative

requirement, then it should not hinder progress.

The responsibility of ensuring pharmacy graduates' competence in state

and federal laws lies with the colleges and schools of pharmacy.

Accreditation standards set by the Accreditation Council for Pharmacy

Education (ACPE) require educational institutions to adequately

prepare graduates in this regard. The role of the Board of Pharmacy is

to evaluate whether passing one exam equates to sufficient competence

in all state laws and rules, thus protecting public safety.

Last July, the American Association of Colleges of Pharmacy (AACP)

which is the association that houses all colleges of pharmacy and

faculty as members passed a national emerging resolution in which the

academy supports removal of a stand alone examination of federal

and/or state pharmacy laws as a requirement for licensure. This was

endorsed by members from neighboring states such as WI, OH, IL, and

IA.

It is also worth considering the examples set by other states that

have revised their requirements:

Idaho (ID): Since 2018, Idaho has operated without an MPJE requirement

and has transitioned to an enforcement approach based on the standard

of care. They have reported no increase in complaints to the board and

no known patient safety issues resulting from the removal of the exam.

Vermont (VT): Vermont recently voted to remove the MPJE requirement,

aligning itself with the evolving trends in pharmacy licensure.

Ohio (OH): Ohio does not require license transfer applicants to

maintain their license by original examination. However, license

transfer applicants must have a license in good standing from a member

board and transfer their license through the NABP clearinghouse. This

approach prioritizes evaluating the equivalence and thoroughness of

the examination taken in another state.

Wisconsin (WI): Wisconsin currently has a bill being heard by the

legislature that would remove unnecessary and unproven licensure

requirements for healthcare professionals. The MPJE is amongst those

exams/requirements. The state association in WI has publically

supported this bill and removal of the MPJE.

In conclusion, I urge the Michigan Board of Pharmacy to carefully

consider the arguments presented in favor of removing the MPJE

requirement. Doing so would represent a progressive and

forward-thinking approach to pharmacy licensure without compromising

patient safety. By streamlining the licensing process, Michigan has

the opportunity to attract highly qualified candidates and ensure a

competent pharmacy workforce that can meet the evolving healthcare

needs of the state. This move also ensures that the Board and staff

are utilizing evidence and logical thinking to remove undue barriers

while protecting the public.

Thank you for your time and consideration. I trust that you will

carefully evaluate this request, keeping in mind the ultimate goal of

protecting public safety while fostering an efficient and effective

pharmacy licensing process.

Sincerely,

Jessica Morris

Archived: Thursday, June 22, 2023 11:37:13 AM

Sent: Friday, June 2, 2023 7:08:12 AM

BPL-BoardSupport@michigan.gov

Subject: FW: Michigan Pharmacists Association - Pharmacy General Rules Comments

Response requested: No

Sensitivity: Normal

Attachments:

Pharmacy General Ruels Comments 05-2023.docx ;

From: Eric Roath <eroath@michiganpharmacists.org>

Sent: Thursday, June 1, 2023 5:36 PM

To: BPL-BoardSupport <BPL-BoardSupport@michigan.gov>

Cc: Farah Jalloul <fjalloul@michiganpharmacists.org>; Mark Glasper <mark@michiganpharmacists.org>

Subject: Michigan Pharmacists Association - Pharmacy General Rules Comments

CAUTION: This is an External email. Please send suspicious emails to abuse@michigan.gov

Department Specialist,

Please see the attached letter for MPA’s formal comments on the Pharmacy General Rules. I can be reached at this email

address if you have any questions.

Sincerely,

Eric Roath, PharmD, MBA

Director of Government Affairs

Michigan Pharmacists Association

408 Kalamazoo Plaza, Lansing, MI 48933

Cell (906) 282-8930

Direct (517) 377-0254

Department of Licensing and Regulatory Aﬀairs

Bureau of Professional Licensing

Boards and Commiꢀees Secﬁon

P.O. Box 30670

Lansing, MI 48909-8170

A T TN: Department Specialist

Thank you for the opportunity to provide comments on the Pharmacy General Rules. Michigan

Pharmacists Associaﬁon (MPA) represents pharmacy pracﬁﬁoners across the state of Michigan. We

represent pharmacists and pharmacy technicians in all pracﬁce areas, from community outpaﬁent pracﬁce

to inpaﬁent health systems.

The areas of the proposed rules we wish to comment on are outlined in the following table:

Proposed Language

Comment

R 338.513 (1) An applicant for an educaﬁonal limited

The phrase “or is within 180 days of compleﬁng”

license shall submit to the department a completed

seems redundant. If an individual is within 180 days of

applicaﬁon on a form provided by the department with compleﬁng a program, it would stand to reason they

the requisite fee. In addiﬁon to saﬁsfying the

requirements of secﬁons 16174 and 17737 of the code,

MCL 333.16174 and MCL 333.17737, the applicant shall

establish either 1 of the following:

are acﬁvely enrolled in the program.

We believe that this phrasing may have been an

oversight, and that the original intent of the rule was

to allow individuals who had recently completed an

educaﬁon program to secure an educaﬁonal limited

(a) That the applicant is acﬁvely enrolled in, or is

within 180 days of compleﬁng, an approved educaﬁonal license. This grace period is important for allowing

program.

new graduates from out of state to work in the

pharmacy while their full license is pending.

(b) That the applicant has received a Foreign

Pharmacy Graduate Examinaﬁon Commiꢀee (FPGEC)

cerﬁﬁcaﬁon from the Naﬁonal Associaﬁon of Boards of

Pharmacy (NABP) Foreign Pharmacy Graduate

Examinaﬁon Commiꢀee, 1600 Feehanville Drive.,

Mount Prospect, Illinois, 60056,

Suggested revision:

“(1)(a) That the applicant is acﬁvely enrolled in an

approved educaﬁonal program or has completed an

approved educaﬁonal program within the past 180

days.”

hꢀps://nabp.pharmacy/programs/fpgec/.)

“(2)(a) At the ﬁme of renewal, the applicant shall

submit veriﬁcaﬁon to the department that the

applicant is acﬁvely enrolled in an approved

educaﬁonal program, or has completed an approved

educaﬁonal program within the past 180 days.”

(2) The educaﬁonal limited license must be renewed

annually as follows:

(a) At the ﬁme of renewal, the applicant shall submit

veriﬁcaﬁon to the department that he or she the

applicant is acﬁvely enrolled in, or is within 180 days of

compleﬁng, an approved educaﬁonal program. The

educaﬁonal limited license is valid for 1 year.

Proposed Language

Comment

R 338.523 (2)(ii)(C)(b) Pass the MPJE as required under

R 338.519Provide an aꢀestaﬁon to the department

that the applicant has suﬃcient knowledge of the

code and the board’s rules to competently pracﬁce

pharmacy in this state.

MPA is opposed to removing the requirement to pass

the MPJE if seeking licensure via endorsement. We

believe an applicant must demonstrate competency in

pharmacy pracﬁce law in the State. Failure to

demonstrate this competency increases the likelihood

that pharmacists may inadvertently pracﬁce outside

of Michigan’s state-speciﬁc regulaﬁons. This

represents not only a risk to paﬁent safety but also

increases liability exposure for the pracﬁﬁoner.

Suggested Revision:

Retain the old language for R 338.532 (2)(ii)(C)(b):

“Pass the MPJE as required under R 338.519.”

R 338.533 (1) The board approves and adopts by

reference the compounding standards of the United

States Pharmacopeia (USP), published by the United

States Pharmacopeial Convenﬁon, 12601 Twinbrook

Parkway, Rockville, Maryland, 20852-1790. This

includes, but is not limited to, USP Chapters 795

(revised 2014) and 797 (revised 2008).

MPA opposes the addiﬁon of dates to this rule

language. The proposed language creates a situaﬁon

in which pharmacies are required to comply with

outdated standards rather than the most current

versions. Pharmacies may also be put in a situaﬁon

where they might need to comply with the latest

versions under federal law or for the purpose of

accreditaﬁon by a non-governmental enﬁty. This may

not be possible as revised standards may conﬂict

suﬃciently with older versions that simultaneous

R 338.555 (1) The board approves and adopts by

reference the current good manufacturing pracﬁce for

ﬁnished pharmaceuﬁcals regulaﬁons set forth in 21 CFR compliance with both old and new versions is not

211.1 to 211.208 (20212022).

feasible. Addiﬁonally, adding these dates punishes

pharmacies that have sought to become compliant

with upcoming versions of the standards in advance of

oﬃcial publicaﬁon.

Suggested Revision:

Do not specify the revision dates for USP 795 and 797

in R 338.533(1).

Remove the 2021 revision date for cGMP in R 338.555

(1), but do not replace it with the 2022 date.

Proposed Language

Comment

R 338.588a Automated devices in non-inpaﬁent

seꢁngs.

MPA advocates for removing the restricﬁon that

automated devices only be used to deliver non-

Rule 88a. (1) A pharmacy that operates an automated controlled drugs in subsecﬁon (1)(a). Current

device to deliver prescripﬁon medicaﬁon directly to an technology allows for the capture of posiﬁve

ulﬁmate user that is not included in R 338.588(2)(a) to idenﬁﬁcaﬁon of a paﬁent at the point of dispensing

(h) shall comply with all of the following requirements: via an automated device. We suggest that rather than

(a) The automated device may only deliver non-

controlled drugs.

(b) The automated device is operated as an

extension of a pharmacy, under the control of a

pharmacist, however, a remote pharmacy may not

operate an automated device.

(c) A pharmacist shall be available for the automated

device to be operable.

(d) The automated device is secured, lockable, and

privacy enabled.

(e) Prescripﬁons must contain a label that idenﬁﬁes

the automated device where the medicaﬁon was

dispensed.

(f) A pharmacist shall be available to provide paﬁent

consultaﬁon through real-ﬁme audio and visual

communicaﬁon. The pharmacist may provide

consultaﬁon from a remote locaﬁon.

prohibit dispensing controlled medicaﬁons via an

automated device, the board introduces language

requiring posiﬁve veriﬁcaﬁon of a paﬁent’s ID at the

point of delivery.

Addiﬁonally, MPA advocates for removing the

limitaﬁon prohibiﬁng a remote pharmacy from

operaﬁng an automated device in subsecﬁon (1)(b). If

a pharmacist is available, as required by subsecﬁon

(1)(c), and a pharmacist may be available for real-ﬁme

consult in subsecﬁon (1)(f), then a remote pharmacy

should be permiꢀed 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

medicaﬁons in a remote pharmacy.

Suggested Revision:

R 338.588a (1) A pharmacy that operates an

automated device to deliver prescripﬁon medicaﬁon

directly to an ulﬁmate user that is not included in R

338.588(2)(a) to (h) shall comply with all of the

following requirements:

(a) The automated device may only deliver non-

controlled drugs.

(b) The automated device is operated as an

extension of a pharmacy, under the control of a

pharmacist, however, a remote pharmacy may not

operate an automated device.

(c) A pharmacist shall be available for the automated

device to be operable.

(d) The automated device is secured, lockable, and

privacy enabled.

(e) Prescripﬁons must contain a label that idenﬁﬁes

the automated device where the medicaﬁon was

dispensed.

(f) A pharmacist shall be available to provide paﬁent

consultaﬁon through real-ﬁme audio and visual

communicaﬁon. The pharmacist may provide

consultaﬁon from a remote locaﬁon.

Proposed Language

Comment

R 338.588a Automated devices in non-inpaﬁent

seꢁngs.

(3) If an automated device is used in a dispensing

prescriber's oﬃce, and the automated device is not

aﬃliated with a pharmacy, the device must be used

only to dispense medicaﬁons to the dispensing

MPA advocates for parity in the requirements for

automated devices operated by pharmacies and

automated devices managed by dispensing

prescribers. In addiﬁon to the recommended revisions

noted below, if the Board believes it necessary to

conﬁnue the prohibiﬁon of dispensing controlled

prescriber's paﬁents and only under the control of the substances from an automated device controlled by a

dispensing prescriber. All of the following apply to the

use of an automated device in a dispensing

prescriber's oﬃce:

(a) If a dispensing prescriber delegates the stocking

of the automated device, then technologies must be in

place and uﬁlized to ensure that the correct drugs are

stocked in their appropriate assignment uﬁlizing a

board-approved error prevenﬁon technology that

complies with R 338.3154.

(b) A dispensing prescriber operaﬁng an automated

device is responsible for all medicaﬁons that are

stocked and stored in that device, as well as removed

from that device.

pharmacy, a similar prohibiﬁon should be put in place

for the oﬃces of a dispensing prescriber.

Suggested Revision:

MPA recommends adding the following language:

R 338.588a (3) (d) The dispensing prescriber shall be

available for the automated device to be operable.

(e) The automated device is secured, lockable, and

privacy enabled.

(f) Prescripﬁons must contain a label that idenﬁﬁes

the automated device where the medicaﬁon was

dispensed.

(c) If any medicaﬁon or device is dispensed from an

automated device in a dispensing prescriber’s oﬃce,

then documentaﬁon as to the type of equipment,

serial numbers, content, policies, procedures, and

locaﬁon within the facility must be maintained by the

dispensing prescriber for review by an agent of the

board. This documentaﬁon must include all of the

following informaﬁon:

(i) Manufacturer name and model.

(ii) Quality assurance policy and procedure to

determine conﬁnued appropriate use and

performance of the automated device.

(iii) Policy and procedures for system operaﬁon that

addresses, at a minimum, all of the following:

(A) Accuracy.

(B) Paﬁent conﬁdenﬁality.

(C) Access.

(D) Data retenﬁon or archival records.

(E) Downﬁme procedures.

(F) Emergency procedures.

(G) Medicaﬁon security.

(H) Quality assurance.

Proposed Language

Comment

R 338.591 Dispensing emergency supply of insulin.

MPA recommends the addiﬁon of language to clarify

Rule 91. (1) A pharmacist may dispense an emergency that although an emergency supply of insulin may

supply of insulin to an individual if the pharmacist

complies with all of the following:

(a) The requirements in secﬁon 17744f of the code,

MCL 333.17744f.

only be dispensed once per qualiﬁed prescripﬁon, this

does not change the ability of a pharmacy to issue

three such emergency supplies per paﬁent per year

(MCL 333.17744f (2)).

(b) An emergency supply of insulin may only be

dispensed from a pharmacy with real ﬁme access to

the qualiﬁed prescripﬁon for insulin.

(c) Only 1 emergency supply, as that term is deﬁned

in MCL 333.17744f, may be dispensed per qualiﬁed

prescripﬁon.

Suggested Revision:

Add R338.591 (d) a pharmacist may dispense an

emergency supply of insulin for up to three qualiﬁed

prescripﬁons within a calendar year for an individual

paﬁent.

Thank you again for the opportunity to provide comments on these rules. If you have any

quesﬁons or require clariﬁcaﬁon regarding our remarks, please do not hesitate to reach out.

Respecﬀully submiꢀed,

Eric Roath, PharmD, MBA

Director of Government Aﬀairs

Michigan Pharmacists Associaﬁon

(906) 282-8930

eroath@michiganpharmacists.org

Archived: Thursday, June 22, 2023 11:43:23 AM

Sent: Thursday, June 1, 2023 3:26:53 PM

Subject: FW: R 338.521 and 338.523 of the Pharmacy – General Rules

Response requested: No

Sensitivity: Normal

From: Colleen Ryan <cryan4710@gmail.com>

Sent: Thursday, June 1, 2023 3:07 PM

To: BPL-BoardSupport <BPL-BoardSupport@michigan.gov>

Subject: R 338.521 and 338.523 of the Pharmacy – General Rules

CAUTION: This is an External email. Please send suspicious emails to abuse@michigan.gov

My comment pertains to R 338.521 and 338.523 of the Pharmacy – General Rules.

The rules should allow licensure by examination by new grads even though they may be licensed in another state with a

score transfer.

Thank you,

Colleen Ryan

Archived: Thursday, June 22, 2023 11:33:36 AM

Sent: Friday, June 2, 2023 1:08:24 PM

Subject: FW: MHA Comments - Administrative Rules for Pharmacy-General Rules 2022-8 LR

Response requested: No

Sensitivity: Normal

Attachments:

MHA Comments Pharmacy-General Rules 2022-8 LR.pdf ;

Hi Andria,

Please see below.

From: Renee Smiddy <rsmiddy@mha.org>

Sent: Friday, June 2, 2023 11:58 AM

To: BPL-BoardSupport <BPL-BoardSupport@michigan.gov>

Subject: MHA Comments - Administrative Rules for Pharmacy-General Rules 2022-8 LR

CAUTION: This is an External email. Please send suspicious emails to abuse@michigan.gov

Good morning,

On behalf of Michigan hospitals, the MHA appreciates the opportunity to provide comments on the Administrative Rules for Pharmacy

– General Rules 2022-8 LR. Please see our attached feedback.

Thank you,

Renée Smiddy, MS | Senior Director, Finance Policy

Michigan Health & Hospital Association

110 W. Michigan Avenue, Suite 1200 | Lansing, MI 48933

(517) 285-0881 | rsmiddy@mha.org

June 2, 2022

Department of Licensing and Regulatory Affairs

Bureau of Professional Licensing

Administrative Rules for Pharmacy – General Rules

2022-8 LR

Submitted via BPL-BoardSupport@michigan.gov

Dear Departmental Specialist:

On behalf of Michigan hospitals, the Michigan Health & Hospital Association (MHA) appreciates the

opportunity to provide comments on the Administrative Rules for Pharmacy – General Rules.

The MHA has significant concerns related to the automated device sections and how the draft rules try to

delineate practices between different types of facilities, specifically related to inpatient and non-inpatient

settings. Some hospital settings are not considered inpatient but reside within the hospital footprint. The

MHA has received multiple questions from members requesting clarification related to hospital emergency

departments and distinct part units, are these areas considered inpatient or non-inpatient?

Please see our feedback and commentary below:

R 338.533 Compounding standards and requirements; outsourcing facilities;

requirements.

Rule 33. (1) The board approves and adopts the latest available by reference the compounding

standards of the United States Pharmacopeia (USP), published by the United States Pharmacopeial

Convention.12601 Twinbrook Parkway, Rockville, Maryland, 20852-1790. This includes, but is not limited

to, USP Chapters 795 (revised 2014) and 797 (revised 2008).

…

(6) An outsourcing facility shall do all of the following:

(a) Compound drugs by or under the supervision of a licensed pharmacist.

(b) Compound drugs pursuant to under current good manufacturing practices for finished

pharmaceuticals set forth in 21 CFR 211.1 to 211.208 (20212022).

The MHA recommends removing date references to avoid confusion and pharmacies inadvertently using

outdated guidance. Clear and concise language should be adopted.

R 338.588a Automated devices in non-inpatient settings. Please define and clarify areas of impact.

The MHA recommends using definitions such as, outpatient clinics, infusion centers, etc., rather than the

term non-inpatient settings.

Rule 88a. (1) A pharmacy that operates an automated device to deliver prescription medication

directly to an ultimate user that is not included in subdivision (a) to (h) of subrule (2) of R 338.588

shall comply with all of the following requirements:

MHA Comments – Administrative Rules for Pharmacy – General Rules

June 2, 2023

Page 2

(a) The automated device may only deliver non-controlled drugs not be used to deliver

controlled substances.

The MHA recommends striking R 338.588a or updating to the suggested language above.

(b) The automated device is operated as an extension of a pharmacy, under the control of a

pharmacist, however, a remote pharmacy may not operate an automated device.

(c) A pharmacist shall be available for the automated device to be operable.

The MHA has received direct feedback from hospitals that this section is unclear and they’re not sure this

would apply to their non-inpatient units. Would the pharmacist need to be onsite, available by phone or

virtually?

(d) The automated device is secured, lockable, and privacy enabled.

Please clarify ‘privacy enabled’, is the intent to ensure patient privacy? If patient privacy is the intent, the

MHA recommends clarifying language that ensures the privacy of the end-user.

(e) Prescriptions must contain a label that identifies the automated device where the medication

was dispensed.

Please clarify if this would be in-addition to the dispensing pharmacy. For non-inpatient settings within a

hospital, would this be satisfied by a room number if the dispensing pharmacy and automated device

share the same address.

(f) A pharmacist shall be available to provide patient consultation through real-time audio and

visual communication. The pharmacist may provide consultation from a remote location.

The MHA suggests combining (f) and (c) subsections.

(g) Before the automated device is put into service, the pharmacy shall notify the department of

the location of the automated device on a form provided by the department.

Please clarify who the department is?

(h) Dispensing activities through the automated device must comply with all recordkeeping,

drug utilization review, and patient counseling requirements that are applicable to a pharmacy.

(2) A pharmacy licensee may locate a non-dispensing storage and pick up device on the premises of the

pharmacy that is used for a patient or agent of the patient to pick up prescription medication if the

pharmacy meets both of the following:

(a) The automated device is secured, lockable, and privacy enabled.

(b) The automated device is located on the inside of the premises of the licensed pharmacy.

Please clarify if acute care hospitals, critical access hospitals, specialty hospitals, inpatient psychiatric

facilities, etc. are excluded from R 338.588a 2(b).

R 338.588b Automated devices in medical institutions.

Rule 88b. (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 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.

The suggested modifications attempt to reduce confusion related if the pharmacist is the default standard

for stocking the automated device, since there is not an explicit language referencing stocking by a

pharmacist. Above statements reference ‘controlled by a pharmacy’, not controlled by a pharmacist.

MHA Comments – Administrative Rules for Pharmacy – General Rules

June 2, 2023

Page 3

Please contact me at rsmiddy@mha.org if you have any questions regarding these comments or if you

need additional information.

Respectfully submitted,

Renée Smiddy

Senior Director, Finance Policy

Archived: Thursday, June 22, 2023 11:47:19 AM

Sent: Friday, May 26, 2023 3:11:21 PM

Subject: FW: Attention Departmental Specialist- BOP General Rules Comments

Response requested: No

Sensitivity: Normal

Attachments:

UMH Comments on BOP General Rules Revisions 2023.docx ;

Hi Andria,

Please see below and attached.

-Kimmy

From: Tharp, Jamie <jcburke@med.umich.edu>

Sent: Friday, May 26, 2023 3:07 PM

To: BPL-BoardSupport <BPL-BoardSupport@michigan.gov>

Cc: Tharp, Jamie <jcburke@med.umich.edu>

Subject: Attention Departmental Specialist- BOP General Rules Comments

CAUTION: This is an External email. Please send suspicious emails to abuse@michigan.gov

Attention Departmental Specialist-

I am writing to submit comments and suggested revisions to the Board of Pharmacy General Rule draft revisions. Please see

attached for a copy of the changes suggested by me as the Assistant Director of Compounding Compliance for the University

of Michigan Health.

Deadline for comment: 6/2/23 17:00

Thoughtfully,

Jamie Tharp

Jamie Tharp, PharmD, BCSCP | she/her/hers

Assistant Director, Compounding Compliance | Department of Pharmacy

jcburke@med.umich.edu |page:7730 | 734-678-7933 (prefer texts)

**********************************************************

Electronic Mail is not secure, may not be read every day, and should not be used for urgent or sensitive issues

Page 1 of 2

Comment Submission for: April 2023 Pharmacy-General Rules

Comment Deadline: June 2, 2023

Comments Submitted: May 26, 2023

Commenter’s Name:

Jamie Tharp, PharmD, BCSCP

Position:

Full Contact Details:

Assistant Director of Pharmacy- Compounding Compliance jcburke@med.umich.edu

University of Michigan Health

General Comments:



The 2023 revisions to the Pharmacy-General Rules that restrict the applicable compounding standards to fixed version dates will result in

o

disparities with standards adherence for pharmacies and outsourcing facilities that are surveyed/inspected for out-of-state licenses, federal

entities (FDA, CMS, etc) and other accrediting agencies who will update their evaluation criteria to be aligned with revised USP standards.

licensees will also find it difficult to obtain continuing education that aligns with past versions of USP and may become confused by learning

opportunities that reflect the revised standards.

o

USP chapters are periodically revised to reflect changing expert consensus and scientific advancements. The chapter revisions are led by expert

committees made up of individuals with significant expertise in the field and also include FDA representatives.¹Revisions undergo public comment period

review and subsequent revisions. Chapter revisions are generally released 6-12 months before their official dates. USP provides guidance about their

recommendations if the revised chapters should be early adopted. In the case of the 2022 revisions of USP 797/795, USP encouraged compounders to

early adopt the chapters.²

It is my recommendation that the Michigan Board of Pharmacy allow the adoption of revised versions of USP chapters, with the adoption to early adopt

before the official date if so recommended by USP. Additionally, I recommend that revisions to cGMP standards be allowed for outsourcing facilities.

References: ¹USP and FDA Working Together to Protect Public Health https://www.usp.org/public-policy/usp-fda-roles accessed 5/11/23 ;

²USP Chapter Revision announcement and encouragement to early adopt https://go.usp.org/Revisions_Announcement_USP_GC_USP_795_and_797 accessed 5/11/23

Specific Comments:

Section(s)

Suggested change:

Comment/Rationale

(Provide the revised suggestion to replace the existing text.)

Suggest deleting the chapter version dates from USP 795 and 797

and adding a statement to allow adoption of future revisions as

follows:

The board approves and adopts by reference the compounding

standards of the United States Pharmacopeia (USP), published by

the United States Pharmacopeial Convention, 12601 Twinbrook

R 338.533

Rule 33. (1)

Allowing pharmacies to adopt USP standards as they are revised will

minimize confusion between state and federal inspections and

accrediting bodies. It is expected that most other states and federal

agencies will recognize revised USP standards and will expect Michigan

licensed pharmacies and licensees to adhere to the current versions of

USP Chapters.

Parkway, Rockville, Maryland, 20852-1790. This includes, but is not Michigan licensed pharmacies will likely have to adopt the strictest

limited to, USP Chapters 795 and 797.Revisions to USP chapters

shall be adopted by the official date or earlier as encouraged by

USP, unless otherwise stated by the Board.

standards of all chapter versions to ensure compliance with Michigan

General Pharmacy Rules and external state licenses and federal

agencies. This will disadvantage Michigan Pharmacies and likely cause

undue financial and labor resources to maintain compliance with

multiple versions of USP.

Page 2 of 2

Section(s)

Suggested change:

(Provide the revised suggestion to replace the existing text.)

Comment/Rationale

R 338.533

Rule 33. (2)

(2) The standards adopted by reference in subrule (1) of this rule

are available for purchase at http://www.usp.org/compounding , or Pharmacies and licensees must purchase or subscribe to USP to gain

USP no longer provides free copies of compounding chapters.

at a cost of 10 cents per page from the Board of Pharmacy, Bureau

of Professional Licensing, Michigan Department of Licensing and

Regulatory Affairs, Ottawa Building, 611 West Ottawa, P.O. Box

30670, Lansing, Michigan, 48909.

access the chapters.

R 338.533

Rule 33. (3)

(3) A pharmacy that provides compounding services shall comply

with all applicable current standards adopted in subrule (1) of this

rule.

The use of the phrase “current standards” is in conflict with the

proposed fixed versions of USP being proposed in subrule (1) of this

rule. I support leaving “current standards” in this sentence if my

proposed changes to subrule (1) are adopted.

R 338.533

Rule 33. (4)

(4) An outsourcing facility located in this state or that dispenses,

provides, distributes, or otherwise

furnishes compounded pharmaceuticals in this state shall must be

It may not be possible for an outsourcing facility to coordinate an FDA

inspection before applying for a pharmacy license in the state if they

are operating within the state of Michigan. Consider aligning this

standard with the Sterile Compounding Pharmacy Licensing

inspected and registered as an outsourcing facility by the United

States Food and Drug Administration (FDA) prior to before applying requirement R 338.534a (2) An applicant for an in-state pharmacy

for a pharmacy license in this state.

license that intends to compound sterile pharmaceutical products shall

complete both of the following:

(a) Obtain an inspection from the department or its designee for the

purpose of meeting R 338.536 and R 338.537 for initial licensure.

(b) Within 6 months after initial licensure under this subrule, a

pharmacy shall obtain, and provide to the department, a subsequent

inspection to assess adherence to cGMP

R 338.533

Rule 33. (5)

Suggest deleting a fixed reference date to cGMP standards

(b) Compound drugs pursuant tounder current good manufacturing processes. Holding outsourcing facilities to outdated cGMP standards

Similar to USP standards, cGPM standards are revised through rigorous

practices for finished pharmaceuticals set forth in 21 CFR 211.1 to

211.208 ().

will cause significant issues with their ability to meet expectations from

out of state and federal entities, who will likely require adherence to

future standards revisions.

Per the FDA 503B Registration FAQ(LINK )- it is the FDAs intention to

visit newly registered 503B entities within 2 months of registration.

Archived: Thursday, June 22, 2023 11:30:57 AM

Sent: Monday, June 5, 2023 7:04:12 AM

Subject: FW: Administrative Rules for Pharmacy - General Rules Comments

Response requested: No

Sensitivity: Normal

From: Jeffrey Thomas <jeffrey.thomas@ascension.org>

Sent: Friday, June 2, 2023 4:16 PM

To: BPL-BoardSupport <BPL-BoardSupport@michigan.gov>

Subject: Administrative Rules for Pharmacy - General Rules Comments

CAUTION: This is an External email. Please send suspicious emails to abuse@michigan.gov

Dear Departmental Specialist,

Thank you for the opportunity to comment on the proposed revisions to the Pharmacy General Rules. Please see my

comments below. Thank you for your time and consideration.

Michigan BOP Proposed

Revision

Comments

R 338.533 Compounding standards

and requirements; outsourcing

facilities;

Suggestion: Delete the phrase “not limited to” and remove the reference

to chapter version dates from USP 795 and 797. Update this section to

adopt “current compendial chapters of USP 795 and 797”.

requirements.

Rationale: It is anticipated that other regulatory and accrediting bodies

(e.g. Joint Commission) will utilize the revised USP standards when

evaluating Michigan pharmacies. This would result in state licensed

pharmacies having to adopt the strict requirements in the updated

chapters without realizing any of the corresponding benefits (e.g.

extended BUDs) and leading to increased operational costs and waste.

Also, the new standards are more in alignment with the FDA definition of

compounding. For multi-state health-systems (like Ascension)

attempting to standardize practice, state-specific compounding policies

and metrics would need to be established for MI sites. Also, for MI

pharmacies licensed outside of the state (e.g. home infusion), other

states may not accept sterile products from MI pharmacies, which would

result in a loss of business. Most recognized training programs (e.g.

ASHP) will update their training and resources to reflect current USP

standards, which will result in confusion for pharmacists licensed in the

state of Michigan and both in-state and out-of-state pharmacy

Rule 33. (1) The board approves and

adopts by reference the compounding

standards of the United States

Pharmacopeia (USP), published by the

United States Pharmacopeial

Convention, 12601 Twinbrook

Parkway, Rockville, Maryland,

20852-1790. This includes, but is not

limited to, USP Chapters 795

(revised 2014) and 797 (revised

2008).

(2) The standards adopted by

reference in subrule (1) of this rule are

available at no cost at

http://www.usp.org/compounding, or

at a cost of 10 cents per page from the students/residents being trained at MI facilities.

Board of Pharmacy, Bureau of

Professional Licensing, Michigan

Department of Licensing and

Regulatory Affairs, Ottawa Building,

611 West Ottawa, P.O. Box 30670,

Lansing, Michigan, 48909.

(3) A pharmacy that provides

compounding services shall comply

with all applicable current standards

adopted in subrule (1) of this rule.

(4) An outsourcing facility located in

this state or that dispenses, provides,

distributes, or otherwise

furnishes compounded pharmaceuticals

in this state shall must be inspected

and registered as an outsourcing facility

by the United States Food and Drug

Administration (FDA) prior to before

applying for a pharmacy license in this

state.

R 338.591 Dispensing emergency Suggestion: Change to also include insulin analogs

supply of insulin.

Rationale: Since many patients are prescribed insulin analogs (e.g.

lispro, aspart), adding this language would clarify that the emergency

supply also pertains to these agents.

Rule 91. (1) A pharmacist may

dispense an emergency supply of

insulin to an individual if the

pharmacist complies with all of the

following:

(a) The requirements in section

17744f of the code, MCL

333.17744f.

(b) An emergency supply of

insulin may only be dispensed from

a pharmacy with real time access to

the qualified prescription for

insulin.

(c) Only 1 emergency supply, as

that term is defined in MCL

333.17744f, may be dispensed per

qualified prescription.0

(2) If the smallest single package

of insulin available exceeds a 30-

day supply, dispensing the package

of insulin that is available complies

with this rule and section 17744f of

the code, MCL 333.17744f.

Jeffrey Thomas, BS, PharmD

Area Clinical Operations Manager - MI & NY Markets

Pharmacy Clinical Operations

t: 734-560-5071

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Archived: Thursday, June 22, 2023 11:44:23 AM

Sent: Thursday, June 1, 2023 2:50:31 PM

Subject: FW: Comments for Proposed Rules for 6/2/23 Public Hearing

Response requested: No

Sensitivity: Normal

From: Chad Whitefield <chad@univrx.com>

Sent: Thursday, June 1, 2023 2:36 PM

To: BPL-BoardSupport <BPL-BoardSupport@michigan.gov>

Subject: Comments for Proposed Rules for 6/2/23 Public Hearing

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Hello, please find our comments below regarding the Proposed Draft Rule Language and our Requests for Change.

Proposed Language

Comment

R 338.533 (1) The board approves and adopts by reference the

compounding standards of the United States Pharmacopeia (USP),

published by the United States Pharmacopeial Convention, 12601

Twinbrook Parkway, Rockville, Maryland, 20852-1790. This

includes, but is not limited to, USP Chapters 795 (revised 2014) and

797 (revised 2008).

MPA opposes the addition of dates to this rule language. We

second this opposition. The proposed language creates a situation

in which pharmacies are required to comply with outdated

standards rather than the most current versions. Pharmacies may

also be put in a situation where they might need to comply with the

latest versions under federal law or for the purpose of

accreditation by a non-governmental entity. This may not be

possible as revised standards may conflict sufficiently with older

versions that simultaneous compliance with both old and new

versions is not feasible. Additionally, adding these dates punishes

pharmacies that have sought to become compliant with upcoming

versions of the standards in advance of official publication.

Suggested Revision:

R 338.555 (1) The board approves and adopts by reference the

current good manufacturing practice for finished pharmaceuticals

regulations set forth in 21 CFR 211.1 to 211.208 (20212022).

Do not specify the revision dates for USP 795 and 797 in R

338.533(1).

Remove the 2021 revision date for cGMP in R 338.555 (1), but do

not replace it with the 2022 date.

Thank you,

Chad Whitefield, RPh, BCSCP

Pharmacist-In-Charge

University Compounding Pharmacy

6054 Livernois Rd.

Troy, MI 48098

Phone: 877-531-1147

Fax:

866-531-1826

www.univrx.com

Helping one patient at a time live their best life

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From: Maria Young

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