From:

BPL-BoardSupport

To:

Ditschman, Andria (LARA)

Subject:

Date:

Attachments:

FW: Public Comment on Pharmacy Controlled Substances Rules 2020-82 LR

Thursday, September 2, 2021 12:11:23 PM

CSrule comments.docx

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

Sent: Thursday, September 2, 2021 11:39 AM

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

Subject: Public Comment on Pharmacy Controlled Substances Rules 2020-82 LR

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

Attention: Policy Analyst,

Please find attached Public Comments on Pharmacy Controlled Substances Rules 2020-82 LR.

Thanks,

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.

Public Comment on Pharmacy Controlled Substances Rules 2020-82 LR

Rose Baran Pharm. D.

Comments on rule 338.3151

Other than the beginning inventory the rule does not state the annual inventory must be kept at

the licensed location. Add to “ (5) A licensee shall maintain the inventory in a written,

typewritten, or printed form at the licensed location. The inventory taken by use of an oral

recording device shall must be promptly transcribed.”

Rule 338.3153

Voided DEA 222 forms must be kept at the licensed location see 21 CFR 1305.17.

Add to “(a) A licensee may keep Acquisition acquisition records, except for executed or voided

DEA 222 order forms, may be in an electronic form kept at a central location, with notice to

the department. subject to the approval of the administrator. The approval shall specify the

nature of the acquisition records to be kept and the exact location where the acquisition records

will be kept. All records shall be readily retrievable within 48 hours.”

The rule no longer states schedule 3, 4 and 5 invoices and acquisition records must be

maintained, add this back to 338.3153(b).

Sept. 9, 2021

Department of Licensing and Regulatory Affairs

Bureau of Professional Licensing

Pharmacy – Controlled Substances

MOAHR #2020-82 LR

Attention: Policy Analyst

P.O. Box 30670

Lansing, MI 48909

BPL-BoardSupport@michigan.gov

Dear Policy Analyst:

On behalf of the Michigan Health & Hospital Association (MHA), we respectfully submit the following

comments on the Pharmacy – Controlled Substances Rule Set.

The MHA is supportive of the proposed change in R 338.3111, Rule 11 where the Board is proposing to

adopt the complete list of drugs and other substances under the Controlled Substance Act (CSA) of 1970,

21 USC 801, that have been divided into five schedules as published in 21 CFR 1308.11 to 1308.15 . The

change modernizes the rule set and allows it to more easily remain up to date. This also eliminates any

confusion since it aligns with the federal level outside of a few exceptions in state law.

The MHA is supportive of the proposed change in R 338.3137, Rule 37 where the Bureau is waiving the

Drug Treatment Program Prescriber License that is currently required. This is removing a barrier to

patient access to care and sustained recovery since primary care physicians will be able to assist in

prescribing buprenorphine for substance use treatment without getting and maintaining an additional

license. Prescribers are already required to have a Michigan Controlled Substance License to prescribe

controlled substances pursuant to statute and rule. To help provide clarity, we recommend referencing

the Drug Treatment Program Prescriber License so providers understand which license is being

discussed.

To provide consistency between the Rules and Code and to avoid confusion, the MHA recommends

stating electronic transmission exceptions are allowed in Michigan in certain instances. Therefore, the

MHA agrees with other healthcare stakeholders that R 338.3162a (4) should be amended to the

following:

(4) Effective October 1, 2021, or the date established by the federal Centers for Medicare and

Medicaid Services for the Medicare electronic transmission requirement, whichever occurs later,

prescribers shall, unless an exception under section 17754a of the code, MCL 333.17754a,

applies, electronically transmit a prescription for a controlled substance consistent with both of

the following requirements:

(a) All the requirements in section 17754a of the code, MCL 333.17754a, are met.

(b) All the requirements in R 338.3161 are met.

MHA Comments

Department of Licensing and Regulatory Affairs

Bureau of Professional Licensing

Sept. 9, 2021

Page 2

As well as clarifying language in subrule (5)(b)(iv) “The prescriber demonstrates attests to exceptional

circumstances including, but not limited to, the following…” The word “demonstrates” indicates there will

be a process in place where a prescriber will need to submit tangible evidence. However, we believe the

intent was for the provider to declare or formally certify in writing. An attestation should suffice with the

department’s ability to follow up.

Thank you for your consideration of our comments.

Respectfully submitted,

Adam Carlson

Vice President, Advocacy

Michigan Health & Hospital Association

Desk: (517) 886-8245 | Cell: (269) 757-2479

acarlson@mha.org

Deeb D. Eid, PharmD | One CVS Drive | Mail Code2325 | Woonsocket, RI 02895 | T: 616-490-7398

September 6^th, 2021

Andria Ditschman, JD

Senior Policy Analyst

Bureauof ProfessionalLicensing, MichiganDepartment of Licensing and RegulatoryAffairs (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 Controlled Substances(MOAHR #2020-82 LR)

Dear Andria and BoardMembers:

I amwriting to you in my capacityas Advisor of RegulatoryAffairs for CVS Healthand its family of pharmacies. CVS

Health, the largest pharmacyhealth care provider in the United States, is uniquely positioned to provide diverse

access points of care to patients in Michiganthrough our integratedofferings across the spectrumof pharmacy care.

CVS Healthappreciates the opportunity to submit comments on the proposed rules for PharmacyControlled

Substances regulations. We would alsolike to thank the Department andBoard for their vigilance to continuously

improve the laws and regulations that guide pharmacists, pharmacyinterns, andpharmacytechnicians serving

Michigan’s patients.

CVS Healthsupports the majority of updates the Department and Boardhave proposed to streamline and modernize

the Controlled Substance rules. These changes include scheduling changes, licensing for pharmacists, prescribing

scope, theft and diversion reporting, recordkeeping, and telepharmacyamongst others.

There are a few sections we suggest couldbe strengthenedto better align withfederal laws, improve patient safety,

and overall outcomes. These recommended changes can be found in the Appendix section which highlights the rules,

comments, proposed language, andany citations or additional information or questions to consider.

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

616-490-7398 if you have any questions.

Sincerely,

DeebD. Eid, PharmD, RPh

Advisor, PharmacyRegulatoryAffairs

CVS Health

deeb.eid@cvshealth.com

Deeb D. Eid, PharmD | One CVS Drive | Mail Code2325 | Woonsocket, RI 02895 | T: 616-490-7398

Appendix

1. SuggestedRule Language Changes:

Part 3 Licenses

R338.3131 Controlled Substance License

(8) The following activities require a separate controlled substance license.

(g) A pharmacy stocking patient medication in an automateddevice located at an affiliated hospitallocation

pursuant to section17760 ofthe code, MCL 333.17760, or a hospital, county medicalcare facility, nursing home,

hospice, or other skilled nursingfacility as defined in section 20109 of the code, MCL 333.20109. The pharmacy

responsible for the device shallobtain an additionalcontrolled substance license for each location. Ifsubstances

are stored at a health facility without an onsite pharmacy or an automateddevice stocked by a pharmacy, a

designated prescriber shallobtain a controlled substance license. This requirement shallnot apply to emergency

kits (automated or non)being used for emergency situations.

Rationale: In 2016, the AmericanSociety of Consultant pharmacist posedthe question to the DEAabout whether

emergencykits (ekits)needed to obtain separate registrations basedon21 CFR 1301.27 and policy statement 70

FR24128 from 4/9/80. The DEAadvised that ekits whether they are electronic or not remain subject to the previous

policy set forth and do not require separate registration provided they satisfythe requirements of the policy. The DEA

alsostresses intheir letter the ekit must be in use for emergencypurposes only to be an exception to the registration

requirement.

We are recommending adding in an exception for emergencykits to ensure alignment with DEA/federalguidance and

to avoid extra regulatoryburden.

References:

•

https://cdn.ymaws.com/ascp.site-ym.com/resource/collection/6F78F67D-C454-4D89-BCE1-

F0C7A17755B3/November_30_DEA_Response_Letter.pdf

2. Proposed Rule Language:

R 338.3153 Invoices, acquisition, dispensing, administration, and distribution records.

Rule 53. (1) For 2 years, A licensee shallkeep and make available for inspection maintain in the pharmacy

responsible for the automateddevice, for reviewby the department, an agency, or the board, allrecords for

controlled substances, including invoices, and other acquisition records, but excluding and sales receipts, however, a

copy of each receipt shall be retainedfor 90 days.as follows:

(c) A licensee shall retain sales receipts for 90 days.

Comments:

•

Suggestionthat the term“sales receipt” be further defined to provide clarity and to explain whether sales

receipts may be storedelectronically or not.

3. SuggestedRule Language Changes:

R 338.3154 Medication records in medicalinstitutions.

Rule 54.

(xix) The use of the automated device that includesa requirement that a pharmacist reviewa prescription or

medication order before systemprofiling or removalofany medication fromthe automated device for immediate

patient administration,except in the following situations where a pharmacist shallreviewthe orders and authorize

any further dispensingwithin 48 hours:

Deeb D. Eid, PharmD | One CVS Drive | Mail Code2325 | Woonsocket, RI 02895 | T: 616-490-7398

(A) The automated device is being used as an after-hours cabinet for medication dispensingin the absence of

a pharmacist under R 338.486(4)(j).

(B) The systemis being used in place of an emergency kit under R 338.486(4)(c).

Rationale: In the same letter response mentioned early from the DEAto the AmericanSociety of Consultant

Pharmacists in2016, they specificallystate “It also bears emphasis that, in accordance with the CSA and DEA

regulations, a controlledsubstance may only be dispensed for emergencypurposes (or otherwise) pursuant to a valid

prescription. Thus, where, asin the scenario describedin your letter, the kit is maintainedat the LTCF by a pharmacy,

controlledsubstances may not be dispensed from the kit for emergencies prior to receipt by the pharmacist of a

valid prescription in accordance with the requirements of in 21 CFR §§ 1306.11 and 1306.21.” Federallaw

differences stricter thanthis exemption createdby the new rule will create confusion amongst licensees. Toensure

compliance with the stricter federallaws, it is recommended to strike the exception for emergencykits.

References:

•

https://cdn.ymaws.com/ascp.site-ym.com/resource/collection/6F78F67D-C454-4D89-BCE1-

F0C7A17755B3/November_30_DEA_Response_Letter.pdf

•

21 CFR 1306.11: https://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_11.htm

21 CFR 1306.21: https://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_21.htm

4. Proposed Rule Language:

R 338.3162a Electronic transmissionof prescriptions prescription; waiver ofelectronic transmission

Rule 62a.

Comments:

Generally, states donot place the burden upon the pharmacist to determine whether the controlled substance

prescription correctlyfalls under an exception to the requirements to electronicallyprescribe. There is currently

language within MCL 333.17754a (8) that provides for a route for pharmacist toexercise their judgement without

having to determine whether an exception applies. Arkansas, California, Iowa, Kansas,Kentucky, Missouri, Nevada,

New York, South Carolina, Tennessee, andVirginia are just some of the states that have imposed electronic

prescribing requirements on prescribers but have continued to allow pharmacists todispense all otherwise lawful

prescriptions, regardless offormat. It may not be needed to copy the statute language withinthe rule unless the

Department/Boardsees fit for clarity.

References:

•

http://www.legislature.mi.gov/(S(pjk3ae1byhmej1ecdz4nz1wl))/mileg.aspx?page=getObject&objectName=m

cl-333-17702

From:

BPL-BoardSupport

To:

Subject:

Date:

Ditschman, Andria (LARA)

FW:

Wednesday, September 8, 2021 10:59:31 AM

image001.png

Attachments:

From: Mankowski, Alicia <Alicia.Mankowski@meijer.com>

Sent: Wednesday, September 8, 2021 9:44 AM

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

Subject:

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

September 8, 2021

Department of Licensing and Regulatory Affairs

Bureau of Professional Licensing– Boards and Committees Section

P.O. Box 30670

Lansing, MI 48909-8170

Dear Policy Analyst

I am submitting this public comment about MOAHR #2020-82LR, the proposed ruleset for

Pharmacy – Controlled Substances.

1. The proposed ruleset needs to add the following citations to its authority paragraph, as they

also authorize these rules:

MCL 333.16141, MCL 333.16201, MCL 333.16204, MCL 333.16204e, MCL 333.16205,

MCL 333.16215, MCL 333.16287, MCL 333.17707, MCL 333.17721, MCL 333.17739,

MCL 333.17742a, MCL 333.17742b, MCL 333.17748e, MCL 333.17754a, MCL, MCL

MCL 333.17775.

2. R 338.3162a Electronic transmission of prescription; waiver of electronic transmission.

The effective date of this rule states October 1, 2021 (or appropriately the statutory delay

based on CMS’s electronic transmission requirement for Medicare). The General Rules for

pharmacy have updated this date to January 1, 2022 and the same should be done in this

ruleset.

Thank you for the opportunity to submit public comments.

Alicia Mankowski | Pharmacy Compliance Specialist

Meijer | 989/1 | 2350 3 Mile Road NW | Grand Rapids, MI 49544

P: 616-791-2654

Alicia.Mankowski@meijer.com

From:

Mollien, Charlie

To:

Subject:

Date:

Ditschman, Andria (LARA)

RE: CS rules

Thursday, September 9, 2021 8:22:16 AM

image003.png

Attachments:

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

Yes, my comment is:

The rules do not address or provide clarity for a definition of what a “cash” transaction is for

purposes of reporting “the prescription payment type” under R 338.3162b(1)(q). The rule should add

a definition or explain what payment types are considered “cash” under the ASAP 4.1 reporting

requirements, which should include cash prices at U&C and, only for purposes of reporting to

MAPS, any discount card used that is not regulated under the Insurance Code (e.g. GoodRx, etc.)

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

Sent: Wednesday, September 8, 2021 12:00 PM

To: Mollien, Charlie <Charlie.Mollien@meijer.com>

Subject: FW: CS rules

Hi Charlie,

You had sent this to me in May. Do you want to make this comment or is your concern addressed in

the proposed rules?

Andria M. Ditschman, JD

Senior Policy Analyst

Boards and Committees Section

Bureau of Professional Licensing

Michigan Department of Licensing and Regulatory Affairs

611 W. Ottawa Street

P.O. Box 30670

Lansing, Michigan 48909

Office: (517) 241-9255

ditschmana@michigan.gov

CONFIDENTIALITY NOTICE: The information contained in this email message from the Michigan Department of Licensing & Regulatory

Affairs is intended solely for the use of the above named recipient(s) and may contain confidential and/or privileged information. Any

unauthorized review, use, disclosure, or distribution of any confidential and/or privileged information contained in this email is expressly

prohibited. If you are not the intended recipient, please contact the sender by reply e-mail and destroy any and all copies of the original

message.

From: Mollien, Charlie <Charlie.Mollien@meijer.com>

Sent: Friday, May 28, 2021 7:31 AM

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

Subject: CS rules

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

I think this needs to make its way into the CS Rules – for purposes of reporting CS dispensings to

MAPS, “discount cards” are considered cash transactions. We can talk more.

Charlie

VIA email at BPL-BoardSupport@michigan.gov

September 9, 2021

Department of Licensing and Regulatory Affairs

Bureau of Professional Licensing– Boards and Committees Section

Attention: Policy Analyst

P.O. Box 30670

Lansing, MI 48909-8170

Re: Administrative Rules for Pharmacy – Controlled Substances (MOAHR #2020-82 LR)

Dear Policy Analyst:

I am writing on behalf of the Michigan State Medical Society (MSMS) regarding proposed Rule

Set 2020-82 LR (Administrative Rules for Pharmacy – Controlled Substances) (the “Proposed Rule

Set”) which updates and clarifies regulations including, but not limited to, the scheduling of

controlled substances and education and licensure requirements for the prescribing, dispensing,

and administering of controlled substances. MSMS represents approximately 15,000 Michigan

physicians, residents, and medical students of all specialties and practice settings. In general,

MSMS supports the Proposed Rule Set and the Department’s attempts to ensure appropriate

alignment with federal statutory and regulatory provisions, as well as greater clarity pertaining to

prescriber obligations.

MSMS offers the following comments to the Proposed Rule Set:

Elimination of the Michigan Drug Treatment Program Prescriber License

MSMS strongly supports the Department’s proposed elimination of the requirement for a

separate controlled substance license for prescribing, dispensing, or administering a controlled

substance to a drug dependent person in a drug treatment and rehabilitation program presently

addressed in Mich Admin Code R. 333.3132(1)(f), also known as the Drug Treatment Program

Prescriber license requirement. The Michigan Drug Treatment Program Prescriber license is

neither acknowledged nor authorized by the Michigan Public Health Code.

MSMS believes this elimination is consistent with the state’s policy goals of ensuring greater

access to treatment for persons diagnosed with opioid use disorder. For these reasons and as

further discussed below, MSMS believes that proposed Rule 37 should be eliminated in its entirety.

R 338.3132 Controlled Substance License

Subrules (3) and (8) appear to be both duplicative and contradictory. For clarity purposes, MSMS

suggests that activities requiring a separate controlled substance licenses be included in subrule

(3), while exceptions to that requirement be addressed in subrule (8) and (9). MSMS believes that

subrules (3) and (8) should be revised to read as follows:

September 9, 2021

Department of Licensing and Regulatory Affairs

Bureau of Professional Licensing– Boards and Committees Section

Page 2

(3) Except as otherwise provided in subrules (8) and (9) of this rule, a separate controlled

substance license is required in each of the following circumstances:

(a) For each principal place of business or professional practice where the applicant

stores, manufactures, distributes, prescribes, or dispenses controlled substances.

(b) Manufacturing and distributing a controlled substance in schedules 2-5. An

individual, partnership, cooperative, association, private corporation, other legal entity, or

governmental entity that is licensed in this state to manufacture a controlled substance

listed in schedules 2 to 5 may also conduct chemical analysis and research with a substance

that is listed in the schedules under the same controlled substance license.

(c) Dispensing a controlled substance listed in schedules 2 to 5. A prescriber or

practitioner who is licensed in this state to prescribe or dispense controlled substances

listed in schedules 2 to 5 may also prescribe, dispense, administer, and conduct research

with those substances under the same controlled substance license.

(d) Conducting research and instructional activity with a controlled substance listed

in schedule 1. An individual, partnership, cooperative, association, private corporation,

other legal entity, or governmental entity that is licensed in this state to conduct research

with controlled substances listed in schedule 1 may do both of the following:

(i) Manufacture the specific substances as set forth in the research protocol

that is filed and approved by the FDA and the DEA pursuant to the provisions of 21 CFR

1301.18 and submitted to the department with the application for licensure.

(ii) Distribute the specific substances to others who are licensed by this state

to conduct research or chemical analysis with the schedule 1 substances.

(e) Conducting research with a controlled substance listed in schedules 2 to 5. An

individual, partnership, cooperative, association, private corporation, other legal entity, or

governmental entity who is licensed in this state to conduct research with the controlled

substances listed in schedules 2 to 5 may also participate in all of the following activities:

(i) Conduct chemical analysis with the specific substances listed in those

schedules.

(ii) Manufacture the specific substances if, and to the extent that, the

manufacture of the specific controlled substances is set forth in a statement filed with the

application for licensure,.

(iii) Distribute the specific substances to others who are licensed in this state

to conduct research, chemical analysis, or instructional activity with the substances,.

(iv) Conduct instructional activities with the specific substances.

(f) Conducting instructional activities with a specific controlled substance listed in

schedules 2 to 5.

(g) Conducting chemical analysis with a controlled substance listed in any schedule.

An individual, partnership, cooperative, association, private corporation, other legal entity,

or governmental entity that is licensed in this state to conduct chemical analysis with all

controlled substances may manufacture the substances for analytical or instructional

purposes, distribute the substances to others who are licensed to conduct chemical

analysis, instructional activity or research with the substances, and conduct instructional

activities with the substances.

September 9, 2021

Department of Licensing and Regulatory Affairs

Bureau of Professional Licensing– Boards and Committees Section

Page 3

(h) A pharmacy stocking patient medication in an automated device located at an

affiliated hospital location pursuant to section 17760 of the code, MCL 333.17760, or a

hospital, county medical care facility, nursing home, hospice, or other skilled nursing

facility as defined in section 20109 of the code, MCL 333.20109. The pharmacy responsible

for the device shall obtain an additional controlled substance license for each location. If

substances are stored at a health facility without an onsite pharmacy or an automated

device stocked by a pharmacy, a designated prescriber shall obtain a controlled substance

license.

(8) A prescriber or practitioner who is licensed in this state to prescribe, administer, or

dispense controlled substances at a principal place of business or professional practice

consisting of multiple locations is not required to obtain a separate controlled substance

license for each additional physical location of the business or professional practice if the

prescriber or practitioner only prescribes controlled substances at each additional physical

location of the business or professional practice.

(9) A pharmacist shall maintain 1 controlled substance license in this state to dispense

from any licensed pharmacy in this state.

R 338.3137 Waiver of License Requirement

MSMS believes that the Department should eliminate proposed Rule 37. As stated above, MSMS

strongly supports the elimination of the Drug Treatment Program Prescriber license requirement

for prescribers who are authorized under federal law to prescribe, dispense or administer

controlled substances to individuals with substance use disorder. With the proposed elimination

of the requirement to have a separate controlled substance license for prescribing, dispensing, or

administering a controlled substance to a drug dependent person in a drug treatment and

rehabilitation program under Rule 32, proposed Rule 37 is both moot and confusing. It is also

duplicative of proposed Rule 63, which requires compliance with federal law to provide treatment

to a “drug-dependent individual.”

R 338.3162a Electronic Transmission of Prescription; Waiver of Electronic Transmission

Under subrules (1) and (4), MSMS encourages the Department to ensure the dates in the Proposed

Rule Set and the proposed Pharmacy – General Rules align with Public Acts 134, 135 and 136 of

2020. For this purpose, MSMS recommends that subrule (4) be amended to recognize the

exceptions to electronic transmissions permitted by MCL §333.17754a, as follows:

(4) Effective October 1, 2021, or the date established by the federal Centers for Medicare

and Medicaid Services for the Medicare electronic transmission requirement, whichever

occurs later, prescribers shall, unless an exception under section 17754a of the code,

MCL 333.17754a, applies, electronically transmit a prescription for a controlled

substance consistent with both of the following requirements:

(a) All the requirements in section 17754a of the code, MCL 333.17754a, are met.

(b) All the requirements in R 338.3161 are met.

September 9, 2021

Department of Licensing and Regulatory Affairs

Bureau of Professional Licensing– Boards and Committees Section

Page 4

MSMS also recommends subrule (5)(b)(iv) be amended to identify examples of qualifying

“exceptional circumstances, as follows:”

(iv) The prescriber demonstrates attests to exceptional circumstances including, but not

limited to, the following:

A. Prescribing fewer than “X” prescriptions (combined controlled and non-controlled

substances) per year.

B. Utilizing electronic transmission for non-controlled substances, but prescribing fewer

than “Y” controlled substance prescriptions per year. (Note: The cost of the enhanced

e-prescribing software for controlled substances is not fiscally responsible for some

prescribers who rarely prescribe them.)

C. Intention to cease practice within the next twelve months.

D. Limited practice due to an illness or other unforeseen event.

R 338.3163 Drug-dependent Individual; Prescribing, Dispensing, and Administering

Controlled Substances

MSMS believes that Rule 63 be eliminated or significantly revised for better clarity and consistency

with federal law. This proposed Rule is confusing and uses terminology that is inconsistent with

similar federal laws regarding the authorized prescribing, administering and dispensing of

controlled substances to an individual for treatment of substance use disorder. For example, the

proposed Rule fails to recognize that while not all “licensed health professionals” are “prescribers,”

all prescribers are licensed health professionals. Accordingly, the proposed Rule’s application of

contradictory standards for “prescribers” and “licensed health professionals” creates confusion for

the scope of authority of physicians and other prescribers to treat an individual for substance use

disorder, and negatively impacts access to substance use disorder treatment. Furthermore, the

term “drug-dependent individual” is not defined in the Proposed Rule Set and is not

acknowledged by the Public Health Code. MSMS questions whether there is a more appropriate

and person-first reference to these individuals than “drug-dependent individual.”

To the extent the Department seeks consistency with standards established by federal law and

regulations, MSMS recommends the Department specifically incorporate by reference such

federal laws and regulations.

Thank you for the opportunity to comment. Should you have any questions regarding our

recommendations, please contact Stacey P. Hettiger, MSMS Senior Director of Medical and

Regulatory Policy, at shettiger@msms.org . Your thoughtful consideration is appreciated.

Sincerely,

Julie L. Novak

Chief Executive Officer

September 9, 2021

Department of Licensing and Regulatory Affairs

Bureau of Professional Licensing

Boards and Committees Section

PO Box 30670

Lansing, MI 48909-8170

Dear Policy Analyst,

The Michigan Pharmacists Association (MPA) would like to thank the Michigan Board of Pharmacy within the

Michigan Department of Licensing and Regulatory Affairs for allowing us to submit our comments on the

proposed administrative rules 2020-82 LR, Pharmacy – Controlled Substances governing the Controlled

Substances rules for health professionals. MPA represents pharmacists, pharmacy technicians, and student

pharmacists across the state. We are strong proponents of offering increased access to care to all Michiganders

in a safe and effective way. We would like to take this opportunity to changes to these rules.

1. Regarding R338.3154 page 38 (vi) states “the name and license number” as a record requirement for

pharmacists checking the automated device. We feel that it is a cumbersome requirement to have our

institutional pharmacists input their license number every time they check the machines. We would

like to see the verbiage requiring the “license number” to be removed completely.

2. Regarding R338.3165 subsection 2(c) which specifies “dispensing pharmacist”. We believe this would

cause undue hardship on our relief pharmacists who may work at different pharmacies each day.

Would the dispensing relief pharmacist have to check each place of work to ensure compliance with

this rule?

3. Regarding R 338.3162b subsection 1(e) which specifies patient/client gender, subsection 1(l) which

specifies “number of refills authorized’, and subsection 1(m) which specifies “refill number of

prescription fill”. We question the need to include gender in the reporting requirements. We believe

that that the inclusion of these subsections requires additional unnecessary efforts on the pharmacy

to comply. For example, a pharmacist knows that if a prescription comes in for a schedule II there

would be no authorized refills, yet to comply with the administrative rules as drafted, would have to

report 0 refills. We ask that these reporting requirements be removed from the administrative rules.

Again, the Michigan Pharmacists Association would like to thank you for taking the time to review our

concerns. If you have any additional questions, I can be reached at the information below.

Sincerely,

Brian Sapita

Director of Government Affairs

Ph: 517-377-0254

Email: Brian@MichiganPharmacists.org

Pharmacy – Controlled Substances - ORR 2020-082 LR

Public Comment Summary

Rules Committee Recommendations and Board Review to September 9, 2021 Public Comments

Testimony/Comments Received:

Rose Baran, PharmD

Barry Cargill, President & CEO, Michigan HomeCare and Hospice Association (MHHA)

Adam Carlson, Vice President, Advocacy, Michigan Health & Hospital Association (MHA)

Deeb Eid, Advisor, Pharmacy Regulatory Affairs, CVS Health

Timothy Gammons, President, Michigan Society of Addiction Medicine (MISAM)

Kolinda Lambert

Alicia Mankowski, Pharmacy Compliance Specialist, Meijer

Charlie Mollien

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

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

Lori Smoker Young, Hospice Care of Southwest Michigan

General

Rule Numbers

Commenter

Lambert

Comment

Objected to controlled substances being limited to a certain amount as doctors are afraid to prescribe

medicines.

Rules Committee There is no recommendation as this does not relate to the rules.

Response

Rule 338.3132

Controlled substance license.

Rule Numbers

Commenter

Comment

October 4, 2021

Section (8)(g)

Eid

Add the following to the end of (g): This requirement shall not apply to emergency kits

(automated or non) being used for emergency situations.

Rationale: In 2016, the American Society of Consultant pharmacist posed the question to the DEA

about whether emergency kits (ekits) needed to obtain separate registrations based on 21 CFR

1301.27 and policy statement 70 FR24128 from 4/9/80. The DEA advised that ekits whether they

are electronic or not remain subject to the previous policy set forth and do not require separate

registration provided they satisfy the requirements of the policy. The DEA also stresses in their

letter the ekit must be in use for emergency purposes only to be an exception to the registration

requirement.

We are recommending adding in an exception for emergency kits to ensure alignment with

DEA/federal guidance and to avoid extra regulatory burden.

References:

• https://cdn.ymaws.com/ascp.site-ym.com/resource/collection/6F78F67D-C454-4D89-BCE1-

F0C7A17755B3/November_30_DEA_Response_Letter.pdf

Sections (3) and

(8)

Novak

Subrules (3) and (8) appear to be both duplicative and contradictory. For clarity purposes, MSMS

suggests that activities requiring a separate controlled substance licenses be included in subrule (3),

while exceptions to that requirement be addressed in subrule (8) and (9). MSMS believes that

subrules (3) and (8) should be revised to read as follows:

(3) Except as otherwise provided in subrules (8) and (9) of this rule, a separate controlled substance

license is required in each of the following circumstances:

(a) For each principal place of business or professional practice where the applicant stores,

manufactures, distributes, prescribes, or dispenses controlled substances.

(b) Manufacturing and distributing a controlled substance in schedules 2-5. An individual,

partnership, cooperative, association, private corporation, other legal entity, or governmental entity

that is licensed in this state to manufacture a controlled substance listed in schedules 2 to 5 may also

conduct chemical analysis and research with a substance that is listed in the schedules under the

same controlled substance license.

2

(c) Dispensing a controlled substance listed in schedules 2 to 5. A prescriber or practitioner who is

licensed in this state to prescribe or dispense controlled substances listed in schedules 2 to 5 may

also prescribe, dispense, administer, and conduct research with those substances under the same

controlled substance license.

(d) Conducting research and instructional activity with a controlled substance listed in schedule 1.

An individual, partnership, cooperative, association, private corporation, other legal entity, or

governmental entity that is licensed in this state to conduct research with controlled substances listed

in schedule 1 may do both of the following:

(i) Manufacture the specific substances as set forth in the research protocol that is filed and

approved by the FDA and the DEA pursuant to the provisions of 21 CFR 1301.18 and submitted to

the department with the application for licensure.

(ii) Distribute the specific substances to others who are licensed by this state to conduct research

or chemical analysis with the schedule 1 substances.

(e) Conducting research with a controlled substance listed in schedules 2 to 5. An individual,

partnership, cooperative, association, private corporation, other legal entity, or governmental entity

who is licensed in this state to conduct research with the controlled substances listed in schedules 2

to 5 may also participate in all of the following activities:

(i) Conduct chemical analysis with the specific substances listed in those schedules.

(ii) Manufacture the specific substances if, and to the extent that, the manufacture of the specific

controlled substances is set forth in a statement filed with the application for licensure,.

(iii) Distribute the specific substances to others who are licensed in this state to conduct research,

chemical analysis, or instructional activity with the substances,.

(iv) Conduct instructional activities with the specific substances.

(f) Conducting instructional activities with a specific controlled substance listed in schedules 2 to

5.

(g) Conducting chemical analysis with a controlled substance listed in any schedule. An individual,

partnership, cooperative, association, private corporation, other legal entity, or governmental entity

that is licensed in this state to conduct chemical analysis with all controlled substances may

manufacture the substances for analytical or instructional purposes, distribute the substances to

others who are licensed to conduct chemical analysis, instructional activity or research with the

substances, and conduct instructional activities with the substances.

3

(h) A pharmacy stocking patient medication in an automated device located at an affiliated hospital

location pursuant to section 17760 of the code, MCL 333.17760, or a hospital, county medical care

facility, nursing home, hospice, or other skilled nursing facility as defined in section 20109 of the

code, MCL 333.20109. The pharmacy responsible for the device shall obtain an additional

controlled substance license for each location. If substances are stored at a health facility without an

onsite pharmacy or an automated device stocked by a pharmacy, a designated prescriber shall obtain

a controlled substance license.

(8) A prescriber or practitioner who is licensed in this state to prescribe, administer, or dispense

controlled substances at a principal place of business or professional practice consisting of multiple

locations is not required to obtain a separate controlled substance license for each additional

physical location of the business or professional practice if the prescriber or practitioner only

prescribes controlled substances at each additional physical location of the business or professional

practice.

(9) A pharmacist shall maintain 1 controlled substance license in this state to dispense from any

licensed pharmacy in this state.

Rules Committee Section (8)(g) Eid - The Rules Committee declines to add the comment “this requirement shall not apply to emergency

Response

kits (automated or non) being used for emergency situations” as the ramifications to adding this exception to the

licensing requirement is not clear at this time and may not be in the best interest of the public.

Section (3) and (8) Novak – The Rules Committee agrees with the comment to reorganize (3) and (8) for clarity.

Board Response

Section (8)(g): The Board declines to add the comment “this requirement shall not apply to emergency kits

(automated or non) being used for emergency situations” as the ramifications to adding this exception to the

licensing requirement is not clear at this time and may not be in the best interest of the public.

Section (3) and (8) – The Board agrees with the comment to reorganize (3) and (8) for clarity.

R 338.3132 Activities requiring separate licenses Controlled substance license.

Rule 32. (1) The following activities are deemed to be independent of each other, shall be conducted under separate licenses, and

shall comply with all of the requirements and duties prescribed by law for persons who are licensed to engage in such coincidental

activities: A person who manufactures, distributes, prescribes, or dispenses a controlled substance in this state or who

proposes to engage in the manufacture, distribution, prescribing, or dispensing of a controlled substance in this state shall

4

apply for a controlled substance license by submitting to the department a completed application on a form provided by the

department along with the requisite fee.

(2) In addition to meeting the requirements of section 7303 of the code, MCL 333.7303, an applicant’s license shall be verified

by the licensing agency of any state of the United States in which the applicant holds or has ever held a controlled substance

license. This includes, but is not limited to, showing proof of any disciplinary action taken or pending against the applicant.

(3) Except for a prescriber or practitioner in subrule (8)(b)(ii) of this rule, a separate license is required for each principal

place of business or professional practice where the applicant stores, manufactures, distributes, prescribes, or dispenses

controlled substances.

Except as otherwise provided in subrules (8) and (9) of this rule, a separate controlled substance license is required in each of

the following circumstances:

(a) For each principal place of business or professional practice where the applicant stores, manufactures, distributes,

prescribes, or dispenses controlled substances.

(b) Manufacturing and distributing a controlled substance in schedules 2-5. An individual, partnership, cooperative,

association, private corporation, other legal entity, or governmental entity that is licensed in this state to manufacture a

controlled substance listed in schedules 2 to 5 may also conduct chemical analysis and research with a substance that is listed

in the schedules under the same controlled substance license.

(c) Dispensing a controlled substance listed in schedules 2 to 5. A prescriber or practitioner who is licensed in this state to

prescribe or dispense controlled substances listed in schedules 2 to 5 may also prescribe, dispense, administer, and conduct

research with those substances under the same controlled substance license.

(d) Conducting research and instructional activity with a controlled substance listed in schedule 1. An individual,

partnership, cooperative, association, private corporation, other legal entity, or governmental entity that is licensed in this

state to conduct research with controlled substances listed in schedule 1 may do both of the following:

(i) Manufacture the specific substances as set forth in the research protocol that is filed and approved by the FDA and the

DEA pursuant to the provisions of 21 CFR 1301.18 and submitted to the department with the application for licensure.

(ii) Distribute the specific substances to others who are licensed by this state to conduct research or chemical analysis with

the schedule 1 substances.

(e) Conducting research with a controlled substance listed in schedules 2 to 5. An individual, partnership, cooperative,

association, private corporation, other legal entity, or governmental entity who is licensed in this state to conduct research

with the controlled substances listed in schedules 2 to 5 may also participate in all of the following activities:

(i) Conduct chemical analysis with the specific substances listed in those schedules.

5

(ii) Manufacture the specific substances if, and to the extent that, the manufacture of the specific controlled substances is set

forth in a statement filed with the application for licensure,.

(iii) Distribute the specific substances to others who are licensed in this state to conduct research, chemical analysis, or

instructional activity with the substances,.

(iv) Conduct instructional activities with the specific substances.

(f) Conducting instructional activities with a specific controlled substance listed in schedules 2 to 5.

(g) Conducting chemical analysis with a controlled substance listed in any schedule. An individual, partnership, cooperative,

association, private corporation, other legal entity, or governmental entity that is licensed in this state to conduct chemical

analysis with all controlled substances may manufacture the substances for analytical or instructional purposes, distribute the

substances to others who are licensed to conduct chemical analysis, instructional activity or research with the substances, and

conduct instructional activities with the substances.

(h) A pharmacy stocking patient medication in an automated device located at an affiliated hospital location pursuant to

section 17760 of the code, MCL 333.17760, or a hospital, county medical care facility, nursing home, hospice, or other skilled

nursing facility as defined in section 20109 of the code, MCL 333.20109. The pharmacy responsible for the device shall obtain

an additional controlled substance license for each location. If substances are stored at a health facility without an onsite

pharmacy or an automated device stocked by a pharmacy, a designated prescriber shall obtain a controlled substance license.

(4) An applicant shall obtain a separate controlled substance license for each practitioner license issued under article 15 of

the code, MCL 333.16101 to 333.18838. The controlled substance license must be renewed when the article 15 license is

renewed and the controlled substance license is renewed for an equal number of years as the article 15 license.

(5) An applicant who intends to conduct research involving controlled substances shall submit all of the following with his or

her application required under subrule (1) of this rule:

(a) The applicant’s credentials to conduct the proposed research.

(b) The protocol and description of the nature of the proposed research that is filed and approved by the FDA and the

Federal Drug Enforcement Administration (DEA) pursuant to the provisions of 21 CFR 1301.18.

(c) A list of the controlled substances and doses to be used.

(6) An applicant who intends to conduct instructional activity involving controlled substances shall submit all of the following

information with his or her application required under subrule (1) of this rule:

(a) The applicant’s credentials to conduct the proposed instructional activity.

(b) A course outline for the proposed instructional activity.

(c) A list of the controlled substances and doses to be used.

6

(7) An applicant who intends to conduct chemical analysis involving controlled substances shall submit all of the following

information with his or her application required under subrule (1) of this rule:

(a) The applicant’s credentials to conduct the proposed chemical analysis.

(b) The protocol and description of the nature of the chemical analysis that is filed and approved by the FDA and the DEA

pursuant to the provisions of 21 CFR 1301.18.

(c) A list of the controlled substances and doses to be used.

(8) A prescriber or practitioner who is licensed in this state to prescribe, administer, or dispense controlled substances at a

principal place of business or professional practice consisting of multiple locations is not required to obtain a separate

controlled substance license for each additional physical location of the business or professional practice if the prescriber or

practitioner only prescribes controlled substances at each additional physical location of the business or professional practice.

(9) A pharmacist shall maintain 1 controlled substance license in this state to dispense from any licensed pharmacy in this

state.

Rule 338.3137

Rule Numbers

Rule 37

Waiver of license requirement.

Commenter

Comment

Carlson

The MHA is supportive of the proposed change in R 338.3137, Rule 37 where the Bureau is

waiving the Drug Treatment Program Prescriber License that is currently required. This is removing

a barrier to patient access to care and sustained recovery since primary care physicians will be able

to assist in prescribing buprenorphine for substance use treatment without getting and maintaining

an additional license. Prescribers are already required to have a Michigan Controlled Substance

License to prescribe controlled substances pursuant to statute and rule.

To help provide clarity, we recommend referencing the Drug Treatment Program Prescriber License

so providers understand which license is being discussed.

Rule 37

Novak

MSMS strongly supports the Department’s proposed elimination of the requirement for a separate

controlled substance license for prescribing, dispensing, or administering a controlled substance to a

drug dependent person in a drug treatment and rehabilitation program presently addressed in Mich

Admin Code R. 333.3132(1)(f), also known as the Drug Treatment Program Prescriber license

requirement. The Michigan Drug Treatment Program Prescriber license is neither acknowledged nor

authorized by the Michigan Public Health Code.

7

MSMS believes this elimination is consistent with the state’s policy goals of ensuring greater access

to treatment for persons diagnosed with opioid use disorder. For these reasons and as further

discussed below, MSMS believes that proposed Rule 37 should be eliminated in its entirety.

MSMS believes that the Department should eliminate proposed Rule 37. As stated above, MSMS

strongly supports the elimination of the Drug Treatment Program Prescriber license requirement for

prescribers who are authorized under federal law to prescribe, dispense or administer controlled

substances to individuals with substance use disorder. With the proposed elimination of the

requirement to have a separate controlled substance license for prescribing, dispensing, or

administering a controlled substance to a drug dependent person in a drug treatment and

rehabilitation program under Rule 32, proposed Rule 37 is both moot and confusing. It is also

duplicative of proposed Rule 63, which requires compliance with federal law to provide treatment to

a “drug-dependent individual.”

Rules Committee The Rules Committee agrees with the comments to provide clarity in the rule by stating that the Drug Treatment

Response

Program Prescriber license is eliminated not waived.

Board Response

The Board agrees with the comments to provide clarity in the rule by stating that the Drug Treatment Program

Prescriber license is eliminated not waived.

R 338.3137 Waiver of Eliminate drug treatment program prescriber license requirement.

Rule 37. (1) The drug treatment program prescriber license is eliminated. requirement of licensure is waived for the following

persons in the circumstances described in this rule: a prescriber, possessing a license issued under section 7303 of the code, MCL

333.7303, who meets both of the following:

(a) A prescriber, who in the course of his or her professional practice, prescribes, dispenses, or administers a controlled

substance listed in schedules 2 to 5 to a drug-dependent person for the purpose of maintenance or detoxification treatment.

(b) A prescriber who is registered with the DEA to provide maintenance or detoxification treatment and who complies with

federal law.

(a) An officer or employee of the drug enforcement administration while engaged in the course of official duties.

(b) An officer of the United States customs service while engaged in the course of official duties.

(c) An officer or employee of the United States food and drug administration while engaged in the course of official duties.

8

(d) A federal officer who is lawfully engaged in the enforcement of a federal law relating to controlled substances, drugs, or

customs and who is duly authorized to possess controlled substances in the course of that person's official duties.

(e) An officer or employee of the state of Michigan, or a political subdivision or agency thereof, who is engaged in the enforcement

of a state or local law relating to controlled substances and who is duly authorized to possess controlled substances in the course of

that person's duties.

(2) An official who is exempted from licensure by this rule may, when acting in the course of that person's official duties, possess a

controlled substance and may transfer a controlled substance to any other official who is also exempted by this rule and who is acting

in the course of that person's official duties.

(3) An official who is exempted by this rule may procure a controlled substance in the course of a criminal investigation involving

the person from whom the substance was procured or in the course of an administrative inspection or investigation.

Rule 338.3151

Rule Numbers

Section (5)

Inventories.

Commenter

Baran

Comment

Other than the beginning inventory the rule does not state the annual inventory must be kept at the

licensed location. Add to “ (5) A licensee shall maintain the inventory in a written, typewritten, or

printed form at the licensed location. The inventory taken by use of an oral recording device shall

must be promptly transcribed.”

Rules Committee Section (5) - The Rules Committee agrees with the comment to add “at the licensed location.”

Response

Board Response

The Board agrees with the comment to add “at the licensed location.”

R 338.3151 Inventories.

Rule 51. (1) A An individual, partnership, cooperative, association, private corporation, other legal entity, or governmental

entity licensed to manufacture, distribute, prescribe, or dispense controlled substances licensee shall annually make perform

and maintain a complete and accurate inventory of all stocks of controlled substances in the possession and control of the licensee.

(2) The inventory shall must contain a complete and accurate record of all controlled substances in the possession or control of the

licensee on the date the inventory is taken as follows:

(a) If the substance is listed in schedule 1 or 2, then the licensee shall make an exact count or measure of the contents.

9

(b) If the substance is listed in schedule 3, 4, or 5, then the licensee shall make an estimated count or measure of the contents, but if

the container holds more than 1,000 dosage units, such as tablets or capsules, then the licensee shall make an accurate account of the

contents.

(3) A licensee shall make a separate inventory for each licensed location on the date that he or she first engages in the activity

covered by his or her license, including a change of a pharmacist in charge. The beginning inventory record for a licensed location

shall be kept at the licensed location and a copy shall be forwarded to the administrator department upon request.

(4) A licensee shall indicate on the inventory record whether the inventory was taken as of at the opening or closing of the day that

the inventory is taken.

(5) A licensee shall maintain the inventory in a written, typewritten, or printed form at the licensed location. The inventory taken by

use of an oral recording device shall must be promptly transcribed.

(6) A licensee shall sign and date the inventory record.

(7) A licensee's printed name, address, and DEA number shall be recorded on the inventory.

(8) Schedule 2 drugs shall must be separated on the inventory from all other drugs.

(9) A licensee that is open for 24 hours shall indicate the time that the inventory was taken.

(10) On the effective date of the addition of a controlled substance to a schedule, which substance was not previously listed in

any schedule, a licensee who possesses the substance shall take an inventory of all stocks of the substance on hand and

incorporate it in the current inventory. Thereafter, the substance shall be included in each inventory taken.

Rule 338.3153

Rule Numbers

Section (a)

Invoices, acquisition, dispensing, administration, and distribution records.

Commenter

Baran

Comment

Voided DEA 222 forms must be kept at the licensed location see 21 CFR 1305.17.

Add to “(a) A licensee may keep Acquisition acquisition records, except for executed or voided

DEA 222 order forms, may be in an electronic form kept at a central location, with notice to the

department. subject to the approval of the administrator. The approval shall specify the nature of

the acquisition records to be kept and the exact location where the acquisition records will be kept.

All records shall be readily retrievable within 48 hours.”

Section (b)

Section (c)

The rule no longer states schedule 3, 4 and 5 invoices and acquisition records must be maintained,

add this back to 338.3153(b).

Suggestion that the term “sales receipt” be further defined to provide clarity and to explain whether

sales receipts may be stored electronically or not.

Eid

10

Rules Committee Section (a) Baran - The Rules Committee agrees with the comment to add “or voided.”

Response

Section (b) Baran – The Rules Committee declines this comment as the rule already states that the records must be

maintained.

Section (c) Eid – The Rules Committee agrees with the comment to clarify that sales receipts may be kept electronically

or in paper form, however, it does not agree that a definition of sales receipt needs to be added to the rule as receipts are

adequately detailed in MCL 333.17757.

Board Response

Section (a) - The Board agrees with the comment to add “or voided.”

Section (b) – The Board declines to add this comment as the rule already states that the records must be

maintained.

Section (c) – The Board agrees with the comment to clarify that sales receipts may be kept electronically or in

paper form, however, it does not agree that a definition of sales receipt needs to be added to the rule as receipts

are adequately detailed in MCL 333.17757.

R 338.3153 Invoices, acquisition, dispensing, administration, and distribution records.

Rule 53. (1) For 2 years, A a licensee shall keep and make available for inspection maintain in the pharmacy responsible for the

automated device, for review by the department, an agency, or the board, all records for controlled substances, including

invoices, and other acquisition records, but excluding and sales receipts, however, a copy of each receipt shall be retained for 90

days.as follows:

(a) A licensee may keep Acquisition acquisition records, except for executed or voided DEA 222 order forms, may be in an

electronic form kept at a central location, with notice to the department. subject to the approval of the administrator. The approval

shall specify the nature of the acquisition records to be kept and the exact location where the acquisition records will be kept. All

records shall be readily retrievable within 48 hours.

(2) A licensee shall maintain acquisition records, which may be electronic, as follows:

(a) (b) A licensee shall maintain Invoices invoices and other acquisition records of all controlled substances listed in schedules 1

and 2 of R 338.3111 to R 338.3119a shall be maintained in a separate file from invoices and other acquisition records of controlled

substances listed in schedules 3, 4, and 5.

(b) Invoices and other acquisition records of all controlled substances listed in schedules 3, 4, and 5 of R 338.3120 to R 338.3125

shall be maintained in a separate file or in such form so that the The information required is must be readily retrievable from the

ordinary acquisition records maintained by the dispenser.

(c) A licensee shall retain sales receipts for 90 days in electronic or paper form.

11

(3) (d) A licensee shall initial or electronically initial the invoice and indicate the date that the controlled substances are received.

(4) (e) A licensee shall keep a record, which may be electronic, of all controlled substances dispensed by him or her.

(5) (f) A licensee that prescriber prescribes controlled substances shall keep a record separate from the patient chart which

contains all of the following information for controlled substances dispensed or administered by the prescriber:

(a) (i) Name of the patient.

(b) (ii) Name and strength of the controlled substance and strength.

(c) (iii) Quantity of the controlled substance.

(d) (iv) Date the controlled substance was dispensed or administered.

(e) (v) Name of the individual who dispensed or administered the controlled substance.

(6) (g) Except in medical institutions, a licensee shall sequentially number and maintain in chronological order the patients’

original prescriptions shall be sequentially numbered and maintained in chronological order as follows:

(a) (i) A licensee shall maintain a separate file shall be maintained for dispensed substances listed in schedule 2 of R 338.3116 to R

338.3119a.

(b) (ii) A licensee shall maintain a separate file shall be maintained for dispensed substances listed in schedules 3, 4, and 5 of R

338.3120 to R 338.3125.

(c) (h) The licensee shall keep the original prescription record shall be kept on site for 5 years from the last date of dispensing.

However, after After 32 years from the last date of dispensing, an if an electronic duplicate is may be made of the original paper

prescription, which shall become becomes the original prescription, the original prescription may be destroyed. Upon request of an

authorized agent of the board, a paper copy of the electronic duplicate prescription shall be presented.

(7) (i) A licensee shall maintain records Records of controlled substances distributed to another licensee, which shall include all of

the following information and be maintained in the appropriate file described in subrule subdivision (2)(b) of this rule or in a separate

record that is available for inspection:

(a) (i) Name, address, and dea DEA number of receiver.

(b) (ii) Name, address, and dea DEA number of supplier.

(c) (iii) Name and quantity of the controlled substances distributed.

(d) (iv) Date the controlled substances were distributed.

(j) A DEA 222 order form shall must be used for schedule 2 drugs.

(8) (k) Except for controlled substance prescriptions pursuant to subdivision (h) of this rule, Complete a licensee shall

maintain controlled substances records shall be maintained or controlled by the licensee for 2 years. , except for controlled substance

prescriptions, which shall be maintained for 5 years from the last date of dispensing. After 3 years, an electronic duplicate may be

12

made of the original paper prescription which shall become the original prescription. Upon request of an authorized agent of the board,

a paper copy of the electronic duplicate prescription shall be presented.

Rule 338.3154

Rule Numbers

Section (5)(h)(vi)

Medication records in medical institutions.

Commenter

Comment

Sapita

Regarding R338.3154 page 38 (vi) states “the name and license number” as a record requirement for

pharmacists checking the automated device. We feel that it is a cumbersome requirement to have

our institutional pharmacists input their license number every time they check the machines. We

would like to see the verbiage requiring the “license number” to be removed completely.

Section

Eid

Delete (B) - “The system is being used in place of an emergency kit under R 338.486(4)(c).”

(5)(f)(xix)(B)

Rationale: In the same letter response mentioned early from the DEA to the American Society of

Consultant Pharmacists in 2016, they specifically state “It also bears emphasis that, in accordance

with the CSA and DEA regulations, a controlled substance may only be dispensed for emergency

purposes (or otherwise) pursuant to a valid prescription. Thus, where, as in the scenario described in

your letter, the kit is maintained at the LTCF by a pharmacy, controlled substances may not be

dispensed from the kit for emergencies prior to receipt by the pharmacist of a valid prescription in

accordance with the requirements of in 21 CFR §§ 1306.11 and 1306.21.” Federal law differences

stricter than this exemption created by the new rule will create confusion amongst licensees. To

ensure compliance with the stricter federal laws, it is recommended to strike the exception for

emergency kits.

References:

https://cdn.ymaws.com/ascp.site-ym.com/resource/collection/6F78F67D-C454-4D89-BCE1-

F0C7A17755B3/November_30_DEA_Response_Letter.pdf

21 CFR 1306.11: https://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_11.htm

21 CFR 1306.21: https://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_21.htm

13

Rules Committee Section (5)(h)(vi) Sapita - The Rules Committee agrees to delete “name and license number” and replace it with

Response

“identification.”

Section (5)(f)(xix)(B) Eid – The Rules Committee declines to delete (B) as the DEA’s letter is not inconsistent with the

pharmacist reviewing the prescription in 48 hours and the rule is needed for safety reasons.

Board Response

Section (5)(h)(vi) - The Board agrees to delete “name and license number” and replace it with “identification.”

Section (5)(f)(xix)(B) – The Board declines to delete (B) as the DEA’s letter is not inconsistent with the

pharmacist reviewing the prescription in 48 hours and the rule is needed for safety reasons.

R 338.3154 Medication records in medical institutions.

Rule 54. (1) A patient's chart shall constitute a record of medications ordered for, and actually administered to, a patient of medical

institutions.

(2) Medication records are required for all controlled substances listed in schedules 2, 3, 4, and 5 of R 338.3116 to R 338.3125. At a

minimum, these records shall must include all of the following information:

(a) The number of doses of controlled substances purchased.

(b) The number of doses dispensed to individual patients or distributed to nursing stations or both.

(c) The number of doses administered.

(d) The number of doses dispensed, but not administered, to the patient.

(e) An annual physical inventory and status of any discrepancies between the inventory and the records of acquisition and the

dispensing records.

(3) If the controlled substance is not dispensed to an individual patient, all of the following provisions shall must be complied with:

(a) Medication records for those controlled substances in schedules 2, 3, 4, and 5 of R 338.3116 to R 338.3125 shall must be

maintained.

(b) Distribution of a controlled substance to a nursing unit shall may not be more than 25 doses per container.

(c) A distribution record for each multiple of 25 doses shall must be used to account for delivery to a nursing unit. The record shall

must include all of the following information:

(i) The name and dose of the controlled substance.

(ii) The quantity of the substance.

(iii) The date of delivery.

(iv) The location of the nursing unit.

(v) The name of the distributing pharmacy and address if a different location from the medical institution.

14

(vi) Name of distributing pharmacist.

(vii) The name of the individual on the nursing unit who receives the substance.

(d) A proof of use record shall must be maintained to account for all doses of an administered substance. The record shall must

include all of the following:

(i) The name of the substance.

(ii) The dose administered.

(iii) The date and time a dose was administered.

(iv) The name of the patient.

(v) The signature of the individual who administered the dose.

(e) Subrule 3 of this rule does not apply to automated dispensing devices.

(4) A controlled substance that is maintained at a nursing unit must be stored in a securely locked cabinet or medication cart

that is accessible only to an individual who is responsible for the administration or distribution of the medication.

(4) (5) If a controlled substance or any medication or device is dispensed from an automated device, then documentation as to the

type of equipment, serial numbers, content, policies, procedures, and location within the facility of all of the following shall 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:. When patient medication is stocked in an automated device, the pharmacy responsible for the device shall obtain an

additional controlled substance license for each hospital, county medical care facility, nursing home, hospice, or other skilled nursing

facility as defined in 1978 PA 368, MCL 333.20109, when the pharmacy is not located at the same address as the facility and

controlled substances are dispensed from the automated device. The documentation shall include at least all of the following

information:

(a) Name The name and address of the pharmacy or facility responsible for the operation of the automated device. Manufacturer

name and model number.

(b) The manufacturer, serial number, and model number of the automated device.

(c) The location of the automated device.

(d) The contents of the automated device.

(c) (e) The Quality quality assurance policy and procedure to determine continued appropriate use and performance of the

automated device. that includes all of the following quality assurance documentation for the use and performance of the

automated device:

(i) Use of monitors that alert the user when the wrong medication is filled or removed for administration to a patient.

(ii) Use of security monitors that include an alert for unauthorized access, patients not in the system, system security

breaches, and controlled substance audits.

15

(iii) Corrective measures to address issues and errors identified in the internal quality assurance program.

(d) (f) The Policy policy and procedure for system operation that includes all of the following:

(i) Safety.

(ii) Security systems and procedures that include prevention of unauthorized access or use and comply with federal and

state regulations.

(iii) Accuracy.

(iv) Patient confidentiality.

(v) Access.

(vi) Type of Controlled controlled substances.

(vii) Data retention or archival.

(viii) Definitions.

(ix) Downtime procedures.

(x) Emergency procedures.

(xi) Inspection Operator inspections.

(xii) Installation requirements.

(xiii) Maintenance.

(xiv) Medication security.

(xv) Quality assurance.

(xvixv) Medication inventory.

(xviixvi) Staff education and training.

(xviiixvii) System set-up and malfunction.

(xixxviii) List of medications qualifying for emergency dose removal without pharmacist prior review of the prescription or

medication order.

(xix) The use of the automated device that includes a requirement that a pharmacist review a prescription or medication

order before system profiling or removal of any medication from the automated device for immediate patient administration,

except in the following situations where a pharmacist shall review the orders and authorize any further dispensing within 48

hours:

(A) The automated device is being used as an after-hours cabinet for medication dispensing in the absence of a

pharmacist under R 338.486(4)(j).

(B) The system is being used in place of an emergency kit under R 338.486(4)(c).

16

(C) The system is being accessed to remove medication required to treat the emergent needs of a patient under R

338.486(4)(c). A sufficient quantity to meet the emergent needs of the patient may be removed until a pharmacist is available

to review the medication order.

(5) Automated devices shall have adequate security systems and procedures, evidenced by written pharmacy policies and procedures

that document all of the following information: Prevention of unauthorized access or use. Compliance with any applicable federal and

state regulations. Maintenance of patient confidentiality.

(6) (g) Records and electronic data kept The automated device must maintain transaction data that includes all by automated

devices shall meet all of the following requirements:

(a) All events involving activity regarding access to the contents of the automated device devices shall be recorded electronically.

(b) (h) The pharmacy responsible for the automated device shall maintain records related to access to the automated device.

The records must Records shall be maintained by the pharmacy responsible for the device and shall be readily retrievable. The

records and shall must include all of the following information:

(i) The unique identity of the device accessed.

(ii) Identification of the individual accessing the automated device.

(iii) The type of transaction.

(iv) The name, strength, dosage form, and quantity of the drug accessed.

(v) The name of the patient for whom the drug was ordered.

(vi) Identification The name and license number identification of the pharmacist checking for the accuracy of the medications to

be stocked or restocked in the automated device.

(vii) If the pharmacist delegates the stocking of the device, then technologies shall be in place and utilized to ensure that the

correct drugs are stocked in their appropriate assignment utilizing a board-approved error prevention technology that is in compliance

with R 338.490. This subdivision takes effect April 11, 2003.

(vii) Any other Additional information as the pharmacist may deem considers necessary.

(i) For medication removed from the automated device for on-site patient administration, the automated device must

document all of the following information:

(i) The name of the patient.

(ii) The date and time medication was removed from the automated device.

(iii) The name, initials, or other unique identifier of the individual removing the drug.

(iv) The name, strength, and dosage form of the drug. The documentation may be on paper or electronic medium.

17

(j) If the pharmacist delegates the stocking of the automated device, 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 a board-approved

error prevention technology.

(7) For medication removed from the system for on-site patient administration, the system shall document all of the following

information:

(a) The name of the patient.

(b) The date and time medication was removed from the device.

(c) The name, initials, or other unique identifier of the person removing the drug.

(d) The name, strength, and dosage form of the drug. The documentation may be on paper or electronic medium.

(8) (k) The automated device shall must provide a mechanism for securing and accounting for controlled substances medications

once removed from and subsequently returned to, the automated device return bin. Neither Controlled substances medication nor a

device may not be returned directly to the system automated device for immediate reissue or reuse. Controlled substances

Medication or devices once removed from the automated device shall may not be reused or reissued, except as indicated in R

338.486(7).

(9) (l) The automated device shall must provide a mechanism for securing and accounting for wasted or discarded medications.

(10) The internal quality assurance documentation for the use and performance of the automated device shall include at least all of

the following:

(a) Safety monitors that include wrong medications removed and administered to patient.

(b) Accuracy monitors that include filling errors and wrong medications removed.

(c) Security monitors that include unauthorized access, patients not in the system, system security breaches, and controlled

substance audits.

(d) Policies that establish corrective measures taken to address the problems and errors identified in the internal quality assurance

program and its integration to the overall quality assurance policies.

(11) Policy and procedures for the use of the automated device shall include a requirement for pharmacist review of the prescription

or medication order before system profiling or removal of any medication from the system for immediate patient administration. This

subrule does not apply to the following situations:

(a) The system is being used as an after-hours cabinet for medication dispensing in the absence of a pharmacist as provided in R

338.486(4)(i).

(b) The system is being used in place of an emergency kit as provided in R 338.486(4)(c).

18

(c) The system is being accessed to remove medication required to treat the emergent needs of a patient as provided in R

338.486(4)(c). A sufficient quantity to meet the emergent needs of the patient may be removed until a pharmacist is available to

review the medication order.

(d) In each of the situations specified in subdivisions (a) to (c) of this subrule, a pharmacist shall review the orders and authorize

any further dispensing within 48 hours.

(12) A copy of all pharmacy policies and procedures related to the use of an automated device shall be maintained at the pharmacy

responsible for the device's specific location and be available for review by an agent of the board.

(13) A controlled substance that is maintained at a nursing unit shall be stored in a securely locked cabinet or medication cart that is

accessible only to an individual who is responsible for the administration or distribution of the medication.

(14) Records and documents required under this rule shall be maintained or controlled by the pharmacy responsible for the device for

2 years.

(15) (6) An individual who is responsible for administering a controlled substance or a portion thereof shall record the quantity,

disposition and an explanation of the destruction of the controlled substance on the proper accountability record. If the institution has

a policy that reflects current practice standards and delineates the method of destruction, an explanation would only be required if

policy was not followed.

Rule 338.3162a

Rule Numbers

R 338.3162a

Electronic transmission of prescription; waiver of electronic transmission.

Commenter

Eid

Comment

Generally, states do not place the burden upon the pharmacist to determine whether the controlled substance

prescription correctly falls under an exception to the requirements to electronically prescribe. There is currently

language within MCL 333.17754a (8) that provides for a route for pharmacist to exercise their judgement

without having to determine whether an exception applies. Arkansas, California, Iowa, Kansas, Kentucky,

Missouri, Nevada, New York, South Carolina, Tennessee, and Virginia are just some of the states that have

imposed electronic prescribing requirements on prescribers but have continued to allow pharmacists to dispense

all otherwise lawful prescriptions, regardless of format. It may not be needed to copy the statute language within

the rule unless the Department/Board sees fit for clarity.

References:

http://www.legislature.mi.gov/(S(pjk3ae1byhmej1ecdz4nz1wl))/mileg.aspx?page=getObject&objectName=mcl-

333-17702

19

Please clarify in Rule if the intention the Act’s reference to an exemption for “A Hospice” includes both a

hospice residence and hospice agency. The act specifically references an exception for a hospice facility, and

thus we are reasonably certain this provision in the Act means a hospice “residence facility”. However, other

references in MILARA Health Facility Rules have defined “A Hospice Facility” to include “a hospice agency”.

MILARA’s clarification in Rule on this definition would be helpful for prescribers working with hospice

patients in their residence. In addition, prescribers prescribing in a hospice will benefit from Rule clarification

of the intent and meaning of language in this section requiring a “prescription must be issued and dispensed in

the same health care facility”.

Cargill

There are hospice prescribers who wish to apply for this waiver, including some that have already requested a

waiver to the department, despite the required form not being unavailable. The non availability of the required

FORM has created uncertainty for hospices with technical and rural challenges who wish to apply for and

receive the allowed waiver. We agree with the two-year period for a qualified waiver and request the waiver

form be produced and made available to prescribers as soon as possible. This would provide prescribers having

appropriate rational for receiving a waiver to apply and have reasonable certainty if they will qualify and

receive the waiver. We further request that the effective date of the Act and penalties be delayed one year to

October 1, 2022, or the final date required by the federal Centers for Medicare and Medicaid Services. We

further request that if the Department does not have discretion to delay implementation by Rule, that the

Department request the Legislature to act to delay implementation and/or related penalties before October 1,

2021. The non availability of the required FORM has created uncertainty for hospices with technical and rural

challenges who wish to apply for and receive the allowed waiver.

Request clarification be added to the rules as to whether a hospice is an automatic exemption to transmitting a

prescription electronically of if an application for a waiver will be required.

Sections (4)

and (5)

Young

The effective date of this rule states October 1, 2021 (or appropriately the statutory delay

Sections

Mankowski

based on CMS’s electronic transmission requirement for Medicare). The General Rules for

(1),(4), and (5)

pharmacy have updated this date to January 1, 2022 and the same should be done in this ruleset.

Under subrules (1) and (4), MSMS encourages the Department to ensure the dates in the Proposed Rule Set and

the proposed Pharmacy – General Rules align with Public Acts 134, 135 and 136 of 2020.

Sections (1)

and (4)

Novak

For this purpose, MSMS recommends that subrule (4) be amended to recognize the exceptions to electronic

transmissions permitted by MCL §333.17754a, as follows:

(4) Effective October 1, 2021, or the date established by the federal Centers for Medicare and Medicaid

20

Services for the Medicare electronic transmission requirement, whichever occurs later, prescribers shall, unless

an exception under section 17754a of the code, MCL 333.17754a, applies, electronically transmit a prescription

for a controlled substance consistent with both of the following requirements:

(a) All the requirements in section 17754a of the code, MCL 333.17754a, are met.

(b) All the requirements in R 338.3161 are met.

To provide consistency between the Rules and Code and to avoid confusion, the MHA recommends stating

electronic transmission exceptions are allowed in Michigan in certain instances. Therefore, the MHA agrees

with other healthcare stakeholders that R 338.3162a (4) should be amended to the following:

Section (4)

Carlson

(4) Effective October 1, 2021, or the date established by the federal Centers for Medicare and Medicaid

Services for the Medicare electronic transmission requirement, whichever occurs later, prescribers shall, unless

an exception under section 17754a of the code, MCL 333.17754a, applies, electronically transmit a prescription

for a controlled substance consistent with both of the following requirements:

(a) All the requirements in section 17754a of the code, MCL 333.17754a, are met.

(b) All the requirements in R 338.3161 are met.

As well as clarifying language in subrule (5)(b)(iv) “The prescriber demonstrates attests to exceptional

circumstances including, but not limited to, the following…” The word “demonstrates” indicates there will be a

process in place where a prescriber will need to submit tangible evidence. However, we believe the intent was

for the provider to declare or formally certify in writing. An attestation should suffice with the department’s

ability to follow up.

Section

(5)(b)(iv)

Carlson

Novak

MSMS also recommends subrule (5)(b)(iv) be amended to identify examples of qualifying “exceptional

circumstances, as follows:”

Section

(5)(b)(iv)

(iv) The prescriber demonstrates attests to exceptional circumstances including, but not limited to, the

following:

A. Prescribing fewer than “X” prescriptions (combined controlled and non-controlled substances) per year.

B. Utilizing electronic transmission for non-controlled substances, but prescribing fewer than “Y” controlled

substance prescriptions per year. (Note: The cost of the enhanced e-prescribing software for controlled

substances is not fiscally responsible for some prescribers who rarely prescribe them.)

C. Intention to cease practice within the next twelve months.

D. Limited practice due to an illness or other unforeseen event.

Rules

Committee

(1), (4), and (5) Mankowski, Carlson, and Novak – The Rules Committee agrees that the language in this rule should be

consistent with both the Pharmacy General rules and the Code. There are three areas in this rule that should be modified for

21

Response

consistency:

• The effective date:

The Public Health Code mandates electronic transmission of prescriptions as of October 1, 2021 but requires that the

Department delay the implementation date of the mandate to the date established by the Federal Centers for Medicare

and Medicaid Services for electronic transmission of prescription for controlled substances. Therefore, the Rules

Committee recommends that the effective date be deleted and the mandate be enforced on the date the mandate is

enforced by the Federal Centers for Medicare and Medicaid Services.

• The requirement that a prescriber is unable to meet the requirements of section 17754a(1) or (2) of the code.

A typographical error that requires a prescriber to meet both (1) and (2) should be changed to (1) or (2) for

consistency with the Pharmacy General Rules and the Code.

• A dispensing prescriber:

In the Pharmacy General Rules the basis for a waiver that “the prescriber and dispensing pharmacy are the same

entity” was modified in the Controlled Substances rules to “if the prescription is dispensed by a dispensing

prescriber.”

• CMS waiver is automatic state waiver:

The Code requires that if a CMS waiver is granted then the Department shall grant a waiver, so provision (5) should

be modified to allow for this waiver without meeting other requirements. Therefore, (5) will be reorganized.

• Professional judgment:

Modify (1)(c) for consistency with the Code and Pharmacy General Rules.

• The Controlled Substances Rules include the following provision which is not in the Pharmacy General Rules. For

consistency it should be deleted from the CS rules or added to the General rules unless there is a valid reason to

differentiate between a CS and non CS prescriptions. “This rule does not apply to the use of electronic equipment to

transmit prescription orders within inpatient medical institutions.”

Section (1) Eid – The Rules Committee does not recommend that the following be deleted “a pharmacist may dispense the

electronically transmitted prescription if all of the following conditions are satisfied: ….”, as the Rules Committee believes

the requirements should remain for the pharmacist.

Section (4) – The Rules Committee agrees with the comments that the rules should be amended to recognize the exceptions

to electronic transmissions permitted by MCL §333.17754a.

22

Hospice – The Rules Committee does not recommend that the rules define “hospice” or clarify what is meant by “hospice”

in the Code, as the terms defined in the Code have the same meaning when used in these rules. The term “hospice” is defined in

section 20106(4) of the Code, MCL 333.20106, as “a health care program that provides a coordinated set of services rendered

at home or in outpatient or institutional settings for individuals suffering from a disease or condition with a terminal

prognosis.” In addition, Part 214 of the Code states that “the term hospice shall not be used to describe or refer to a health

program or agency unless that program or agency is licensed as a hospice by the department as required under this article or

is exempted from licensure as provided in subsection (5).” Therefore, “hospice” is already defined by the Code.

Section (5)(b)(iv) Novak – The Rules Committee agrees with the suggested language, except, it does not recommend adding

(B) and would suggest modifying (A) to: prescribing fewer than 100 controlled substances prescriptions per year or the number

of controlled substances prescriptions used in the Federal Centers for Medicare and Medicaid Services waiver for electronic

transmission of prescriptions for controlled substances, whichever is less.

Section (5)(b)(iv) Carlson – The Rules Committee agrees with the comment to add “attests” instead of “demonstrates.”

Board Response

(1), (4), and (5) – The Board agrees that the language in this rule should be consistent with both the Pharmacy

General rules and the Code. There are three areas in this rule that should be modified for consistency:

• The effective date:

The Public Health Code mandates electronic transmission of prescriptions as of October 1, 2021 but

requires that the Department delay the implementation date of the mandate to the date established by the

Federal Centers for Medicare and Medicaid Services for electronic transmission of prescription for

controlled substances. Therefore, the effective date will be deleted and the rule will state that the

mandate is enforced on the date the mandate is enforced by the Federal Centers for Medicare and

Medicaid Services.

• The requirement that a prescriber is unable to meet the requirements of section 17754a(1) or (2) of the

code.

A typographical error that requires a prescriber to meet both (1) and (2) will be changed to (1) or (2) for

consistency with the Pharmacy General Rules and the Code.

• A dispensing prescriber:

23

In the Pharmacy General Rules the basis for a waiver that “the prescriber and dispensing pharmacy are

the same entity” was modified to “if the prescription is dispensed by a dispensing prescriber.” The

change will also be made in the CS rules.

• CMS waiver is automatic state waiver:

The Code requires that if a CMS waiver is granted then the Department shall grant a waiver. Provision

(5) will be modified to allow for this waiver without meeting other requirements.

• Professional judgment:

The language in (1)(c) will be modified for consistency with the Code and Pharmacy General Rules.

• The Controlled Substances Rules include the following provision, “this rule does not apply to the use of

electronic equipment to transmit prescription orders within inpatient medical institutions” which is not in

the Pharmacy General Rules. For consistency it will be deleted from the CS rules.

Section (1) – The Board declines the comment to delete “a pharmacist may dispense the electronically

transmitted prescription if all of the following conditions are satisfied: ….”, as it believes the requirements

should remain for the protection of the patient.

Section (4) – The Board agrees with the comment that the rules should recognize the exceptions to electronic

transmissions permitted by MCL §333.17754a.

Hospice – The Board declines the comment to provide a definition of “hospice” as the terms defined in the Code

have the same meaning when used in these rules. The term “hospice” is defined in section 20106(4) of the Code,

MCL 333.20106, as “a health care program that provides a coordinated set of services rendered at home or in

outpatient or institutional settings for individuals suffering from a disease or condition with a terminal

prognosis.” In addition, Part 214 of the Code states that “the term hospice shall not be used to describe or refer to

a health program or agency unless that program or agency is licensed as a hospice by the department as required

under this article or is exempted from licensure as provided in subsection (5).” Therefore, “hospice” is already

defined by the Code.

Section (5)(b)(iv) – The Board declines to add (B) as these are controlled substances rules and allowing for a

limit on controlled substances rules in new (A) addresses a waiver when the number of CS prescriptions is at a

below a certain level. The Board agrees with adding (A) as follows: “prescribing fewer than 100 controlled

24

substances prescriptions per year or the number of controlled substances prescriptions used in the Federal Centers for

Medicare and Medicaid Services waiver for electronic transmission of prescriptions for controlled substances,

whichever is more.

Section (5)(b)(iv) – The Board agrees with the comment to add “attests.”

R 338.3162a Electronic transmission of prescriptions prescription; waiver of electronic transmission"electronically transmitted

prescription drug order" defined.

Rule 62a. (1) As used in this rule, "electronically transmitted prescription drug order" means a prescription drug order that is

communicated from the prescriber directly to the pharmacy by electronic means, so that the data cannot be altered, modified,

extracted, viewed, or manipulated in the transmission process.

(2) (1) Until October 1, 2021, or the enforcement date established by the federal Centers for Medicare and Medicaid Services

for the Medicare electronic transmission requirement, whichever occurs later, a prescription may be electronically

transmitted, and a pharmacist may dispense the electronically transmitted prescription if all of the following conditions are

satisfied:

(a) The An electronically transmitted prescription order shall be is transmitted to the pharmacy of the patient's choice and shall

occur occurs only at the option of the patient.

(3) A pharmacist may dispense an electronically transmitted prescription drug order only if both of the following conditions are

satisfied:

(a)(b) The electronically transmitted prescription drug order includes all of the following information:

(i) The name and address of the prescriber.

(ii) An electronic signature or other board-approved means of ensuring prescription validity.

(iii) The prescriber's telephone number for verbal confirmation of the order.

(iv) The time and date of the electronic transmission.

(v) The name of the pharmacy intended to receive the electronic transmission.

(vi) Unless otherwise authorized under section 17754(1)(b) of the code, MCL 333.17754, the full name of the patient for

whom the prescription is issued.

(vi)(vii) All other information that is required to must be contained in a prescription under the provisions of R 338.3161.

25

(b) (c) The pharmacist exercises professional judgment regarding the accuracy, validity, or and authenticity of the transmitted

prescription. Technological devices shall not be used to circumvent any applicable prescription documentation and verification

requirement.

(d) All requirements in section 17754 of the code, MCL 333.17754 are met.

(4) (2) An electronically transmitted prescription drug order that meets the requirements of subrule (3) (1) of this rule shall be

deemed to be is the original prescription.

(5) (3) This rule does not apply to the use of electronic equipment to transmit prescription orders within inpatient medical

institutions.

(4) Effective October 1, 2021, or on the enforcement date established by the federal Centers for Medicare and Medicaid

Services for the Medicare electronic transmission requirement, whichever occurs later, prescribers shall, unless an exception

under section 17754a of the Code, MCL 333.17754a, applies, electronically transmit a prescription for a controlled substance

consistent with both of the following requirements:

(a) All the requirements in section 17754a of the code, MCL 333.17754a, are met.

(b) All the requirements in R 338.3161 are met.

(5) A prescriber applying for a waiver from section 17754a of the code, MCL 333.17754a, shall submit a completed

application to the department, on a form provided by the department, and satisfy either all of the following requirements:

(a) The prescriber provides evidence satisfactory to the department that the prescriber has received a waiver of the

Medicare requirement for the electronic transmission of controlled substances prescriptions from the federal Centers for

Medicare and Medicaid Services.

(b) The prescriber is unable to meet the requirements of section 17754a(1) and or (2) of the code, MCL 333.17754a, and b)

The prescriber also meets 1 of the following:

(i) The prescriber provides evidence satisfactory to the department that he or she has received a waiver of the Medicare

requirements for the electronic transmission of controlled substances prescriptions at the federal Centers for Medicare and

Medicaid Services.

(i) The prescriber and dispensing pharmacy are the same entity prescription is dispensed by a dispensing prescriber.

(ii) The prescriber demonstrates economic hardship or technological limitations that are not within the control of the

prescriber.

(iii) The prescriber demonstrates by attesting to exceptional circumstances including, but not limited to, the following:

(A) Prescribing fewer than 100 controlled substances prescriptions per year or the number of controlled substances

prescriptions used in the Federal Centers for Medicare and Medicaid Services waiver for electronic transmission of

prescriptions for controlled substances, whichever is more.

26

(B) Intention to cease practice within the next twelve months.

(C) Limited practice due to an illness or other unforeseen event.

(iv) The prescriber issues prescriptions from a non-profit charitable medical clinic.

(6) A waiver is valid for 2 years and is applicable to the specific circumstances included in the application. A waiver may be

renewed by application to the department.

Rule 338.3162b

Electronic system for monitoring schedules 2, 3, 4, and 5 controlled substances.

Rule Numbers

Commenter

Comment

Sections (1)(e), (l), Sapita

and (m)

Regarding R 338.3162b subsection 1(e) which specifies patient/client gender, subsection 1(l) which

specifies “number of refills authorized’, and subsection 1(m) which specifies “refill number of

prescription fill”. We question the need to include gender in the reporting requirements. We believe

that that the inclusion of these subsections requires additional unnecessary efforts on the pharmacy

to comply. For example, a pharmacist knows that if a prescription comes in for a schedule II there

would be no authorized refills, yet to comply with the administrative rules as drafted, would have to

report 0 refills. We ask that these reporting requirements be removed from the administrative rules.

The rules do not address or provide clarity for a definition of what a “cash” transaction is for

purposes of reporting “the prescription payment type” under R 338.3162b(1)(q). The rule should

add a definition or explain what payment types are considered “cash” under the ASAP 4.1 reporting

requirements, which should include cash prices at U&C and, only for purposes of reporting to

MAPS, any discount card used that is not regulated under the Insurance Code (e.g. GoodRx, etc.)

Section (1)(q)

Mollien

Rules Committee Section (1)(e), (l), and (m) Sapita - The Rules Committee declines the comment as this information is already reported.

Response

Section (1)(q) Mollien – The rules Committee agrees that it would be helpful to those reporting information to know that

cash discount cards are considered cast transactions.

Board Response

Section (1)(e), (l), and (m) - The Board declines the comment as this information is already reported.

Section (1)(q) – The Board agrees to add “cash discount cards are considered cash transactions” as it would be

helpful to those reporting information.

R 338.3162b Electronic system for monitoring schedules 2, 3, 4, and 5 controlled substances.

Rule 62b. (1) Except as otherwise exempt under section 7333a of the code, MCL 333.7333a, A a pharmacist, dispensing

prescriber, and veterinarian licensed under Part 177 of the code, MCL 333.17701 to 333.17780, who dispenses a prescription drug

27

which that is a controlled substance listed in schedules 2 to 5 or a pharmacy licensed by the state that dispenses in this state or

dispenses to an address in this state a controlled substance listed in schedules 2 to 5 shall report to the department or the department's

contractor by means of an electronic data transmittal process the following information for each prescription of a schedules

scheduled 2 to 5 controlled substance prescription that has been dispensed:

(a) The patient identifier identification number, as defined in R 338.3102(1)(f). For purposes of this subdivision, all of The the

following apply:

(i) An identification number, as specified in R 338.3102(1)(f)(iv)(A) or to (B)(C), is not required for patients under the age of 16.

(ii) If the patient is under 16 years of age, zeroes shall must be entered as the identification number.

(iii) If the medication being dispensed is for patient is an animal, the patient identification number applies to positive

identification of the animal's owner, the client, that meets the requirements of R 338.3102(1)(f)(iv). If the animal’s owner cannot

be identified, zeroes must be entered as the identification number.

(b) The name of the controlled substance dispensed. The patient’s name; client’s name, including first name, middle name, or

middle initial, if available; and last name.

(c) The patient’s or client’s address, including street, city, state, and zip code.

(d) The patient’s or client’s phone number.

(e) The patient’s or client’s gender.

(f) The patient’s or client’s date of birth.

(g) The species code, as specified by ASAP.

(c) (h) The metric quantity of the controlled substance dispensed.

(d) (i) The national drug code number (ndc) NDC of the controlled substance dispensed.

(e) (j) The date of issue of the prescription.

(f) (k) The date of dispensing.

(l) The number of refills authorized.

(m) The refill number of the prescription fill.

(g) (n) The estimated days of supply of the controlled substance dispensed.

(h) (o) The prescription number assigned by the dispenser.

(p) The prescription transmission form code, as specified by ASAP, that indicates how the pharmacy received the

prescription.

(q) The prescription payment type. Cash discount cards are considered cash transactions.

(r) The electronic prescription reference number, if applicable.

(s) The patient’s or client’s location code when receiving pharmacy services, as specified by ASAP.

28

(i) (t) The (dea) DEA registration number of the prescriber and the dispensing pharmacy.

(j) The Michigan license number of the dispensing pharmacy.

(2) A pharmacist, dispensing prescriber, or veterinarian may presume that the patient identification information provided by a patient,

or a patient's representative, or veterinarian’s client is correct.

(3) As used in this rule, R 338.3162c, and R 338.3162d, the term “dispense” or “dispensing” means the preparation,

compounding, packaging, or labeling of a controlled substance along with delivery of the controlled substance pursuant to a

prescription or other authorization issued by a prescriber, and does not include the acts of prescribing a controlled substance

or administering a controlled substance directly to a patient.

(4) As used in this rule, the term “patient” refers to an individual, not an animal.

Rule 338.3163

Rule Numbers

R 338.3163

Drug-dependent individual; prescribing, dispensing, and administering controlled substance.

Commenter

Novak

Comment

MSMS believes that Rule 63 be eliminated or significantly revised for better clarity and consistency

with federal law. This proposed Rule is confusing and uses terminology that is inconsistent with

similar federal laws regarding the authorized prescribing, administering and dispensing of controlled

substances to an individual for treatment of substance use disorder. For example, the proposed Rule

fails to recognize that while not all “licensed health professionals” are “prescribers,” all prescribers

are licensed health professionals. Accordingly, the proposed Rule’s application of contradictory

standards for “prescribers” and “licensed health professionals” creates confusion for the scope of

authority of physicians and other prescribers to treat an individual for substance use disorder, and

negatively impacts access to substance use disorder treatment. Furthermore, the term “drug-

dependent individual” is not defined in the Proposed Rule Set and is not acknowledged by the

Public Health Code. MSMS questions whether there is a more appropriate and person-first reference

to these individuals than “drug-dependent individual.”

To the extent the Department seeks consistency with standards established by federal law and

regulations, MSMS recommends the Department specifically incorporate by reference such federal

laws and regulations.

Rules Committee Novak: The Rules Committee recommends the following changes consistent with the suggested comments:

29

Response

• Drug dependent person be modified to individual with substance use disorder.

• The various terms, licensee, health professional, and prescriber, be modified for consistency to practitioner.

• Modify the rule to state the behavior that is allowed instead of what is prohibited.

• Modify “drug treatment and rehabilitation program”, which is not defined in the Code, to “program” as that term

is defined in the Mental Health Code, MCL 330.1260(1)(i).

• Further align the rule with the federal regulations.

Board Response

The Board agrees with the following changes to the rule:

• “Drug dependent person” will be modified to “individual with substance use disorder.”

• The various terms, licensee, health professional, and prescriber, will be modified for consistency to

practitioner.

• The rule will be modified to state the behavior that is allowed instead of what is prohibited.

• “Drug treatment and rehabilitation program”, which is not defined in the Code, will be modified to

“program” which is defined in the Mental Health Code, MCL 330.1260(1)(i).

• To further align the rule with the federal regulations (b)(i)(A) and (B) have been modified to (b) and (c)

as not more than 1 days supply may be administered at one time and not for more than 3 days to treat

acute withdrawal symptoms, however, these limitations do not apply if the person is in a program.

R 338.3163 Drug-dependent person Individual with substance use disorder; prescribing, dispensing, and administering controlled

substance.

Rule 63. (1) A practitioner, prescription shall not be issued within his or her scope of practice, may either prescribe, dispense,

or administer for a controlled substance nor shall a controlled substance be dispensed or administered to a drug-dependent person an

individual with substance use disorder for the purpose of maintenance or detoxification treatment pursuant to any of the

following situations continuing his or her drug dependency, except as follows:

(a) A prescriber , licensed in accordance with practitioner acting pursuant to federal and state law or regulations to conduct the

drug treatment of a drug-dependent person an individual with a substance use disorder in a program may prescribe, dispense, and

administer a controlled substance for the purpose of legitimate treatment of the drug-dependent person individual with substance

use disorder. A prescription may only be issued for a schedule 3 through 5 substance.

(b) A practitioner may administer or dispense a controlled substance may be administered or dispensed, or both, by a dispenser,

approved by the FDA specifically for use in maintenance or detoxification treatment directly to a drug-dependent person an

30

individual with substance use disorder for the purpose of continuing his or her dependence who is enrolled participating in a drug

treatment and rehabilitation program.

(c) A practitioner may administer a controlled substance approved by the FDA specifically for use in maintenance or

detoxification treatment directly to an individual with substance use disorder who is experiencing acute withdrawal symptoms

and administration of a controlled substance is necessary while the practitioner is arranging referral for treatment. The

following requirements must be followed:

(i) Not more than 1 day's supply of medication may be administered to the individual with drug addiction or dependence.

(ii) The emergency treatment may be carried out for not more than 3 consecutive days and may not be renewed or

extended.

(2) Notwithstanding subrule (1), a practitioner within the scope of his or her practice, A controlled substance may be prescribed

administer or dispensed dispense a controlled substance in an acute care a hospital or similar setting to continue maintenance

treatment for drug dependency for a patient whose hospitalization is for treatment of a medical condition other than addiction. The

enrollment of the patient in an approved maintenance treatment program shall be verified. to an individual with substance use

disorder consistent with both of the following:

(a) The controlled substance is administered or dispensed to continue maintenance or detoxification treatment as an

adjunct to medical or surgical treatment of conditions other than addiction.

(ii) The controlled substance is administered or dispensed to relieve intractable pain for which no relief or cure is possible,

or none has been found after reasonable efforts.

(3) As use in this Rule:

(a) “Practitioner” means the term defined in section 7109 of the Code, MCL 333.7109.

(b) “Program” means the term defined in section 260 of the Mental Health Code, 1974 PA 258, MCL 330.1260.

(c) “Substance use disorder” means that term as defined in section 100d of the Mental Health Code, 1974 PA 258, MCL

330.1100d.

Rule 338.3165

Rule Numbers

Section (2)(c)

Emergency dispensing of schedule 2 substances; written prescriptions.

Commenter

Sapita

Comment

Regarding R338.3165 subsection 2(c) which specifies “dispensing pharmacist”. We believe this

would cause undue hardship on our relief pharmacists who may work at different pharmacies each

31

day. Would the dispensing relief pharmacist have to check each place of work to ensure compliance

with this rule?

Rules Committee Section (2)(c) - The Rules Committee agrees that the term “dispensing pharmacist” and “pharmacist” should be modified

Response

to “pharmacy.”

Board Response

The Board agrees that the term “dispensing pharmacist” and “pharmacist” should be modified to “pharmacy.”

R 338.3165 Emergency dispensing of schedule 2 substances; written prescriptions.

Rule 65. (1) Within 7 days after authorizing an emergency oral prescription of a controlled substance listed in schedule 2, the

prescriber shall comply with all of the following:

(a) The prescriber shall deliver to the dispensing pharmacist a written prescription or electronically transmit the

prescription pursuant to R 338.3162a. reduce the prescription to writing and have recorded on the

(b) The prescriber shall include on the prescription's face prescription both "Authorization for Emergency Dispensing" and the

date of the oral order. The written prescription shall be delivered to the pharmacist in person or by mail within 7 days after the oral

prescription is issued.

(2) A pharmacist that has dispensed a prescription on an emergency oral prescription shall comply with all of the following:

(a) The dispensing pharmacist shall reduce the oral prescription to writing.

(b) Upon receipt of the prescription, the dispensing pharmacist shall attach this the prescription to the oral order which was earlier

had been reduced to writing.

(c) The dispensing pharmacist pharmacy shall notify the department of consumer and industry services if the prescriber fails to

deliver to him or her either a written prescription or a prescription transmitted electronically to him or her.

(3) The failure of a pharmacist the pharmacy to notify the department if the prescriber fails to deliver a written prescription

pursuant to subrule (1) of this rule voids the authority conferred by this rule to dispense without a written prescription of a

prescriber.

32