Administrative Rules for Pharmacy – Controlled Substances

Public Comment on Rule Set 2022-6 LR

Rose Baran Pharm. D.

Rule

Issue

Suggested Change

Rule 338.3102(ed)

"Michigan automated

prescription system (MAPS)

claim form" means a form, to Standard is 4.2B. The 2023

be determined by the

department, that is in the

format and includes the

information as specified by

the American Society for

Automation in Pharmacy

(ASAP) 4.1 Standard for

Prescription Drug Monitoring

Programs and contains the

information specified in R

338.3162b.

Issue

Suggested Change

ASAP 4.1 Standard is

outdated. The current

MAPS claim form" means a

form, determined by the

department, that is in the

format and includes the

information as specified by

the ASAP 5.0 Standard for

Prescription Drug Monitoring

Programs and contains the

information specified in R

338.3162b.

version 5.0 to be

implemented January 2024.

Rule 338.3102(df)

Issue

Suggested Change

"NDC” means a National

national drug code number

The definition in the Code of Delete vendor in the

Federal Regulations 21 USC

definition.

(NDC)" means a number that 207.33(a) does not have

identifies the labeler, vendor, vendor. “The NDC for a drug

product, and package size and is a numeric code. Each

is assigned to each drug

finished drug product or

product listed under section

unfinished drug subject to the

510 Registration of Producers listing requirements of this

of Drugs and Devices, of the part must have a unique NDC

Federal Food, Drug, and

Cosmetic Act (FDCA, ) of

2017, 21 USC 36021 USC

360.

to identify its labeler, product,

and package size and type.”

Rule 338.3102(h)(iv)

A tribal government

identification is used at

pharmacies at or near a tribal government issued

nation.

Issue

Suggested change

Add (D) to

338.3102(h)(iv)(D) A tribal

government identification

number obtained from a tribal

Residents of a tribal nation

may only have a tribal

identification. To make it

clear that a tribal government government issued

issued identification can be

used for MAPS.

Issue

identification.

Rule 338.3141 (3)

Suggested Change

1

Within 15 days of after

completion of an

The DEA has set a time

period when the registrant

To be less confusing for

licensees change the 15 days

investigation regarding a

must file the 106 form which to 45 days.

suspected theft or significant is different from the state

loss of a controlled substance, requirement. “21 USC

a licensee shall notify the

department of the suspected

theft or significant loss of a

controlled substance and

submit a copy of the DEA

theft and loss report form

1301.74 (c) ….The registrant

must also file a complete and

accurate DEA Form 106 with

the Administration through

the DEA Diversion Control

Division secure network

106, or equivalent document, application within 45

to the department, whether or calendar days after discovery

not the controlled substance

is recovered or the

of the theft or loss……….”

responsible personindividual

is identified and action is

taken against him or herthe

responsible individual, and

whether or not it is also

reported to the DEA.

Rule 338.3153(1)

Issue

Suggested Change

(1) For 2 years, a licensee

shall maintain in the

The 2 year record keeping

requirement conflicts with the Change 338.3153(1) to 5

Both rule sets are open.

pharmacy responsible for the Rule 338.583a(1) which

automated device, for review requires 5 years.

by the department, an agency,

or the board, all records for

years.

controlled substances,

including invoices, and

acquisition records, and sales

receipts, as follows:

Rule 338.3153(3)

Issue

Suggested Change

TheA licensee shall keep the Controlled substance

Leave on site in the rule.

original prescription record

on site for 5 years fromafter

the last date of dispensing.

However, after 2 years

fromafter the last date of

dispensing, if an electronic

duplicate is made of the

prescriptions must be kept on

site. 21 CFR 1304.04(h)

states paper prescriptions for

Schedule II, III, IV and V

controlled substances shall be

maintained at the registered

location in a separate

original paper prescription,

which becomes the original

prescription, the original

prescription may be destroyed

a licensee may make an

prescription file. Deleting the

on site would conflict with

federal rules.

2

electronic duplicate of the

original paper prescription,

which becomes the original

prescription.

Rule 338.3153(6)

Issue

Suggested Change

(6) A pharmacy that holds

an additional license for an controlled substance

Schedule 2 order forms and

Delete (6). The pharmacy is

already required to maintain

executed DEA 222 forms and

automated dispensing

system that dispenses

controlled substances shall

store inventories and

schedule 2 order forms at

the licensed location of the

automated device.

inventories are required by

federal law to be stored at the controlled substance

pharmacy. Controlled

inventories. See Rule

338.3151(5) and 338.3153(1)

substances in the automated

dispensing system (ADS)

belong to the pharmacy

because the drugs are not

considered dispensed until the

ADS provides them, thus

drugs in the ADS are counted

as pharmacy inventory.

Schedule 2 order forms (DEA

222 form) used to order the

2s for the ADS location

belong to the pharmacy. The

ADS at a different address

than the pharmacy is not a

pharmacy. See LARA’s

licensing guide for Controlled

Substance Automated Device

License.

Rule 338.3161(6)

(6) The professional

designation for the

prescribing practitioner

must be stored

Issue

Suggested Change

The professional designation

Stored electronically is

vague. It could be stored in a for the prescribing

separate computer or in a

separate word file from the

pharmacy’s automated data

processing system.

Issue

practitioner must be stored

electronically in the

pharmacy’s automated data

processing system.

electronically.

Rule 338.3162a

Suggested change

Section 333.17754 no longer See attached Rule 338.3162a

applies. Rule revised to meet in Attachment A.

333.17754a.

Rule 338.3162b

Issue

Suggested Change

(a) The patient identifier

identification number. For

purposes ofAs used in this

subdivision, all of the

following apply:

To add tribal government

identification

(a) The patient identifier

identification number. For

purposes ofAs used in this

subdivision, all of the

following apply:

3

(i) An identification

number, as specified in R

338.3102(1)(f)(iv)(A) to (C),

is not required for patients

under the age of 16.

(i) An identification

number, as specified in R

338.3102(1)(fh)(iv)(A) to

(CE), is not required for

patients under the age of 16.

Suggested Change

Rule 338.3162c

Issue

(2) The data must be

To bring it current with ASAP (2) The data must be

transmitted in the format

established by the ASAP 4.1

Standard for Prescription

Drug Monitoring Programs

Rule 338.3165(1)

standard

transmitted in the format

established by the ASAP 4.1

5 Standard for Prescription

Drug Monitoring Programs.

Suggested change

Issue

(a) The prescriber shall

deliver to the dispensing

pharmacist a written

DEA under 1306.11(d) only

allows a written prescription

for an oral emergency

(a) The prescriber shall

deliver to the dispensing

pharmacist a written

prescription postmarked

prescription not an electronic prescription postmarked

within 7 days after the date prescription.

the prescription was

dispensed, or electronically

transmit the prescription

pursuant tounder R

within 7 days after the date

the prescription was

dispensed, or electronically

transmit the prescription

pursuant tounder R

338.3162a.

(c) The pharmacy shall notify

the department if the

(c) The pharmacy shall

notify the department if the

prescriber fails to deliver to

him or her the pharmacy

either a written prescription

or a prescription transmitted

electronically.

prescriber fails to deliver to

him or her the pharmacy

either a written prescription

or a prescription transmitted

electronically.

Rule 338.3183

Issue

Suggested Change

Delete entire rule.

The rule is confusing. If the

intent of this rule is to allow a

licensee to return controlled

substances from whom they

obtained the drug lawfully it

is already allowed under rule

338.3153.

Delete entire rule.

Attachment A

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

Rule 62a. (1) Until the enforcement date established by the federal Centers for Medicare and

Medicaid ServicesCMS for the Medicare electronic transmission requirement, a prescription

may be electronically transmitted, and a pharmacist may dispense the electronically transmitted

4

prescription, if all of the following conditions are satisfied: Effective on January 1, 2023

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

applies, electronically transmit a prescription and a pharmacist may dispense the

electronically transmitted prescription, if all of the following conditions are satisfied:

(a) The prescription is transmitted to the pharmacy of the patient's choice and occurs only at

the option of the patient.

(b) The electronically transmitted prescription 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.

(vii) All other information that must be contained in a controlled substance prescription under

R 338.3161.

(c) The pharmacist exercises professional judgment regarding the accuracy, validity, and

authenticity of the transmitted prescription.

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

(2) An electronically transmitted prescription that meets the requirements of subrule (1) of this

rule is the original prescription.

(3) Effective on the enforcement date established by the federal Centers for Medicare and

Medicaid ServicesCMS for the Medicare electronic transmission requirement, prescribers shall,

unless an exception under section 17754a of the Code, 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.

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 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 ServicesCMS.

(b) The prescriber is unable to meet the requirements of section 17754a(1) or (2) of the code,

MCL 333.17754a, and the prescriber meets 1 of the following:

(i) The prescription is dispensed by a dispensing prescriber. The prescriber demonstrates

economic hardship or technological limitations that are not within the control of the prescriber.

(ii) 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

ServicesCMS waiver for electronic transmission of prescriptions for controlled substances,

whichever is more.

5

(B) The prescriber has or intends within the next 12 months to no longer regularly

practice their licensed profession for financial gain or as a means of livelihoodIntention to

cease practice within the next twelve months.

(C) Limited practice due to an illness or other unforeseen event.

(iv)(iii) The prescriber issues prescriptions from a non-profit charitable not-for-profit

medical clinic that provides free or low-cost services to the public.

(5) A waiver is valid for 2 years and is applicableapplies to the specific circumstances included

in the application. A waiver may be renewed by application to the department.

6

Przybylo, Kerry (LARA)

From:

Sent:

To:

BPL-BoardSupport

Thursday, October 5, 2023 3:29 PM

Shaltry, Jennifer (LARA); Przybylo, Kerry (LARA)

FW: Comments on proposed Pharmacy – Controlled Substances rule set

Subject:

From: Chludzinski, Paul <pchludz1@hfhs.org>

Sent: Thursday, October 5, 2023 3:19 PM

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

Subject: Comments on proposed Pharmacy – Controlled Substances rule set

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

Comments on proposed Pharmacy – Controlled Substances rule set

For schedules:

Regarding the proposal to remove gabapentin as a Schedule 5 drug (R338.3111) to align with the federal scheduling and

the majority of the states in the Great Lakes Region:

If the Public Health Code requires the board to schedule a substance if it has a potential for abuse (333.7203), and

gabapentin presents a potential for abuse, shouldn't it remain a scheduled drug in Michigan?



Gabapentin Presents High Potential for Misuse (November

2022). https://www.pharmacytimes.com/view/gabapentin-presents-high-potential-for-misuse

Gabapentin Abuse Potential (June 2023), https://americanaddictioncenters.org/neurontin-abuse

For controlled substance prescriptions:

R338.3161(1)(b) does not require the prescriber's professional designation to be on a prescription, but R338.3161(6)

states that the professional designation must be stored electronically.

If the prescriber isn't required to supply a professional designation on a prescription, how will a pharmacy identify and

store it?

Thank you.

Paul Chludzinski, RPh

Pharmacy Regulatory Specialist

Community Care Services

Ambulatory Pharmacy Administration

Mobile: 313-263-8005

Office: 313-916-8362

Fax: 313-916-1315

pchludz1@hfhs.org

1

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Dear BPL:

I have reviewed the Controlled Substances rules and have the following suggestions:

1. R 338.3111: Schedules; federal controlled substance schedules adopt by reference; exceptions.

Subrule (3)(d) pertains to the definition of isomers. It needs clarification to avoid confusion with the

chart.

Suggested language:

(d) Isomers:

The definition of the term “isomer” used in 21 CFR 1308.11, schedule 1, is modified to include any

optical, positional, or geometric isomer. The definition of “isomer” used in 21 CFR 1308.12 to 1308.15,

schedules 2 to 5, remains as set forth in 21 CFR 1300, which includes the optical, position, and geometric

isomers.

2. R 338.3132 pertains a controlled substance license.

There are revisions to the protocol required for licensure for CS research and analytical labs. References

to some of the CFR’s are not needed as these do not apply and the inclusion causes confusion.

The suggested edits are below to eliminate confusion of what is required:

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

following with his or herthe 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 contains the following

information: is filed and approved by the FDA and the Federal Drug Enforcement Administration (DEA)

pursuant tounder the provisions of 21 CFR 1301.18.:

(i) Investigator:

(a) Name, address, and DEA registration number; if any.

(b) Institutional affiliation.

(c) Qualifications, including a curriculum vitae and an appropriate list of publications.

(ii) Research project:

(a) Title of project.

(b) Statement of the purpose.

(c) Name of the controlled substance or substances involved and the amount of each needed.

(d) Description of the research to be conducted, including the number and species of research

subjects, the dosage to be administered, the route and method of administration, and the duration of

the project.

(e) Location where the research will be conducted.

(f) Statement of the security provisions for storing the controlled substances in accordance with R

338.3143 and for dispensing the controlled substances in order to prevent diversion.

(g) If the investigator desires to manufacture any controlled substance, a statement of the quantity

to be manufactured and the sources of the chemicals to be used.

(iii) Authority:

(a) Institutional approval.

(b) Approval of a Human Research Committee for human studies.

(c) Indication of an approved active Notice of Claimed Investigational Exemption for a New Drug

(number).

(d) Indication of an approved funded grant (number), if any.

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

all of the following information with his or herthe 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 contains the following

information: is filed and approved by the FDA and the DEA pursuant tounder the provisions of 21 CFR

1301.18.

(1) Investigator:

(a) Name, address, and DEA registration number, if any.

(b) Institutional affiliation.

(c) Qualifications, including a curriculum vitae and an appropriate list of publications.

(2) Chemical analysis project:

(a) Title of project.

(b) Statement of the purpose.

(c) Name of the controlled substance or substances involved and the amount of each needed.

(d) Description of the chemical analysis and instructional activity to be conducted, and the

duration of the project.

(e) Location where the chemical analysis will be conducted.

(f) Statement of the security provisions for storing the controlled substances in accordance with R

338.3143.

(g) If the investigator desires to manufacture any controlled substance for analytical or

instructional purposes, a statement of the quantity to be manufactured and the sources of the

chemicals to be used.

(3) Authority:

(a) Institutional approval.

(b) Approval of a Human Research Committee for human studies.

(c) Indication of an approved funded grant (number), if any.

3. R 338.3135 Opioids and other controlled substances awareness training standards for prescribers and

dispensers of controlled substances; requirements.

Due to the federal requirement of 8 hours of training for substance abuse and controlled substances,

and the state’s direction to accept the 8 hours training in lieu of the training required in this rule until

the rule is modified, the rule language needs to be corrected to edit the training content for those

licensees who are required to obtain a DEA registration in subrule(1)(a) to include only utilizing the

MAPS and State and federal laws regarding prescribing and dispensing controlled substances.

The rule also needs to require others who do not get the DEA registration to meet all the subjects in the

current rule and require the training for each cycle, not just a 1-time training.

Suggested Edits are in red.

Rule 35. (1) An individual who is applying for or renewing a controlled substance license or who is

licensed to prescribe or dispense controlled substances pursuant tounder section 7303 of the code, MCL

333.7303, shall complete a 1-time training in opioids and controlled substances awareness before

applying for the license or renewal. The training must meet that meets the following standards:

(a) Training content must cover allboth of the following topics:

(i) Use of opioids and other controlled substances.

(ii) Integration of treatments.

(iii) Alternative treatments for pain management.

(iv) Counseling on the effects and risks associated with using opioids and other controlled substances.

(v) The stigma of addiction.

(vi) Utilizing the MAPS.

(vii) (ii) State and federal laws regarding prescribing and dispensing controlled substances.

(viii) Security features for opioids and other controlled substances and prescriptions, and proper

disposal requirements for opioids and other controlled substances.

(b) Topics covered under subrule (1)(a) of this rule may be obtained from more than 1 program.

(c) Acceptable providers or methods of training include any of the following:

(i) Training offered by a nationally recognized or state-recognized health-related organization.

(ii) Training offered by, or in conjunction with, a state or federal agency.

(iii) Training offered by a continuing education program or activity that is accepted by a licensing

board established under article 15 of the code, MCL 333.16101 to 333.18838.

(iv) Training obtained in an educational program that has been approved by a board established

under article 15 of the code, MCL 333.16101 to 333.18838, for initial licensure or registration, or by a

college or university.

(d) Acceptable modalities of training include any of the following:

(i) Teleconference or webinar.

(ii) Online presentation.

(iii) Live presentation.

(iv) Printed or electronic media.

(2) A prescriber or dispenser shallmay not delegate, allow by a practice agreement, or order the

prescribing, or dispensing of a controlled substance as allowed by the code to an individual, other than a

physician’s assistant, only after the individual has complied with subrules subrule (1) and (5) of this rule.

A physician’s assistant is subject to subrules (1), (3), and (4) of this rule.

(3) The department may select and audit licensees and request documentation of proof of completion

of training. A licensee shall maintain proof of completion of training for 3 renewal periods plus 1

additional year. If audited, an individual shall provide an acceptable proof of completion of training,

including either1 of the following:

(a) A completion certificate issued by the training provider that includes the date, provider name,

name of training, and individual’s name.

(b) A self-attestation by the individual that includes the date, provider name, name of training, and

individual’s name.

(4) An individual who has been issued a controlled substance license pursuant tounder section 7303 of

the code, MCL 333.7303, shall complete the controlled substance training required by subrule (1) of this

rule as follows:

(a) A licensee who is renewing his or hera controlled substance license shall complete the controlled

substance training by the end of the first renewal cycle that begins after January 4, 2019.

(b) Other than a license renewal under subdivision (a) of this subrule, beginning September 1, 2019,

the department shall not issue a controlled substance license until an applicant provides proof of having

completed the controlled substance training.

(5) Beginning December 31, 2021, Except as exempted under subrule (6) of this rule, veterinarians

and an individual, other than a physician’s assistant, who is a delegatee, or allowed by a practice

agreement or an order to prescribe or dispense a controlled substance by a prescriber or dispenser as

allowed by the code, shall complete the a controlled substance training required by subrule (1) of this

rule. The training must be taken 1 time during the current license cycle. The training must cover that

covers all of the following topics:

(a) Use of opioids and other controlled substances.

(b) Integration of treatments.

(c) Alternative treatments for pain management.

(d) Counseling on the effects and risks associated with using opioids and other controlled

substances.

(e) The stigma of addiction.

(f) Utilizing the MAPS.

(g) State and federal laws regarding prescribing and dispensing controlled substances.

(h) Security features for opioids and other controlled substances and prescriptions, and proper

disposal requirements for opioids and other controlled substances.

(6) An individual who is licensed under section 7303 of the code, MCL 333.7303, to prescribe or

dispense controlled substances only for research on animals is exempt from this rule.

Sincerely,

Martha O’Connor