Michigan Office of Administrative Hearings and Rules

MOAHR-Rules@michigan.gov

AGENCY REPORT TO THE

JOINT COMMITEE ON ADMNINISTRATIVE RULES (JCAR)

1. Agency Information

Agency name:

Licensing and Regulatory Affairs

Division/Bureau/Office:

Bureau of Professional Licensing

Name of person completing this form:

Jennifer Shaltry

Phone number of person completing this form:

517-241-3085

E-mail of person completing this form:

ShaltryJ1@michigan.gov

Name of Department Regulatory Affairs Officer reviewing this form:

Elizabeth Arasim

2. Rule Set Information

MOAHR assigned rule set number:

2022-6 LR

Title of proposed rule set:

Pharmacy - Controlled Substances

3. Purpose for the proposed rules and background:

The purpose of the Pharmacy - Controlled Substances Rules is to regulate the schedules, licenses,

security, records, dispensing and administering, prescriptions, distributions, and administrative and

disciplinary procedures for controlled substances. The proposed rules will: clarify the requirements

for controlled substance prescriptions; address transferring prescriptions between pharmacies; clarify

the schedules of controlled substances; clarify the the requirements related to investigations of

suspected theft or significant loss of a controlled substance; address comments made by the public;

and update provisions pursuant to changes in the Public Health Code.

4. Summary of proposed rules:

MCL 24.242 and 24.245

Agency Report to JCAR-Page 2

The proposed rules will be modified as follows:

For schedules, the proposed changes adopt the federal schedule subject to drugs scheduled by the

state after January 6, 2022, and the rules promulgated by the Michigan Board of Pharmacy; remove

Brorphine and Gabapentin as exceptions to the federal schedule; remove Pentazocine from Schedule

5 to Schedule 4; provide an exception to the federal scheduling for isomers, Salvia Divorum,

Salvinorum A, Synthetic Cannabinoids, and Synthetic Cathinones.

For controlled substances licensure, the proposed changes require a designated prescriber to have a

controlled substance license for a health facility if substances are stored there without an on-site

pharmacy or an automated device stocked by a pharmacy and provide an exception to licensure for an

emergency kit that contains controlled substances.

For records, the proposed rules permit an electronic duplicate of the original paper prescription,

which will become the original prescription, 2 years from the last dispensing date; require a pharmacy

that holds an additional license for an automated dispensing system, that dispenses controlled

substances, to store inventories and schedule order forms at the licensed location of the automated

device; and clarify that if a controlled substance is dispensed from an automated device,

documentation maintained on-site in the pharmacy must include the automated device’s

manufacture’s name, model number, and the name and address of the facility where the automated

device is located.

For controlled substance prescriptions, the proposed changes clarify that a paper prescription is not

required to have preprinted numbers representing the quantity next to a box or line; require that the

professional designation for the prescribing practitioner be stored electronically; allow a prescriber to

seek waiver of electronic prescription transmission requirements if the prescriber can attest that he or

she intends, within 12 months, to not regularly practice their licensed profession for financial gain or

as a means of livelihood; and clarify that the prescriber must deliver to the dispensing pharmacist a

written prescription postmarked within 7 days after the date the prescription was dispensed, or

electronically transmit the prescription under R 338.3162a.

For controlled substance distributions, the proposed changes require a licensee to provide written

notification to the department 15 days before controlled substances are transferred.

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

publication dates:

The Flint Journal, September 21, 2023

The Grand Rapids Press, September 21, 2023

The Mining Journal, September 23, 2023

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

10/15/2023

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

10/16/2023 09:00 AM at UL-3 , 611 W. Ottawa Street, Lansing, Michigan or

https://ars.apps.lara.state.mi.us/Transaction/RFRTransaction?TransactionID=1365

MCL 24.242 and 24.245

Agency Report to JCAR-Page 3

8. Provide the link the agency used to post the regulatory impact statement and cost-benefit

analysis on its website:

https://ARS.apps.lara.state.mi.us/Transaction/RFRTransaction?TransactionID=1365

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

Jennifer Shaltry, Specialist, Bureau of Professional Licensing.

Kerry Przybylo, Manager, Bureau of Professional Licensing.

10. Persons submitting comments of support:

None.

11. Persons submitting comments of opposition:

Rose Baran, Paul Chludzinski.

12. Persons submitting other comments:

Rose Baran, Martha O’Connor.

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

public comment period:

Name &

Organization public hearing

Comments made at Written

Agency Rationale Rule number

for Rule Change & citation

and Description changed

of Change(s)

Comments

Made

1

Baran

Commenter

suggested

The board agreed R 338.3102

with the

(d) and R

updating the

standard for a

MAPS claim

form referenced

in the rule to

ASAP 5.0

suggestion and

updated the

standard.

338.3162c

Standard for

Prescription Drug

Monitoring

Programs.

2

Baran

Commenter

suggested

The board agreed R 338.3102(f)

with the

removing

suggestion and

“vendor” from

modified the

the definition of definition of

“NDC” to “NDC” to

correspond with correspond with

the definition the federal

found in 21 USC regulation.

§ 207.33.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 4

Commenter The board agreed R 338.3102

3

Baran

suggested adding that a tribal

(h)(iv)(D) and

(E) and R

a tribal

government

identification

number to the

information

making up a

identification

338.3162b(1)

number should be (a)(i)

part of the patient

identifier and

added

patient identifier subparagraph (D).

in R 338.3102(h) As a result of the

(iv) and updating additional

the reference in R subparagraph, the

338.3162b to

reflect the

addition.

previous R

338.3102(h)(iv)

(D) was

renumbered to (E),

and the reference

in 338.3162b(1)(a)

(i) was updated to

reflect the change.

The board agreed R 338.3111

4

5

O'Connor

Commenter

suggested

removing

unneeded

language to

clarify the

definition of

“isomer.”

Commenter

suggested

replacing

with the

(3)(d)

suggestion to

clarify the rule by

removing

unneeded

language.

The board agreed R 338.3132

with the

(5) and (7)

suggestion to

references to the specify the

federal regulation requirements for

with the specific licensure instead

information

required for

of referencing the

federal regulation.

licensure, as

some of the

references no

longer apply and

their inclusion is

confusing.

6

O'Connor

Commenter

The board agreed R 338.3135

suggested that

due to the state’s substance abuse

direction to and controlled

to require the

(1), (2) and

(5)

MCL 24.242 and 24.245

Agency Report to JCAR-Page 5

accept the federal substances

8-hour substance awareness training

abuse and

controlled

substances

for each licensure

cycle, to remove

topics duplicated

training in lieu of by the federal

the training

training

required under

requirements for

the rule, subrule licensees required

(1)(a) should be to have a DEA

corrected to

registration and

require only the continue to require

topics of utilizing all training topics

the MAPS and

state and federal required to obtain

laws regarding a DEA

for licensees not

prescribing and registration.

dispensing

controlled

substances for

licensees required

to obtain a DEA

registration. For

licensees who are

not required to

obtain a DEA

registration, the

commenter

suggested

specifying all of

the required

training topics in

subrule (5).

Commenter

suggested that the

substance abuse

and controlled

substance training

should be

required for each

licensure cycle

rather than just

one time.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 6

7

Baran

Commenter

suggested

increasing the

time period for

notifying the

The Board agreed R 338.3141

that more time is (3)

needed to

complete DEA

form 106 before

department of a submitting it to the

suspected theft or Department and

significant loss of modified the time

a controlled

period to notify

substance and

the Department of

submitting a copy the loss or theft to

of DEA form 106 45 days after

or an equivalent completion of the

document to the investigation.

department to 45

days after

completion of the

investigation

because the DEA

provides 45 days

from the

discovery of the

theft or loss to

file DEA form

106.

8

Baran

Commenter

opposed

removing the

The board agreed R 338.3153

with the comment (3)

and kept "on site"

words, "on site" in the rule.

from the rule

because 21 CFR

1304.04(h)

requires paper

prescriptions to

be kept at the

pharmacy.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 7

9

Baran

Commenter

suggested

deleting the

The board agreed R 338.3153

with the comment (6)

that the subrule is

subrule because unnecessary

schedule 2 order because a

forms and

pharmacy is

controlled

substance

inventories are

already required to

keep schedule 2

order forms and

already required controlled

to be kept at a substance

pharmacy under inventories on site.

federal law and R The board decided

338.3151(5) and to remove the

3153(1).

subrule.

10

Chludzinski

Commenter

The board agreed R 338.3161

questioned how a to clarify the rule (1)(b) and (6)

pharmacy may by modifying

identify and store subdivision (1)(b)

a prescriber’s

professional

to require the

prescriber’s

designation when professional

a prescriber is not designation be

required to

supply it.

either written on

the prescription or

stored

electronically in

the pharmacy’s

automated data

processing system

and deleting

subrule (6)

requiring the

professional

designation to be

stored

electronically.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 8

11

Baran

Commenter

suggested

The board agreed R 338.3162a

to update the rule

modifying the

rule to comply

with the

to comply with

MCL 333.17754a.

requirements for

electronic

prescribing under

MCL 333.17754a

because

333.17754 no

longer applies.

14.Date report completed:

3/8/2024

MCL 24.242 and 24.245