DEPARTMENT OF LICENSING AND REGULATORY AFFAIRS

BOARD OF PHARMACY

PHARMACY – CONTROLLED SUBSTANCES

Filed with the secretary of state on May 28, 2024

These rules become effective immediately after filing with the secretary of state unless

adopted under section 33, 44, or 45a(9) of the administrative procedures act of 1969, 1969

PA 306, MCL 24.233, 24.244, or 24.245a. Rules adopted under these sections become

effective 7 days after filing with the secretary of state.

(By authority conferred on the director of the department of licensing and regulatory affairs

and the board of pharmacy by sections 7106, 7109, 7203, 7216, 7301, 7303, 7303a, 7321,

7333, 7333a, and 17754 of the public health code, 1978 PA 368, MCL 333.7106, 333.7109,

333.7203, 333.7216, 333.7301, 333.7303, 333.7303a, 333.7321, 333.7333, 333.7333a, and

333.17754, and Executive Reorganization Order Nos. 1991-9, 1996-2, 2003-1, and 2011-

4, MCL 338.3501, 445.2001, 445.2011, and 445.2030)

R 338.3101, R 338.3102, R 338.3104, R 338.3111, R 338.3132, R 338.3135, R 338.3141,

R 338.3143, R 338.3145, R 338.3151, R 338.3153, R 338.3153a, R 338.3154, R 338.3161,

R 338.3161a, R 338.3162, R 338.3162a, R 338.3162b, R 338.3162c, R 338.3162d, R

338.3164, R 338.3165, R 338.3166, R 338.3167, R 338.3170, R 338.3181, R 338.3183,

and R 338.3185, of the Michigan Administrative Code are amended, and R 338.3137 and

R 338.3163 are rescinded, as follows:

PART 1. GENERAL PROVISIONS

R 338.3101 Definitions; A to H.

Rule 1. As used in these rules:

(a) “ASAP” means the American Society for Automation in Pharmacy.

(b) “Automated device” means a mechanical system that performs an operation or

activity, other than compounding or administration, relating to the storage, packaging,

dispensing, or delivery of a drug and that collects, controls, and maintains transaction

information.

(c) “Board” means the board of pharmacy.

(d) “CMS” means the United States Centers for Medicare and Medicaid Services.

(e) “Code” means the public health code, 1978 PA 368, MCL 333.1101 to 333.25211.

(f) “CSA” means the controlled substances act, Public Law 91-513.

(g) “DEA” means the United States Drug Enforcement Administration.

(h) "Department" means the department of licensing and regulatory affairs.

(i) "Electronic signature" means an electronic sound, symbol, or process attached to or

associated with a record and executed or adopted by an individual with the intent to sign

March 5, 2024

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the record. An electronic signature also is a unique identifier protected by appropriate

security measures that is only available for use by the intended individual and ensures

nonrepudiation so that the signature may not be rejected based on its validity.

(j) “FDA” means the United States Food and Drug Administration.

(k) “FDCA” means the Federal Food, Drug, and Cosmetic Act, 21 USC 301 to 399g.

R 338.3102 Definitions; I to P.

Rule 2. As used in these rules:

(a) "Inventory" means all stocks in finished form of a controlled substance that are

manufactured or otherwise acquired by a licensee, whether in bulk or commercial

containers or contained in pharmaceutical preparations in the possession of the licensee.

(b) "Licensee" means a person that is licensed under section 7303 of the code, MCL

333.7303.

(c) “MAPS” means the Michigan automated prescription system.

(d) 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.

(e) "Medical institution" means that term as defined in R 338.486.

(f) "NDC” means a national drug code number that identifies the labeler, product, and

package size and is assigned to each drug product listed under section 510 of the FDCA,

21 USC 360.

(g) "Officer" means a federal, state, county, or local law enforcement officer who

enforces the laws of this state.

(h) "Patient identifier" means all of the following information about a patient:

(i) Full name.

(ii) Address, including zip code.

(iii) Date of birth.

(iv) One of the following identification numbers:

(A) A state-issued driver's license number obtained from a state-issued driver’s license.

(B) A state-issued identification number obtained from a state-issued photo

identification card.

(C) A federal passport number obtained from a federal passport.

(D) A tribal government identification number obtained from a tribal government

issued identification.

(E) The number zero. Zeroes must be entered as the identification number, if the

positive identification presented for the patient or client does not include a license

number, identification number, or passport number as listed in subparagraphs (A) to (C)

of this paragraph, the patient is under the age of 16, or the animal’s owner cannot be

identified.

(i) "Positive identification" means identification that includes a photograph of an

individual in addition to the individual’s date of birth. Positive identification includes an

identification card issued by a governmental agency.

R 338.3104 Definitions; R, S.

Rule 4. As used in these rules:

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(a) "Readily retrievable" means a record that is maintained and can be separated from all

other records within 48 hours and is a listed controlled substance that is marked with an

asterisk, redlined, or in some other manner visually identifiable apart from the other

substances listed in the record.

(b) "Substance" means a controlled substance unless the context indicates otherwise.

PART 2. SCHEDULES

R 338.3111 Schedules; federal controlled substance schedules adopt by reference;

exceptions.

Rule 11. (1) The board approves and adopts by reference the complete list of drugs and

other substances that are considered controlled substances under the CSA, that have been

divided into 5 schedules as published in 21 CFR 1308.11 to 1308.15, except for the

following:

(a) Drugs or other substances scheduled, rescheduled, or descheduled by this state’s

laws enacted after January 6, 2022.

(b) Drugs listed in subrule (3) of this rule, which are scheduled differently than

scheduled in 21 CFR 1308.11 to 1308.15.

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

at https://www.ecfr.gov/current/title-21/chapter-II/part-1308 , or at 10 cents per page from

the Board of Pharmacy, Bureau of Professional Licensing, Michigan Department of

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

Lansing, Michigan 48909.

(3) The following drugs and other substances are designated as a schedule 1, 2, 3, 4, or 5

drug, as follows:

Drug or Substance

1 2 3 4 5

x

(a) Synthetic cannabinoid:

Includes a material, compound, mixture, or preparation that is not

otherwise listed as a controlled substance in this schedule or in

schedules 2 to 5, is not approved by the FDA as a drug, and contains

a quantity of the following substances, their salts, isomers (whether

optical, positional, or geometric), homologues (analogs), and salts of

isomers and homologues (analogs), unless specifically excepted,

whenever the existence of these salts, isomers, homologues

(analogs), and salts of isomers and homologues (analogs) is possible

within the specific chemical designation:

(i) A compound containing a 3-(1-naphthoyl)indole structure, also

known as napthoylindoles, with substitution at the nitrogen atom of

the indole ring by an alkyl, haloalkyl, alkenyl, cycloalkylmethyl,

cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl, or 2-(4-

morpholinyl)ethyl group, whether or not further substituted on the

indole ring to an extent and whether or not substituted on the

naphthyl ring to an extent. Examples of this structural class include,

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but are not limited to, JWH-007, JWH-015, JWH-018, JWH-019,

JWH-073, JWH-081, JWH-122, JWH-200, JWH-210, JWH-398,

AM-1220, AM-2201, and WIN-55, 212-2.

(ii) A compound containing a 1H-indol-3-yl-(1-naphthyl)methane

structure, also known as napthylmethylindoles, with substitution at

the nitrogen atom of the indole ring by an alkyl, haloalkyl, alkenyl,

cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-

piperidinyl)methyl, or 2-(4-morpholinyl)ethyl group, whether or not

further substituted on the indole ring to an extent and whether or not

substituted on the naphthyl ring to an extent. Examples of this

structural class include, but are not limited to, JWH-175 and JWH-

184.

(iii) A compound containing a 3-(1-naphthoyl)pyrrole structure,

also known as naphthoylpyrroles with substitution at the nitrogen

atom of the pyrrole ring by an alkyl, haloalkyl, alkenyl,

cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-

piperidinyl)methyl, or 2-(4-morpholinyl)ethyl group, whether or not

further substituted on the pyrrole ring to an extent and whether or

not substituted on the naphthyl ring to an extent. Examples of this

structural class include, but are not limited to, JWH-370 and JWH-

030.

(iv) A compound containing a naphthylideneindene structure with

substitution at the 3-position of the indene ring by an alkyl,

haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-

2-piperidinyl)methyl, or 2-(4-morpholinyl)ethyl group, whether or

not further substituted on the indene ring to an extent and whether or

not substituted on the naphthyl ring to an extent. Examples of this

structural class include, but are not limited to, JWH-176.

(v) A compound containing a 3-phenylacetylindole structure, also

known as phenacetylindoles, with substitution at the nitrogen atom

of the indole ring by an alkyl, haloalkyl, alkenyl, cycloalkylmethyl,

cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl, or 2-(4-

morpholinyl)ethyl group, whether or not further substituted on the

indole ring to an extent and whether or not substituted on the phenyl

ring to an extent. Examples of this structural class include, but are

not limited to, RCS-8 (SR-18), JWH-250, JWH-203, JWH-251, and

JWH-302.

(vi) A compound containing a 2-(3-hydroxycyclohexyl)phenol

structure, also known as cyclohexylphenols, with substitution at the

5-position of the phenolic ring by an alkyl, haloalkyl, alkenyl,

cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-

piperidinyl)methyl, or 2-(4-morpholinyl)ethyl group, whether or not

substituted on the cyclohexyl ring to an extent. Examples of this

structural class include, but are not limited to, CP-47,497 (and

homologues(analogs)), cannabicyclohexanol, and CP-55,940.

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(vii) A compound containing a 3-(benzoyl)indole structure, also

known as benzoylindoles, with substitution at the nitrogen atom of

the indole ring by an alkyl, haloalkyl, alkenyl, cycloalkylmethyl,

cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl, or 2-(4-

morpholinyl)ethyl group, whether or not further substituted on the

indole ring to an extent and whether or not substituted on the phenyl

ring to an extent. Examples of this structural class include, but are

not limited to, AM-694, pravadoline (WIN-48,098), RCS-4, AM-

630, AM-679, AM-1241, and AM-2233.

(viii) A compound containing a 11-hydroxy-/\8-

tetrahydrocannabinol structure, also known as dibenzopyrans, with

further substitution on the 3-pentyl group by an alkyl, haloalkyl,

alkenyl, cycloalkylmethyl, cycloalkyethyl, 1-(N-methyl-2-

piperidinyl)methyl, or 2-(4-morpholinyl)ethyl group. Examples of

this structural class include, but are not limited to, HU-210, JWH-

051, JWH-133.

(ix) A compound containing a 3-(1-adamantoyl)indole structure,

also known as adamantoylindoles, with substitution at the nitrogen

atom of the indole ring by an alkyl, haloalkyl, alkenyl,

cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-

piperidinyl)methyl, or 2-(4-morpholinyl)ethyl group, whether or not

further substituted on the adamantyl ring system to an extent.

Examples of this structural class include, but are not limited to, AM-

1248.

(x) A synthetic chemical compound that is a cannabinoid receptor

agonist and mimics the pharmacological effect of naturally

occurring cannabinoids that is not listed in schedules 2 through 5

and is not approved by the FDA as a drug.

(b) Synthetic cathinone:

x

Includes a material, compound, mixture, or preparation that is not

otherwise listed as a controlled substance in this schedule or in

schedules 2 through 5, is not approved by the FDA as a drug, and

contains a quantity of the following substances, their salts, isomers

(whether optical, positional, or geometric), homologues (analogs),

and salts of isomers and homologues (analogs), unless specifically

excepted, whenever the existence of these salts, isomers,

homologues (analogs), and salts of isomers and homologues

(analogs) is possible within the specific chemical designation:

(i) A compound containing a 2-amino-1-propanone structure with

substitution at the 1-position with a monocyclic or fused polycyclic

ring system and a substitution at the nitrogen atom by an alkyl

group, cycloalkyl group, or incorporation into a heterocyclic

structure. Examples of this structural class include, but are not

limited to, dimethylcathinone, ethcathinone, and alpha-

pyrrolidinopropiophenone.

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(ii) A compound containing a 2-amino-1-propanone structure with

substitution at the 1-position with a monocyclic or fused polycyclic

ring system and a substitution at the 3-position carbon with an alkyl,

haloalkyl, or alkoxy group. An example of this structural class

includes, but is not limited to, naphyrone.

(iii) A compound containing a 2-amino-1-propanone structure with

substitution at the 1-position with a monocyclic or fused polycyclic

ring system and a substitution at a position of the ring system with

an alkyl, haloalkyl, halogen, alkylenedioxy, or alkoxy group,

whether or not further substituted at a position on the ring system to

an extent. Examples of this structural class include, but are not

limited to, mephedrone, methylone, and 3-fluoromethylone.

(c) Ephedrine:

x

A salt of ephedrine, an optical isomer of ephedrine, a salt of an

optical isomer of ephedrine, or a compound, mixture, or preparation

containing ephedrine, a salt of ephedrine, an optical isomer of

ephedrine, or a salt of an optical isomer of ephedrine except for both

the following:

(i) A product containing ephedrine, a salt of ephedrine, an optical

isomer of ephedrine, or a salt of an optical isomer of ephedrine is

not included in schedule 5 if the drug product meets all of the

following criteria:

(A) May lawfully be sold over the counter without a prescription

under federal law.

(B) Is labeled and marketed in a manner consistent with the

pertinent over-the-counter tentative final or final monograph.

(C) Is manufactured and distributed for legitimate medical use in a

manner that reduces or eliminates the likelihood for abuse.

(D) Is not marketed, advertised, or labeled for an indication of

stimulation, mental alertness, energy, weight loss, appetite control,

or muscle enhancement.

(E) The drug product is 1 of the following:

(I) A solid dosage form, including, but not limited to, a soft

gelatin caplet that combines as active ingredients not less than 400

milligrams of guaifenesin and not more than 25 milligrams of

ephedrine per dose and is packaged in blister packs with not more

than 2 tablets or caplets per blister.

(II) An anorectal preparation containing not more than 5%

ephedrine.

(ii) A food product or a dietary supplement containing ephedrine, if

the food product or dietary supplement meets all of the following

criteria:

(A) Contains, per dosage unit or serving, not more than the lesser

of 25 milligrams of ephedrine alkaloids or the maximum amount of

ephedrine alkaloids in applicable regulations adopted by the FDA

and contains no other controlled substance.

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(B) Does not contain hydrochloride or sulfate salts of ephedrine

alkaloids.

(C) Is packaged with a prominent label securely affixed to each

package that includes all of the following:

(I) The amount in milligrams of ephedrine in a serving or dosage

unit.

(II) The amount of the food product or dietary supplement that

constitutes a serving or dosage unit.

(III) That the maximum recommended dosage of ephedrine for a

healthy adult human is the lesser of 100 milligrams in a 24-hour

period or the maximum recommended dosage or period of use in

applicable regulations adopted by the FDA.

(IV) That improper use of the product may be hazardous to an

individual’s health.

(d) Isomers:

x

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.

(e) Marijuana:

x

As that term is defined in section 3 of the Michigan Regulation and

Taxation of Marihuana Act, 2018 IL 1, MCL 333.27953, and

pharmaceutical-grade cannabis, as that term is defined in section

8105 of the code, MCL 333.8105, if it is manufactured, obtained,

stored, dispensed, possessed, grown, or disposed of in compliance

with the code but only for the purpose of treating a debilitating

medical condition, as that term is defined in section 3 of the

Michigan Medical Marihuana Act, 2008 IL 1, MCL 333.26423, and

as allowed under the code.

(f) Salvia divinorum:

x

All parts of the plant presently classified botanically as Salvia

divinorum, whether growing or not; the leaves and seeds of that

plant; an extract from a part of that plant; and every compound, salt,

derivative, mixture, or preparation of that plant or its leaves, seeds,

or extracts.

(g) Salvinorin A

(h) Tianeptine sodium:

x

By whatever official, common, usual, chemical, or brand name

designated.

PART 3. LICENSES

R 338.3132 Controlled substance license.

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Rule 32. (1) A person that manufactures, distributes, prescribes, or dispenses a

controlled substance in this state or proposes to engage in the manufacture, distribution,

prescribing, or dispensing of a controlled substance in this state shall apply for a

controlled substance license by submitting to the department a completed application on a

form provided by the department along with the required fee.

(2) In addition to meeting the requirements of section 7303 of the code, MCL 333.7303,

an applicant’s license must be verified by the licensing agency of a state where the

applicant holds or has ever held a controlled substance license. This includes, but is not

limited to, showing proof of disciplinary action taken or pending against the applicant.

(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 listed 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

submitted to the department with the application for licensure and filed and approved by

the FDA and the DEA under 21 CFR 1301.18.

(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 that 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 that 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 a schedule. An

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

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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 that 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 under section 17760 of the code, MCL 333.17760, or a

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

facility, as that term is 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 for the address where the drugs are stored. If a

controlled substance is stored in an emergency kit, a controlled substance license solely

for the emergency kit is not required by this rule.

(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 if the license issued under article 15 of the code, MCL

333.16101 to 333.18838 is renewed and the controlled substance license is renewed for

an equal number of years.

(5) An applicant who intends to conduct research involving controlled substances shall

submit all of the following with the 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:

(i) The following investigator information:

(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) The following research project information:

(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) The following authorization information:

(a) Institutional approval.

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(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.

(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 the 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.

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

substances shall submit all of the following information with the 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:

(i) The following investigator information:

(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) The following chemical analysis project information:

(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.

(iii) The following authorization information:

(a) Institutional approval.

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

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

(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.

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

from a licensed pharmacy in this state.

R 338.3135 Opioids and other controlled substances awareness training standards for

prescribers and dispensers of controlled substances; requirements.

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

license shall complete a training in opioids and controlled substances awareness before

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

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

(i) Utilizing the MAPS.

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

(b) Topics covered under subdivision (a) of this subrule may be obtained from more

than 1 program.

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

(i) Teleconference or webinar.

(ii) Online presentation.

(iii) Live presentation.

(iv) Printed or electronic media.

(2) A prescriber or dispenser may 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

subrule (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, the individual shall provide an

acceptable proof of completion of training, including 1 of the following:

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

provider’s name, name of the training, and the individual’s name.

(b) A self-attestation by the individual that includes the date, the provider’s name, name

of the training, and the individual’s name.

(4) An individual who has been issued a controlled substance license under 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 a controlled substance license shall complete the

controlled substance training by the end of the first renewal cycle that begins after

January 4, 2019.

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(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 the

applicant provides proof of having completed the controlled substance training.

(5) 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 a controlled substance training. The training must be

taken 1 time during the current license cycle and cover 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.

R 338.3137 Rescinded.

PART 4. SECURITY

R 338.3141 Thefts and diversions.

Rule 41. (1) An applicant or licensee shall provide effective controls against theft and

diversion of controlled substances.

(2) A licensee shall confirm that a person is licensed to possess a controlled substance

before distributing the substance to the person.

(3) Within 45 days after completion of an investigation regarding a suspected theft or

significant loss of a controlled substance, 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 106, or equivalent document, to the department, whether or not

the controlled substance is recovered or the responsible individual is identified and action

is taken against the responsible individual, and whether or not it is also reported to the

DEA.

(4) A licensee shall use all of the following criteria to determine if the loss in subrule (3)

of this rule is significant:

(a) The quantity of the controlled substance lost in relation to the type of business.

(b) The specific controlled substance lost.

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(c) Whether the loss of the controlled substance can be associated with access to the

controlled substance by specific individuals, or whether the loss can be attributed to

unique activities that may take place involving the controlled substance.

(d) A pattern of loss over a specific time period, whether the loss appears to be random,

and the results of efforts taken to resolve the loss.

(e) Whether the specific controlled substance is a likely candidate for diversion.

(f) Local trends and other indicators of the diversion potential of the missing controlled

substance.

R 338.3143 Storage of controlled substances.

Rule 43. (1) A licensee shall store controlled substances that are listed in schedule 1 in a

securely locked, substantially constructed cabinet that is anchored to a wall or the floor.

(2) A licensee shall store controlled substances that are listed in schedules 2, 3, 4, and 5

in a securely locked, substantially constructed cabinet, room, or cart. However, in a

pharmacy, the controlled substances may be dispersed throughout the stock of non-

controlled substances in a manner to obstruct the theft or diversion of controlled

substances.

R 338.3145 Employees; disqualification.

Rule 45. (1) An individual, partnership, cooperative, association, private corporation,

other legal entity, or governmental entity that is licensed by the department under section

7303 or 17748 of the code, MCL 333.7303, or 333.17748, shall not employ or utilize,

with or without compensation, or allow the following individuals access to controlled

substances:

(a) An individual who the licensee knows, or reasonably should know, has a substance

use disorder, as that term is defined in section 1100d of the mental health code, 1974 PA

258, MCL 330.1100d. This subdivision does not apply to a licensee enrolled in the health

professional recovery program under a current monitoring agreement.

(b) An individual whose controlled substance license is suspended, revoked, or denied.

(c) An individual whose license issued by this state or another state is under suspension

or revoked for a violation that involves controlled substances.

(d) An individual who has been convicted of a crime that involves controlled

substances and is currently under sentence for that conviction.

(2) A licensee shall not delegate, under section 16215 of the code, MCL 333.16215, to a

licensed or unlicensed individual unless the delegation complies with this rule.

PART 5. RECORDS

R 338.3151 Inventories.

Rule 51. (1) An individual, partnership, cooperative, association, private corporation,

other legal entity, or governmental entity licensed to manufacture, distribute, prescribe, or

dispense controlled substances shall annually perform and maintain a complete and

accurate inventory of all stocks of controlled substances in the possession and control of

the licensee.

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(2) The inventory 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, the licensee shall make an exact count or

measure of the contents.

(b) If the substance is listed in schedule 3, 4, or 5, the licensee shall estimate the count

or measure of the contents, but if the container holds more than 1,000 dosage units, 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

the licensee first engages in the activity covered by the license, including a change of a

pharmacist in charge. The beginning inventory record for a licensed location must be

maintained at the licensed location and a copy must be forwarded to the department on

request.

(4) A licensee shall indicate on the inventory record whether the inventory was taken 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 must be

promptly transcribed.

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

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

inventory.

(8) Schedule 2 drugs 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 that

was not previously listed in a 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. The substance must be included in each subsequent inventory taken.

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

Rule 53. (1) For 2 years, a licensee shall maintain in the pharmacy for review by the

department, an agency, or the board, all records for controlled substances, including

invoices and acquisition records as follows:

(a) A licensee may keep acquisition records, except for executed or voided DEA 222

order forms, in an electronic form at a central location with notice to the department.

(b) A licensee shall maintain invoices and other acquisition records of all controlled

substances listed in schedules 1 and 2 in a separate file from invoices and other

acquisition records of controlled substances listed in schedules 3, 4, and 5. The

information must be readily retrievable from the ordinary acquisition records maintained

by the dispenser.

(c) A licensee shall initial or electronically initial the invoice and indicate the date that

the controlled substances are received.

(2) A licensee shall maintain in the pharmacy for review by the department, an agency,

or the board, patient sales receipts and dispensing records as follows:

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

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(b) A licensee shall keep a record, which may be electronic, of all controlled substances

dispensed by the licensee.

(c) A licensee that prescribes controlled substances shall keep a record separate from

the patient chart that contains all of the following information for controlled substances

dispensed or administered by the prescriber:

(i) Name of the patient.

(ii) Name and strength of the controlled substance.

(iii) Quantity of the controlled substance.

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

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

(d) Except in medical institutions, a licensee shall sequentially number and maintain in

chronological order the patients’ original prescriptions as follows:

(i) A licensee shall maintain a separate file for dispensed substances listed in schedule

2.

(ii) A licensee shall maintain a separate file for dispensed substances listed in

schedules 3, 4, and 5.

(3) A licensee shall keep the original prescription record on-site for 5 years after the last

date of dispensing. However, 2 years after the last date of dispensing, a licensee may

make an electronic duplicate of the original paper prescription, which becomes the

original prescription.

(4) A licensee shall maintain records of controlled substances distributed to another

licensee that must include all of the following information and be maintained in the

appropriate file described in subrule (1)(b) of this rule or in a separate record that is

available for inspection:

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

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

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

(d) Date the controlled substances were distributed.

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

R 338.3153a Medication orders for patients in medical institutions.

Rule 53a. (1) A licensee shall include all of the following information in a prescription

for controlled substance medications to be dispensed for administration to an inpatient in

a medical institution:

(a) The patient's name.

(b) The prescriber's name, address, and DEA number. In place of including the address

and DEA number on each medication order, the pharmacy may maintain a separate list of

prescribers. The list must contain the prescriber's name, address, and DEA number.

(c) The prescriber's signature.

(d) The name, dose, and frequency of administration of the medication.

(e) The date of the medication order.

(2) If alternative therapy has been evaluated and the immediate administration of a

controlled substance, including a schedule 2 medication, is necessary for the proper

treatment of a patient, a pharmacist may dispense the controlled substance for

administration to the inpatient if all of the following conditions are met:

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(a) The oral order of the prescriber is committed to a written or electronic order in the

patient chart by a nurse licensed under part 172 of the code, MCL 333.17201 to

333.17242, a physician's assistant licensed under part 170 of the code, MCL 333.17001 to

333.17097, or part 175 of the code, MCL 333.17501 to 333.17556, or a pharmacist

licensed under part 177 of the code, MCL 333.17701 to 333.17780, who has

communicated directly with the prescriber.

(b) The order states the name of the prescriber and the name of the nurse, physician's

assistant, or pharmacist who received the verbal order.

(c) The order is forwarded to the pharmacy.

(d) The prescriber signs the original order at the next visit or within 7 days.

(3) A licensee shall preserve an original order for a period of 5 years after the patient

discharge date and the original order must be readily retrievable. After 2 years, a licensee

may make an electronic duplicate of the original order that becomes the original order. If

a licensee maintains patient records electronically, a printed copy must be immediately

available for a current inpatient and within 48 hours on request of an authorized agent of

the board for a patient discharged in the last 5 years.

R 338.3154 Medication records in medical institutions.

Rule 54. (1) A patient's chart must 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. At a minimum, these records 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.

(3) If the controlled substance is not dispensed to an individual patient, all of the

following provisions must be complied with:

(a) Medication records for those controlled substances listed in schedules 2, 3, 4, and 5

must be maintained.

(b) Distribution of a controlled substance to a nursing unit may not be more than 25

doses per container.

(c) A distribution record for each multiple of 25 doses must be used to account for

delivery to a nursing unit. The record 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 it is a different location from

the medical institution.

(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 must be maintained to account for all doses of an

administered substance. The record must include all of the following:

(i) The name of the substance.

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(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) This subrule does not apply to automated 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.

(5) If a controlled substance is dispensed from an automated device, documentation of

all of the following must be maintained on-site in the pharmacy responsible for the

automated device for 2 years for review by the department, an agency, or the board.

(a) The name and address of the pharmacy responsible for the operation of the

automated device.

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

(c) The name and address of the facility where the automated device is located.

(d) The contents of the automated device.

(e) The 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 if 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.

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

assurance program.

(f) The 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 substances.

(vii) Data retention or archival.

(viii) Definitions.

(ix) Downtime procedures.

(x) Emergency procedures.

(xi) Operator inspections.

(xii) Installation requirements.

(xiii) Maintenance.

(xiv) Medication security.

(xv) Medication inventory.

(xvi) Staff education and training.

(xvii) System set-up and malfunction.

(xviii) List of medications qualifying for emergency dose removal without pharmacist

prior review of the prescription or medication order.

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(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

medication from the automated device for immediate patient administration, except in the

following situations where a pharmacist shall review the orders and authorize 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).

(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.

(g) The automated device must maintain transaction data that includes all

activity regarding access to the contents of the automated device.

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

access to the automated device. The records must be readily retrievable and must include

all of the following information:

(i) The unique identity of the device.

(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.

(vi) The identification of the pharmacist checking for the accuracy of the medications

stocked or restocked in the automated device.

(vii) Any information the pharmacist 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 completed electronically.

(j) If the pharmacist delegates the stocking of the automated device, technologies must

be in place and utilized to ensure that the correct drugs are stocked in their appropriate

assignment utilizing bar-coding or another a board-approved error prevention technology.

(k) The automated device must provide a mechanism for securing and accounting for

controlled substances removed from the automated device return bin. Controlled

substances must not be returned directly to the automated device for immediate reissue or

reuse. Controlled substances removed from the automated device may not be reused or

reissued, except as indicated in R 338.486(7).

(l) The automated device must provide a mechanism for securing and accounting for

wasted or discarded medications.

(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

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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.

PART 6. DISPENSING AND ADMINISTERING CONTROLLED SUBSTANCE

PRESCRIPTIONS

R 338.3161 Controlled substance prescriptions.

Rule 61. (1) A prescription that is issued for a controlled substance must be dated and

signed by the prescriber, when issued, and contain all of the following information:

(a) The full name and address of the patient for whom the substance is being

prescribed.

(b) The prescriber's DEA registration number, preprinted, stamped, typed, or manually

printed name, address, and telephone number or pager number, and professional

designation that is either written on the prescription or stored in the pharmacy’s

automated data processing system.

(c) The drug name, strength, and dosage form.

(d) The quantity prescribed. For a paper prescription received in writing, the

prescription must contain the quantity in both written and numerical terms. A paper

prescription complies if it contains preprinted numbers representative of the quantity next

to a box or line that the prescriber may check.

(e) The directions for use.

(f) If the prescription is for an animal, the species of the animal and the full name and

address of the owner.

(2) A written prescription for a controlled substance listed in schedules 2 to 5 must be

written legibly with ink or an indelible pencil or prepared using a printer and signed by

the prescriber.

(3) An agent of the prescriber may prepare a prescription for the signature of the

prescriber, however, under sections 16106 and 17744 of the code, MCL 333.16106 and

333.17744, the prescriber is liable if the prescription does not conform to these rules. A

pharmacist who dispenses a controlled substance under a prescription not prepared in the

form required by these rules is liable under the code.

(4) If the controlled substance prescription or order in a medical institution is issued

under delegation, the printed name of the delegatee, the licensure designation, the

delegating prescriber, and the signature of the delegatee must be on the written

prescription. In medical facilities, orders must contain the signatures of the delegatee and

the printed name of the delegating prescriber.

(5) A prescriber shall not issue a prescription to obtain a stock of a controlled substance

for the purpose of dispensing or administering the substance to patients.

R 338.3161a. Exception to bona fide prescriber-patient relationship; alternative

requirements.

Rule 61a. (1) Except as provided in subrule (2) of this rule and for a patient who is

under the care of a hospice, a bona fide prescriber-patient relationship is required before a

licensed prescriber may prescribe a controlled substance listed in schedules 2 to 5.

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(2) Under section 16204e of the code, MCL 333.16204e, a licensed prescriber may

prescribe a controlled substance listed in schedules 2 to 5 without first establishing the

bona fide prescriber-patient relationship required under section 7303a of the code, MCL

333.7303a, in the following situations:

(a) The prescriber is providing on-call coverage or cross-coverage for another

prescriber who is not available and has established a bona fide prescriber-patient

relationship with the patient for whom the on-call or covering prescriber is prescribing a

controlled substance, the prescriber, or an individual licensed under article 15 of the

code, MCL 333.16101 to 333.18838, reviews the patient’s relevant medical or clinical

records, medical history, and change in medical condition, and provides documentation in

the patient’s medical record consistent with medically accepted standards of care.

(b)The prescriber is following or modifying the orders of a prescriber who has

established a bona fide prescriber-patient relationship with a hospital in-patient or nursing

care facility resident and provides documentation in the patient’s medical record

consistent with medically accepted standards of care.

(c) The prescriber is prescribing for a patient that has been admitted to a licensed

nursing care facility, completes the tasks identified in subdivisions (a) and (b) of this

subrule in compliance with R 325.45377, as applicable, and provides documentation in

the patient’s medical record consistent with medically accepted standards of care.

(d) The prescriber is prescribing for a patient for whom the tasks listed in subdivisions

(a) and (b) of this subrule are performed by an individual licensed under article 15 of the

code, MCL 333.16101 to 333.18838, and the prescriber provides documentation in the

patient’s medical record consistent with medically accepted standards of care.

(e) The prescriber is treating a patient in a medical emergency. As used in this

subdivision, “medical emergency” means a situation that, in the prescriber’s good-faith

professional judgment, creates an immediate threat of serious risk to the life or health of

the patient for whom the controlled substance prescription is being prescribed.

R 338.3162 Dispensing by pharmacists; delivery of controlled substances.

Rule 62. (1) Except for a remote pharmacy that is regulated by section 17742a of the

code, MCL 333.17742a, and that allows a qualified pharmacy technician to assist in the

dispensing process while being overseen by a pharmacist through the use of a

surveillance system and telepharmacy system, a controlled substance must be dispensed

by a pharmacist or a pharmacy intern in the presence, and under the personal charge of, a

pharmacist.

(2) A pharmacist shall require positive identification of individuals to whom controlled

substances are dispensed or delivered if the individual is not known to the pharmacist or

pharmacy employees, except if positive identification is not available and a pharmacist,

who in exercising professional judgment, determines that a delay in dispensing the

controlled substance may be detrimental to a patient.

(3) Subrule (2) of this rule does not exempt a pharmacist from the requirement to submit

a patient identifier to the electronic system for monitoring controlled substances.

(4) The dispensing pharmacist and pharmacy are both responsible for complying with

this rule.

(5) A pharmacist may dispense a controlled substance that is listed in schedules 3 to 5

and that is a prescription drug under section 503 of the FDCA, 21 USC 353, under a

21

prescription on a prescription form, an oral prescription of a practitioner, or a prescription

that is electronically transmitted pursuant to R 338.3162a and that contains all of the

required information under R 338.3161, except that the signature of the prescriber is not

required if the controlled substance is obtained under an oral order.

(6) In addition to the requirements in section 17744 of the code, MCL 333.17744, if a

prescriber’s agent under delegation transmits an oral prescription for a controlled

substance to a pharmacy, all of the following must be recorded on the prescription

generated at the pharmacy:

(a) The information required by R 338.3161.

(b) The transmitting agent's identity.

(c) The individual who received the prescription at the pharmacy.

(7) Only a prescription that is issued in the usual course of professional treatment or in

the course of legitimate and authorized research is a prescription.

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

Rule 62a. (1) 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 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) 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 CMS.

(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:

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(i) 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 CMS waiver for electronic

transmission of prescriptions for controlled substances, whichever is more.

(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 livelihood.

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

(iii) The prescriber issues prescriptions from a not-for-profit medical clinic that

provides free or low-cost services to the public.

(4) A waiver is valid for 2 years and applies to the specific circumstances included in

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

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 pharmacist, dispensing prescriber, or veterinarian licensed under part 177 of

the code, MCL 333.17701 to 333.17780, who dispenses a prescription drug that is a

controlled substance listed in schedules 2 to 5 or a pharmacy licensed by this 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 scheduled 2 to 5 controlled substance that has been dispensed:

(a) The patient identifier identification number. As used in this subdivision, all of the

following apply:

(i) An identification number, as specified in R 338.3102(h)(iv)(A) to (E), is not

required for patients under the age of 16.

(ii) If the patient is under 16 years of age, zeroes must be entered as the identification

number.

(iii) If the medication being dispensed is for an animal, the patient identification

number applies to the animal's owner, the client, that meets the requirements of R

338.3102(h)(iv). If the animal’s owner cannot be identified, zeroes must be entered as the

identification number.

(b) 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.

(h) The metric quantity of the controlled substance dispensed.

(i) The NDC of the controlled substance dispensed.

(j) The date the prescription is issued.

(k) The date the prescription is filled.

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(l) The number of refills authorized.

(m) The refill number of the prescription fill.

(n) The estimated days of supply of the controlled substance dispensed.

(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 the dispensed controlled

substance, as specified by ASAP.

(t) The DEA registration number of the prescriber and the dispensing pharmacy.

(2) A pharmacist, dispensing prescriber, or veterinarian may presume that the patient

identification information provided by a patient, a patient's representative, or

veterinarian’s client is correct.

(3) As used in this rule, R 338.3162c, and R 338.3162d, “dispense” or “dispensing”

means the preparation, compounding, packaging, or labeling of a controlled substance

along with delivery of the controlled substance under 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, “patient” means an individual, not an animal.

R 338.3162c Format for electronic transmission of data to electronic system for

monitoring; waiver.

Rule 62c. (1) A pharmacist, dispensing prescriber, or veterinarian who dispenses a

prescription drug that is a controlled substance listed in schedules 2 to 5 shall transmit the

data, as specified under R 338.3162b, by electronic media or other means as approved by

the department or the department's contractor.

(2) The data must be transmitted in the format established by the ASAP 5.0 Standard for

Prescription Drug Monitoring Programs.

(3) A pharmacist, dispensing prescriber, or veterinarian who dispenses controlled

substances and does not have an automated record-keeping system capable of producing

an electronic report in the format established by subrule (2) of this rule may request a

waiver from electronic reporting. The request must be made in writing to the department.

(4) A pharmacist, dispensing prescriber, or veterinarian may be granted a waiver, if the

pharmacist, dispensing prescriber, or veterinarian demonstrates an inability to report as

required by R 338.3162b and agrees in writing to report the data to the department or the

department's contractor by submitting a completed MAPS claim form or transmitting data

via an internet web portal that is provided by the department or the department’s

contractor for this purpose.

R 338.3162d Required reporting of prescription data; error reporting.

Rule 62d. (1) A pharmacist, pharmacy, dispensing prescriber, or veterinarian shall

report all scheduled 2 to 5 controlled substances dispensed.

(2) The licensee shall forward the data required by R 338.3162b by online transmission,

computer diskette, compact disk, or other approved medium, as specified in R 338.3162c

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to the department or the department’s contractor, on a daily basis, by the end of the next

business day and include the data for all controlled substances dispensed since the

previous transmission or report.

(3) A pharmacist, pharmacy, dispensing prescriber, or veterinarian that does not have

the capacity to forward the information as specified in R 338.3162b, shall mail or deliver

the information to a location specified by the department or the department’s contractor

not later than 7 calendar days after the date that the controlled substance has been

dispensed, and include the data for all controlled substances dispensed since the previous

transmission or report.

(4) The department or the department’s contractor shall notify a pharmacist, pharmacy,

dispensing prescriber, or veterinarian of an error in data reporting. If a pharmacist,

pharmacy, dispensing prescriber, or veterinarian receives notification of an error in data

reporting, the pharmacist, pharmacy, dispensing prescriber, or veterinarian shall take

appropriate measures to correct the error and transmit the corrected data to the

department or the department’s contractor within 7 calendar days after being notified of

the error.

(5) A pharmacist, pharmacy, dispensing prescriber, or veterinarian that fails to report the

dispensing of a prescription for a controlled substance listed in schedules 2 to 5 as

required, is subject to the penalty provisions in section 16221, 17741, or 17768 of the

code, MCL 333.16221, 333.17741, or 333.17768.

R 338.3163 Rescinded.

R 338.3164 Emergency dispensing of schedule 2 substances; oral prescriptions.

Rule 64. A pharmacist may dispense a controlled substance listed in schedule 2 in an

emergency if all the following conditions are met:

(a) The prescriber advises the pharmacist of all of the following:

(i) Immediate administration of the controlled substance is necessary for proper

treatment of the patient.

(ii) Appropriate alternative treatment is not available, including administration of a

drug that is not a controlled substance under schedule 2.

(iii) It is not reasonably possible for the prescriber to provide a written prescription to

the dispenser before the dispensing.

(iv) The quantity prescribed and dispensed is limited to the amount adequate to treat the

patient during the emergency period and under a written prescription.

(b) The pharmacist shall immediately put the prescription in writing, which contains the

information that must be contained in a prescription under R 338.3161, except for the

prescriber's signature.

(c) If the prescriber is not known to the pharmacist, the pharmacist shall make a

reasonable effort to determine that the oral authorization came from a prescriber by

returning the prescriber's call, using the telephone number listed in the telephone

directory, and other good faith efforts to ensure the prescriber's identity.

R 338.3165 Emergency dispensing of schedule 2 substances; written prescriptions.

Rule 65. (1) After authorizing an emergency oral prescription of a controlled substance

listed in schedule 2, the prescriber shall comply with all of the following within 7 days:

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(a) The prescriber shall 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.

(b) The prescriber shall include on the prescription both "Authorization for Emergency

Dispensing" and the date of the oral order.

(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) After the dispensing pharmacist receives the prescription the pharmacist shall attach

the prescription to the oral order that was earlier reduced to writing.

(c) The pharmacy shall notify the department if the prescriber fails to deliver to the

pharmacy either a written prescription or a prescription transmitted electronically.

(3) The failure of the pharmacy to notify the department if the prescriber fails to deliver

a prescription under subrule (1) of this rule voids the authority conferred by this rule.

R 338.3166 Partial dispensing of controlled substances.

Rule 66. (1) A pharmacist may partially dispense a controlled substance listed in

schedule 2 in conformance with the following:

(a) The pharmacist is unable to supply the full quantity called for in a written or

emergency oral prescription.

(b) The pharmacist notes the quantity supplied on the face of the written prescription,

written record of the emergency oral prescription, or in the electronic prescription record.

(c) The pharmacist may dispense the remainder of the prescription within 72 hours after

the first partial dispensing.

(d) If the remainder of the prescription is not or cannot be dispensed within the 72

hours, the pharmacist shall notify the prescriber.

(e) The pharmacist shall not dispense an additional quantity of the drug beyond 72

hours without a new prescription.

(f) The pharmacy has the balance of the prescription ready for dispensing before the 72-

hour limit, but the patient is not required to pick up the balance of the prescription within

that 72-hour limit.

(2) A pharmacist may partially dispense a prescription for a controlled substance listed

in schedule 2 at the request of the patient or the prescribing practitioner in conformance

with the following:

(a) The prescription is written and filled under the CSA and DEA regulations and state

law.

(b) The total quantity dispensed in all partial fillings does not exceed the total quantity

prescribed.

(c) The remaining portions of a partially filled prescription listed in schedule 2, if filled,

must be filled not later than 30 days after the date the prescription was written.

(d) For each partial filling, the dispensing pharmacist shall record, on the back of the

prescription or on another appropriate record that is uniformly maintained and readily

retrievable, all of the following information:

(i) Date of the partial filling.

(ii) Quantity dispensed.

(iii) Remaining quantity that may be dispensed.

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(iv) Identification of the dispensing pharmacist.

(3) A pharmacist may partially dispense, including individual dosage units, a

prescription for a schedule 2 controlled substance that is written for a patient in a long-

term care facility or for a patient with a medical diagnosis that documents a terminal

illness in conformance with all of the following:

(a) For each partial filling, the dispensing pharmacist shall record, on the back of the

prescription or on another appropriate record that is uniformly maintained and readily

retrievable, all of the following information:

(i) Date of the partial filling.

(ii) Quantity dispensed.

(iii) Remaining quantity authorized to be dispensed.

(iv) Identification of the dispensing pharmacist.

(b) The total quantity of schedule 2 controlled substances dispensed in all partial

fillings may not be more than the total quantity prescribed.

(c) Prescriptions are valid for a period of not more than 60 days after the issue date

unless terminated at an earlier date by the discontinuance of medication.

(d) A pharmacist shall record on the prescription whether the patient is terminally ill or

is a long-term care facility patient.

(4) A pharmacy may partially fill a prescription for a schedule 3, 4, or 5 controlled

substance if all of the following provisions are met:

(a) Each partial filling is recorded in the same manner as a refilling.

(b) The total quantity dispensed in all partial fillings does not exceed the total quantity

prescribed.

(c) No dispensing occurs 6 months after the date the prescription was issued for

schedules 3, 4, and 5.

R 338.3167 Dispensing schedule 5 substances without prescriptions.

Rule 67. (1) A pharmacist may, without a prescription, dispense a controlled substance

listed in schedule 5 that is not a prescription medication as determined under the FDCA,

if all of the following provisions are met:

(a) The dispensing pharmacist determines the controlled substance is intended to be

used for a medical purpose.

(b) Not more than 240 cc, 8 ounces, or 48 solid doses of a substance containing opium

or more than 120 cc, 4 ounces, or 24 solid doses of another substance listed in schedule 5

are distributed at retail to the same purchaser in a 48-hour period.

(c) The purchaser is not younger than 18 years of age.

(d) The dispensing pharmacist requires a purchaser, not known to the pharmacist, to

furnish suitable identification, including proof of age where appropriate.

(2) If a pharmacist dispenses a controlled substance listed in schedule 5 without a

prescription, the pharmacist shall affix a label to the container that holds the substance

that includes all the following:

(a) The date the controlled substance was dispensed.

(b) The pharmacist’s name.

(c) The name and address of the pharmacy where the substance is dispensed.

(3) The pharmacist shall maintain a record of the dispensing without a prescription of

controlled substances listed in schedule 5 with the following requirements:

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(a) The record must be maintained for 5 years after the date of dispensing. After 2

years, an electronic duplicate of the original order may be made which becomes the

original record.

(b) The record must be immediately retrievable and may be maintained in the same

manner as required for schedule 5 prescription medication.

(c) The record must contain all of the following information:

(i) The name and address of the patient.

(ii) The name and address of the purchaser if different from the patient.

(iii) The name and quantity of substance purchased.

(iv) The date purchased.

(v) The name or initials of the pharmacist or pharmacy intern who dispensed the

substance.

(vi) The medical purpose of the medication as determined by the pharmacist.

R 338.3170 Dispensing and administering controlled substances by prescribers.

Rule 70. (1) A prescriber in the course of the prescriber’s professional practice may

dispense, administer, or delegate under direct supervision the administering of a

controlled substance listed in schedules 2 to 5.

(2) A veterinarian, in the course of the veterinarian’s professional practice may

dispense, administer, or delegate the administering under direct supervision of a

controlled substance listed in schedules 2 to 5 to an animal.

PART 7. DISTRIBUTIONS

R 338.3181 Distributions by dispensers.

Rule 81. (1) A dispenser who is not licensed as a wholesale distributor may distribute a

controlled substance to another dispenser for the purpose of general dispensing to the

dispenser’s patients if all of the following conditions are satisfied:

(a) The receiving dispenser is licensed to dispense the substance.

(b) The distribution is recorded by the distributing dispenser and a receipt record is

maintained by the receiving dispenser.

(c) An order form for substances listed in schedules 1 and 2 is used.

(d) The total number of dosage units of all controlled substances distributed by the

distributing dispenser during the 12-month period the dispenser is licensed is not more

than 5% of the total number of all dosage units distributed and dispensed during the 12-

month period.

(2) If the dispenser has reason to believe that the total number of dosage units

distributed by the dispenser under this rule are more than 5% of the total number of

dosage units of all controlled substances distributed and dispensed by the dispenser

during the 12-month period, the dispenser shall obtain a license to distribute controlled

substances.

R 338.3183 Distribution to suppliers.

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Rule 83. (1) An individual who is lawfully in possession of a controlled substance that is

listed in a schedule may return the substance to the individual who gave the person the

substance or to the manufacturer of the substance without obtaining a license to

distribute. The individual who distributes the substance shall maintain a written record

that contains all of the following information:

(a) The date of the distribution.

(b) The name, form, and quantity of the substance.

(c) The name, address, and license number of the individual who distributes the

substance.

(d) The name, address, and license number, if known, of the supplier or manufacturer.

(2) In the case of a controlled substance listed in schedules 1 or 2, an order form must be

used and maintained as the written record of the distribution.

R 338.3185 Discontinuances and transfers.

Rule 85. A licensee who wants to discontinue or transfer business activities or a

professional practice altogether or only with respect to controlled substances state-

controlled substances license to the department. The transfer of the controlled substances

is subject to approval by the DEA under 21 CFR 1301.52 and written notification must be

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