Mich. Admin. Code R. 338.3111

Current through Vol. 24-19, November 1, 2024
Section 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

(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, 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.

(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.

x

(b) Synthetic cathinone:

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.

(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.

x

(c) Ephedrine:

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.

(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.

x

(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.

x

(e) Marijuana:

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.

x

(f) Salvia divinorum:

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.

x

(g) Salvinorin A

x

(h) Tianeptine sodium:

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

x

Mich. Admin. Code R. 338.3111

1979 AC; 1982 AACS; 1985 AACS; 1986 AACS; 1988 AACS; 1995 AACS; 2022 AACS; 2024 MR 10, Eff. 5/28/2024