AB 2018: Controlled substances: fenfluramine.
- Session Year: 2023-2024
- House: Assembly
- Latest Version Date: 2024-07-15
Current Status:
Passed
(2024-07-15: Chaptered by Secretary of State - Chapter 98, Statutes of 2024.)
Introduced
In Committee
First Chamber
In Committee
Second Chamber
Enacted
What does this bill do?
The bill removes the drug fenfluramine from California’s Schedule IV list of controlled substances and deletes it from the list of drugs whose possession or sale is a crime. That change affects people who make, sell, prescribe, or use fenfluramine by eliminating those specific state criminal penalties.
The summary is provided by generative AI which can make mistakes. For original language, please view the details in the table below.
Existing law, the California Uniform Controlled Substances Act, categorizes controlled substances into 5 schedules and places the greatest restrictions on those substances contained in Schedule I. Under existing law, the substances in Schedule I are deemed to have a high potential for abuse and no accepted medical use while substances in Schedules II through V are substances that have an accepted medical use, but have the potential for abuse. Existing law categorizes fenfluramine as a Schedule IV controlled substance. Existing law makes it a crime to possess, possess for sale, or to sell materials, compounds, mixtures, or preparations containing specified controlled substances, including fenfluramine, as specified.
This bill would remove fenfluramine from the list of Schedule IV controlled substances under the California Uniform Controlled Substances Act and remove it from the list of controlled substances that are a crime to possess or sell, as specified.
Existing law, the California Uniform Controlled Substances Act, categorizes controlled substances into 5 schedules and places the greatest restrictions on those substances contained in Schedule I. Under existing law, the substances in Schedule I are deemed to have a high potential for abuse and no accepted medical use while substances in Schedules II through V are substances that have an accepted medical use, but have the potential for abuse. Existing law categorizes fenfluramine as a Schedule IV controlled substance. Existing law makes it a crime to possess, possess for sale, or to sell materials, compounds, mixtures, or preparations containing specified controlled substances, including fenfluramine, as specified.
This bill would remove fenfluramine from the list of Schedule IV controlled substances under the California Uniform Controlled Substances Act and remove it from the list of controlled substances that are a crime to possess or sell, as specified.
Existing law, the California Uniform Controlled Substances Act, categorizes controlled substances into 5 schedules and places the greatest restrictions on those substances contained in Schedule I. Under existing law, the substances in Schedule I are deemed to have a high potential for abuse and no accepted medical use while substances in Schedules II through V are substances that have an accepted medical use, but have the potential for abuse. Existing law categorizes fenfluramine as a Schedule IV controlled substance. Existing law makes it a crime to possess, possess for sale, or to sell materials, compounds, mixtures, or preparations containing specified controlled substances, including fenfluramine, as specified.
This bill would remove fenfluramine from the list of Schedule IV controlled substances under the California Uniform Controlled Substances Act and remove it from the list of controlled substances that are a crime to possess or sale, as specified.
(a)The controlled substances listed in this section are included in Schedule IV.
(b)Schedule IV shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section.
(c)Narcotic drugs. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation containing any of the following narcotic drugs, or their salts calculated as the free anhydrous base or alkaloid, in limited quantities as set forth below:
(1)Not more than 1 milligram of difenoxin and not less than 25 micrograms of atropine sulfate per dosage unit.
(2)Dextropropoxyphene (alpha-(+)-4-dimethylamino-1, 2-diphenyl-3-methyl-2-propionoxybutane).
(3)Butorphanol.
(d)Depressants. Unless specifically excepted in Section 11059 or elsewhere, or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances, including its salts, isomers, and salts of isomers whenever the existence of those salts, isomers, and salts of isomers is possible within the specific chemical designation:
(1)Alprazolam.
(2)Barbital.
(3)Chloral betaine.
(4)Chloral hydrate.
(5)Chlordiazepoxide.
(6)Clobazam.
(7)Clonazepam.
(8)Clorazepate.
(9)Diazepam.
(10)Estazolam.
(11)Ethchlorvynol.
(12)Ethinamate.
(13)Flunitrazepam.
(14)Flurazepam.
(15)Halazepam.
(16)Lorazepam.
(17)Mebutamate.
(18)Meprobamate.
(19)Methohexital.
(20)Methylphenobarbital (Mephobarbital).
(21)Midazolam.
(22)Nitrazepam.
(23)Oxazepam.
(24)Paraldehyde.
(25)Petrichoral.
(26)Phenobarbital.
(27)Prazepam.
(28)Quazepam.
(29)Temazepam.
(30)Triazolam.
(31)Zaleplon.
(32)Zolpidem.
(e)Stimulants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system, including its salts, isomers (whether optical, position, or geometric), and salts of those isomers is possible within the specific chemical designation:
(1)Diethylpropion.
(2)Mazindol.
(3)Modafinil.
(4)Phentermine.
(5)Pemoline (including organometallic complexes and chelates thereof).
(6)Pipradrol.
(7)SPA ((-)-1-dimethylamino-1,2-diphenylethane).
(8)Cathine ((+)-norpseudoephedrine).
(f)Other substances. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of pentazocine, including its salts.
SEC. 2.Section 11375 of the Health and Safety Code, as amended by Section 2 of Chapter 838 of the Statutes of 2001, is amended to read:11375.(a) As to the substances specified in subdivision (c), this section, and not Sections 11377, 11378, 11379, and 11380, shall apply.
(b) (1) A person who possesses for sale, or who sells, a substance specified in subdivision (c) shall be punished by imprisonment in the county jail for a period of not more than one year or state prison.
(2) A person who possesses a controlled substance specified in subdivision (c), unless upon the prescription of a physician, dentist, podiatrist, or veterinarian, licensed to practice in this state, shall be guilty of an infraction or a misdemeanor.
(c) This section shall apply to a material, compound, mixture, or preparation containing any of the following substances:
(1) Chlordiazepoxide.
(2) Clonazepam.
(3) Clorazepate.
(4) Diazepam.
(5) Flurazepam.
(6) Lorazepam.
(7) Mebutamate.
(8) Oxazepam.
(9) Prazepam.
(10) Temazepam.
(11) Halazepam.
(12) Alprazolam.
(13) Propoxyphene.
(14) Diethylpropion.
(15) Phentermine.
(16) Pemoline.
(17)Triazolam.
(a)The controlled substances listed in this section are included in Schedule IV.
(b)Schedule IV shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section.
(c)Narcotic drugs. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation containing any of the following narcotic drugs, or their salts calculated as the free anhydrous base or alkaloid, in limited quantities as set forth below:
(1)Not more than 1 milligram of difenoxin and not less than 25 micrograms of atropine sulfate per dosage unit.
(2)Dextropropoxyphene (alpha-(+)-4-dimethylamino-1, 2-diphenyl-3-methyl-2-propionoxybutane).
(3)Butorphanol.
(d)Depressants. Unless specifically excepted in Section 11059 or elsewhere, or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances, including its salts, isomers, and salts of isomers whenever the existence of those salts, isomers, and salts of isomers is possible within the specific chemical designation:
(1)Alprazolam.
(2)Barbital.
(3)Chloral betaine.
(4)Chloral hydrate.
(5)Chlordiazepoxide.
(6)Clobazam.
(7)Clonazepam.
(8)Clorazepate.
(9)Diazepam.
(10)Estazolam.
(11)Ethchlorvynol.
(12)Ethinamate.
(13)Flunitrazepam.
(14)Flurazepam.
(15)Halazepam.
(16)Lorazepam.
(17)Mebutamate.
(18)Meprobamate.
(19)Methohexital.
(20)Methylphenobarbital (Mephobarbital).
(21)Midazolam.
(22)Nitrazepam.
(23)Oxazepam.
(24)Paraldehyde.
(25)Petrichoral.
(26)Phenobarbital.
(27)Prazepam.
(28)Quazepam.
(29)Temazepam.
(30)Triazolam.
(31)Zaleplon.
(32)Zolpidem.
(e)Stimulants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system, including its salts, isomers (whether optical, position, or geometric), and salts of those isomers is possible within the specific chemical designation:
(1)Diethylpropion.
(2)Mazindol.
(3)Modafinil.
(4)Phentermine.
(5)Pemoline (including organometallic complexes and chelates thereof).
(6)Pipradrol.
(7)SPA ((-)-1-dimethylamino-1,2-diphenylethane).
(8)Cathine ((+)-norpseudoephedrine).
(f)Other substances. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of pentazocine, including its salts.
SEC. 2.Section 11375 of the Health and Safety Code, as amended by Section 2 of Chapter 838 of the Statutes of 2001, is amended to read:11375.(a) As to the substances specified in subdivision (c), this section, and not Sections 11377, 11378, 11379, and 11380, shall apply.
(b) (1) A person who possesses for sale, or who sells, a substance specified in subdivision (c) shall be punished by imprisonment in the county jail for a period of not more than one year or state prison.
(2) A person who possesses a controlled substance specified in subdivision (c), unless upon the prescription of a physician, dentist, podiatrist, or veterinarian, licensed to practice in this state, shall be guilty of an infraction or a misdemeanor.
(c) This section shall apply to a material, compound, mixture, or preparation containing any of the following substances:
(1) Chlordiazepoxide.
(2) Clonazepam.
(3) Clorazepate.
(4) Diazepam.
(5) Flurazepam.
(6) Lorazepam.
(7) Mebutamate.
(8) Oxazepam.
(9) Prazepam.
(10) Temazepam.
(11) Halazepam.
(12) Alprazolam.
(13) Propoxyphene.
(14) Diethylpropion.
(15) Phentermine.
(16) Pemoline.
(17)Triazolam.
(a)The controlled substances listed in this section are included in Schedule IV.
(b)Schedule IV shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section.
(c)Narcotic drugs. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation containing any of the following narcotic drugs, or their salts calculated as the free anhydrous base or alkaloid, in limited quantities as set forth below:
(1)Not more than 1 milligram of difenoxin and not less than 25 micrograms of atropine sulfate per dosage unit.
(2)Dextropropoxyphene (alpha-(+)-4-dimethylamino-1, 2-diphenyl-3-methyl-2-propionoxybutane).
(3)Butorphanol.
(d)Depressants. Unless specifically excepted in Section 11059 or elsewhere, or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances, including its salts, isomers, and salts of isomers whenever the existence of those salts, isomers, and salts of isomers is possible within the specific chemical designation:
(1)Alprazolam.
(2)Barbital.
(3)Chloral betaine.
(4)Chloral hydrate.
(5)Chlordiazepoxide.
(6)Clobazam.
(7)Clonazepam.
(8)Clorazepate.
(9)Diazepam.
(10)Estazolam.
(11)Ethchlorvynol.
(12)Ethinamate.
(13)Flunitrazepam.
(14)Flurazepam.
(15)Halazepam.
(16)Lorazepam.
(17)Mebutamate.
(18)Meprobamate.
(19)Methohexital.
(20)Methylphenobarbital (Mephobarbital).
(21)Midazolam.
(22)Nitrazepam.
(23)Oxazepam.
(24)Paraldehyde.
(25)Petrichoral.
(26)Phenobarbital.
(27)Prazepam.
(28)Quazepam.
(29)Temazepam.
(30)Triazolam.
(31)Zaleplon.
(32)Zolpidem.
(e)Fenfluramine. Any material, compound, mixture, or preparation which contains any quantity of the following substances, including its salts, isomers (whether optical, position, or geometric), and salts of those isomers, whenever the existence of those salts, isomers, and salts of isomers is possible:(1)Fenfluramine. (f)(e)Stimulants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system, including its salts, isomers (whether optical, position, or geometric), and salts of those isomers is possible within the specific chemical designation:
(1)Diethylpropion.
(2)Mazindol.
(3)Modafinil.
(4)Phentermine.
(5)Pemoline (including organometallic complexes and chelates thereof).
(6)Pipradrol.
(7)SPA ((-)-1-dimethylamino-1,2-diphenylethane).
(8)Cathine ((+)-norpseudoephedrine).
(g)(f)Other substances. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of pentazocine, including its salts.
SEC. 2.Section 11375 of the Health and Safety Code, as amended by Section 2 of Chapter 838 of the Statutes of 2001, is amended to read:11375.(a) As to the substances specified in subdivision (c), this section, and not Sections 11377, 11378, 11379, and 11380, shall apply.
(b) (1) Every A person who possesses for sale, or who sells, any a substance specified in subdivision (c) shall be punished by imprisonment in the county jail for a period of not more than one year or state prison.
(2) Every A person who possesses any a controlled substance specified in subdivision (c), unless upon the prescription of a physician, dentist, podiatrist, or veterinarian, licensed to practice in this state, shall be guilty of an infraction or a misdemeanor.
(c) This section shall apply to any a material, compound, mixture, or preparation containing any of the following substances:
(1) Chlordiazepoxide.
(2) Clonazepam.
(3) Clorazepate.
(4) Diazepam.
(5) Flurazepam.
(6) Lorazepam.
(7) Mebutamate.
(8) Oxazepam.
(9) Prazepam.
(10) Temazepam.
(11) Halazepam.
(12) Alprazolam.
(13) Propoxyphene.
(14) Diethylpropion.
(15) Phentermine.
(16) Pemoline.
(17) Fenfluramine. (18)(17)Triazolam.
|
Date
|
Status
|
|---|---|
| Jul 15, 2024 | Chaptered by Secretary of State - Chapter 98, Statutes of 2024. |
| Jul 15, 2024 | Approved by the Governor. |
| Jul 1, 2024 | Enrolled and presented to the Governor at 4 p.m. |
| Jun 20, 2024 | In Assembly. Ordered to Engrossing and Enrolling. |
| Jun 20, 2024 | Read third time. Passed. Ordered to the Assembly. (Ayes 36. Noes 0. Page 4626.). |
| Jun 18, 2024 | Read second time. Ordered to Consent Calendar. |
| Jun 17, 2024 | From committee: Be ordered to second reading file pursuant to Senate Rule 28.8 and ordered to Consent Calendar. |
| Jun 4, 2024 | From committee: Do pass and re-refer to Com. on APPR with recommendation: To Consent Calendar. (Ayes 5. Noes 0.) (June 4). Re-referred to Com. on APPR. |
| May 1, 2024 | Referred to Com. on PUB S. |
| Apr 4, 2024 | In Senate. Read first time. To Com. on RLS. for assignment. |
| Apr 4, 2024 | Read third time. Passed. Ordered to the Senate. (Ayes 70. Noes 0. Page 4630.) |
| Mar 21, 2024 | Read second time. Ordered to Consent Calendar. |
| Mar 20, 2024 | From committee: Do pass. To Consent Calendar. (Ayes 12. Noes 0.) (March 20). |
| Mar 12, 2024 | From committee: Do pass and re-refer to Com. on APPR. with recommendation: To Consent Calendar. (Ayes 8. Noes 0.) (March 12). Re-referred to Com. on APPR. |
| Feb 20, 2024 | Referred to Com. on PUB. S. |
| Feb 1, 2024 | From printer. May be heard in committee March 2. |
| Jan 31, 2024 | Read first time. To print. |
|
Date
|
Description
|
Location
|
Votes
|
|
|---|---|---|---|---|
| Jun 20, 2024 | Consent Calendar 2nd AB2018 Rodriguez et al. | Senate Floor |
Passed |
|
| Jun 4, 2024 | Do pass, but first be re-referred to the Committee on [Appropriations] with the recommendation: To Consent Calendar | Senate Standing Committee on Public Safety |
Passed |
|
| Apr 4, 2024 | AB 2018 Rodriguez Consent Calendar Second Day Regular Session | Assembly Floor |
Passed |
|
| Mar 20, 2024 | Do pass. To Consent Calendar. | Assembly Standing Committee on Appropriations |
Passed |
|
| Mar 12, 2024 | Do pass and be re-referred to the Committee on [Appropriations] with recommendation: To Consent Calendar | Assembly Standing Committee on Public Safety |
Passed |
This list shows positions taken on this bill by organizations on the date displayed, which is linked to the original source.
Positions by individuals are not included.
|
Organization
|
Position
|
Date
|
|---|---|---|
| Biocom California | ** Support | |
| California Neurology Society | ** Support | |
| California Public Defenders Association | ** Support | |
| Dravet Syndrome Foundation | ** Support | |
| Epilepsy Foundation | ** Support | |
| Ucb, Inc. | ** Support |
SENATE RULES COMMITTEE Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 | AB 2018 |
CONSENT
Bill No: AB 2018
Author: Rodriguez (D), et al.
Introduced: 1/31/24
Vote: 21
SENATE PUBLIC SAFETY COMMITTEE: 5-0, 6/4/24
AYES: Wahab, Seyarto, Bradford, Skinner, Wiener
SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8
ASSEMBLY FLOOR: 70-0, 4/4/24 (Consent) - See last page for vote
SUBJECT: Controlled substances: fenfluramine
SOURCE: UCB Inc.
DIGEST:
This bill removes fenfluramine from the list of Schedule IV controlled substances under the Uniform Controlled Substances Act and removes it from the list of controlled substances that are a crime to possess for sale, sell, or possess without a prescription.
ANALYSIS:
Existing law:
- Establishes the California Uniform Controlled Substances Act, which regulates controlled substances. (Health & Saf. Code § 11000 et seq.)
- Classifies controlled substances into five schedules according to their danger and potential for abuse. Provides that Schedule I controlled substances have the greatest restrictions and penalties, including prohibiting the prescribing of a Schedule I controlled substance. (Health & Saf. Code §§ 11054-11058)
- Classifies fenfluramine as a Schedule IV controlled substance. (Health & Saf. Code § 11057, subd. (e))
- Makes possession of fenfluramine for personal use, without a valid prescription, punishable as a misdemeanor or an infraction. (Health & Saf. Code § 11375, subd. (b)(2))
- Makes the possession for sale or sale of fenfluramine a misdemeanor punishable by up to one year in county jail or state prison. (Health & Saf. Code § 11375, subd. (b)(1))
This bill removes fenfluramine from the list of Schedule IV controlled substances and removes fenfluramine from the list of controlled substances that are a crime to possess without a prescription, possess for sale, or sell.
Background
Fenfluramine is a drug prescribed to treat seizures in patients with Dravet syndrome and Lennox-Gastaut syndrome, severe forms of epilepsy. Fenfluramine was removed from the federal Controlled Substances Act (CSA) in 2022. (87 Fed. Reg. 78857 (Dec. 23, 2022)) It had previously been a schedule IV controlled substance.
Under federal law, the Attorney General may remove any drug or other substance from the schedules if the Attorney General finds that the drug or other substance does not meet the requirements for inclusion in any schedule. (21 U.S.C § 811(a)) Before removing a controlled substance from one of the schedules, the Attorney General must request a scientific and medical evaluation from the Secretary of the U.S. Department of Health and Human Services (HHS) as well as the Secretary’s recommendations regarding whether the drug should remain scheduled or should be removed as a controlled substance (21 U.S.C § 811(b)) As part of the evaluation, the Secretary must consider the drug’s actual or relative potential for abuse; the scientific evidence of its pharmacological effects; the state of current scientific knowledge regarding the drug or other substance; its history and current pattern of abuse; the scope, duration, and significance of abuse; the potential risk to public health, if any; the substance’s psychic or physiological dependence liability; and whether the substance is an immediate precursor of a substance already controlled. (21 U.S.C § 811(b), (c)) HHS recommended that fenfluramine be removed from the controlled substances schedules. The Drug Enforcement Administration, which has been delegated the Attorney General’s scheduling authority, subsequently determined that fenfluramine should be removed from the CSA.
Although fenfluramine was removed from the federal CSA, it remains a schedule IV controlled substance under state law. This bill conforms state law to federal law by removing fenfluramine from the list of Schedule IV controlled substances. This bill additionally removes fenfluramine from the list of controlled substances that are a crime to possess without a prescription, possess for sale, or sell.
FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: No
SUPPORT: (Verified 6/17/24)
UCB, Inc. (source)
ACLU California Action
California Public Defenders Association
Children’s Specialty Care Coalition
Los Angeles County District Attorney’s Office
OPPOSITION: (Verified 6/17/24)
None received
ASSEMBLY FLOOR: 70-0, 4/4/24
AYES: Addis, Aguiar-Curry, Alanis, Alvarez, Arambula, Bains, Bauer-Kahan, Bennett, Berman, Boerner, Bonta, Bryan, Calderon, Juan Carrillo, Wendy Carrillo, Connolly, Davies, Essayli, Flora, Mike Fong, Friedman, Gabriel, Gallagher, Garcia, Gipson, Grayson, Haney, Hart, Holden, Irwin, Jackson, Jones-Sawyer, Kalra, Lackey, Low, Lowenthal, Maienschein, McKinnor, Muratsuchi, Ortega, Pacheco, Papan, Jim Patterson, Joe Patterson, Pellerin, Petrie-Norris, Quirk-Silva, Ramos, Rendon, Reyes, Luz Rivas, Rodriguez, Blanca Rubio, Sanchez, Santiago, Schiavo, Soria, Ta, Ting, Valencia, Villapudua, Waldron, Wallis, Ward, Weber, Wicks, Wilson, Wood, Zbur, Robert Rivas
NO VOTE RECORDED: Cervantes, Chen, Megan Dahle, Dixon, Vince Fong, Hoover, Lee, Mathis, McCarty, Stephanie Nguyen
Prepared by: Stephanie Jordan / PUB. S. /
6/18/24 10:49:53
SENATE COMMITTEE ON PUBLIC SAFETY
Senator Aisha Wahab, Chair
2023 - 2024 Regular
Bill No: AB 2018 Hearing Date: June 4, 2024
Author: | Rodriguez | ||
Version: | January 31, 2024 | ||
Urgency: | No | Fiscal: | Yes |
Consultant: | SJ | ||
Subject: Controlled substances: fenfluramine
HISTORY
Source: UBC Inc.
Prior Legislation: AB 1021 (Wicks), Ch. 274, Stats. 2023
AB 527 (Wood), Ch. 618, Stats. 2021
AB 710 (Wood), Ch. 62, Stats. 2018
Support: ACLU California Action; California Public Defenders Association; Children’s Specialty Care Coalition
Opposition: None known
Assembly Floor Vote: 70 - 0
PURPOSE
The purpose of this bill is to remove fenfluramine from the list of Schedule IV controlled substances under the Uniform Controlled Substances Act and remove it from the list of controlled substances that are a crime to possess for sale, sell, or possess without a prescription.
Existing law establishes the California Uniform Controlled Substances Act, which regulates controlled substances. (Health & Saf. Code, § 11000 et seq.)
Existing law classifies controlled substances into five schedules according to their danger and potential for abuse. Provides that Schedule I controlled substances have the greatest restrictions and penalties, including prohibiting the prescribing of a Schedule I controlled substance. (Health & Saf. Code, §§ 11054-11058.)
Existing law classifies fenfluramine as a Schedule IV controlled substance. (Health & Saf. Code, § 11057, subd. (e).)
Existing law makes possession of fenfluramine for personal use, without a valid prescription, punishable as a misdemeanor or an infraction. (Health & Saf. Code, § 11375, subd. (b)(2).)
Existing law makes the possession for sale or sale of fenfluramine a misdemeanor punishable by up to one year in county jail or state prison. (Health & Saf. Code, § 11375, subd. (b)(1).)
This bill removes fenfluramine from the list of Schedule IV controlled substances.
This bill removes fenfluramine from the list of controlled substances that are a crime to possess without a prescription, possess for sale, or sell.
COMMENTS
- Need For This Bill
According to the author:
It is important that California remove fenfluramine from the list of schedule IV controlled substances to align with the federal Controlled Substances Act and ensure access to this critical medicine to help patients suffering from rare and severe forms of epilepsy.
- Fenfluramine
Fenfluramine is a drug prescribed to treat seizures in patients with Dravet syndrome and Lennox-Gastaut syndrome, severe forms of epilepsy. Fenfluramine was removed from the federal Controlled Substances Act (CSA) in 2022. (87 Fed. Reg. 78857 (Dec. 23, 2022).) It had previously been a schedule IV controlled substance.
Under federal law, the Attorney General may remove any drug or other substance from the schedules if the Attorney General finds that the drug or other substance does not meet the requirements for inclusion in any schedule. (21 U.S.C § 811(a).) Before removing a controlled substance from one of the schedules, the Attorney General must request a scientific and medical evaluation from the Secretary of the U.S. Department of Health and Human Services (HHS) as well as the Secretary’s recommendations regarding whether the drug should remain scheduled or should be removed as a controlled substance (21 U.S.C § 811(b).) As part of the evaluation, the Secretary must consider the drug’s actual or relative potential for abuse; the scientific evidence of its pharmacological effects; the state of current scientific knowledge regarding the drug or other substance; its history and current pattern of abuse; the scope, duration, and significance of abuse; the potential risk to public health, if any; the substance’s psychic or physiological dependence liability; and whether the substance is an immediate precursor of a substance already controlled. (21 U.S.C § 811(b), (c).) HHS recommended that fenfluramine be removed from the controlled substances schedules. The Drug Enforcement Administration, which has been delegated the Attorney General’s scheduling authority, subsequently determined that fenfluramine should be removed from the CSA.
Although fenfluramine was removed from the federal CSA, it remains a schedule IV controlled substance under state law. This bill conforms state law to federal law by removing fenfluramine from the list of Schedule IV controlled substances. This bill additionally removes fenfluramine from the list of controlled substances that are a crime to possess without a prescription, possess for sale, or sell.
- Argument in Support
The California Public Defenders Association writes:
AB 2018 will ensure that medications with fenfluramine are accessible to patients in need. Fenfluramine is the active ingredient in medications approved for treatment of Dravet syndrome and Lennox-Gastaut syndrome, rare and severe forms of epilepsy. …[T]he U.S. DEA removed fenfluramine from the federal Controlled Substances Act based on studies showing its safety and efficacy in treating Dravet syndrome and Lennox-Gastaut syndrome. Without legislative action to do the same in California, fenfluramine remains on the state’s list of schedule IV controlled substances limiting how it can be prescribed. AB 2018 will deschedule fenfluramine thus increasing access to this critical medication by allowing physicians to write prescriptions for up to a year and prescribe it electronically.
…CPDA is supportive of any effort to reduce the harm imposed by the criminal system regarding drug possession and use. AB 2018 is a common sense and cost saving reform that will remove any confusion around the medicine and ensure that Dravet syndrome and Lennox-Gastaut syndrome patients have convenient and comprehensive access to their treatment.
-- END --
Date of Hearing: March 20, 2024
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Buffy Wicks, Chair
ABPCA Bill Id:AB 2018
Author:(Rodriguez) – As Introduced Ver:January 31, 2024
Policy Committee: | Public Safety | Vote: | 8 - 0 |
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Urgency: No State Mandated Local Program: No Reimbursable: No
SUMMARY:
This bill removes fenfluramine from the Uniform Controlled Substances Act (UCSA) list of controlled substances and removes related criminal penalties.
FISCAL EFFECT:
No significant state costs. Possible future cost savings to the counties and the California Department of Corrections and Rehabilitation for incarceration, to the extent this bill eliminates future convictions for fenfluramine-related offenses.
COMMENTS:
- Purpose. According to the author:
It is important that California remove fenfluramine from the list of schedule IV controlled substances to align with the federal Controlled Substances Act and ensure access to this critical medicine to help patients suffering from rare and severe forms of epilepsy.
- Background. Through separate statutory schemes, the federal government and California restrict the use of certain drugs and substances. Both schemes classify a controlled substance into one of five “schedules” based on a number of factors, including the substance’s risk for abuse or dependence and whether it has currently accepted medical uses. Schedule I substances pose the greatest risk and are most highly regulated; substances in each subsequent tier pose a lesser risk in comparison. For example, in California, heroin, cocaine, and LSD are Schedule I drugs, while codeine and buprenorphine are Schedule V drugs. Fenfluramine is currently a Schedule IV drug in California.
In 2020, The Federal Drug Administration approved fenfluramine for treatment of seizures related to Dravet syndrome, a rare and severe form of epilepsy. Subsequently, after a rigorous process conducted by the U.S. Attorney General and the U.S. Department of Health and Human Services, the federal government removed fenfluramine from its controlled substances schedules. California is not required to follow suit, but the state has generally aligned its regulation of controlled substances with the federal schedules.
This bill removes fenfluramine from the UCSA’s list of controlled substances and eliminates criminal offenses for possession and sales of fenfluramine.
Analysis Prepared by: Annika Carlson / APPR. / (916) 319-2081
Date of Hearing: March 12, 2024
Counsel: Andrew Ironside
ASSEMBLY COMMITTEE ON
Kevin McCarty, Chair
ABPCA Bill Id:
Author:() – As Ver:
SUMMARY:
Removes fenfluramine as a controlled substance under the California Uniform Controlled Substances Act (UCSA). Specifically, this bill: Removes fenfluramine from Schedule IV of the UCSA and eliminates criminal penalties for possession for personal use, possession for sale, or sale of fenfluramine.
EXISTING LAW:
- Lists controlled substances in five “schedules” - intended to list drugs in decreasing order of harm and increasing medical utility or safety - and provides penalties for possession of and commerce in controlled substances. Schedule I includes the most serious and heavily controlled substances, with Schedule V being the least serious and most lightly controlled substances. (Health & Saf. Code, §§ 11054-11058.)
- Lists fenfluramine as a Schedule IV controlled substance. (Health & Saf. Code, § 11057, subd. (e).)
- Makes possession of fenfluramine for personal use, without a valid prescription, punishable as a misdemeanor or an infraction. (Health & Saf. Code, § 11375, subd. (b)(2).)
- Makes the possession for sale or sale of fenfluramine a misdemeanor punishable by up to one year in county jail or state prison. (Health & Saf. Code, § 11375, subd. (b)(1).)
- Provides, that except in cases where a different punishment is prescribed, every offense declared to be an infraction is punishable by a fine not exceeding $250. (Pen. Code, § 19.8, subd. (b).)
- Provides that, except in cases where a different punishment is prescribed by any law of this state, every offense declared to be a misdemeanor is punishable by imprisonment in the county jail not exceeding six months, or by fine not exceeding $1,000, or by both. (Pen. Code, § 19.)
- Provides that, except in cases where a different punishment is prescribed by any law of this state, every offense declared to be a felony is punishable by imprisonment for 16 months, or two or three years in state prison. (Pen. Code, § 18, subd. (a).)
FISCAL EFFECT:
Unknown
COMMENTS:
- Author's Statement: According to the author, “It is important that California remove fenfluramine from the list of schedule IV controlled substances to align with the federal Controlled Substances Act and ensure access to this critical medicine to help patients suffering from rare and severe forms of epilepsy.”
- Effect of the Bill: Under existing law, fenfluramine is a Schedule IV controlled substance under UCSA. Existing law prohibits possession of fenfluramine for personal use, without a valid prescription, an offense punishable as either an infraction or a misdemeanor. (Health & Saf. Code, § 11375, subd. (b)(2).) The penalty is up to six months in county jail or a fine of $250. (Pen. Code, § 19; Pen. Code, § 19.8, subd. (b).) Possession for sale or sale of fenfluramine is also proscribed, punishable by imprisonment in county jail for up to one year or in state prison for 16 months, 2 years, or 3 years. (Health & Saf. Code, § 11375, subd. (b)(1); Pen. Code, § 18, subd. (a).)
This bill would remove fenfluramine from the California’s list of controlled substances, aligning state law with the federal Controlled Substances Act. As such, it would also eliminate criminal penalties for possession for personal use, possession for sale, or sale of fenfluramine. - Fenfluramine: Fenfluramine is drug prescribed to people suffering seizures as a result of Dravet syndrome and Lennox-Gastaut syndrome, severe forms of epilepsy. (https://www.mayoclinic.org/drugs-supplements/fenfluramine-oral-route/description/drg-20490822 ) According to the Dravet Syndrom Foundation, “Dravet syndrome, previously known as Severe Myoclonic Epilepsy of Infancy (SMEI), is an intractable developmental and epileptic encephalopathy that begins in infancy and proceeds with accumulating morbidity that significantly impacts individuals throughout their lifetime.” (https://dravetfoundation.org/what-is-dravet-syndrome/.) The syndrome usually presents in infancy, is characterized by severe seizures and developmental delays, and requires constant care. (Ibid.) Lennox-Gastaut syndrome is also a severe form of epilepsy, with seizures typically beginning before the age of four years. (https://www.ninds.nih.gov/health-information/disorders/lennox-gastaut-syndrome) According to the National Institute of Neurological Disorders and Stroke, the syndrome is very difficult to treat and most people suffering from it experience “some degree of impaired intellectual functioning and information processing.” (Ibid.) Neither syndrome has a cure.
Under federal law, “[p]roceedings for the issuance, amendment, or repeal [scheduling] rules may be initiated by the Attorney General (1) on his own motion, (2) at the request of Secretary [of the U.S. Department of Health and Human Services], or (3) on the petition of any interested party.” (21 U.S.C § 811(a); 21 U.S.C § 802(24)).) The pharmaceutical company named Zogenix made the most recent petition to de-schedule fenfluramine. (Levine, Assistant Secretary of Health, U.S. Department of Health and Human Services, Letter to DEA Recommending the Removal of Fenfluramine from All Schedules (Apr. 16, 2021) at p. 1.)
Before removing a controlled substance from one of the schedules, the Attorney General must “request from the Secretary [of the U.S. Department of Health and Human Services] a scientific and medical evaluation, and his recommendations, as to whether such drug or substance should be…removed as a controlled substance.” (21 U.S.C § 811(b).) The Secretary must consider its actual or relative potential for abuse; the scientific evidence of its pharmacological effects; the state of current scientific knowledge regarding the drug or other substance; its history and current pattern of abuse; the scope, duration, and significance of abuse; the potential risk to public health, if any; the substance’s psychic or physiological dependence liability; and whether the substance is an immediate precursor of a substance already controlled. (21 U.S.C § 811(b) & (c).) Upon review, the Assistant Secretary for Health at the U.S. Department of Health and Human Services summarized,
Upon consideration of the eight factors determinative of control of a substance under 21 U.S.C. 811(c), the Food and Drug Administration (FDA) recommends that fenfluramine be removed from all schedules of control under the CSA. The National Institute on Drug Abuse (NIDA) has reviewed the enclosed document (which was prepared by FDA’s Controlled Substance Staff and is the basis for FDA’s recommendation) and concurs with FDA’s recommendation. Fenfluramine does not conform with the findings for schedule IV in 21 U.S.C. 812(b)(4) or in any other schedule as set forth in 21 U.S.C. 812(b).
FDA and NIDA have also considered the abuse potential of fenfluramine and, based on the totality of the scientific data, recommend that fenfluramine be removed from all schedules of control under the CSA. Based on my review of the evidence and FDA’s recommendation, it is my recommendation as the Assistant Secretary for Health that fenfluramine should be removed from all schedules of control under the CSA.
(Levine, supra.)
The Drug Enforcement Administration, as delegated by the U.S. Attorney General, also reviewed whether fenfluramine should be removed from the CSA. (28 C.F.R. 0.100 [assigning the Administrator of the DEA “functions vested in the Attorney General by the Comprehensive Drug Abuse Prevention and Control Act of 1970]; DEA, Schedule of Controlled Substances: Removal fenfluramine and its salts from controls under the Controlled Substances Act (Jan. 2022) at p.4.) Upon review, the DEA determined that fenfluramine “has no potential for abuse and does not meet the finding for control under any CSA schedule”; it “has currently accepted medical use in treatment in the United States”; and abuse by users of the substance is unlikely “to lead to limited physical dependence or psychological dependence.” (Id. pp. 27-28.) As a result, it found that “flenfluramine does not meet requirements for inclusion in any schedule and should be removed from control under the CSA.” (Id. at p. 27.) As a result, fenfluramine was removed from all schedules under the federal Controlled Substances Act. (87 Fed. Reg. 78857 (Dec. 23, 2022).)
Although de-scheduled by the federal government, California is under no obligation to follow suit. There is precedent for states more tightly regulating controlled substances than the federal government. “For example, some states have controlled the fentanyl analogues benzylfentanyl and thenylfentanyl, but those substances are not currently scheduled under the [federal] CSA.” (The Controlled Substances ACT (CSA): A Legal Overview for the 118th Congress, Congressional Research Service (Jan. 19, 2023) p. 5 <https://crsreports.congress.gov/product/pdf/r/r45948> [last visited Feb 29, 2024].) Nevertheless, California generally has aligned its Uniform Controlled Substances Act with the federal government’s scheduling decisions. (See People v. Ward (2008) 167 Cal.App.4th 252, 259 [“In the California Uniform Controlled Substances Act, California adopted the five schedules of controlled substances used in federal law and in the Uniform Controlled Substances Act”]; Williamson v. Bd. Of Medical Quality Assurance (1990) 271 Cal.App.3d 1343, 1352, fn. 1. [“Effective January 1, 1985, Schedules I through V of the California Uniform Controlled Substances Act were revised so as to generally parallel the five schedules contained in the Federal Controlled Substances Act.”].) With regards to fenfluramine, this bill would align California with the federal law.
- Arguments in Support:
- According to UCB, Inc., “UCB is a global biopharmaceutical company with U.S. headquarters located in Atlanta, Georgia. With more than 8,000 employees globally, we are inspired by patients and driven by science. Our focus is on innovating new medicines to treat severe, chronic neurological, immunological, and rare conditions.
“In April 2023, the US. Drug Enforcement Administration (DEA) published a final rule stating that fenfluramine is no longer subject to the Controlled Substances Act. This rule means all federally controlled substance restrictions have been removed from fenfluramine, which is the active ingredient in one of UCB’s medicines, Fintepla ® (fenfluramine). This medication treats patients with Dravet syndrome and Lennox-Gastaut syndrome, rare and severe childhood-onset forms of epilepsy that significantly impair patients’ quality of life due to a number of debilitating symptoms, including frequent and severe seizures.
“Removal of fenfluramine from the Controlled Substances Act allows prescribers to write a prescription for a full year’s supply versus the current limit of six months. Additionally, descheduling fenfluramine will enable prescribers to send a prescription to pharmacies electronically. AB 2018would ensure equitable access to fenfluramine for patients in California living with these two rare epilepsy syndromes.” - According to the Dravet Syndrome Foundation, “We have many children and adult patients with Dravet syndrome in California that are seeing great success with the medication Fintepla, which is produced by UCB and contains the active ingredient fenfluramine. We wholeheartedly support any change that would make it easier for them to continue to access this life saving medication. Families in our community have so many obstacles to accessing the medications their loved ones need, so the ability to have a prescriber send a prescription for a full year instead of just six months and allowing it to be sent to the pharmacy electronically would be a huge benefit for our families and their providers.
“We ask you to please consider the removal of fenfluramine from the Controlled Substances Act in California to align with the change made by the federal government in April 2023.”
- According to UCB, Inc., “UCB is a global biopharmaceutical company with U.S. headquarters located in Atlanta, Georgia. With more than 8,000 employees globally, we are inspired by patients and driven by science. Our focus is on innovating new medicines to treat severe, chronic neurological, immunological, and rare conditions.
- Argument in Opposition: None submitted.
- Prior Legislation:
- SB 58 (Wiener), of the 2023-2024 Legislative Session, would have made lawful the possession for personal use of specified hallucinogenic substances by persons 21 years of age or older, and would have made lawful the facilitated and supported use of these substances once the state develops a regulatory framework for these activities. The Governor vetoed SB 58.
- AB 2246 (Petrie-Norris), of the 2021-2022 Legislative Session, would have, among other things, classified non-FDA approved fentanyl analogs as Schedule I controlled substances. AB 2246 failed passage in this committee.
- SB 519 (Wiener), of the 2021-2022 Legislative Session, was substantially similar to SB 58. SB 519 died on the Assembly inactive file.
- AB 710 (Wood), Chapter 62, Statues of 2018 provides that if cannabidiol (CBD) is federally rescheduled or otherwise made a legally prescribable controlled substance, it shall also be legal to prescribe under state law.
- SB 58 (Wiener), of the 2023-2024 Legislative Session, would have made lawful the possession for personal use of specified hallucinogenic substances by persons 21 years of age or older, and would have made lawful the facilitated and supported use of these substances once the state develops a regulatory framework for these activities. The Governor vetoed SB 58.
REGISTERED SUPPORT / OPPOSITION:
Support
Biocom California
California Neurology Society
California Public Defenders Association
Dravet Syndrome Foundation
Epilepsy Foundation
UCB, Inc.
Opposition
None
Analysis Prepared by:
Bill Author
Bill Co-Author(s):