Compare Versions


PDF |Add To My Favorites |Track Bill | print page

AB-527 Controlled substances.(2021-2022)



Current Version: 10/07/21 - Chaptered Compare Versions information image


AB527:v94#DOCUMENT

Assembly Bill No. 527
CHAPTER 618

An act to amend Sections 11056, 11057, 11150.2, and 11165 of, and to add Section 11059 to, the Health and Safety Code, relating to controlled substances.

[ Approved by Governor  October 07, 2021. Filed with Secretary of State  October 07, 2021. ]

LEGISLATIVE COUNSEL'S DIGEST


AB 527, Wood. Controlled substances.
(1) Existing law, the California Uniform Controlled Substances Act (the act), classifies controlled substances into 5 designated schedules, with the most restrictive limitations generally placed on controlled substances classified in Schedule I, and the least restrictive limitations generally placed on controlled substances classified in Schedule V.
This bill would exempt from Schedule III specific compounds, mixtures, or preparations that contain a nonnarcotic controlled substance in combination with a derivative of barbituric acid or any salt thereof that are listed in the federal Table of Exempted Prescription Products and have been exempted pursuant to federal law or regulation. The bill would exempt from Schedule IV specific compounds, mixtures, or preparations that contain a nonnarcotic controlled substance in combination with a chlordiazepoxide or phenobarbital that are listed in the federal Table of Exempted Prescription Products and have been exempted from scheduling under federal law or regulation.
Under the act, cannabis is placed in Schedule I. Cannabidiol and other cannabinoids are compounds contained in cannabis. The act restricts the prescription, furnishing, possession, sale, and use of controlled substances, including cannabis and synthetic cannabinoid compounds, and makes a violation of those laws a crime, except as specified. Existing law, if one of specified changes in federal law regarding the controlled substance cannabidiol occurs, deems a physician, pharmacist, or other healing arts licensee who prescribes, furnishes, or dispenses a product composed of cannabidiol, in accordance with federal law, to be in compliance with state law governing those acts and provides that, upon the effective date of one of those changes in federal law, the prescription, furnishing, dispensing, transfer, transportation, possession, or use of that product in accordance with federal law is for a legitimate medical purpose and is authorized pursuant to state law.
This bill would expand the provisions authorizing the prescription, furnishing, dispensing, transfer, transportation, possession, or use of cannabidiol products in accordance with federal law, upon the specified changes being made to federal law, to include all products with cannabinoids.
(2) Existing law requires the Department of Justice to maintain the Controlled Substances Utilization Review and Evaluation System (CURES) for the electronic monitoring of the prescribing and dispensing of Schedule II, Schedule III, and Schedule IV controlled substances by a health care practitioner authorized to prescribe, order, administer, furnish, or dispense a Schedule II, Schedule III, or Schedule IV controlled substance. Existing law limits the entities to which data may be provided from CURES, as well as the type of data that may be released and the uses to which it may be put.
This bill would require the Department of Justice to provide the University of California with access to identifiable data for research purposes.
Vote: MAJORITY   Appropriation: NO   Fiscal Committee: YES   Local Program: NO  

The people of the State of California do enact as follows:


SECTION 1.

 Section 11056 of the Health and Safety Code is amended to read:

11056.
 (a) The controlled substances listed in this section are included in Schedule III.
(b) Stimulants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation that 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 whenever the existence of those salts, isomers, and salts of isomers is possible within the specific chemical designation:
(1) Those compounds, mixtures, or preparations in dosage unit form containing any stimulant substances listed in Schedule II which compounds, mixtures, or preparations were listed on August 25, 1971, as excepted compounds under Section 1308.32 of Title 21 of the Code of Federal Regulations, and any other drug of the quantitative composition shown in that list for those drugs or that is the same except that it contains a lesser quantity of controlled substances.
(2) Benzphetamine.
(3) Chlorphentermine.
(4) Clortermine.
(5) Mazindol.
(6) Phendimetrazine.
(c) Depressants. Unless specifically excepted in Section 11059 or elsewhere, or unless listed in another schedule, any material, compound, mixture, or preparation that contains any quantity of the following substances having a depressant effect on the central nervous system:
(1) Any compound, mixture, or preparation containing any of the following:
(A) Amobarbital.
(B) Secobarbital.
(C) Pentobarbital
or any salt thereof and one or more other active medicinal ingredients that are not listed in any schedule.
(2) Any suppository dosage form containing any of the following:
(A) Amobarbital.
(B) Secobarbital.
(C) Pentobarbital
or any salt of any of these drugs and approved by the federal Food and Drug Administration for marketing only as a suppository.
(3) Any substance that contains any quantity of a derivative of barbituric acid or any salt thereof.
(4) Chlorhexadol.
(5) Lysergic acid.
(6) Lysergic acid amide.
(7) Methyprylon.
(8) Sulfondiethylmethane.
(9) Sulfonethylmethane.
(10) Sulfonmethane.
(11) Gamma hydroxybutyric acid, and its salts, isomers, and salts of isomers, contained in a drug product for which an application has been approved under Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 355).
(d) Nalorphine.
(e) 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 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with an equal or greater quantity of an isoquinoline alkaloid of opium.
(2) Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
(3) Not more than 1.8 grams of dihydrocodeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active nonnarcotic ingredients in recognized therapeutic amounts.
(4) Not more than 300 milligrams of ethylmorphine per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
(5) Not more than 500 milligrams of opium per 100 milliliters or per 100 grams or not more than 25 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
(6) Not more than 50 milligrams of morphine per 100 milliliters or per 100 grams, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
(f) Anabolic steroids and chorionic gonadotropin. Any material, compound, mixture, or preparation containing chorionic gonadotropin or an anabolic steroid (excluding anabolic steroid products listed in the “Table of Exempt Anabolic Steroid Products” (Section 1308.34 of Title 21 of the Code of Federal Regulations), as exempt from the federal Controlled Substances Act (Section 801 and following of Title 21 of the United States Code)), including, but not limited to, the following:
(1) Androisoxazole.
(2) Androstenediol.
(3) Bolandiol.
(4) Bolasterone.
(5) Boldenone.
(6) Chloromethandienone.
(7) Clostebol.
(8) Dihydromesterone.
(9) Ethylestrenol.
(10) Fluoxymesterone.
(11) Formyldienolone.
(12) 4-Hydroxy-19-nortestosterone.
(13) Mesterolone.
(14) Methandriol.
(15) Methandrostenolone.
(16) Methenolone.
(17) 17-Methyltestosterone.
(18) Methyltrienolone.
(19) Nandrolone.
(20) Norbolethone.
(21) Norethandrolone.
(22) Normethandrolone.
(23) Oxandrolone.
(24) Oxymesterone.
(25) Oxymetholone.
(26) Quinbolone.
(27) Stanolone.
(28) Stanozolol.
(29) Stenbolone.
(30) Testosterone.
(31) Trenbolone.
(32) Human chorionic gonadotropin (hCG), except when possessed by, sold to, purchased by, transferred to, or administered by a licensed veterinarian, or a licensed veterinarian’s designated agent, exclusively for veterinary use.
(g) Ketamine. Any material, compound, mixture, or preparation containing ketamine.
(h) Hallucinogenic substances. Any of the following hallucinogenic substances: dronabinol (synthetic) in sesame oil and encapsulated in a soft gelatin capsule in a drug product approved by the federal Food and Drug Administration.

SEC. 2.

 Section 11057 of the Health and Safety Code is amended to read:

11057.
 (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) 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) 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. 3.

 Section 11059 is added to the Health and Safety Code, to read:

11059.
 (a) Specific compounds, mixtures, or preparations that contain a nonnarcotic controlled substance in combination with a derivative of barbituric acid or any salt thereof that are listed in the federal Table of Exempted Prescription Products and have been exempted pursuant to federal law or regulation (Section 1308.32 of Title 21 of the Code of Federal Regulations or its successors), are excepted from scheduling under subdivision (c) of Section 11056.
(b) Specific compounds, mixtures, or preparations that contain a nonnarcotic controlled substance in combination with a chlordiazepoxide or phenobarbital that are listed in the federal Table of Exempted Prescription Products and have been exempted from scheduling under federal law or regulation (Section 1308.32 of Title 21 of the Code of Federal Regulations or its successors) are excepted from scheduling under subdivision (d) of Section 11057.

SEC. 4.

 Section 11150.2 of the Health and Safety Code is amended to read:

11150.2.
 (a) Notwithstanding any other law, if cannabinoids are excluded from Schedule I of the federal Controlled Substances Act and placed on a schedule of the act other than Schedule I, or if a product composed of cannabinoids is approved by the federal Food and Drug Administration and either placed on a schedule of the act other than Schedule I, or exempted from one or more provisions of the act, so as to permit a physician, pharmacist, or other authorized healing arts licensee acting within their scope of practice, to prescribe, furnish, or dispense that product, the physician, pharmacist, or other authorized healing arts licensee who prescribes, furnishes, or dispenses that product in accordance with federal law shall be deemed to be in compliance with state law governing those acts.
(b) For purposes of this chapter, upon the effective date of one of the changes in federal law described in subdivision (a), notwithstanding any other state law, a product composed of cannabinoids may be prescribed, furnished, dispensed, transferred, transported, possessed, or used in accordance with federal law and is authorized pursuant to state law.
(c) This section does not apply to any product containing cannabinoids that is made or derived from industrial hemp, as defined in Section 11018.5 and regulated pursuant to that section.

SEC. 5.

 Section 11165 of the Health and Safety Code is amended to read:

11165.
 (a) To assist health care practitioners in their efforts to ensure appropriate prescribing, ordering, administering, furnishing, and dispensing of controlled substances, law enforcement and regulatory agencies in their efforts to control the diversion and resultant abuse of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances, and for statistical analysis, education, and research, the Department of Justice shall, contingent upon the availability of adequate funds in the CURES Fund, maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of, and internet access to information regarding, the prescribing and dispensing of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances by all practitioners authorized to prescribe, order, administer, furnish, or dispense these controlled substances.
(b) The department may seek and use grant funds to pay the costs incurred by the operation and maintenance of CURES. The department shall annually report to the Legislature and make available to the public the amount and source of funds it receives for support of CURES.
(c) (1) The operation of CURES shall comply with all applicable federal and state privacy and security laws and regulations.
(2) (A) CURES shall operate under existing provisions of law to safeguard the privacy and confidentiality of patients. Data obtained from CURES shall only be provided to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the department, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. Data may be provided to public or private entities, as approved by the department, for educational, peer review, statistical, or research purposes, if patient information, including information that may identify the patient, is not compromised. The University of California shall be provided access to identifiable data for research purposes if the requirements of subdivision (t) of Section 1798.24 of the Civil Code are satisfied. Further, data disclosed to an individual or agency as described in this subdivision shall not be disclosed, sold, or transferred to a third party, unless authorized by, or pursuant to, state and federal privacy and security laws and regulations. The department shall establish policies, procedures, and regulations regarding the use, access, evaluation, management, implementation, operation, storage, disclosure, and security of the information within CURES, consistent with this subdivision.
(B) Notwithstanding subparagraph (A), a regulatory board whose licensees do not prescribe, order, administer, furnish, or dispense controlled substances shall not be provided data obtained from CURES.
(3) The department shall, no later than January 1, 2021, adopt regulations regarding the access and use of the information within CURES. The department shall consult with all stakeholders identified by the department during the rulemaking process. The regulations shall, at a minimum, address all of the following in a manner consistent with this chapter:
(A) The process for approving, denying, and disapproving individuals or entities seeking access to information in CURES.
(B) The purposes for which a health care practitioner may access information in CURES.
(C) The conditions under which a warrant, subpoena, or court order is required for a law enforcement agency to obtain information from CURES as part of a criminal investigation.
(D) The process by which information in CURES may be provided for educational, peer review, statistical, or research purposes.
(4) In accordance with federal and state privacy laws and regulations, a health care practitioner may provide a patient with a copy of the patient’s CURES patient activity report as long as no additional CURES data are provided and the health care practitioner keeps a copy of the report in the patient’s medical record in compliance with subdivision (d) of Section 11165.1.
(d) For each prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance, as defined in the controlled substances schedules in federal law and regulations, specifically Sections 1308.12, 1308.13, 1308.14, and 1308.15, respectively, of Title 21 of the Code of Federal Regulations, the dispensing pharmacy, clinic, or other dispenser shall report the following information to the department or contracted prescription data processing vendor as soon as reasonably possible, but not more than one working day after the date a controlled substance is released to the patient or patient’s representative, in a format specified by the department:
(1) Full name, address, and, if available, telephone number of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services, and the gender and date of birth of the ultimate user.
(2) The prescriber’s category of licensure, license number, national provider identifier (NPI) number, if applicable, the federal controlled substance registration number, and the state medical license number of a prescriber using the federal controlled substance registration number of a government-exempt facility.
(3) Pharmacy prescription number, license number, NPI number, and federal controlled substance registration number.
(4) National Drug Code (NDC) number of the controlled substance dispensed.
(5) Quantity of the controlled substance dispensed.
(6) The International Statistical Classification of Diseases (ICD) Code contained in the most current ICD revision, or any revision deemed sufficient by the State Board of Pharmacy, if available.
(7) Number of refills ordered.
(8) Whether the drug was dispensed as a refill of a prescription or as a first-time request.
(9) Prescribing date of the prescription.
(10) Date of dispensing of the prescription.
(11) The serial number for the corresponding prescription form, if applicable.
(e) The department may invite stakeholders to assist, advise, and make recommendations on the establishment of rules and regulations necessary to ensure the proper administration and enforcement of the CURES database. A prescriber or dispenser invitee shall be licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, in active practice in California, and a regular user of CURES.
(f) The department shall, prior to upgrading CURES, consult with prescribers licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, one or more of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, and any other stakeholder identified by the department, for the purpose of identifying desirable capabilities and upgrades to the CURES Prescription Drug Monitoring Program (PDMP).
(g) The department may establish a process to educate authorized subscribers of the CURES PDMP on how to access and use the CURES PDMP.
(h) (1) The department may enter into an agreement with an entity operating an interstate data sharing hub, or an agency operating a prescription drug monitoring program in another state, for purposes of interstate data sharing of prescription drug monitoring program information.
(2) Data obtained from CURES may be provided to authorized users of another state’s prescription drug monitoring program, as determined by the department pursuant to subdivision (c), if the entity operating the interstate data sharing hub, and the prescription drug monitoring program of that state, as applicable, have entered into an agreement with the department for interstate data sharing of prescription drug monitoring program information.
(3) An agreement entered into by the department for purposes of interstate data sharing of prescription drug monitoring program information shall ensure that all access to data obtained from CURES and the handling of data contained within CURES comply with California law, including regulations, and meet the same patient privacy, audit, and data security standards employed and required for direct access to CURES.
(4) For purposes of interstate data sharing of CURES information pursuant to this subdivision, an authorized user of another state’s prescription drug monitoring program shall not be required to register with CURES, if the authorized user is registered and in good standing with that state’s prescription drug monitoring program.
(5) The department shall not enter into an agreement pursuant to this subdivision until the department has issued final regulations regarding the access and use of the information within CURES as required by paragraph (3) of subdivision (c).
(i) Notwithstanding subdivision (d), a veterinarian shall report the information required by that subdivision to the department as soon as reasonably possible, but not more than seven days after the date a controlled substance is dispensed.
(j) If the dispensing pharmacy, clinic, or other dispenser experiences a temporary technological or electrical failure, it shall, without undue delay, seek to correct any cause of the temporary technological or electrical failure that is reasonably within its control. The deadline for transmitting prescription information to the department or contracted prescription data processing vendor pursuant to subdivision (d) shall be extended until the failure is corrected. If the dispensing pharmacy, clinic, or other dispenser experiences technological limitations that are not reasonably within its control, or is impacted by a natural or manmade disaster, the deadline for transmitting prescription information to the department or contracted prescription data processing vendor shall be extended until normal operations have resumed.