Bill Text: CA AB2115 | 2023-2024 | Regular Session | Chaptered

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Bill Title: Controlled substances: clinics.

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Passed) 2024-09-27 - Chaptered by Secretary of State - Chapter 634, Statutes of 2024. [AB2115 Detail]

Download: California-2023-AB2115-Chaptered.html

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Assembly Bill No. 2115

CHAPTER 634

An act to amend Section 4184 of the Business and Professions Code, and to amend Sections 11158, 11839.2, and 11839.3 of, and to add Section 11839.01 to, the Health and Safety Code, relating to controlled substances, and declaring the urgency thereof, to take effect immediately.

[ Approved by Governor  September 27, 2024. Filed with Secretary of State  September 27, 2024. ]

LEGISLATIVE COUNSEL'S DIGEST

AB 2115, Haney. Controlled substances: clinics.

Existing law, the Pharmacy Law, provides for the licensure and regulation of pharmacists by the California State Board of Pharmacy and makes a violation of the act a crime. Under existing law, specified clinics, including surgical clinics, may purchase drugs at wholesale for administration or dispensing to the clinic’s patients. Existing law requires these clinics to maintain certain records and to obtain a license from the board. Existing law prohibits specified substances from being dispensed by a nonprofit or free clinic, as defined.

This bill would authorize a practitioner authorized to prescribe a narcotic drug at a nonprofit or free clinic, as specified, to dispense the narcotic drug from clinic supply for the purpose of relieving acute withdrawal symptoms while arrangements are being made for referral for treatment, as described, and would require the clinic dispensing the narcotic to be subject to specified reporting, labeling, and recordkeeping requirements. The bill would require clinics with a supply of narcotic drugs being dispensed pursuant to these provisions to establish policies or procedures for dispensing the narcotics, as specified. Because the bill would specify additional requirements under the Pharmacy Law, a violation of which would be a crime, it would impose a state-mandated local program.

Existing law classifies certain controlled substances into designated schedules. Existing law prohibits a controlled substance classified in Schedule II from being dispensed without a prescription, except when dispensed directly to the user in an amount not to exceed a 72-hour supply for the patient when the patient is not expected to require any additional amount of the controlled substance beyond the 72 hours.

This bill would additionally authorize a practitioner to directly dispense no more than a 3-day supply of a Schedule II controlled substance to be dispensed to the ultimate user at one time for the purpose of initiating maintenance treatment or detoxification treatment, as specified.

Existing law requires the State Department of Health Care Services to regulate and license narcotic treatment programs, including in the use of narcotic replacement therapy and medication-assisted treatment. Existing regulation specifies certain requirements and considerations for a patient to be eligible for treatment at a licensed narcotic treatment program, such as a medical evaluation conducted by the program, laboratory tests for disease, and minimum monthly participation in counseling, among others. Existing regulation also imposes specified criteria to be considered before a patient is eligible for take-home doses of medication.

This bill would require the department to amend specified regulations regarding narcotic treatment programs to comply with federal regulations pertaining to dispensing of narcotic drugs for maintenance treatment or detoxification treatment. The bill would require the department to adopt these regulations by April 30, 2029.

Existing law authorizes the use of specific medications for use in narcotic replacement therapy and medication-assisted treatment by licensed narcotic treatment programs, including Levo-alpha-acetylmethadol (LAAM). Existing law states the intent of the Legislature that take-home doses of narcotic replacement therapy medications are to be provided if the patient is clearly adhering to the requirements of the program and if daily attendance at a clinic would be incompatible with gainful employment, education, responsible homemaking, and retirement or medical disability, or as otherwise specified.

This bill would remove LAAM from the list of authorized medications for use in narcotic replacement therapy and medication-assisted treatment by licensed narcotic treatment programs and would make conforming changes. The bill would remove from the statement of the Legislature’s intent the requirement that daily attendance at a clinic would be incompatible with gainful employment, education, responsible homemaking, and retirement or medical disability.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

This bill would declare that it is to take effect immediately as an urgency statute.

Digest Key

Vote: 2/3   Appropriation: NO   Fiscal Committee: YES   Local Program: YES  

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Bill Text

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

SECTION 1.

 Section 4184 of the Business and Professions Code is amended to read:

4184.

 (a) Except as described in subdivision (b), a Schedule II controlled substance shall not be dispensed by the clinic. This limitation does not prohibit a physician dispensing a Schedule II drug to the extent permitted by law.

(b) A practitioner authorized to prescribe a narcotic drug at a clinic registered with the board pursuant to this chapter and with any necessary federal agencies may dispense that narcotic drug from clinic supply for the purpose of relieving acute withdrawal symptoms when necessary while arrangements are being made for referral for treatment consistent with Section 1306.07(b) of Title 21 of the Code of Federal Regulations.

(c) A narcotic drug that is dispensed from a clinic’s supply pursuant to subdivision (b) is subject to the requirements of subdivision (d) of Section 11165 of the Health and Safety Code, the labeling requirements imposed upon pharmacists by Section 4076, the recordkeeping requirements of this chapter, and all of the packaging requirements of good pharmaceutical practice, including, but not limited to, the use of childproof containers.

(d) A clinic with a supply of narcotic drugs that is being dispensed pursuant to subdivision (b) shall establish policies or procedures for dispensing, including, but not limited to, all of the following:

(1) Assessment of the patient’s ability to safely manage and self-administer a narcotic drug for the purposes of treating withdrawal.

(2) Assessment of the patient’s appropriateness for medications for opioid use disorder.

(3) Connecting patients to ongoing treatment for opioid use disorder.

(4) Limiting dispensing to patients who return for repeated withdrawal medication to ensure treatment is not renewed or extended.

(e) The dispensing of a narcotic drug shall be performed only by a physician, a pharmacist, or other person lawfully authorized to dispense drugs, and only in compliance with all applicable laws and regulations.

(f) It is the intent of the Legislature that a clinic from which narcotic drugs are dispensed operate under appropriate registration and licensing and prioritize safe and secure storage, including any inventory reconciliation methodology, consistent with regulations, to prevent loss or diversion of controlled substances.

SEC. 2.

 Section 11158 of the Health and Safety Code is amended to read:

11158.

 (a)  Except as provided in Section 11159 or in subdivision (b) of this section, no controlled substance classified in Schedule II shall be dispensed without a prescription meeting the requirements of this chapter. Except as provided in Section 11159 or when dispensed directly to an ultimate user by a practitioner, other than a pharmacist or pharmacy, no controlled substance classified in Schedule III, IV, or V may be dispensed without a prescription meeting the requirements of this chapter.

(b) A practitioner specified in Section 11150 may dispense a controlled substance classified in Schedule II, which may be from a hospital pharmacy inventory, directly to an ultimate user in either of the following circumstances:

(1) In an amount not to exceed a 72-hour supply for the patient in accordance with directions for use given by the dispensing practitioner only where the patient is not expected to require any additional amount of the controlled substance beyond the 72 hours.

(2) For the purpose of initiating maintenance treatment or detoxification treatment, or both, for a person with an opioid use disorder. Not more than a three-day supply of such medication may be dispensed to the person at one time while arrangements are being made for referral for treatment. Such emergency treatment may not be renewed or extended.

(c)  Except as otherwise prohibited or limited by law, a practitioner specified in Section 11150, may administer controlled substances in the regular practice of their profession.

SEC. 3.

 Section 11839.01 is added to the Health and Safety Code, to read:

11839.01.

 (a) (1) Notwithstanding any other law, the department shall amend Chapter 4 (commencing with Section 10000) of Division 4 of Title 9 of the California Code of Regulations to comply with Part 8 of Title 42 of the Code of Federal Regulations, as published in the Federal Register on February 2, 2024 (89 FR 7528).

(2) In the event that Part 8 of Title 42 of the Code of Federal Regulations, as published on February 2, 2024, in the Federal Register (89 FR 7528), renders state narcotic treatment program regulations inconsistent with, but not in violation of, federal narcotic treatment program requirements, the department may amend Chapter 4 (commencing with Section 10000) of Division 4 of Title 9 of the California Code of Regulations to align with the Code of Federal Regulations.

(b) (1) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may implement, interpret, or make specific this section, in whole or in part, by means of plan or county letters, information notices, plan or provider bulletins, or other similar instructions, without taking any further regulatory action.

(2) By April 30, 2029, the department shall adopt any regulations necessary to implement this section in accordance with the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.

SEC. 4.

 Section 11839.2 of the Health and Safety Code is amended to read:

11839.2.

 The following medications are authorized for use in narcotic replacement therapy and medication-assisted treatment by licensed narcotic treatment programs:

(a) Methadone.

(b) Buprenorphine products or combination of products approved by the federal Food and Drug Administration for maintenance or detoxification of opioid dependence.

(c) Any other medication approved by the federal Food and Drug Administration for the purpose of narcotic replacement treatment or medication-assisted treatment of substance use disorders.

(d) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may implement, interpret, or make specific this section by means of plan or provider bulletins, or similar instructions. The department shall adopt regulations by no later than January 1, 2021.

SEC. 5.

 Section 11839.3 of the Health and Safety Code is amended to read:

11839.3.

 (a) In addition to the duties authorized by other statutes, the department shall perform all of the following:

(1) License the establishment of narcotic treatment programs in this state to use narcotic replacement therapy in the treatment of addicted persons whose addiction was acquired or supported by the use of a narcotic drug or drugs, not in compliance with a physician and surgeon’s legal prescription, except that the Research Advisory Panel shall have authority to approve methadone research programs. The department shall establish and enforce the criteria for the eligibility of patients to be included in the programs, program operation guidelines, such as dosage levels, recordkeeping and reporting, urinalysis requirements, take-home doses of controlled substances authorized for use pursuant to Section 11839.2, security against redistribution of the narcotic replacement drugs, and any other regulations that are necessary to protect the safety and well-being of the patient, the local community, and the public, and to carry out this chapter. A program may admit a patient to narcotic maintenance or narcotic detoxification treatment at the discretion of the medical director. The program shall assign a unique identifier to, and maintain an individual record for, each patient of the program. The arrest and conviction records and the records of pending charges against a person seeking admission to a narcotic treatment program shall be furnished to narcotic treatment program directors upon written request of the narcotic treatment program director provided the request is accompanied by a signed release from the person whose records are being requested.

(2) Inspect narcotic treatment programs in this state and ensure that programs are operating in accordance with the law and regulations. The department shall have sole responsibility for compliance inspections of all programs in each county. Annual compliance inspections shall consist of an evaluation by onsite review of the operations and records of licensed narcotic treatment programs’ compliance with applicable state and federal laws and regulations and the evaluation of input from local law enforcement and local governments, regarding concerns about the narcotic treatment program. At the conclusion of each inspection visit, the department shall conduct an exit conference to explain the cited deficiencies to the program staff and to provide recommendations to ensure compliance with applicable laws and regulations. The department shall provide an inspection report to the licensee within 30 days of the completed onsite review describing the program deficiencies. A corrective action plan shall be required from the program within 30 days of receipt of the inspection report. All corrective actions contained in the plan shall be implemented within 30 days of receipt of approval by the department of the corrective action plan submitted by the narcotic treatment program. For programs found not to be in compliance, a subsequent inspection of the program shall be conducted within 30 days after the receipt of the corrective action plan in order to ensure that corrective action has been implemented satisfactorily. Subsequent inspections of the program shall be conducted to determine and ensure that the corrective action has been implemented satisfactorily. For purposes of this requirement, “compliance” shall mean to have not committed any of the grounds for suspension or revocation of a license provided for under subdivision (a) of Section 11839.9 or paragraph (2) of subdivision (b) of Section 11839.9. Inspection of narcotic treatment programs shall be based on objective criteria including, but not limited to, an evaluation of the programs’ adherence to all applicable laws and regulations and input from local law enforcement and local governments. Nothing in this section shall preclude counties from monitoring their contract providers for compliance with contract requirements.

(3) Charge and collect licensure fees. In calculating the licensure fees, the department shall include staff salaries and benefits, related travel costs, and state operational and administrative costs. Fees shall be used to offset licensure and inspection costs, not to exceed actual costs.

(4) Study and evaluate, on an ongoing basis, narcotic treatment programs including, but not limited to, the adherence of the programs, to all applicable laws and regulations and the impact of the programs on the communities in which they are located.

(5) Provide advice, consultation, and technical assistance to narcotic treatment programs to ensure that the programs comply with all applicable laws and regulations and to minimize any negative impact that the programs may have on the communities in which they are located.

(6) In its discretion, to approve local agencies or bodies to assist it in carrying out this chapter provided that the department may not delegate responsibility for inspection or any other licensure activity without prior and specific statutory approval. However, the department shall evaluate recommendations made by county alcohol and drug program administrators regarding licensing activity in their respective counties.

(7) The director may grant exceptions to the regulations adopted under this chapter if the director determines that this action would improve treatment services or achieve greater protection to the health and safety of patients, the local community, or the general public. An exception shall not be granted if it is contrary to, or less stringent than, the federal laws and regulations that govern narcotic treatment programs.

(b) It is the intent of the Legislature in enacting this section, in order to protect the general public and local communities, that take-home doses of narcotic replacement therapy medications authorized for use pursuant to Section 11839.2 shall only be provided when the patient is clearly adhering to the requirements of the program, or if the program is closed on Sundays or holidays and providing a take-home dose is not contrary to federal laws and regulations governing narcotic treatment programs. The department shall define “satisfactory adherence” and shall ensure that patients not satisfactorily adhering to their programs shall not be provided take-home doses. A narcotic treatment program medical director shall determine whether or not to dilute take-home doses.

(c) There is established in the State Treasury the Narcotic Treatment Program Licensing Trust Fund. All licensure fees collected from the providers of narcotic treatment services shall be deposited in this fund. Except as otherwise provided in this section, if funds remain in this fund after appropriation by the Legislature and allocation for the costs associated with narcotic treatment licensure actions and inspection of narcotic treatment programs, a percentage of the excess funds shall be annually rebated to the licensees based on the percentage their licensing fee is of the total amount of fees collected by the department. A reserve equal to 10 percent of the total licensure fees collected during the preceding fiscal year may be held in each trust account to reimburse the department if the actual cost for the licensure and inspection exceed fees collected during a fiscal year.

(d) Notwithstanding any provision of this code or regulations to the contrary, the department shall have sole responsibility and authority for determining if a state narcotic treatment program license shall be granted and for administratively establishing the maximum treatment capacity of a license. However, the department shall not increase the capacity of a program unless it determines that the licensee is operating in full compliance with applicable laws and regulations.

SEC. 6.

 No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution.

SEC. 7.

 This act is an urgency statute necessary for the immediate preservation of the public peace, health, or safety within the meaning of Article IV of the California Constitution and shall go into immediate effect. The facts constituting the necessity are:

To enable the State Department of Health Care Services to meet the federal Substance Abuse and Mental Health Services Administration requirements relating to opioid treatment programs and the standards for treatment of opioid use disorder by the October 2, 2024, compliance deadline, it is necessary that this act take effect immediately.