Bill Text: CA AB2115 | 2023-2024 | Regular Session | Amended
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Controlled substances: clinics.
Sponsorship: Partisan Bill (Democrat 1)
Status: (Passed) 2024-09-27 - Chaptered by Secretary of State - Chapter 634, Statutes of 2024. [AB2115 Detail]
Download: California-2023-AB2115-Amended.html
Bill Title: Controlled substances: clinics.
Sponsorship: Partisan Bill (Democrat 1)
Status: (Passed) 2024-09-27 - Chaptered by Secretary of State - Chapter 634, Statutes of 2024. [AB2115 Detail]
Download: California-2023-AB2115-Amended.html
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Amended
IN
Senate
June 17, 2024 |
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Amended
IN
Assembly
May 20, 2024 |
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Amended
IN
Assembly
April 01, 2024 |
CALIFORNIA LEGISLATURE—
2023–2024 REGULAR SESSION
Assembly Bill
No. 2115
| Introduced by Assembly Member Haney |
February 05, 2024 |
An act to amend Section 4184 of the Business and Professions Code, and to add Section 11839.35 to the Health and Safety Code, relating to controlled substances.
LEGISLATIVE COUNSEL'S DIGEST
AB 2115, as amended, 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 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, requires revocation of those privileges if a patient tests positive for illicit substances on 2 consecutive monthly samples, and prescribes criteria for the restoration of those privileges, including test results that are negative for illicit substances. Existing regulation requires a patient who is absent from a program for 2 weeks without contacting the program be terminated from the program.
This bill would specify that medical evaluation may be conducted by any health care provider, if it is verified by a narcotic treatment program practitioner, would authorize a program to allow patients to refuse or delay laboratory tests for disease, and would state that a patient receiving maintenance treatment is
not precluded from receiving medication by a refusal to participate in counseling. The bill would revise the criteria to be considered prior to providing a patient with take-home medication privileges to include the absence of active substance use disorders and known recent diversion activity and the regularity of attendance for supervised medication administration, among others. The bill would state that a practitioner is not required to restrict a patient’s take-home medication privileges if the patient tests positive for an illicit substance as described above and a practitioner is not required to establish a specified number of negative tests to restore those privileges to a patient. The bill would authorize a program to allow a patient to be absent from the program for up to 30 days without contact before requiring that they be terminated from the program.
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.
Digest Key
Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: YESBill 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.
(d)
(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.
(e)
(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 11839.35 is added to the Health and Safety Code, to read:11839.35.
(a) A medical evaluation of a patient prior to admittance to a detoxification or maintenance treatment may be conducted by any health care provider, if it is verified by a narcotic treatment program practitioner as true and accurate and it is transmitted in accordance with all applicable privacy laws.(b) A narcotic treatment program may authorize a patient to decline laboratory testing for disease or may authorize a patient to complete that testing within two weeks of the date of admittance to the program.
(c) A narcotic treatment program shall not deny a patient maintenance treatment due to the length
of time a person has been addicted to opiates.
(d) A patient receiving maintenance treatment is not precluded from receiving medication for opiate use disorder by refusing to participate in counseling services.
(e) A narcotic treatment program practitioner shall update a patient’s treatment plan annually.
(f) The initial dose of methadone provided to a patient in a narcotic treatment program shall not exceed 50 milligrams unless the practitioner finds sufficient medical rationale that a higher dose is clinically indicated. The practitioner shall document that rationale in the patient’s records.
(g) Notwithstanding subdivision (b) of Section 11839.3, a decision
to dispense take-home doses of narcotic replacement therapy medications shall be determined by a medical practitioner, who shall consider, among other pertinent factors, all of the following criteria:
(1) The absence of active substance use disorders, other physical or behavioral health conditions that increase the risk of patient harm as it relates to the potential for overdose, or the ability to function safely.
(2) The regularity of attendance for supervised medication administration.
(3) The absence of serious behavioral problems that endanger the patient, the public, or others.
(4) The absence of known recent diversion activity.
(5) Whether take-home medication can be safely transported and stored.
(6) Any other criteria that the medical director or medical
practitioner considers relevant to the patient’s safety and the public’s health.
(h) A decision to dispense take-home medication shall not be contingent on the length of time a patient has participated in treatment. A patient eligible for take-home medication may receive up to a seven-day take-home supply of medication. After 15 days of treatment, a patient may receive up to a two-week take-home supply of medication, and after 31 days in treatment may receive a 28-day take-home supply of medication.
(i) A medical practitioner is not required to restrict a patient’s take-home medication privileges if that patient’s monthly bodily specimen has tested positive for illicit drugs in two consecutive months.
(j) In restoring a patient’s take-home medication privileges, a practitioner is not required to impose any requirement that the patient’s monthly bodily specimen test negative for illicit drugs for any specified period of time.
(k) A patient may be absent from a maintenance treatment program for up to 30 days, without contacting the program.
(l) The department shall review existing regulations promulgated pursuant to this chapter and remove outdated, stigmatizing language and obsolete references.
