Current through Register 2024 Notice Reg. No. 38, September 20, 2024
(a) The
following definitions shall apply to terminology contained in Chapter 4, Division 4,
Title 9, California Code of Regulations.
(1)
Amendment. "Amendment" means written changes in the protocol.
(2) Buprenorphine. "Buprenorphine" means a
semisynthetic narcotic analgesic that is derived from thebaine and is administered
in the form of its hydrochloride
C29H41NO4
· HCl to control moderate to severe pain and treat opioid
dependence.
(3) Buprenorphine Products.
"Buprenorphine products" means buprenorphine combination products approved by the
FDA for maintenance treatment or detoxification of opioid dependence.
(4) DEA. "DEA" means the United States Drug
Enforcement Administration.
(5)
Department. "Department" means the Department of Health Care Services.
(6) Detoxification Treatment. "Detoxification
treatment" means the treatment modality whereby replacement narcotic therapy is used
in decreasing, medically determined dosage levels for a period not more than 21 days
to treat physical dependence, while the patient is provided a comprehensive range of
treatment services.
(7) FDA. "FDA" means
the United States Food and Drug Administration.
(8) Illicit Drug. "Illicit drug" means any
substance defined as a drug in Section
11014, Chapter 1, Division 10 of the
Health and Safety Code, except:
(A) Drugs or
medications prescribed by a physician or other person authorized to prescribe drugs,
pursuant to Section
4040, Chapter 9, Division 2 of the
Business and Professions Code, and used in the dosage and frequency prescribed;
or
(B) Over-the-counter drugs or
medications used in the dosage and frequency described on the box, bottle, or
package insert.
(9)
Laboratory. "Laboratory" means a drug analysis laboratory approved and licensed by
the California Department of Public Health to test or analyze samples of patient
body specimens for the substances named in Section
10315 for a narcotic treatment
program.
(10) Levoalphacetylmethadol
(LAAM). "Levoalphacetylmethadol (LAAM)," also known as Levo-Alpha-Acetyl-Methadol or
levomethadyl acetate hydrochloride, means the substance that can be described
chemically as levo-alpha-6-dimethylamino-4, 4-diphenyl-3-heptyl acetate
hydrochloride.
(11) License. "License"
means a written permit issued by the Department to operate a narcotic treatment
program in the State of California.
(12)
Licensing Action. "Licensing action" means any administrative action taken by the
Department that would adversely affect the license of a narcotic treatment program,
including:
(A) Denial of an application for a
license;
(B) Denial of a protocol
amendment;
(C) Denial of a supplemental
written protocol for a medication unit;
(D) Denial of a supplemental written protocol for
an OBNTN;
(E) Denial of a request for
license renewal;
(F) Denial of a request
to relocate a narcotic treatment program outside of its current county;
(G) Assessment of a civil penalty; or
(H) Suspension or revocation of a
license.
(13) Maintenance
Treatment. "Maintenance treatment" means the treatment modality whereby replacement
narcotic therapy is used in sustained, stable, medically determined dosage levels
for a period in excess of 21 days to treat opioid addiction, while the patient is
provided a comprehensive range of treatment services.
(14) Medical Director. "Medical director" means
the physician licensed to practice medicine in California who is responsible for
medical services provided by the program.
(15) Medication. "Medication" means any opioid
agonist medications that have been approved for use in replacement narcotic therapy,
including:
(A) Methadone;
(B) Levoalphacetylmethadol (LAAM);
(C) Buprenorphine and buprenorphine products
approved by the FDA for maintenance treatment or detoxification treatment of opioid
addiction; and
(D) Any other medication
approved by the FDA for the purpose of narcotic replacement treatment or
medication-assisted treatment of substance use disorders.
(16) Medication Unit. "Medication unit" means a
facility established as part of, but geographically separate from, a narcotic
treatment program, from which licensed private practitioners or community
pharmacists dispense or administer an opioid agonist treatment medication or collect
samples for drug testing or analysis.
(17) Methadone. "Methadone" means the substance
that can be described as 6-dimenthylamino-4, 4-diphenyl-3-heptanone. Methadone doses
are usually administered as methadone hydrochloride.
(18) Narcotic Drug. "Narcotic drug" means any
controlled substance which produces insensibility or stupor and applies especially
to opium or any of its natural derivatives or synthetic substitutes.
(19) Narcotic Treatment Program (NTP). "Narcotic
treatment program (NTP)" means a licensed opioid addiction treatment program,
whether inpatient or outpatient, which offers all of the following: evaluation,
maintenance treatment and/or detoxification treatment, and other services in
conjunction with replacement narcotic therapy.
(20) Office-Based Narcotic Treatment Network
(OBNTN). "Office-Based Narcotic Treatment Network (OBNTN)" means a network of
providers that are affiliated and associated with a primary narcotic treatment
program, offering one or more of the following: evaluation of medical, employment,
alcohol, criminal, and psychological problems; screening for diseases that are
disproportionately represented in the substance use disorder population; counseling
by addiction counselors who are evaluated through ongoing supervision; and
professional medical, social work, and mental health services, on-site or by
referral.
(21) Opiate. "Opiate" means
one of a group of alkaloids derived from the opium poppy (Papaver somniferum), with
the ability to induce analgesia, euphoria, and, in higher doses, stupor, coma, and
respiratory depression. The term excludes synthetic opioids.
(22) Opioid. "Opioid" means any psychoactive
chemical that resembles morphine in pharmacological effects, including opiates and
synthetic/semisynthetic agents that exert their effects by binding to highly
selective receptors in the brain where morphine and endogenous opioids affect their
actions.
(23) Opioid Addiction. "Opioid
Addiction," and the related term "addiction to opioids," mean a condition
characterized by compulsion and lack of control that lead to illicit or
inappropriate opioid-seeking behavior, including an opioid addiction that was
acquired or supported by the misuse of a physician's legally prescribed narcotic
medication.
(24) Physical Dependence.
"Physical Dependence," and related terms "dependence," "dependency," "dependent,"
and "physiological dependence," means a condition resulting from repeated
administration of a drug that necessitates its continued use to prevent withdrawal
syndrome that occurs when the drug is abruptly discontinued.
(25) Primary Metabolite of Methadone. "Primary
metabolite of methadone" means 2-ethylidene-1, 5-dimethyl-3,
3-diphenylpyrrolidine.
(26) Primary
Narcotic Treatment Program. "Primary Narcotic Treatment Program" means a program
with an affiliated and associated medication unit and/or OBNTN.
(27) Program. "Program" means a narcotic treatment
program.
(28) Program Director. "Program
director" means the person who has primary administrative responsibility for
operation of an approved and licensed program.
(29) Program Sponsor. "Program sponsor" means the
person or organization named in the Initial Application Coversheet form DHCS 5014
(04/16), herein incorporated by reference, as responsible for the operation of the
narcotic treatment program and who assumes responsibility for all of its employees,
including any practitioners, agents, or other persons providing medical,
rehabilitative, or counseling services at the program or any of its medication units
and OBNTNs. The program sponsor need not be a licensed physician but shall employ a
licensed physician for the position of medical director.
(30) Protocol. "Protocol" means a written
document, including required forms, which sets forth a program's treatment concept,
organization, and operational procedures.
(31) Rationale. "Rationale" means a rational
statement of principles or the logical basis for a procedure.
(32) Replacement Narcotic Therapy. "Replacement
narcotic therapy" means Medication-assisted treatment that uses agonist or partial
agonist medication to normalize brain chemistry, block the euphoric effects of
opioids and relieve physiological cravings and normalize body functions.
(33) SAMHSA. "SAMHSA" means the Substance Abuse
and Mental Health Services Administration.
(34) Treatment. "Treatment" means services which
will habilitate and rehabilitate patients with an opioid addiction to a basic level
of social, life, work, and health capabilities that help them become productive,
independent members of society and will include:
(A) Replacement narcotic therapy;
(B) Evaluation of medical, employment, alcohol,
criminal, and psychological problems;
(C) Screening for diseases that are
disproportionately represented in the substance use disorder population;
(D) Monitoring for illicit drug use;
(E) Counseling by addiction counselors that are
evaluated through ongoing supervision; and
(F) Professional medical, social work, and mental
health services, on-site or by referral (through contracted interagency
agreements).
1. New subchapter
4 (articles 1-22, sections
9995-10340, not consecutive) filed
9-1-83; effective upon filing pursuant to Government Code section
11346.2(d)
(Register 83, No. 36). CROSS REFERENCE: title 9, chapter 1, subchapter 6, sections
1000-1311.
2. Change without
regulatory effect renumbering and amending former section
9995 to section
10000 filed 6-3-91 pursuant to section
100, title 1, California Code of
Regulations (Register 91, No. 34).
3. Amendment filed 3-15-96 as an
emergency; operative 3-15-96 (Register 96, No. 11). A Certificate of Compliance must
be transmitted to OAL by 7-13-96 or emergency language will be repealed by operation
of law on the following day.
4. Amendment refiled 7-8-96 as an emergency;
operative 7-12-96 (Register 96, No. 28). A Certificate of Compliance must be
transmitted to OAL by 11-12-96 or emergency language will be repealed by operation
of law on the following day.
5. Amendment refiled 10-23-96 as an
emergency; operative 10-29-96 (Register 96, No. 43). A Certificate of Compliance
must be transmitted to OAL by 2-26-97 or emergency language will be repealed by
operation of law on the following day.
6. Amendment refiled 2-11-97 as an
emergency; operative 2-24-97 (Register 97, No. 7). A Certificate of Compliance must
be transmitted to OAL by 6-24-97 or emergency language will be repealed by operation
of law on the following day.
7. Certificate of Compliance as to 2-11-97
order transmitted to OAL 3-4-97; disapproved by OAL and order of repeal as to
2-11-97 order filed 4-15-97 (Register 97, No. 16).
8. Amendment filed
4-15-97 as an emergency; operative 4-15-97 (Register 97, No. 16). A Certificate of
Compliance must be transmitted to OAL by 8-13-97 or emergency language will be
repealed by operation of law on the following day.
9. Certificate of
Compliance as to 4-15-97 order, including amendment of subsections (a)(2),
(a)(4)(A), (a)(5), (a)(10), (a)(12), (a)(16) and (a)(17), transmitted to OAL 6-2-97
and filed 6-13-97 (Register 97, No. 24).
10. New subsection (a)(22) and
subsection renumbering filed 6-29-98; operative 6-29-98 pursuant to Government Code
section
11343.4(d)
(Register 98, No. 27).
11. Change without regulatory effect amending NOTE
filed 4-19-2006 pursuant to section
100, title 1, California Code of
Regulations (Register 2006, No. 16).
12. Amendment of section and NOTE
filed 5-7-2020; operative 7-1-2020 (Register 2020, No. 19).
Note: Authority cited: Sections
11750,
11755,
11835,
11839.3,
11839.6
and
11839.20,
Health and Safety Code. Reference: Sections
11839.2,
11839.3,
11839.5,
11839.6,
11839.7
and
11839.19,
Health and Safety Code.
