California Code of Regulations › Title 9 - Rehabilitative and Developmental Services › Division 4 - Department of Alcohol and Drug Programs › Chapter 4 - Narcotic Treatment Programs › Subchapter 1 - General Administration › Section 10000 - Definitions

Current through Register 2024 Notice Reg. No. 28, July 12, 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).