Appendix F—Standard Definitions Used During Application and Monitoring

Definitions Used by FDA (21 CFR § 291.505 (a)):

Detoxification Treatment

The dispensing of a narcotic drug in decreasing doses to an individual to alleviate adverse physiological or psychological effects incident to withdrawal from the continuous or sustained use of narcotic drug and as a method of bringing the individual to a narcotic drug-free state.

Short-term Detoxification Treatment

Detoxification treatment for a period not in excess of 30 days.

Long-term Detoxification Treatment

Detoxification treatment for a period more than 30 days but not in excess of 180 days.

Maintenance Treatment

The dispensing of a narcotic drug, at relatively stable dosage levels, in the treatment of an individual for dependence on heroin or other morphine-like drug. There are two types of maintenance treatment: comprehensive maintenance treatment and interim maintenance treatment.

(i) Comprehensive maintenance treatment is maintenance treatment provided in conjunction with a comprehensive range of appropriate medical and rehabilitative services.

(ii) Interim maintenance treatment is maintenance treatment provided in conjunction with appropriate medical services while a patient is awaiting transfer to comprehensive maintenance treatment.

Medical Director

A physician licensed to practice medicine in the jurisdiction in which the program is located, who assumes responsibility for the administration of all medical services performed by the narcotic treatment program including ensuring that the program is in compliance with all Federal, State, and local laws and regulations regarding the medical treatment of narcotic addiction with a narcotic drug.

Medication Unit

A facility established as part of, but geographically dispersed, i.e., separate from a narcotic treatment program from which licensed private practitioners and community pharmacists: (1) are permitted to administer and dispense a narcotic drug; (2) are authorized to collect samples for drug testing or analysis for narcotic drugs.

Narcotic Dependent

An individual who physiologically needs heroin or a morphine-like drug to prevent the onset of signs of withdrawal.

Narcotic Treatment Program

An organization (or person, including a private physician) that adminsters or dispenses a narcotic drug to a narcotic addict for maintenance or detoxification treatment, provides when appropriate and necessary, a comprehensive range of medical and rehabilitative services, is approved by the State authority and the Food and Drug Administration, and is registered with the Drug Enforcement Administration to use a narcotic drug for the treatment of narcotic addiction.

Program Sponsor

A person (or a representative of an organization) who is responsibile for the operation of a narcotic treatment program and who assumes responsibility for all its employees including any practitioners, agents, or other persons providing services at the program (including its medication units).

Service

Medical evaluations, counseling, rehabilitative and other social programs (e.g., vocational and educational guidance, employment placement), which help the patient become a productive member of society.

State Authority

The agency designated by the governor or other appropriate official to exercise the responsibility and authority within the State or territory for governing the treatment of narcotic addiction with a narcotic drug.

Definitions Used by the DEA (21 CFR §1301.02 (a)):

Act

The Controlled Substances Act (84 Stat. 1242; 21 U.S.C. 801) and/or the Controlled Substances Import and Export Act (84 Stat. 1285; 21 U.S.C. 951).

Basic Class

The controlled substances listed in Schedules I and II including each of the opiates; each of the opium derivatives; each of the hallucinogenic substances; various substances produced directly or indirectly by extraction from substances of vegetable origin, or independently by combination of extraction and chemical synthesis; methamphetamine; amphetamine; phenmetrazine and its salts; methylphenidate; each of the substances having depressant effects on the central nervous system.

Administration

The Drug Enforcement Administration

Compounder

Any person engaging in maintenance or detoxification treatment who also mixes, prepares, packages, or changes the dosage form of a narcotic drug listed in Schedules II, III, IV or V for use in maintenance or detoxification treatment by another narcotic treatment program.

Detoxification Treatment

The dispensing of a narcotic drug in decreasing doses to an individual to alleviate adverse physiological or phychological effects incident to withdrawal from the continuous or sustained use of a narcotic drug and as a method of bringing the individual to a narcotic drug-free state.

Short-term Detoxification Treatment

Detoxification treatment for a period not in excess of 30 days.

Long-term Detoxification Treatment

Detoxification treatment for a period more than 30 days but not in excess of 180 days.

Administrator

The administrator of the Drug enforcement Administration with delegated authority under the Act of the Attorney General (28 CFR § 0.100).

Hearing

Any hearing held pursuant to the granting, denial, revocation, or suspension of a registration.

Maintenance Treatment

The dispensing for a period in excess of 21 days, of a narcotic drug or narcotic drugs in the treatment of an individual for dependence on heroin or other morphine-like drug.

Narcotic Treatment Program

A program engaged in maintenance and/or detoxification treatment with narcotic drugs.

Register/Registration

The registration required and permitted by section 303 of the Act (21 U.S.C. 823)

Registrant

Any person (individual, corporation, government, or governmental subdivision or agency, business trust, partnership, association, or other legal entity) who is registered.

Definitions Used by the Public Health Service, HHS for Confidentiality (42 CFR § 2.11):

Alcohol Abuse

The use of an alcoholic beverage which impairs the physical, mental, emotional, or social well-being of the user.

Drug Abuse

The use of a psychoactive substance for other than medicinal purposes which impairs the physical, mental, emotional, or social well-being of the user.

Diagnosis

Any reference to an individual's alcohol or drug abuse or to a condition which is identified as having been caused by that abuse which is made for the purpose of treatment or referral for treatment.

Disclose or disclosure

A communication of patient identifying information, the affirmative verification of another person's communication of patient identifying information, or the communication of any information from the record of a patient who has been identified.

Informant

An individual who is a patient or employee of a program or who becomes a patient or employee of a program at the request of a law enforcement agency or official, who at the request of a law enforcement agency or official observes one or more patients or employees of the program for the purpose of reporting the information obtained to the law enforcement agency or official.

Patient

Any individual who has applied for or been given diagnosis or treatment for alcohol or drug abuse at a Federally assisted program and includes any individual who, after arrest on a criminal charge, is identified as an alcohol or drug abuser in order to determine that individual's eligibility to participate in a program.

Patient Identifying Information

The name, address, social security number, fingerprints, photograph, or similar information by which the identity of a patient can be determined with reasonable accuray and speed either directly or by reference to other publicly available information. This does not include a number assigned to the patient by a program, if that number does not consist of, or contain numbers which could be used to identify the patient with reasonable accuracy and speed.

Person

An individual, parternship, corporation, Federal, State, local government agency, or any other legal entity.

Program

A person, as defined above, that provides alcohol or drug abuse diagnosis, treatment, or referral for treatment. For a general medical care facility to be a program it must have an identified unit that provides alcohol, or drug abuse diagnosis, treatment, or referral for treatment or medical personnel or other staff to provide these services.

Program Director

For a program that is an individual, the program director is that individual. For a program that is an organization, the individual designated as director, managing director, or otherwise vested with authority to act as chief executive of the organization.

Qualified Service Organization

A person that provides services to a program such as data processing, bill collecting, dosage preparation, laboratory analysis, or legal or medical, accounting, or other professional services, or services to prevent or treat child abuse or neglect including training on nutrition and child care, and individual and group therapy, who has entered into a written agreement with a program. In the written agreement, the person acknowledges that receiving, storing, processing, or other dealing with any patient records from the program is bound by regulation and will resist in judicial proceedings any efforts to obtain access to patient records except as permitted by regulations.

Records

Any information, whether recorded or not, relating to a patient receiving or acquired by a Federally assisted alcohol or drug program.

Third Party Payer

A person who pays, or agrees to pay, for diagnosis or treatment furnished to a patient on the basis of a contractual relationship with the patient or a member of the patient's fammily or on the basis of the patient's eligibility for Federal, State, or local governmental benefits.

Treatment

The management and care of a patient suffering from alcohol or drug abuse, a condition identified as having been caused by that abuse, or both, in order to reduce or eliminate the adverse effects upon the patient.

Undercover Agent

An officer of any Federal, State, or local law enforcement agency who enrolls in or becomes an employee of a program for the purpose of investigating a suspected violation of law or who pursues that purpose after enrolling or becoming employed for other purposes.

Definitions Used by HHS for Research Subjects (45 CFR § 46.101):

Department of Agency Head

The head of any Federal department or agency and any other officer or employee of any department or agency to whom authority has been delegated.

Institution

Any public or private entity or agency including Federal, State, or other agencies.

Legally Authorized Representative

Individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.

Research

A systematic investigation including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Research Subject to Regulation

Research activities for which a Federal department or agency has specific responsibility for regulating as a research activity.

Human Subject

A living individual about whom an investigation conducting research obtains data and identifiable private information.

Intervention

Both physical procedures by which data are gathered and manipulations of the subject or the subject's environment that are performed for research purposes. This includes communication or interpersonal contact between investigator and subject.

Private Information

Includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public. Such information must be individually identifiable in order for obtaining the information to constitute research information involving human subjects.

IRB

An institutional review board established in accord with and for the purposes expressed in the research using human subjects policy (45 CFR § 46.103).

IRB Approval

The determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements.

Minimal Risk

The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Certification

The official notification by the institution to the supporting department or agency that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance.

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