[Code of Federal Regulations]
[Title 21, Volume 4, Parts 200 to 299]
[Revised as of April 1, 1998]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR291]
[Page 125-147]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
PART 291--DRUGS USED FOR TREATMENT OF NARCOTIC ADDICTS--Table of Contents
Sec.
291.501 Narcotic drugs in the maintenance treatment of narcotic
addicts.
291.505 Conditions for the use of narcotic drugs; appropriate methods
of professional practice for medical treatment of the narcotic
addiction of various classes of narcotic addicts under section
4 of the Comprehensive Drug Abuse Prevention and Control Act
of 1970.
Authority: 21 U.S.C. 355, 371, 823; 42 U.S.C. 241(d), 257a, 290ee-3,
300y-11.
Sec. 291.501 Narcotic drugs in the maintenance treatment of narcotic
addicts.
(a) The Food and Drug Administration, the National Institute on Drug
Abuse, and the Drug Enforcement Administration, Department of Justice,
recognize that the use of narcotic drugs in the prolonged maintenance of
narcotic dependence has been shown to be an effective part of a total
treatment effort in the management and rehabilitation of selected
narcotic addicts. It is also recognized that a number of dangers and
possible abuses may arise from such efforts if professional services and
controls are inadequately applied.
(b) Therefore, the Commissioner of Food and Drugs, the Director of
the National Institute on Drug Abuse, and the Administrator of the Drug
Enforcement Administration, Department of Justice, agree that interested
professionals, municipalities, and organizations should be allowed to
use narcotic drugs in the medical treatment of narcotic addiction within
a framework of adequate controls designed to protect the individual
patients and the community. Narcotic drugs that are to be used as part
of the treatment of narcotic addiction must have an approved new drug
application for such use. To facilitate this purpose, the Food and Drug
Administration, the National Institute on Drug Abuse, and the Drug
Enforcement Administration, Department of Justice, have jointly agreed
upon acceptable conditions for the use of narcotic drugs in a treatment
program, which are set forth in Sec. 291.505. In addition, such other
provisions of the Federal narcotic laws and regulations as are
applicable must also be observed.
[58 FR 38709, July 20, 1993]
Sec. 291.505 Conditions for the use of narcotic drugs; appropriate
methods of professional practice for medical treatment of the
narcotic addiction of various classes of narcotic addicts
under section 4 of the Comprehensive Drug Abuse Prevention and
Control Act of 1970.
(a) Definitions. As used in this part:
(1) Detoxification treatment means 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 a narcotic drug and as a method of bringing the
individual to a narcotic drug-free state within such period.
[[Page 126]]
There are two types of detoxification treatment: short-term
detoxification treatment and long-term detoxification treatment.
(i) Short-term detoxification treatment is for a period not in
excess of 30 days.
(ii) Long-term detoxification treatment is for a period more than 30
days but not in excess of 180 days.
(2) Maintenance treatment means 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.
(3) A medical director is 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.
(4) A medication unit is 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--
(i) Are permitted to administer and dispense a narcotic drug, and
(ii) Are authorized to collect samples for drug testing or analysis
for narcotic drugs.
(5) Narcotic dependent means an individual who physiologically needs
heroin or a morphine-like drug to prevent the onset of signs of
withdrawal.
(6) A narcotic treatment program is an organization (or a person,
including a private physician) that administers or dispenses a narcotic
drug to a narcotic addict for maintenance or detoxification treatment,
provides, when appropriate or necessary, a comprehensive range of
medical and rehabilitative services, is approved by the State authority
and the Food and Drug Administration, and that is registered with the
Drug Enforcement Administration to use a narcotic drug for the treatment
of narcotic addiction.
(7) A program sponsor is a person (or representative of an
organization) who is responsible 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).
(8) The term services, as used in this part, includes medical
evaluations, counseling, rehabilitative and other social programs (e.g.,
vocational and educational guidance, employment placement), which will
help the patient become a productive member of society.
(9) A State authority is 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.
(10) The term HIV disease means infection with the etiologic agent
for acquired immunodeficiency syndrome.
(b) Organizational structure and approval requirements--(1)
Organizational structure. (i) A narcotic treatment program may be an
independent organization or part of a centralized organization. For
example, if a centralized organizational structure consists of a primary
facility and other outpatient facilities, all of which conduct initial
evaluation of patients and administer or dispense medication, the
primary facility and each outpatient facility are separate programs,
even though some services (e.g., the same hospital or rehabilitative
services) are shared.
(ii) The program sponsor shall submit to the Food and Drug
Administration and the State authority a description of the
organizational structure of the program, the name of the persons
responsible for the program, the address of the program, and the
responsibilities
[[Page 127]]
of each facility or medication unit. The sources of funding for each
program shall be listed and the name and address of each governmental
agency providing funding shall be stated.
(iii) Where two or more programs share a central administration
(e.g., a city or State-wide organization), the person responsible for
the organization (administrator or program sponsor) is required to be
listed as the program sponsor for each separate participating program.
An individual program shall indicate its participation in the central
organization at the time of its application. The administrator or
sponsor may fulfill all recordkeeping and reporting requirements for
these programs, but each program must continue to receive separate
approval.
(iv) One physician may assume primary medical responsibility for
more than one program and be listed as medical director. If a physician
assumes medical responsibility for more than one program, a statement
documenting the feasibility of the arrangement is required to be
attached to the application.
(v) Interim maintenance treatment. A public or nonprofit private
narcotic treatment program may provide interim maintenance treatment
only if the program also provides comprehensive maintenance treatment to
which interim maintenance treatment patients may be transferred.
(2)(i) Program approval. Before a narcotic treatment program may be
lawfully operated, the program, whether an outpatient facility or a
private practitioner, shall submit the applications specified in this
section simultaneously to the Food and Drug Administration and the State
authority and must receive the approval of both, except as provided for
in paragraph (h)(5) of this section. Before granting approval, the Food
and Drug Administration will consult with the Drug Enforcement
Administration, Department of Justice, to ascertain if the program is in
compliance with Federal controlled substances laws. Each physical
location within any program is required to be identified and listed in
the approval application. At the time of application for approval, the
program sponsor shall indicate whether medication will be administered
or dispensed at the facility. Before medication may be administered or
dispensed at a location not previously approved for this purpose, the
program is required to obtain approval from FDA and the State agency.
However, no approval is necessary, but notification is required when a
facility in which medication is administered or dispensed is deleted by
a program. In that event, the program shall notify the Food and Drug
Administration and the State authority within three weeks of the
deletion. Similarly, addition or deletion of facilities which provide
services other than administering or dispensing medication is also
permitted without approval, but notification must be made within 3 weeks
to the Food and Drug Administration and the State authority about the
addition and/or deletion.
(ii) Exemption of Federal programs. The provisions of this section
requiring approval (or permitting disapproval or revocation of approval)
by the State authority, compliance with requirements imposed by State
law, or the submission of applications or reports required by the State
authority do not apply to programs operated directly by the Veterans'
Administration or any other department or agency of the United States.
Federal agencies operating narcotic treatment programs have agreed to
cooperate voluntarily with State agencies by granting permission on an
informal basis for designated State representatives to visit Federal
narcotic treatment programs and by furnishing a copy of Federal reports
to the State authority, including the reports required under this
section.
(iii) Services. Each narcotic treatment program shall provide
medical and rehabilitative services and programs. (See paragraph (d)(4)
of this section.) These services should normally be made available at
the primary facility, but the program sponsor may enter into a formal
documented agreement with private or public agencies, organizations, or
institutions for these services if they are available elsewhere. The
program sponsor, in any event, must be able to document that medical and
rehabilitative services are fully available to patients.
[[Page 128]]
(iv) Prohibition against unapproved use of narcotic drugs. No
prescribing, administering, or dispensing of a narcotic drug for the
treatment of narcotic addiction may occur without prior approval by the
Food and Drug Administration and the State authority, except as provided
for in paragraph (h)(5) of this section, unless specifically exempted by
this section.
(v) Approved narcotic drugs for use in treatment programs. The
following narcotic drugs have been approved for use in the treatment of
narcotic addiction: Methadone and Levo-Alpha-Acetyl-Methadol (LAAM).
(vi) Interim maintenance treatment program approval. Before a public
or nonprofit private narcotic treatment program may provide interim
maintenance treatment, the program must receive approval of both the
Food and Drug Administration and the chief public health officer of the
State. Before such approval is granted, the program must provide the
Food and Drug Administration with certification from the chief public
health officer of the State that:
(A) Such officer does not object to the authorization of programs
providing interim maintenance treatment in the State and that programs
seeking such authorization are unable to place patients in a public or
nonprofit private comprehensive treatment program within a reasonable
geographic area within 14 days of the time patients seek admission to
such programs;
(B) The authorization of programs providing interim maintenance
treatment in the State will not reduce the capacity of comprehensive
programs in the State to admit individuals to these programs (relative
to the date on which such officer so certifies);
(C) The State guarantees that individuals enrolled in interim
maintenance treatment will be transferred to comprehensive programs not
later than 120 days, as provided by section 1923 of the Public Health
Service Act (the PHS Act) and applicable regulations; and
(D) Requests for authorization should be submitted to the address
specified in paragraph (l) of this section.
(3)(i) Medication unit. A program may establish a medication unit to
facilitate the needs of patients who are stabilized on an optimal dosage
level. To lawfully operate a medication unit, the program shall, for
each separate unit, obtain approval from the Food and Drug
Administration, the Drug Enforcement Administration, and the State
authority, except as provided for in paragraph (h)(5) of this section.
The Food and Drug Administration, in determining whether to approve a
medication unit, will consider the distribution of units within a
particular geographic area. Any new medication unit is required to
receive approval before it may lawfully commence operation.
(ii) Revocation of approval. If the Food and Drug Administration
revokes the primary program's approval, the approval for any medication
unit associated with the program is deemed to be automatically revoked.
The Food and Drug Administration's revocation of the approval of a
particular medication unit, will not, in and of itself, affect the
approval of the primary program.
(iii) Narcotic drug supply. A medication unit must receive its
supply of the narcotic drug directly from the stocks of the primary
facility. Only persons permitted to administer or dispense the drug or
security personnel licensed or otherwise authorized by State law to do
so may deliver the drug to a medication unit.
(iv) Referral. (A) The patient shall be stabilized at his or her
optimal dosage level before he or she may be referred to a medication
unit.
(B) Since the medication unit does not provide a range of services,
the program sponsor shall determine that the patient to be referred is
not in need of frequent counseling, rehabilitative, and other services
which are only available at the primary program facility.
(v) Services. A medication unit is limited to administering or
dispensing a narcotic drug and collecting samples for drug testing or
analysis for narcotic drugs in accordance with paragraph (d)(2) of this
section. If a private practitioner wishes to provide other services
besides administering or dispensing a narcotic drug and collecting
samples for drug testing or analysis for narcotic drugs, he or she must
submit an application for separate approval.
[[Page 129]]
(vi) Responsibility for patient. After a patient is referred to a
medication unit, the program sponsor retains continuing responsibility
for the patient's care. The program sponsor shall ensure that the
patient receives needed medical and rehabilitative services at the
primary facility.
(c) Conditions for approval of the use of a narcotic drug in a
treatment program--(1) Applicants. An individual listed as program
sponsor for a treatment program using a narcotic drug need not
personally be a licensed practitioner but shall employ a licensed
physician for the position of medical director. Persons responsible for
administering or dispensing the narcotic drug shall be practitioners as
defined by section 102(21) of the Controlled Substances Act (21 U.S.C.
802(21)) and licensed to practice by the State in which the program is
to be established.
(2)(i) Assent to regulation. A person who sponsors a narcotic
treatment program, and any persons responsible for a particular program,
shall agree to adhere to all the rules, directives, and procedures, set
forth in this section, and any regulation regarding the use of narcotic
drugs in the treatment of narcotic addiction which may be promulgated in
the future. The program sponsor has responsibility for all personnel and
individuals providing services, who work in the program at the primary
facility or at other facilities or medication units. The program
sponsors shall agree to inform all personnel and individuals providing
services of the provisions of this section and to monitor their
activities to assure compliance with the provisions.
(ii) The Food and Drug Administration and the State authority are
required to be notified within 3 weeks of any replacement of the program
sponsor or medical director. Activities in violation of this regulation
may give rise to the sanctions set forth in paragraph (i) of this
section.
(3) Description of facilities. Only program site(s) approved by
Federal, State, and local authorities may treat narcotic addicts with a
narcotic drug. To obtain program approval, the applicant shall
demonstrate that he or she will have access to adequate physical
facilities to provide all necessary services. A program must have ready
access to a comprehensive range of medical and rehabilitative services
so that the services may be provided when necessary. The name, address,
and description of each hospital, institution, clinical laboratory, or
other facility available to provide the necessary services are required
to be included in the application submitted to the Food and Drug
Administration and the State authority. The application is also required
to include the name and address of each medication unit.
(4) Submission of proper applications. The following applications
shall be filed simultaneously with both the Food and Drug Administration
and the State authority:
(i) Form FDA-2632 ``Application for Approval of Use of Narcotic
Drugs in a Treatment Program.'' This form, required by paragraph (l) of
this section, shall be completed and signed by the program sponsor and
submitted in duplicate to the Food and Drug Administration and the State
authority.
(ii) Form FDA-2633 ``Medical Responsibility Statement for Use of
Narcotic Drugs in a Treatment Program.'' This form, required by
paragraph (l) of this section, shall be completed and signed by each
licensed physician authorized to administer or dispense narcotic drugs
and submitted in duplicate to the Food and Drug Administration and the
State authority. The names of any other persons licensed by law to
administer or dispense narcotic drugs working in the program shall be
listed even if they are not responsible for administering or dispensing
the drug at the time the application is submitted.
(5) State and Federal approval, denial, and revocation of approval
of narcotic treatment programs. (i) The Food and Drug Administration may
grant approval to a program only after FDA has received notification
from both the State authority and the Drug Enforcement Administration
that the program conforms to all pertinent State and Federal
requirements.
(ii) The Food and Drug Administration will revoke the approval of a
narcotic treatment program if so requested by the State authority or the
Drug Enforcement Administration. If
[[Page 130]]
approval of a program is denied or revoked, the program shall have a
right to appeal to the Commissioner, as provided for in paragraph (h)(5)
of this section.
(iii) No shipment of a narcotic drug may lawfully be made to any
program which does not have current approval from the Food and Drug
Administration. Within 60 days after receipt of the application from the
program sponsor for approval, the Food and Drug Administration will
notify the sponsor whether the application is approved or denied.
(d)(1) Minimum standards for admission--(i) History of addiction and
current physiologic dependence. (A) A person may be admitted as a
patient for a comprehensive maintenance program only if a program
physician determines that the person is currently physiologically
dependent upon a narcotic drug and became physiologically dependent at
least 1 year before admission for comprehensive maintenance treatment. A
1-year history of addiction means that an applicant for admission to a
comprehensive maintenance program was physiologically addicted to a
narcotic at a time at least 1 year before admission to a program and was
addicted, continuously or episodically, for most of the year immediately
before admission to a program. In the case of a person for whom the
exact date on which physiological addiction began cannot be ascertained,
the admitting program physician may, in his or her reasonable clinical
judgment, admit the person to comprehensive maintenance treatment, if
from the evidence presented, observed, and recorded in the patient's
record, it is reasonable to conclude that there was physiologic
dependence at a time approximately 1 year before admission.
(B) Although daily use of a narcotic for an entire year could
satisfy the regulatory definition of a 1-year history of addiction,
operationally one might be physiologically dependent without daily use
during the entire 1-year period and still satisfy the definition. The
following, although not exhaustive, are examples of applicants who would
meet the minimum standard of a 1-year history of addiction and who, if
currently physiologically dependent on the date of application for
admission, would be eligible for admission to a comprehensive
maintenance program:
(1) Physiologic addiction began in August 1987 and continued to the
date of application for admission in August 1988.
(2) Physiologic addiction began in January 1988 and continued until
April 1988. Physiologic addiction began again in July 1988 and continued
until the application for admission in January 1989.
(3) Physiologic addiction began in January 1987 and continued until
October 1987. The date of application for admission was January 1988, at
which time the patient had been readdicted for 1 month preceding his or
her admission.
(4) Physiologic addiction consisted of four episodes in the last
year, each episode lasting 2\1/2\ months.
(C) The program physician or an appropriately trained staff member
designated and supervised by the physician shall record in the patient's
record the criteria used to determine the patient's current physiologic
dependence and history of addiction. In the latter circumstance, the
program physician shall review, date, and countersign the supervised
staff member's evaluation to demonstrate his or her agreement with the
evaluation. The program physician shall make the final determination
concerning a patient's physiologic dependence and history of addiction.
The program physician shall sign, date, and record a statement that he
or she has reviewed all the documented evidence to support a 1-year
history of addiction and the current physiologic dependence and that in
his or her reasonable clinical judgment the patient fulfills the
requirements for admission to comprehensive maintenance treatment. The
program physician shall complete and record the statement before the
program administers any narcotic drug to the patient.
(ii) Voluntary participation, informed consent. The person
responsible for the program shall ensure that: A patient voluntarily
chooses to participate in a program; all relevant facts concerning the
use of the narcotic drug used by the program are clearly and adequately
explained to the patient; all patients,
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with full knowledge and understanding of its contents, sign the
``Consent to Treatment with an Approved Narcotic Drug'' Form FDA-2635
(see paragraph (l) of this section); a parent, legal guardian, or
responsible adult designated by the State authority (e.g., ``emancipated
minor'' laws) sign for patients under the age of 18 the second part of
Form FDA-2635 ``Consent to Treatment with an Approved Narcotic Drug.''
(iii) Exceptions to minimum admission criteria--(A) Penal or chronic
care. A person who has resided in a penal or chronic care institution
for 1 month or longer may be admitted to comprehensive maintenance
treatment within 14 days before release or discharge, or within 6 months
after release from such an institution without documented evidence to
support findings of physiological dependence, provided the person would
have been eligible for admission before he or she was incarcerated or
institutionalized and, in the reasonable clinical judgment of a program
physician, treatment is medically justified. Documented evidence of the
prior residence in a penal or chronic care institution and evidence of
all other findings and the criteria used to determine the findings are
required to be recorded in the patient's record by the admitting program
physician, or by program personnel supervised by the admitting program
physician. The admitting program physician shall date and sign these
recordings or review the health-care professional's recordings before
the initial dose is administered to the patient. In the latter case, the
admitting program physician shall date and sign the recordings in the
patient's record made by the health-care professional within 72 hours of
administration of the initial dose to the patient.
(B) Pregnant patients. (1) Pregnant patients, regardless of age, who
have had a documented narcotic dependency in the past and who may return
to narcotic dependency, with all its attendant dangers during pregnancy,
may be placed on a comprehensive maintenance regimen, except as provided
in paragraph (d)(1)(iii)(B)(6) of this section. For such patients,
evidence of current physiological dependence on narcotic drugs is not
needed if a program physician certifies the pregnancy and, in his or her
reasonable clinical judgment, finds treatment to be medically justified.
Evidence of all findings and the criteria used to determine the findings
are required to be recorded in the patient's record by the admitting
program physician, or by program personnel supervised by the admitting
program physician. The admitting program physician shall date and sign
these recordings or review the health-care professional's recordings
before the initial dose is administered to the patient. In the latter
case, the admitting program physician shall date and sign the recordings
in the patient's record made by the health-care professional within 72
hours of administration of the initial dose to the patient. Pregnant
patients are required to be given the opportunity for prenatal care
either by the program or by referral to appropriate health-care
providers.
(2) If a program cannot provide direct prenatal care for pregnant
patients in treatment, the program shall establish a system for
informing the patients of the publicly or privately funded prenatal care
opportunities available. If there are no publicly funded prenatal
referral opportunities and the program cannot provide such services or
the patient cannot afford them or refuses them, then the treatment
program shall, at a minimum, offer her basic prenatal instruction on
maternal, physical, and dietary care as part of its counseling service.
(3) Counseling records and/or other appropriate patient records are
required to reflect the nature of prenatal support provided by the
program. If the patient is referred for prenatal services, the physician
to whom she is referred is required to be notified that she is in
comprehensive maintenance treatment, provided that notification is in
accordance with the Department of Health and Human Services'
confidentiality regulations (42 CFR part 2). If a pregnant patient
refuses direct treatment or appropriate referral for treatment, the
treating program physician should consider using informed consent
procedures; e.g., to have the patient acknowledge in writing that
[[Page 132]]
she had the opportunity for this treatment but refuses it. The program
physician, consistent with the confidentiality regulations, shall
request the physician or the hospital to which a patient is referred to
provide, following birth, a summary of the delivery and treatment
outcome for the patient and offspring. If the program physician does not
receive a response to the request, he or she shall document in the
record that such a request was made.
(4) Within 3 months after termination of pregnancy, the program
physician shall enter an evaluation of the patient's treatment state
into her record and state whether she should remain in the comprehensive
maintenance program or be detoxified.
(5) Caution should be taken in the comprehensive maintenance
treatment of pregnant patients. Dosage levels should be maintained at
the lowest effective dose if treatment is deemed necessary. The program
sponsor shall ensure that each female patient is fully informed of the
possible risks to her or to her unborn child from continued use of
illicit drugs and from the use of, or withdrawal from, a narcotic drug
administered or dispensed by the program in comprehensive maintenance or
detoxification treatment.
(6) Patients who are or become pregnant shall not be started or
continued on LAAM, except by the written order of a physician who
determines this to be the best choice of therapy for that patient.
Clinics providing treatment with LAAM must advise all patients of
childbearing potential of the risks of LAAM and make a medical
evaluation available to all patients who become pregnant while taking
the drug. An initial pregnancy test shall be performed for each
prospective female patient of childbearing potential before admission to
LAAM comprehensive maintenance treatment and monthly pregnancy tests
performed thereafter on such female patients in LAAM comprehensive
maintenance treatment. Analysis of such tests shall be performed in a
laboratory approved under the Clinical Laboratory Improvement Amendments
of 1988 or in a laboratory certified by a State or private accrediting
body approved by the Health Care Financing Administration.
(C) Previously treated patients. Under certain circumstances a
patient who has been treated and later voluntarily detoxified from
comprehensive maintenance treatment may be readmitted to maintenance
treatment, without evidence to support findings of current physiologic
dependence, up to 2 years after discharge, if the program attended is
able to document prior narcotic drug comprehensive maintenance treatment
of 6 months or more, and the admitting program physician, in his or her
reasonable clinical judgment, finds readmission to comprehensive
maintenance treatment to be medically justified. For patients meeting
these criteria, the quantity of take-home medication, if take-home
medication is permitted for the narcotic drug, will be determined in the
reasonable clinical judgment of the program physician, but in no case
may the quantity of take-home medication be greater than would have been
allowed at the time the patient voluntarily terminated previous
treatment. The admitting program physician or a program employee under
supervision of the admitting program physician must enter in the
patient's record documented evidence of the patient's prior treatment
and evidence of all decisions and criteria used relating to the
admission of the patient and the quantity of take-home medication
permitted. The admitting program physician shall date and sign these
entries in the patient's record or review the health-care professional's
entries therein before the program administers any medication to the
patient. In the latter case, the admitting program physician shall date
and sign the entries in the patient's record made by the health-care
professional within 72 hours of administration of the initial dose to
the patient.
(iv) Special limitation; treatment of patients under 18 years of
age. (A) A person under 18 years of age is required to have had two
documented attempts at short-term detoxification or drug-free treatment
to be eligible for maintenance treatment, except as provided in
paragraph (d)(1)(iv)(B) of this section. A 1-week waiting period is
required after such a detoxification attempt, however, before an attempt
is repeated. The program physician shall document
[[Page 133]]
in the patient's record that the patient continues to be or is again
physiologically dependent on narcotic drugs. No person under 18 years of
age may be admitted to a maintenance treatment program unless a parent,
legal guardian, or responsible adult designated by the State authority
(e.g., ``emancipated minor'' laws) completes and signs consent form,
Form FDA-2635 ``Consent to Treatment with an Approved Narcotic Drug.''
(B) A person under 18 years of age shall not be admitted to LAAM
maintenance treatment.
(v) Denial of admission. If in the reasonable clinical judgment of
the medical director a particular patient would not benefit from
treatment with a narcotic drug, the patient may be refused such
treatment even if the patient meets the admission standards.
(2) Minimum testing or analysis for drugs: Uses and frequency. (i)
The person(s) responsible for a program shall ensure that: An initial
drug-screening test or analysis is completed for each prospective
patient; at least eight additional random tests or analyses are
performed on each patient during the first year in comprehensive
maintenance treatment; and at least quarterly random tests or analyses
are performed on each patient in comprehensive maintenance treatment for
each subsequent year, except that a random test or analysis is performed
monthly on each patient who receives a 6-day supply of take-home
medication. When a sample is collected from each patient for such test
or analysis, it must be done in a manner that minimizes opportunity for
falsification. Each test or analysis must be analyzed for opiates,
methadone, amphetamines, cocaine, and barbiturates. In addition, if any
other drug or drugs have been determined by a program to be abused in
that program's locality, or as otherwise indicated, each test or
analysis must be analyzed for any of those drugs as well. Any laboratory
that performs the testing required under this regulation shall be in
compliance with all applicable Federal proficiency testing and licensing
standards and all applicable State standards. If a program proposes to
change a laboratory used for such testing or analysis, the program shall
have the change approved by the Food and Drug Administration.
(ii) The person responsible for a program shall ensure that test
results are not used as the sole criterion to force a patient out of
treatment but are used as a guide to change treatment approaches. The
person responsible for a program shall also ensure that when test
results are used, presumptive laboratory results are distinguished from
results that are definitive.
(3) Patient evaluation; minimum admission and periodic
requirements--(i) Minimum contents of medical evaluation. Each patient
is required to have a medical evaluation by a program physician or an
authorized health-care professional under the supervision of a program
physician on admission to a program. At a minimum, this evaluation is
required to consist of a medical history which includes the required
history of narcotic dependence, evidence of current physiologic
dependence unless excepted by the regulations, and a physical
examination, and includes the following laboratory examinations:
serological test for syphilis, a tuberculin skin test, and a test or
analysis for drug determination. A pregnancy test is required for any
woman of childbearing potential before she may be administered LAAM as
directed in paragraph (d)(1)(iii)(B)(1) of this section. If in the
reasonable clinical judgment of the program physician, a patient's
subcutaneous veins are severely damaged to the extent that a blood
specimen cannot be obtained, the serological test for syphilis may be
omitted. The physical examination is required to consist of an
investigation of the organ systems for possibilities of infectious
disease, pulmonary, liver, and cardiac abnormalities, and dermatologic
sequelae of addiction. In addition, the physical examination is required
to include a determination of the patient's vital signs (temperature,
pulse, and blood pressure and respiratory rate); an examination of the
patient's general appearance, head, ears, eyes, nose, throat (thyroid),
chest (including heart, lungs, and breasts), abdomen, extremities, skin,
and neurological assessment; and the program physician's overall
impression of the patient.
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(ii) Recordings of findings. The admitting program physician or an
appropriately trained health care professional supervised by the
admitting program physician shall record in the patient's record all
findings from the admission medical evaluation. In each case the
admitting program physician shall date and sign these entries, or date,
review, and countersign these recordings in the patient's record to
signify his or her review of and concurrence with the history and
physical findings.
(iii) Admission evaluation. (A) Each patient seeking admission or
readmission for treatment services is required to be interviewed by a
well-trained program counselor, qualified by virtue of education,
training, or experience to assess the psychological and sociological
background of drug abusers, to determine the appropriate treatment plan
for the patient. To determine the most appropriate treatment plan for a
patient, the interviewer shall obtain and document in the patient's
record the patient's history.
(B) A patient's history includes information relating to his or her
educational and vocational achievements. If a patient has no such
history; i.e., he or she has no formal education or has never had an
occupation, this requirement is met by writing this information in the
patient's history.
(iv) Initial treatment plan. (A)(1) The initial treatment plan is
required to contain a statement that outlines realistic short-term
treatment goals which are mutually acceptable to the patient and the
program. The initial treatment plan is also required to spell out the
behavioral tasks a patient must perform to complete each short-term
goal; the patient's requirements for education, vocational
rehabilitation, and employment; and the medical, psychosocial, economic,
legal, or other supportive services that a patient needs. The plan is
also required to identify the frequency with which these services are
likely to be provided. Prior to developing a treatment plan, the
patient's needs for medical, social, and psychological services;
education; vocational rehabilitation; and employment must be assessed,
and the needs reflected, when clinically appropriate, in the treatment
plan.
(2) A primary counselor is one who is assigned by the program to
develop, implement, and evaluate the patient's initial and periodic
treatment plan and to monitor a patient's progress in treatment. The
primary counselor shall enter in the patient's record the counselor's
name, the contents of a patient's initial assessment, and the initial
treatment plan. The primary counselor shall make these entries
immediately after the patient is stabilized on a dose or within 4 weeks
after admission, whichever is sooner.
(B) It is recognized that patients need varying degrees of treatment
and rehabilitative services which are often dependent on or limited by a
number of variables; e.g., patient resources, available program, and
community services. It is not the intent of this regulation to prescribe
a particular treatment and rehabilitative service or the frequency at
which a service should be offered.
(C) The program supervisory counselor or other appropriate program
personnel so designated by the program physician shall review and
countersign all the information and findings required to be recorded in
each patient's record under paragraph (d)(3)(iv) of this section.
(v) Periodic treatment plan evaluation. (A) The program physician or
the primary counselor shall review, reevaluate, and alter where
necessary each patient's treatment plan at least once each 90 days
during the first year of treatment, and then at least twice a year after
the first year of continuous treatment.
(B) The program physician shall ensure that the periodic treatment
plan becomes part of each patient's record and that it is signed and
dated in the patient's record by the primary counselor and is
countersigned and dated by the supervisory counselor.
(C) At least once a year, the program physician shall date, review,
and countersign the treatment plan recorded in each patient's record and
ensure that each patient's progress or lack of progress in achieving the
treatment goals is entered in the patient's record by the primary
counselor. When appropriate, the treatment plan and progress
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notes should deal with the patient's mental and physical problems, apart
from drug abuse. The treatment plan is required to include the name of
and the reasons for prescribing any medication for emotional or physical
problems.
(D) The requirement for annual physician review and signature by the
program physician in paragraph (d)(3)(v)(C) of this section is
discretionary, however, as it applies to a patient who has
satisfactorily adhered to program rules for at least 3 consecutive years
from his or her entrance into the comprehensive maintenance treatment
program and who has made substantial progress in rehabilitation.
(4) Minimum program services--(i)(A) Access to a range of services.
A treatment program shall provide a comprehensive range of medical and
rehabilitative services to its patients especially during the first 3
years of treatment.
(B) Pregnant patients. (1) For pregnant patients in a treatment
program who were not admitted under paragraph (d)(1)(iii)(B) of this
section, a treatment program shall give them the opportunity for
prenatal care either by the narcotic treatment program or by referral to
appropriate health care providers. If a program cannot provide direct
prenatal care for pregnant patients in treatment, it shall establish a
system of referring them for prenatal care which may be either publicly
or privately funded. If there is no publicly funded prenatal care
available to which a patient may be referred, and the program cannot
provide such services, or the patient cannot afford or refuses prenatal
care services, then the treatment program shall, at a minimum, offer her
basic prenatal instruction on maternal, physical, and dietary care as a
part of its counseling service.
(2) Counseling records and other appropriate patient records are
required to reflect the nature of prenatal support provided by the
program. If the program refers a patient for prenatal services, it shall
inform the physician to whom she is referred that the patient is in
comprehensive maintenance treatment, provided such notification is in
accordance with the Department of Health and Human Services'
confidentiality regulations (42 CFR part 2). If a pregnant patient
refuses direct prenatal services or appropriate referral for prenatal
services, the treating program physician should consider using informed
consent procedures; i.e., to have the patient acknowledge in writing
that she has the opportunity for this treatment but refuses it. The
program physician shall request the physician or the hospital to which a
patient is referred to provide, following birth, a summary of the
delivery and treatment outcome for the patient and offspring. The
information should be obtained in accordance with the Department of
Health and Human Services' confidentiality regulations (42 CFR part 2).
If no response is received, the program physician shall document in the
record that such a request was made and no response was received.
(3) Caution should be taken in the maintenance treatment of pregnant
patients. Dosage levels should be maintained at the lowest effective
dose if continued treatment is deemed necessary. It is the
responsibility of the program sponsor to ensure that each female patient
is fully informed of the possible risks to a pregnant woman and her
unborn child from continued use of illicit drugs and from the use of, or
withdrawal from, a narcotic drug administered or dispensed by the
program in maintenance or detoxification treatment.
(C) Counseling on HIV disease. A narcotic treatment program shall
provide counseling on preventing exposure to, and the transmission of,
HIV disease for each patient admitted or readmitted to maintenance or
detoxification treatment. Although HIV testing is not required, an
interim program shall inform patients of the availability of HIV
testing. The program sponsor shall also ensure that HIV testing is
accessible to patients who request such testing either on site or by the
programs entering into agreements with HIV testing facilities to make
HIV testing accessible to those patients who request it.
(D) Off-site services. Any service not furnished at the primary
facility is required to be listed in any application for approval
submitted to the Food and Drug Administration or to the State authority.
The addition, modification, or deletion of any program service is
[[Page 136]]
required to be reported immediately to the Food and Drug Administration.
(ii) Minimum medical services; designation of medical director and
responsibilities. Each program shall have a designated medical director
who assumes responsibility for administering all medical services
performed by the program. The medical director and other authorized
program physicians are required to be licensed to practice medicine in
the jurisdiction in which the program is located. The medical director
is responsible for ensuring that the program is in compliance with all
Federal, State, and local laws and regulations regarding medical
treatment of narcotic addiction. In addition, the medical director or
other authorized physicians shall:
(A) Ensure that evidence of current physiologic dependence, length
of history of addiction, or exceptions to criteria for admission are
documented in the patient's record before the patient receives the
initial dose.
(B) Ensure that a medical evaluation including a medical history has
been taken, and physical examination has been done before the patient
receives the initial dose (except that in an emergency situation, the
initial dose may be given before the physical examination).
(C) Ensure that appropriate laboratory studies have been performed
and reviewed.
(D) Sign or countersign all medical orders as required by Federal or
State law. (Such medical orders include but are not limited to the
initial medication orders and all subsequent medication order changes,
all changes in the frequency of take-home medication, and prescribing
additional take-home medication for an emergency situation.)
(E) Review and countersign treatment plans at least annually as
qualified by paragraph (d)(3)(v)(D) of this section.
(F) Ensure that justification is recorded in the patient's record
for reducing the frequency of clinic visits for observed drug ingesting,
providing additional take-home medication under exceptional
circumstances or when there is physicial disability, or prescribing any
medication for physical or emotional problems.
(iii) Use of health-care professionals. Although the final decision
to accept a patient for treatment may be made only by the medical
director or other designated program physician, it is recognized that
physicians can train program personnel to detect and document narcotic
abstinence symptons and that some jurisdictions allow State-licensed or
certified health-care professionals; e.g., physician's assistants, nurse
practitioners, to perform certain functions--record medical histories,
perform physicial examinations, and prescribe, administer, or dispense
certain medications--that are ordinarily performed by a licensed
physician. These regulations do not prohibit licensed or certified
health-care professionals from performing those functions in narcotic
treatment programs if it is authorized by Federal, State, and local laws
and regulations, and if those functions are delegated to them by the
medical director, and records are properly countersigned by the medical
director or a licensed physician.
(iv) Vocational rehabilitation, education, and employment. Each
program shall provide opportunities directly, or through referral to
community resources, for patients who either desire or have been deemed
by the program staff to be ready to participate in educational job
training programs or to obtain gainful employment as soon as possible.
(v) Authorized dispensers of narcotic drugs; responsibility. A
narcotic drug may be administered or dispensed only by a practitioner
licensed under the appropriate State law and registered under the
appropriate State and Federal laws to order narcotic drugs for patients,
or by an agent of such a practitioner, supervised by and under the order
of the practitioner. This agent is required to be a pharmacist,
registered nurse, or licensed practical nurse, or any other health care
professional authorized by Federal and State law to administer or
dispense narcotic drugs. The licensed practitioner assumes
responsibility for the amounts of narcotic drugs administered or
dispensed and shall record and countersign all changes in dosage
schedule.
[[Page 137]]
(5) Staffing patterns--(i) Program personnel. The person(s)
responsible for a program shall determine program personnel requirements
after considering the number of patients who are vocationally and
educationally impaired; the number of patients with significant
psychopathology; the number of patients who are also nonnarcotic drug or
alcohol abusers; the number of patients with behavioral problems in the
program; and the number of patients with serious medical problems.
(ii) Supportive services. The person(s) responsible for the program
shall take notice, when considering the staffing pattern, that
comprehensive maintenance treatment programs need to establish
supportive services in accordance with the varying characteristics and
needs of their patient populations. The person(s) responsible for a
program shall also take notice of the availability of existing community
resources which may complement or enhance the program's delivery of
supportive services and then establish a staffing pattern based on a
combination of patient needs and available, accessible community
resources.
(6) Use of methadone in a treatment program; frequency of
attendance; quantity of take-home medication; dosage of methadone;
initial and stabilization--(i) Dosage and responsibility. (A) The
person(s) responsible for the program shall ensure that the initial dose
of methadone does not exceed 30 milligrams and that the total dose for
the first day does not exceed 40 milligrams, unless the program medical
director documents in the patient's record that 40 milligrams did not
suppress opiate abstinence symptoms.
(B) A licensed physician shall assume responsibility for the amount
of the narcotic drug administered or dispensed and shall record, date,
and sign in each patient's record each change in the dosage schedule.
(C) The administering licensed physician shall ensure that a daily
dose greater than 100 milligrams is justified in the patient's record.
(ii) [Reserved]
(iii) Form. Methadone may be administered or dispensed in oral form
only when used in a treatment program. Hospitalized patients under care
for a medical or surgical condition are permitted to receive methadone
in parenteral form when the attending physician judges it advisable.
Although tablet, syrup concentrate, or other formulations may be
distributed to the program, all oral medication is required to be
administered or dispensed in a liquid formulation. The oral dosage form
is required to be formulated in such a way as to reduce its potential
for parenteral abuse. Take-home medication is required to be labeled
with the treatment center's name, address, and telephone number and must
be packaged in special packaging as required by 16 CFR 1700.14 in
accordance with the Poison Prevention Packaging Act (Pub. L. 91-601, 15
U.S.C. 1471 et seq.) to reduce the chances of accidental ingestion.
Exceptions may be granted when these provisions conflict with State law
with regard to the administering or dispensing of drugs.
(iv) Take-home medication. (A) Take-home medication may be given
only to a patient who, in the reasonable clinical judgment of the
program physician, is responsible in handling narcotic drugs. Before the
program physician reduces the frequency of a patient's clinical visits,
she or he or a designated staff member shall record the rationale for
the decision in the patient's clinical record. If this is done by a
designated staff member, a program physician shall review, countersign,
and date the patient's record where this information is recorded.
(B) The program physician shall consider the following in
determining whether, in his or her reasonable clinical judgment, a
patient is responsible in handling narcotic drugs:
(1) Absence of recent abuse of drugs (narcotic or nonnarcotic),
including alcohol;
(2) Regularity of clinic attendance;
(3) Absence of serious behavioral problems at the clinic;
(4) Absence of known recent criminal activity, e.g., drug dealing;
(5) Stability of the patient's home environment and social
relationships;
(6) Length of time in comprehensive maintenance treatment;
(7) Assurance that take-home medication can be safely stored within
the patient's home; and
[[Page 138]]
(8) Whether the rehabilitative benefit to the patient derived from
decreasing the frequency of clinic attendance outweighs the potential
risks of diversion.
(v) Take-home requirements. The requirement of time in treatment is
a minimum reference point after which a patient may be eligible for
take-home privileges. The time reference is not intended to mean that a
patient in treatment for a particular time has a specific right to take-
home medication. Thus, regardless of time in treatment, a program
physician may, in his or her reasonable judgment, deny or rescind the
take-home medication privileges of a patient.
(A)(1) In comprehensive maintenance treatment it is required that a
patient come to the clinic for observation daily or at least 6 days a
week. If, in the reasonable clinical judgment of the program physician,
a patient demonstrates that he or she has satisfactorily adhered to
program rules for at least 3 months, has made substantial progress in
rehabilitation and responsibility in handling narcotic drugs (see
paragraphs (d)(6)(iv)(B) (1) through (8) of this section, and would
improve his or her rehabilitative progress by decreasing the frequency
of attendance at the clinic for observation, the patient may be
permitted to reduce his or her attendance at the clinic for observation
to three times weekly. The patient may receive no more than a 2-day
take-home supply of medication.
(2) If, in the reasonable clinical judgment of the program
physician, a patient demonstrates that he or she has satisfactorily
ahered to program rules for at least 2 years from his or her entrance
into the program, has made substantial progress in rehabilitation and
responsibility in handling narcotic drugs (see paragraphs (d)(6)(iv)(B)
(1) through (8) of this section), and would improve his or her
rehabilitative progress by decreasing the frequency of attendance at the
clinic for observation, the patient may be permitted to reduce his or
her clinic attendance at the clinic for observation to twice weekly.
Such a patient may receive no more than a 3-day take-home supply of
medication.
(3) If, in the reasonable clinical judgment of the program
physician, a patient demonstrates that he or she has satisfactorily
adhered to program rules for at least 3 consecutive years from his or
her entrance into the comprehensive maintenance treatment program, has
made substantial progress in rehabilitation, has no major behavioral
problems, is responsible in handling narcotic drugs (see paragraphs
(d)(6)(iv)(B) (1) through (8) of this section), and would improve his or
her rehabilitative progress by decreasing the frequency of his or her
clinic attendance for observation, the patient may be permitted to
reduce clinic attendance for observation to once weekly, provided that
the following additional criteria are met: The program physician has
written into the patient's record an evaluation that the patient is
responsible in handling narcotic drugs (paragraphs (d)(6)(iv)(B) (1)
through (8) of this section); the patient is employed (or actively
seeking employment), attends school, is a homemaker, or is considered
unemployable for mental or physical reasons by a program physician; the
patient is not known to have abused drugs including alcohol in the last
year; and the patient is not known to have engaged in criminal activity;
e.g., drug dealing, in the last year. A patient permitted to reduce
clinic attendance for observation to once weekly may receive no more
than a 6-day take-home supply of medication.
(B)(1) If a patient, after receiving a supply of take-home
medication, is inexcusably absent from or misses a scheduled appointment
with a treatment program without authorization from the program staff,
the program physician shall increase the frequency of the patient's
clinic attendance for drug ingestion under observation. For such a
patient, the program physician shall not reduce the frequency of the
patient's clinic attendance for drug ingestion under observation until
she or he has had at least three consecutive monthly tests or analyses
that are neither positive for morphine-like drugs (except from the
narcotic drug administered or dispensed by the program) or other drugs
of abuse, nor negative for the narcotic drug administered or dispensed
by the program, and until she or he is again determined by a program
[[Page 139]]
physician to be responsible in handling narcotic drugs (see paragraphs
(d)(6)(iv)(B) (1) through (8) of this section) and to meet criteria in
paragraph (d)(6)(v)(A) of this section.
(2) If a patient, after receiving a 6-day supply of take-home
medication, has a test or analysis which is confirmed to be positive for
morphine-like drugs (except for the narcotic drug administered or
dispensed by the program) or other drugs of abuse, or negative for the
narcotic drug administered or dispensed by the program, the program
physician shall place the patient on probation for 3 months. If, during
this probation, the patient has a test or analysis either positive for
morphine-like drugs (except for the narcotic drug administered or
dispensed by the program) or other drugs of abuse, or negative for the
narcotic drug administered or dispensed by the program, the program
physician shall increase the frequency of the patient's clinic
attendance for observation to at least twice weekly. Such a patient may
receive no more than a 3-day take-home supply of medication until she or
he has had at least three consecutive monthly tests or analyses which
are neither positive for morphine-like drugs (except for the narcotic
drug administered or dispensed by the program) or other drugs of abuse,
nor negative for the narcotic drug administered or dispensed by the
program, and the program physician again determines that the patient is
responsible in handling narcotic drugs (see paragraphs (d)(6)(iv)(B) (1)
through (8) of this section) and meets the criteria contained in
paragraph (d)(6)(v)(A) of this section.
(C) In calculating the number of years of comprehensive maintenance
treatment, the period is considered to begin on the first day the
medication is administered, or on readmission if a patient has had a
continuous absence of 90 days or more. Cumulative time spent by the
patient in more than one program is counted toward the number of years
of treatment, provided there has not been a continuous absence of 90
days or more.
(D) Each patient whose daily dose is above 100 milligrams is
required to be under observation while ingesting the drug at least 6
days per week irrespective of the length of time in treatment, unless
the program has received prior approval from the Food and Drug
Administration with the concurrence of the State authority.
(vi) Exceptions to take-home requirements. If, in the reasonable
clinical judgment of the program physician:
(A) A patient is found to have a physical disability which
interferes with his or her ability to conform to the applicable
mandatory schedule, she or he may be permitted a temporarily or
permanently reduced schedule, provided she or he is also found to be
responsible in handling narcotic drugs.
(B) A patient, because of exceptional circumstances such as illness,
personal or family crises, travel, or other hardship, is unable to
conform to the applicable mandatory schedule, she or he may be permitted
a temporarily reduced schedule, provided she or he is also found to be
responsible in handling narcotic drugs. The rationale for an exception
to a mandatory schedule is to be based on the reasonable clinical
judgment of the program physician and shall be recorded in the patient's
record by the program physician or by program personnel supervised by
the program physician. In the latter situation, the physician shall
review, countersign, and date the patient's record where this rationale
is recorded. In any event, a patient may not be given more than a 2-week
supply of narcotic drugs at one time.
(vii) Official State holidays. If a treatment center program is not
in operation due to the observance of an official State holiday,
patients may be permitted one extra take-home dose per visit and one
fewer clinic visit per week to allow patients not to have to attend the
clinic on an official State holiday. An official State holiday is a
holiday on which most State offices are usually closed and routine State
government business is not conducted.
(7) Minimum standards for interim maintenance treatment. The
person(s) responsible for a program may place an individual, who is
eligible for admission to comprehensive maintenance treatment, in
interim maintenance treatment if the individual cannot be placed in a
public or nonprofit private
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comprehensive program within a reasonable geographic area and within 14
days of the individual's application for admission. An initial and at
least two other urine screens shall be taken from interim patients
during the maximum of 120 days permitted for such treatment. A program
shall establish and follow reasonable criteria for establishing
priorities for transferring patients from interim maintenance to
comprehensive maintenance treatment. These transfer criteria shall be in
writing and available for inspection and shall include, at a minimum, a
preference for pregnant women in admitting patients to interim
maintenance and in transferring patients from interim maintenance to
comprehensive maintenance treatment. Interim maintenance shall be
provided in a manner consistent with all applicable Federal and State
laws including sections 1923 (mandatory transfer) and 1927(a) (pregnant
patients) of the PHS Act. The program shall notify the State health
officer when a patient begins interim treatment, when a patient leaves
interim treatment, and before the date of mandatory transfer to a
comprehensive program, and shall document such notifications. Programs
in States not in compliance with provisions of this regulation risk loss
of authorization for interim maintenance. All requirements for
comprehensive maintenance treatment apply to interim maintenance
treatment with the following exceptions:
(i) The narcotic drug is required to be administered daily under
observation;
(ii) Take-home medication is not allowed;
(iii) The initial treatment plan and periodic treatment plan
evaluation are not required;
(iv) A primary counselor is not required to be assigned to a
patient;
(v) Interim maintenance cannot be provided for longer than 120 days
in any 12 month-period; and
(vi) The requirements and exceptions in paragraphs (b)(2)(iii) (as
apply to rehabilitative services), in paragraphs (b)(3)(iv)(B) and
(d)(4)(i)(A) (as apply to rehabilitative services), and in paragraphs
(d)(4)(ii)(E), (d)(4)(ii)(F), (d)(4)(iv), (d)(6)(iv), (d)(6)(v),
(d)(6)(vi), and (d)(6)(vii) of this section do not apply.
(8) Minimum standards for short-term detoxification treatment. (i)
For short-term detoxification from narcotic drugs, the narcotic drug is
required to be administered by the program physician or by an authorized
agent of the physician, supervised by and under the order of the
physician. The narcotic drug is required to be administered daily, under
close observation, in reducing dosages over a period not to exceed 30
days. All requirements for comprehensive maintenance treatment apply to
short-term detoxification treatment with the following exceptions:
(A) Take-home medication is not allowed during short-term
detoxification.
(B) A history of 1 year physiologic dependence is not required for
admission to short-term detoxification.
(C) Patients who have been determined by the program physician to be
currently physiologically narcotic dependent may be placed in short-term
detoxification treatment, regardless of age.
(D) No test or analysis is required except for the initial drug
screening test or analysis.
(E) The initial treatment plan and periodic treatment plan
evaluation required for comprehensive maintenance patients are not
necessary for short-term detoxification patients. However, a primary
counselor must be assigned by the program to monitor a patient's
progress toward the goal of short-term detoxification and possible drug-
free treatment referral.
(F) The requirements of paragraph (d)(4) of this section, except
paragraphs (d)(4)(i)(C), (d)(4)(ii)(A) through (d)(4)(ii)(D), and
(d)(4)(iii) of this section, do not apply to short-term detoxification
treatment.
(ii) A patient is required to wait at least 7 days between
concluding a short-term detoxification treatment episode and beginning
another. Before a short-term detoxification attempt is repeated, the
program physician shall document in the patient's record that the
patient continues to be, or is again, physiologically dependent on
narcotic
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drugs. The provisions of these requirements, except as noted in
paragraph (d)(8)(i) of this section, apply to both inpatient and
ambulatory short-term detoxification treatment.
(iii) Short-term detoxification treatment is not recommended for a
pregnant patient.
(9) Minimum standards for long-term detoxification treatment. (i)
For long-term detoxification from narcotic drugs, the narcotic drug is
required to be administered by the program physician or by an authorized
agent of the physician, supervised by and under the order of the
physician. The narcotic drug is required to be administered on a regimen
designed to reach a drug-free state and to make progress in
rehabilitation in 180 days or less. All requirements for comprehensive
maintenance treatment apply to long-term detoxification treatment with
the following exceptions.
(A) In long-term detoxification treatment it is required that the
patient be under observation while ingesting the drug daily or at least
6 days a week, for the duration of the long-term detoxification
treatment.
(B) A history of 1 year physiologic dependence is not required for
admission to long-term detoxification.
(C) The program physician shall document in the patient's record
that short-term detoxification is not a sufficiently long enough
treatment course to provide the patient with the additional program
services he or she deems necessary for the patient's rehabilitation. The
program physician shall document this information in the patient's
record before long-term detoxification may begin.
(D) Patients who have been determined by the program physician to be
currently physiologically dependent on narcotics may be placed in long-
term detoxification treatment, regardless of age.
(E) An initial drug screening test or analysis is required for each
patient. And at least one additional random test or analysis must be
performed monthly on each patient during long-term detoxification.
(F) The initial treatment plan and periodic treatment plan
evaluation required for comprehensive maintenance patients are also
required for long-term detoxification patients, except that the required
periodic treatment plan evaluation is required to occur monthly.
(ii) A patient is required to wait at least 7 days between
concluding a long-term treatment episode and beginning another. Before a
long-term detoxification attempt is repeated, the program physician
shall document in the patient's record that the patient continues to be
or is again physicologically dependent on narcotic drugs. The provisions
of these requirements apply to both inpatient and ambulatory long-term
detoxification treatment.
(iii) Long-term detoxification is not recommended for a pregnant
patient.
(10) Inspections of programs; patient confidentiality. A program
shall allow inspections by duly authorized employees of the State
authority, and in accordance with Federal controlled substances laws and
Federal confidentiality laws, by duly authorized employees of the Food
and Drug Administration, the Drug Enforcement Administration of the
Department of Justice, and the National Institute on Drug Abuse.
(11) Exemptions from specific program standards. (i) A program is
permitted, at the time of application or any time thereafter, to request
exemption from specific program standards. The rationale for an
exemption shall be thoroughly documented in an appendix to be submitted
with the application or at some later time. The Food and Drug
Administration will approve such exemptions of program standards at the
time of application, or any time thereafter, with the concurrence of the
State authority. An example of a case in which an exemption might be
granted would be for a private practitioner who wishes to treat a
limited number of patients in a nonmetropolitan area with few physicians
and no rehabilitative services geographically accessible and requests
exemption from some of the staffing and service standards.
(ii) The Food and Drug Administration has the right to withhold the
granting of an exemption requested at the time of application until a
program is in actual operation in order to assess if the exemption is
necessary. If periodic inspections of the progam reveal
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that discrepancies or adverse conditions exist, the Food and Drug
Administration shall reserve the right to revoke any or all exemptions
previously granted.
(12) Research. When a program conducts research on human subjects or
provides subjects for research, there must be written policies and
written review to assure the rights of the patients involved.
Appropriate informed consent forms are required to be signed by the
patient and to be retained in his or her patient record at the program.
All research, development, and related activities which involve human
subjects and which are funded by grants from or contracts with the
Department of Health and Human Services are required to comply with the
Department of Health and Human Services' regulations on the protection
of human subjects, 45 CFR part 46, and confidentiality of information,
42 CFR part 2. All investigational research involving human subjects
conducted for submission to the Food and Drug Administration must be
conducted in compliance with part 312 of this chapter.
(13) Patient record system--(i) Patient care. The person(s)
responsible for a program shall establish a record system to document
and monitor patient care. This system is required to comply with all
Federal and State reporting requirements relevant to narcotic drugs
approved for use in treatment of narcotic addiction. All records are
required to be kept confidential and in accordance with all applicable
Federal and State regulations regarding confidentiality.
(ii) Drug dispensing. The person(s) responsible for a program shall
ensure that accurate records traceable to specific patients are
maintained showing dates, quantity, and batch or code marks of the drug
dispensed. These records must be retained for a period of 3 years from
the date of dispensing.
(iii) Patient's record. An adequate record must be maintained for
each patient. The record is required to contain a copy of the signed
consent form(s), the date of each visit, the amount of drug administered
or dispensed, the results of each test or analysis for drugs, any
significant physical or psychological disability, the type of
rehabilitative and counseling efforts employed, an account of the
patient's progress, and other relevant aspects of the treatment program.
For recordkeeping purposes, if a patient misses appointments for 2 weeks
or more without notifying the program, the episode of care is considered
terminated and is to be so noted in the patient's record. This does not
mean that the patient cannot return for care. If the patient does return
for care and is accepted into the program, this is considered a
readmission and is to be so noted in the patient's record. This method
of recordkeeping helps assure the easy detection of sporadic attendance
and decreases the possibility of administering inappropriate doses of
narcotic drugs (e.g., the patient who has received no medication for
several days or more and upon return receives the usual stabilization
dose). An annual evaluation of the patient's progress must be entered in
the patient's record.
(14) Security of drug stocks. adequate security is required to be
maintained over drug stocks, over the manner in which it is administered
or dispensed, over the manner in which it is distributed to medication
units, and over the manner in which it is stored to guard against theft
and diversion of the drug. The program is required to meet the security
standards for the distribution and storage of controlled substances as
required by the Drug Enforcement Administration, Department of Justice
(21 CFR 1301.72-1301.76).
(e) Multiple enrollments--(1) Administering or dispensing to
patients enrolled in other programs. There is a danger of drug dependent
persons attempting to enroll in more than one narcotic treatment program
to obtain quantities of drugs for the purpose of self-administration or
illicit marketing. Therefore, except in an emergency situation, drugs
shall not be provided to a patient who is known to be currently
receiving drugs from another treatment program
(2) Patient attendance requirements. The patient shall always report
to the same treatment facility unless prior approval is obtained from
the program
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sponsor for treatment at another program. Permission to report for
treatment at the facility of another program shall be granted only in
exceptional circumstances and shall be noted on the patient's clinical
record.
(f) Conditions for use of narcotic drugs in hospitals for
detoxification treatment--(1) Form. The drug may be administered or
dispensed in either oral or parenteral form. (See paragraph (d)(6)(iii)
of this section.)
(2) Use of narcotic drugs in hospitals--(i) Approved uses. For
hospitalized patients, the use of a narcotic drug for narcotic addict
treatment may be administered or dispensed only for detoxification
treatment. If a narcotic drug is administered for treatment of narcotic
dependence for more than 180 days, the procedure is no longer considered
detoxification but is, rather, considered maintenance treatment. Only
approved narcotic treatment programs may undertake maintenance
treatment. This does not preclude the maintenance treatment of a patient
who is hospitalized for treatment of medical conditions other than
addiction and who requires temporary maintenance treatment during the
critical period of his or her stay or whose enrollment in a program
which has approval for maintenance treatment using narcotic drugs has
been verified. (See 21 CFR 1306.07(c).) Any hospital which already has
received approval under this paragraph (f) may serve as a temporary
narcotic treatment program when an approved treatment program has been
terminated and there is no other facility immediately available in the
area to provide narcotic drug treatment for the patients. The Food and
Drug Administration may give this approval upon the request of the State
authority or the hospital, When no State authority has been established.
(ii) Individuals responsible for supplies. Hospitals shall submit to
the Food and Drug Administration and the State authority the name of the
individual (e.g., pharmacist) responsible for receiving and securing
supplies of narcotic drugs for the treatment of narcotic addicts. The
individual responsible for supplies shall ensure that the only persons
who receive supplies of narcotic drugs are those who are authorized to
do so by Federal or State law.
(iii) General description. The hospital shall submit to the Food and
Drug Administration and the State authority a general description of the
hospital including the number of beds, specialized treatment facilities
for drug dependence, and nature of patient care undertaken.
(iv) Anticipated quantity of drug needed. The hospital shall submit
to the Food and Drug Administration and the State authority the
anticipated quantity of narcotic drugs for narcotic addict treatment
needed per year.
(v) Records. The hospital shall maintain accurate records showing
dates, quantity, and batch or code marks of the drug used for inpatient
treatment. The hospital shall retain the records for at least a period
of 3 years.
(vi) Inspection. The hospital shall permit the Food and Drug
Administration and the State authority to inspect supplies of the drug
at the hospital and evaluate the uses to which the drug is being put.
The Food and Drug Administration and the State authority will keep the
identity of the patients confidential in accordance with confidentiality
requirements of 42 CFR part 2. Records on the receipt, storage, and
distribution of narcotic medication are subject to inspection under
Federal controlled substances laws; but use or disclosure of records
identifying patients will, in any case, be limited to actions involving
the program or its personnel.
(vii) Approval of hospital pharmacy. Application for a hospital
pharmacy to provide narcotic drugs for detoxification treatment must be
submitted to the Food and Drug Administration and the State authority
and approval from both is required, except as provided for in paragraph
(h)(5) of this section. Within 60 days after the Food and Drug
Administration receives the application, it will notify the applicant of
approval or denial or will request additional information, when
necessary.
(viii) Approval of shipments to hospital pharmacies. Before a
hospital pharmacy may lawfully receive shipments of narcotic drugs for
detoxification treatment, a responsible official shall complete, sign,
and file in duplicate with
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the Food and Drug Administration and the State authority Form FDA-2636
``Hospital Request for Methadone Detoxification Treatment'' (see
paragraph (l) of this section) and must have received from the Food and
Drug Administration a notice that the request has been approved.
(ix) Sanctions. Failure to abide by the requirements described in
this section may result in revocation of approval to receive shipments
of narcotic drugs for narcotic addict treatment, seizure of the drug
supply on hand, injunction, and criminal prosecution.
(g) Confidentiality of patient records. (1) Except as provided in
paragraph (g)(2) of this section, disclosure of patient records
maintained by any program is governed by the provisions of 42 CFR part
2, and every program must comply with that part. Records on the receipt,
storage, and distribution of narcotic medication are also subject to
inspection under Federal controlled substances laws: But use or
disclosure of records identifying patients will, in any case, be limited
to actions involving the program or its personnel.
(2) A treatment program or medication unit or any part thereof,
including any facility or any individual, shall permit a duly authorized
employee of the Food and Drug Administration to have access to and to
copy all records on the use of narcotic drugs in accordance with the
provisions of 42 CFR part 2. A treatment program may reveal such records
only when necessary in a related administrative or court proceeding.
(h) Denial or revocation of approval. (1) Complete or partial denial
or revocation of approval of an application to receive shipments of
narcotic drugs (Forms FDA-2632 ``Application for Approval of Use of
Narcotic Drugs in a Treatment Program'' and FDA-2636 ``Hospital Request
for Methadone Detoxification Treatment'') may be proposed to the
Commissioner of Food and Drugs by the Director of the Food and Drug
Administration's Center for Drug Evaluation and Research, on his or her
own initiative or at the request of representatives of the Drug
Enforcement Administration, Department of Justice, National Institute of
Drug Abuse, the State authority, or any other interested person.
(2) Before presenting such a proposal to the Commissioner, the
Director of the Center for Drug Evaluation and Research, or his or her
representative, will notify the applicant in writing of the proposed
action and the reasons therefor and will offer the applicant an
opportunity to explain the matters in question in an informal conference
and/or in writing within 10 days after receipt of such notification. The
applicant shall have the right to hear and to question the information
on which the proposal to deny or revoke approval is based, and may
present any oral or written information and views.
(3) If the explanation offered by the applicant is not accepted by
the Center for Drug Evaluation and Research as sufficient to justify
approval of the application, and denial or revocation of approval is
therefore proposed, the Commissioner will evaluate information obtained
in the informal conference and/or in writing before the Director of the
Center for Drug Evaluation and Research. If the Commissioner finds that
the applicant has failed to submit adequate assurance justifying
approval of the application, the Commissioner shall issue a notice of
opportunity for hearing with respect to the matter pursuant to
Sec. 314.200 of this chapter and the matter shall thereafter be handled
in accordance with established procedures for denial or revocation of
approval of a new drug application. If the Secretary determines that
there is an imminent hazard to health, revocation of approval will
become effective immediately and any administrative procedure will be
expedited. Upon revocation of approval of an application, the
Commissioner will notify the applicant, the State authority, the Drug
Enforcement Administration, Department of Justice, and all other
appropriate persons that the applicant may no longer receive shipments
of narcotic drugs, and will require the recall of all of the drugs from
the applicant. Revocation of approval may also result in criminal
prosecution.
(4) Denial or revocation of approval may be reversed when the
Commissioner determines that the applicant
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has justified approval of the application.
(5) A treatment program or medication unit or any part thereof,
including any facility or any individual, may appeal to the Food and
Drug Administration a complete or partial denial or revocation of
approval by the State authority unless the denial or revocation is based
upon a State law or regulation. The appeal shall first be made to the
Director of the Center for Drug Evaluation and Research, who shall hold
an informal conference on the matter in accordance with paragraph (h)(2)
of this section. The State authority may participate in the conference.
The appellant or the State authority may appeal the Director's decision
to the Commissioner, who shall decide the matter in accordance with
paragraph (h)(3) of this section. If the Commissioner denies or revokes
approval, such action shall be handled in accordance with paragraph
(h)(3) of this section. The Commissioner may not grant or retain Food
and Drug Administration approval if the Commissioner finds that the
appellant is not in compliance with all applicable State laws and
regulations and with this section.
(i) Sanctions--(1) Program sponsor or individual responsible for a
particular program. If the program sponsor or the person responsible for
a particular program fails to abide by all the requirements set forth in
this regulation, or fails to adequately monitor the activities of those
employed in the program, he or she may have the approval of his or her
application revoked, his or her narcotic drug supply seized, an
injunction granted precluding operation of his or her program, and
criminal prosecution instituted against him or her.
(2) Persons responsible for administering or dispensing narcotic
drugs. If a person responsible for administering or dispensing narcotic
drugs for narcotic addict treatment fails to abide by all the
requirements set forth in this regulation, criminal prosecution may be
instituted against him or her, his or her drug supply may be seized, the
approval of the program may be revoked, and an injunction may be granted
precluding operation of the program.
(j) Requirements for distribution by manufacturers of narcotic drugs
for narcotic addict treatment--(1) Distribution requirements. Shipments
of narcotic drugs for narcotic addict treatment are restricted to direct
shipments by manufacturers of the drugs to approved treatment programs
using the narcotic drugs and to approved hospital pharmacies. If
requested by a manufacturer or State authority, wholesale pharmacy
outlets in some regions or States may be authorized to stock narcotic
drugs for narcotic addict treatment for that area and then transship the
drug to approved narcotic treatment programs and approved hospital
pharmacies. Alternative methods of distribution will be permitted if
they are approved by the Food and Drug Administration and the State
authority. Prior to any approval of an alternative method of
distribution there will be consultation with the Drug Enforcement
Administration, Department of Justice, to assure compliance with its
regulations regarding controlled substance distribution.
(2) Information regarding approved programs and hospitals. The Food
and Drug Administration will provide manufacturers and the public with
names and locations of programs and hospitals that have been approved to
receive shipments of narcotic drugs for narcotic addiction treatment.
All information contained in the forms required by paragraph (k) of this
section is available for public disclosure, except the names or other
identifying information with respect to patients.
(3) Acceptance of delivery. Delivery shall only be made to a
licensed practitioner or a licensed pharmacist employed at the facility.
At the time of delivery the licensed practitioner or licensed pharmacist
shall sign for the drugs and place his or her specific title and
identification number on any invoice. Copies of these signed invoices
shall be kept by the manufacturer.
(k) Use of narcotics other than methadone in a treatment program.
Narcotic drug products other than methadone that have been approved for
treatment of narcotic addiction are listed in paragraph (b)(2)(v) of
this section. Detailed information on the conditions for use of narcotic
drug products other than methadone, with the exception of take-home and
dosage form requirements,
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can be found in the respective approved product labeling. Treatment
programs shall review the most recent approved product labeling for up-
to-date information on important treatment parameters for each drug.
Deviation from doses, frequencies, and conditions of usage described in
the approved labeling shall be justified in the patient's record.
Treatment programs that dispense narcotics other than methadone shall
conform with the requirements set forth under paragraphs (a), (b), (c),
(d)(1) through (d)(5), (d)(8) through (d)(14), and (e) through (l) of
this section. Specifics regarding take-home and dosage form requirements
along with any additional requirements are set forth in this paragraph.
(1) LAAM--(i) Dosage and responsibility for administration. After a
patient's tolerance to LAAM is established, LAAM shall be administered
no more frequently than every other day. Dosage of LAAM shall be
individualized at doses, frequencies, and under conditions of usage
described in approved labeling and as follows:
(A) New patients. The persons responsible for the program shall
ensure that the initial dose of LAAM to a patient whose tolerance for
the drug is unknown does not exceed 40 milligrams.
(B) Stabilized methadone maintenance patient. The persons
responsible for the program shall ensure that the initial dose of LAAM
for a previously stabilized methadone maintenance patient is less than
or equal to 1.3 times the patient's daily methadone dose, not to exceed
120 milligrams.
(C) A licensed physician shall assume responsibility for the amount
of the narcotic drug administered or dispensed and shall record, date,
and sign or countersign in each patient's record each change in dosage
schedule.
(D) The administering licensed physician shall ensure that a single
dose of LAAM greater than 140 milligrams is justified in the patient's
record.
(ii) Dosage form. LAAM may be administered in oral form when used in
a maintenance treatment program. Hospitalized patients under care for a
medical or surgical condition are permitted to receive LAAM in oral form
when the attending physician judges it advisable. Although syrup
concentrate or other formulations may be distributed to the program, all
oral medication is required to be administered in a liquid formulation.
Clinics that administer both LAAM and methadone shall take appropriate
measures, including contrasting color and taste, to ensure that dosage
forms of LAAM and methadone are easily distinguished.
(iii) Take-home medication. Take-home doses of LAAM are not
permitted. A patient who is eligible for one or more take-home doses of
methadone under paragraph (d)(6) of this section and who is unable to
conform to the applicable mandatory LAAM dosing schedule because of
exceptional circumstances such as illness, personal or family crises,
travel, or other hardship, or official State holidays, may be
temporarily transferred to methadone. Take-home doses of methadone for a
patient eligible for a planned temporary discontinuation of treatment
with LAAM shall be individualized at doses, frequencies, and under
conditions of usage described in the approved labeling and the
applicable provisions for take-home methadone medication under paragraph
(d)(6) of this section. The maximum number of take-home doses of
methadone shall be determined in accordance with the provisions of 21
CFR 291.505 (d)(6)(v) and (d)(6)(vi).
(2) [Reserved]
(l) Program forms. The program sponsor must ensure that the
following forms are completed by the proper program staff and submitted
to the appropriate State authority and the Division of Scientific
Investigations, Regulatory Management Branch (HFD-342), Food and Drug
Administration, 7520 Standish Pl., Rockville, MD 20855. The sponsor will
indicate on the appropriate form which treatment drug is being utilized.
Forms are available upon request from the Regulatory Management Branch
(HFD-342) at the same address.
Forms
FDA-2632 Application for Approval of Use of Narcotic Drugs in a
Treatment Program.
FDA-2633 Medical Responsibility Statement for Use of Narcotic Drugs in
a Treatment Program.
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FDA-2635 Consent to Treatment with an Approved Narcotic Drug.
FDA-2636 Hospital Request for Methadone Detoxification Treatment.
(Approved by the Office of Management and Budget under number 0910-0140)
[54 FR 8960, Mar. 2, 1989; 54 FR 12531, Mar. 27, 1989; 58 FR 498, Jan.
6, 1993; 58 FR 38709, July 20, 1993]