Methadone in the Maintenance Treatment of Narcotic Addicts

(b) Therefore, the commissioner of Food and
Drugs and the Director of the Drug Enforcement Administration Department of
Justice, agree that interested professionals, municipalities, and organizations
should be allowed to conduct further research in this area within a framework of
adequate controls designed to protect the individual patients and the community.
To facilitate this purpose, the Food and Drug Administration and the Drug
Enforcement Administration, Department of Justice, have jointly agreed upon
acceptable criteria and guidelines which are set forth in 291.505. In
addition, such other provisions of the Federal narcotic laws and regulations as
are applicable must also be observed 
 

[42 FR 46698, Sept. 16, 1977] 

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. There are two types of
   detoxification treatment: short term detoxification treatment and long term
   detoxification treatment.

1. “Short term detoxification treatment” is for a period not in
   excess of 30 days.

2. “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
   in the treatment of an individual for dependence on heroin or other morphine
   like drug.

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

1. Are permitted to administer and dispense a narcotic drug, and
2. 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.

(b) Organizational structure and approval requirements 

1. Organizational structure
1. 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.

2. 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 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.

3. 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 fur 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.

4. 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.

5. [Reserved]
2. Program approval
1. 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.

2. 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.

3. 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.

4. 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.

5. Approved narcotic drugs for use in treatment programs. The following
   narcotic drug has been approved for use in the treatment of narcotic
   addiction: Methadone.

3.  Medication unit.
1. 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.

2. 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.

3. 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.

4. Referral
1. The patient shall be stabilized at his or her optimal dosage level
   before he or she may be referred to a medication unit.

2. 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.

5. 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.

6. 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. Assent to regulation.
1. 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.

2. 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.

1. Form FDA 2632 “Application for Approval of Use of Methadone in a
   Treatment Program.” This form, required by Paragraph ((k)) 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.

2. Form FDA 2633 “Medical Responsibility Statement for Use of
   Methadone in a Treatment Program.” This form required by Paragraph
   ((k)) 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.

1. 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.

2. 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 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.

3. 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
1. History of addiction and current physiologic dependence.
1. A person may be admitted as a patient for a 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
   maintenance treatment. A 1 year history of addiction means that an
   applicant for admission to a 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 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.

2. 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 in August
   1988.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 maintenance program:

1. Physiologic addiction began in August 1987 and continued to the date
   of application for admission

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.

 

3. 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 circumstances, 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 maintenance treatment. The program
   physician shall complete and record the statement before the program
   administers any methadone to the patient.

2. 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, with full knowledge and understanding of its
   contents, sign the “Consent to Methadone Treatment” Form FDA
   2635 (see Paragraph ((k)) 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 Methadone
   Treatment.”

3. Exceptions to minimum admission criteria
1. 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 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.

2. 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 maintenance regimen. 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, find! 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 I health care
   professional’s recordings before the initial methadone 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 methadone 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 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 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 maintenance
   program or be detoxified.

5. Caution should be taken in the 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 maintenance or
   detoxification treatment.

3. Previously treated patients. Under certain circumstances, a patient
   who has been treated and later voluntarily detoxified from 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 maintenance treatment of 6 months or more, and the
   admitting program physician, in his or her reasonable clinical judgment,
   finds readmission to maintenance treatment to be medically justified.
   For patients meeting these criteria, the quantity of take home
   medication 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.

4. Special limitation; treatment of patients under 18 years of age. A
   person under 18 is required to have had two documented attempts at short
   term detoxification or drug free treatment to be eligible for maintenance
   treatment. A 1 week waiting period is required after such a detoxification
   attempt, however, before an 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 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 Methadone Treatment.

5. 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.
1. 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 maintenance treatment; and at least
   quarterly random tests or analyses are performed on each patient in
   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.

2. 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
1. 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. 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.

2. 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.

3. Admission evaluation.
1. 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.

2. 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.

4. Initial treatment plan.
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.

 

1. 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.

2. 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.

5. Periodic treatment plan evaluation.
1. 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.

2. 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.

3. 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 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.

4. 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 maintenance treatment program and who
   has made substantial progress in rehabilitation.

6. Minimum program services
1. 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.

2. Pregnant patients
1. For pregnant patients in a treatment program who were not admitted
   under Paragraph (d)(l)(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 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.

3. [Reserved]
4. 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 required
   to be reported immediately to the Food and Drug Administration.

1. 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:

1. 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.

2. 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).

3. Ensure that appropriate laboratory studies have been performed and
   reviewed.

4. 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.)

5. Review and countersign treatment plans at least annually as
   qualified by Paragraph (d)(3)(v)(D) of this section.

6. 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 physical disability, or prescribing any
   medication for physical or emotional problems.

2. 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
   symptoms 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 physical 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.

3. 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.

7. Staffing patterns
1. 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 non narcotic drug or alcohol abusers; the number of patients with
   behavioral problems in the program; and the number of patients with
   serious medical problems.

2. Supportive services. The person(s) responsible for the program shall
   take notice, when considering the staffing pattern, that 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.

4. Frequency of attendance; quantity of take home medication; dosage of
   methadone; initial and stabilization

1. Dosage and responsibility for administration.
1. 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.

2. 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 dosage schedule.

3. The administering licensed physician shall ensure that a daily dose
   greater than 100 milligrams is justified in the patient’s record.

2. 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.

3. 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.

4. Take home medication
1. 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.

2. 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 non narcotic),
   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 maintenance treatment;
7. Assurance that take home medication can be safely stored within the
   patient’s home; and

8. Whether the rehabilitative benefit to the patient derived from
   decreasing the frequency of clinic attendance outweighs the potential
   risks of diversion.

5. 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.

1. In 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 adhered 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 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 is permitted to reduce clinic attendance for
observation to once weekly may receive no more than a 6 day take home
supply of medication. 

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
   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.

1. In calculating the number of years of 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.

2. 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.

6. Exceptions to take home requirements. If, in
   the reasonable clinical judgment of the program physician:

1. 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.

2. 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.

7. 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 of
   official State holiday. An of official State holiday is a holiday on which
   most State offices are usually closed and routine State government
   business is not conducted.

5. [Reserved]
6. Minimum standards for short term detoxification treatment.
1. 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 maintenance treatment apply to short term
   detoxification treatment with the following exceptions:

1. Take home medication is not allowed during short term detoxification.
2. A history of 1 year physiologic dependence is not required for
   admission to short term detoxification.

3. 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.

4. No test or analysis is required except for the initial drug screening
   test or analysis.

5. The initial treatment plan and periodic treatment plan evaluation
   required for 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.

6. The requirements of Paragraph (d)(4) of this section, except
   Paragraphs (d)(4)(ii) (A) through (D) and (d)(4)(iii) of this section,
   do not apply to short term detoxification treatment.

2. 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 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.

3. Short term detoxification treatment is not recommended for a pregnant
   patient.

7. Minimum standards for long term detoxification treatment.
1. 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 maintenance treatment apply to
   long term detoxification treatment with the following exception.

1. 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.

2. A history of 1 year physiologic dependence is not required for
   admission to long term detoxification.

3. 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.

4. 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.

5. 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.

6. The initial treatment plan and periodic treatment plan evaluation
   required for maintenance patients are also required for long term
   detoxification patients, except that the required periodic treatment
   plan evaluation is required to occur monthly.

2. 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
   physiologically dependent on narcotic drugs. The provisions of these
   requirements apply to both inpatient and ambulatory long term
   detoxification treatment.

3. Long term detoxification is not recommended for a pregnant patient.
8. 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 law 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.

9. Exemptions from specific program standards.
1. 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.

2. 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 program reveal that discrepancies or adverse
   conditions exist, the Food and Drug Administration shall reserve the right
   to revoke any or all exemptions previously granted.

10. 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.

11. Patient record system
1. 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 methadone. All records are required to be kept confidential
   and in accordance with all applicable Federal and State regulations
   regarding confidentiality.

2. 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.

3. 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.

12. 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
   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 Paragraph (d)(6)(iii) of this section.)

2. Use of narcotic drugs in hospitals

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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 law; but use or disclosure of records identifying patients
   will, in any case, be limited to actions involving the program or its
   personnel.

7. 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.

8. 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 the Food and Drug Administration and the State authority
   Form FDA 2636 “Hospital Request for Methadone Detoxification
   Treatment” (see Paragraph ((k)) of this section) and must have
   received from the Food and Drug Administration a notice that the request
   has been approved.

9. 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, 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 Methadone 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 . 14.200 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 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 manufacturer 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.

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)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, 5600 Fishers Lane, Rockville,, MD 20857.
Forms are available upon request from the Regulatory Management Branch ((HFD
352)) at the same address.

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