Part 291 --DRUGS USED FOR TREATMENT OF NARCOTIC ADDICTS [INTERIM RULE]

1. The authority citation for 21 CFR part 291 continues to read as follows:

Authority: Secs. 505, 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 371); 21 U.S.C. 823; secs. 301(d), 548, 1976 of the Public Health Services Act (42 U.S.C. 241(d), 290ee-3, 300y-11); 42 U.S.C. 257a.

2. Section 291.501 is revised to read as follows:

§ 291.501 Narcotic drugs in the maintenance treatment of narcotic addicts.

(a) The Food and Drug Administration, the National Institute of 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 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 291.505. In addition, such other provisions of the Federal narcotic laws and regulations as are applicable must also be observed.

3. Section 291.505 is amended by revising paragraphs (b)(2)(v), (b)(2)(vi)(D), (c)(4)(i), (c)(4)(ii), the last sentence in paragraph (d)(1)(i)(C), paragraph (d)(1)(ii), the first sentence in paragraph (d)(1)(iii)(B)(1) and by removing the word "methadone" in the two places it appears in paragraph (d)(1)(iii)(B)(1), by adding new paragraph (d)(1)(iii)(B)(6), by revising the second sentence in paragraph (d)(1)(iii)(C), paragraph (d)(1)(iv), by adding a new sentence after the second sentence in paragraph (d)(3)(i), by adding new paragraph (d)(4)(v), by revising the paragraph headings of paragraphs (d)(6) and (d)(6)(i), by removing paragraph (d)(6)(ii) and reserving it, by revising the second sentence in paragraph (d)(13)(i), in paragraph (f)(2)(viii) by removing the phrase "paragraph (k) of this section" and adding in in its place "paragraph (l) of this section", [sic] by revising paragraph (h)(1), by redesignating paragraph (k) as paragraph (l) and revising it, and by adding new paragraph (k) to read as follows:

§ 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.

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(b) * * *

(2) * * *

(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)* * *

(D) Requests for authorization should be submitted to the address specified in paragraph (l) of this section.

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(c) * * *

(4) * * *

(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.

* * * * *

(d)(1) * * * (i) * * *

(C) * * * 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, 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) * * *

(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. * * *

* * * * *

(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) * * * 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. * * *

(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 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 designed 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.

* * * * *

(3) * * * (i) * * * 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. * * *

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(4) * * *

(v) Authorized dispensers of narcotic drugs; responsibility. A narcotic drug nay 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.

* * * * *

(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. * * *

(ii) [Reserved]

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(13) * * *

(i) * * * 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. * * *

* * * * *

(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 Drugs 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.

* * * * *

(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, 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.

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.)

Michael R. Taylor,
Deputy Commissioner for Policy.
Dated: April 8, 1993.

Richard A. Millstein,
Acting Director, National Institute on Drug Abuse.
[FR Doc. 93-17134 Filed 7-19-93; 8:45 am]
BILLING CODE 4160-01-P

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