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

1. The authority citation for 21 CFR part 291 is revised 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 Service Act (42 U.S.C. 241(d), 290ee-3, 300y-11); 42 U.S.C. 257a.

2. Section 291.505 is amended by inserting the word "comprehensive" before the word "maintenance" everywhere it appears in paragraphs (d)(1)(i), (d)(1)(iii), (d)(1)(iv), (d)(2)(i), (d)(3)(v)(D), (d)(4)(i)(B)(2), (d)(5)(ii), (d)(6)(iv)(B)(6), (d)(6)(v)(A)(1) and (d)(6)(v)(A)(3), (d)(6)(v)(C), (d)(8)(i) introductory text and (d)(8)(i)(E), (d)(9)(i) introductory text and (d)(9)(i)(F), and by revising paragraph (a)(2), by adding paragraphs (a)(10), (b)(1)(v), (b)(2)(vi), (d)(4)(i)(C), and (d)(7), and by revising paragraph (d)(8)(i)(F) to read as follows:

Sec. 291.505 Conditions for the use of narcotic drugs; appropriate methods of professional practice for medical treatment of the narcotic addiction of various classes of narcotic addicts under section 4 of the Comprehensive Drug Abuse Prevention and Control Act of 1970.

(a) * * *

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

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

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

* * * * *

(10) The term HIV disease means infection with the etiologic agent for acquired immunodeficiency syndrome.

* * * * *

(b) * * *

(1) * * *

(v) Interim maintenance treatment. A public or nonprofit private narcotic treatment program may provide interim maintenance treatment only if the program also provides comprehensive maintenance treatment to which interim maintenance treatment patients may be transferred.

(2) * * *

(vi) Interim maintenance treatment program approval. Before a public or nonprofit private narcotic treatment program may provide interim maintenance treatment, the program must receive approval of both the Food and Drug Administration and the chief public health officer of the State. Before such approval is granted, the program must provide the Food and Drug Administration with certification from the chief public officer of the State that:

(A) Such officer does not object to the authorization of programs providing interim maintenance treatment in the State and that programs seeking such authorization are unable to place patients in a public or nonprofit private comprehensive treatment program within a reasonable geographic area within 14 days of the time patients seek admission to such programs;

(B) The authorization of programs providing interim maintenance treatment in the State will not reduce the capacity of comprehensive programs in the State to admit individuals to these programs (relative to the date on which such officer so certifies);

(C) The State guarantees that individuals enrolled in interim maintenance treatment will be transferred to comprehensive programs not later than 120 days, as provided by section 1923 of the Public Health Service Act (the PHS Act) and applicable regulations; and

(D) Requests for authorization should be submitted to the address specified in Sec. 291.505(k).

* * * * *

(d) * * *

(4) * * *

(i) * * *

(C) Counseling on HIV disease. A narcotic treatment program shall provide counseling on preventing exposure to, and the transmission of, HIV disease for each patient admitted or readmitted to maintenance or detoxification treatment. Although HIV testing is not required, an interim program shall inform patients of the availability of HIV testing. The program sponsor shall also ensure that HIV testing is accessible to patients who request such testing either on site or by the programs entering into agreements with HIV testing facilities to make HIV testing accessible to those patients who request it.

* * * * *

(7) Minimum standards for interim maintenance treatment. The person(s) responsible for a program may place an individual, who is eligible for admission to comprehensive maintenance treatment, in interim maintenance treatment if the individual cannot be placed in a public or nonprofit private comprehensive program within a reasonable geographic area and within 14 days of the individual's application for admission. An initial and at least two other urine screens shall be taken from interim patients during the maximum of 120 days permitted for such treatment. A program shall establish and follow reasonable criteria for establishing priorities for transferring patients from interim maintenance to comprehensive maintenance treatment. These transfer criteria shall be in writing and available for inspection and shall include, at a minimum, a preference for pregnant women in admitting patients to interim maintenance and in transferring patients from interim maintenance to comprehensive maintenance treatment. Interim maintenance shall be provided in a manner consistent with all applicable Federal and State laws including sections 1923 (mandatory transfer) and 1927(a) (pregnant patients) of the PHS Act. The program shall notify the State health officer when a patient begins interim treatment, when a patient leaves interim treatment, and before the date of mandatory transfer to a comprehensive program, and shall document such notifications. Programs in States not in compliance with provisions of this regulation risk loss of authorization for interim maintenance. All requirements for comprehensive maintenance treatment apply to interim maintenance treatment with the following exceptions:

(i) The narcotic drug is required to be administered daily under observation;

(ii) Take-home medication is not allowed;

(iii) The initial treatment plan and periodic treatment plan evaluation are,not [sic] required;

(iv) A primary counselor is not required to be assigned to a patient;

(v) Interim maintenance cannot be provided for longer than 120 days in any 12 month-period [sic]; and

(vi) The requirements and exceptions in paragraphs (b)(2)(iii) (as apply to rehabilitative services), in paragraphs (b)(3)(iv)(B) and (d)(4)(i)(A) (as apply to rehabilitative services), and in paragraphs (d)(4)(ii)(E), (d)(4)(ii)(F), (d)(4)(iv), (d)(6)(iv), (d)(6)(v), (d)(6)(vi), and (d)(6)(vii) of this section do not apply.

* * * * *

(8) * * *

(i) * * *

(F) The requirements of paragraph (d)(4) of this section, except paragraphs (d)(4)(i)(C), (d)(4)(ii)(A) through (d)(4)(ii)(D), and (d)(4)(iii) of this section, do not apply to short-term detoxification treatment.

Back to Top