42 U.S.C. § 300y–11

(a) Requirement regarding Secretary Subject to the following subsections of this section, for the purpose of reducing the incidence of the transmission of HIV disease pursuant to the intravenous use of heroin or other morphine-like drugs, the Secretary, in establishing conditions for the use of methadone in public or nonprofit private programs of treatment for dependence on such drugs, shall authorize such programs— (1) to dispense methadone for treatment purposes to individuals who— (A) meet the conditions for admission to such programs that dispense methadone as part of comprehensive treatment for such dependence; and (B) are seeking admission to such programs that so dispense methadone, but as a result of the limited capacity of the programs, will not gain such admission until 14 or more days after seeking admission to the programs; and (2) in dispensing methadone to such individuals, to provide only minimum ancillary services during the period in which the individuals are waiting for admission to programs of comprehensive treatment. (b) Inapplicability of requirement in certain circumstances (1) In general The requirement established in subsection (a) for the Secretary does not apply if any or all of the following conditions are met: (A) The preponderance of scientific research indicates that the risk of the transmission of HIV disease pursuant to the intravenous use of drugs is minimal. (B) The preponderance of scientific research indicates that the medically supervised dispensing of methadone is not an effective method of reducing the extent of dependence on heroin and other morphine-like drugs. (C) The preponderance of available data indicates that, of treatment programs that dispense methadone as part of comprehensive treatment, a substantial majority admit all individuals seeking services to the programs not later than 14 days after the individuals seek admission to the programs. (2) Evaluation by Secretary In evaluating whether any or all of the conditions described in paragraph (1) have been met, the Secretary shall consult with the National Commission on Acquired Immune Deficiency Syndrome. (c) Conditions for obtaining authorization from Secretary (1) In general In carrying out the requirement established in subsection (a), the Secretary shall, after consultation with the National Commission on Acquired Immune Deficiency Syndrome, by regulation issue such conditions for treatment programs to obtain authorization from the Secretary to provide interim maintenance treatment as may be necessary to carry out the purpose described in such subsection. Such conditions shall include conditions for preventing the unauthorized use of methadone. (2) Counseling on HIV disease The regulations issued under paragraph (1) shall provide that an authorization described in such paragraph may not be issued to a treatment program unless the program provides to recipients of the treatment counseling on preventing exposure to and the transmission of HIV disease. (3) Permission of relevant State as condition of authorization The regulations issued under paragraph (1) shall provide that the Secretary may not provide an authorization described in such paragraph to any treatment program in a State unless the chief public health officer of the State has certified to the Secretary that— (A) such officer does not object to the provision of such authorizations to treatment programs in the State; and (B) the provision of interim maintenance services in the State will not reduce the capacity of comprehensive treatment programs in the State to admit individuals to the programs (relative to the date on which such officer so certifies). (4) Date certain for issuance of regulations; failure of Secretary The Secretary shall issue the final rule for purposes of the regulations required in paragraph (1), and such rule shall be effective, not later than the expiration of the 180-day period beginning on July 10, 1992 . If the Secretary fails to meet the requirement of the preceding sentence, the proposed rule issued on March 2, 1989 , with respect to part 291 of title 21, Code of Federal Regulations (docket numbered 88N–0444; 54 Fed. Reg. 8973 et seq.) is deemed to take effect as a final rule upon the expiration of such period, and the provisions of paragraph (3) of this subsection are deemed to be incorporated into such rule. (d) Definitions For purposes of this section: (1) The term “interim maintenance services” means the provision of methadone in a treatment program under the circumstances described in paragraphs (1) and (2) of subsection (a). (2) The term “HIV disease” means infection with the etiologic agent for acquired immune deficiency syndrome. (3) The term “treatment program” means a public or nonprofit private program of treatment for dependence on heroin or other morphine-like drugs.