Page:United States Statutes at Large Volume 104 Part 2.djvu/558

 104 STAT. 1388-150 PUBLIC LAW 101-508—NOV. 5, 1990 "(C) Agents when used for cosmetic purposes or hair growth. "(D) Agents when used for the symptomatic relief of cough and colds. "(E) Agents when used to promote smoking cessation. "(F) Prescription vitamins and mineral products, except prenatal vitamins and fluoride preparations. "(G) Nonprescription drugs. "(H) Covered outpatient drugs which the manufacturer seeks to require as a condition of sale that associated tests or monitoring services be purchased exclusively from the manufacturer or its designee. "(I) Drugs described in section 107(c)(3) of the Drug Amendments of 1962 and identical„similar, or related drugs (within the meaning of section 310.6(b)(1) of title 21 of the Code of Federal Regulations CDESr drugs)). "(J) Barbiturates. "(K) Benzodiazepines. "(3) UPDATE OF DRUG USTINGS.— The Secretary shall (except with respect to new drugs approved by the FDA for the first 6 months following the date of approval of such drugs shall not be subject to being listed in paragraph (2) under the provisions of this paragraph), by regulation, periodically update the list of drugs described in paragraph (2) or classes of drugs, or their medical uses, which the Secretary has determined, based on data collected by surveillance and utilization review programs of State medical assistance programs, to be subject to clinical abuse or inappropriate use. "(4) INNOVATOR MULTIPLE-SOURCE DRUGS.— Innovator multiplesource drugs shall be treated under applicable State and Federal law and regulation, "(5) PRIOR AUTHORIZATION PROGRAMS.— A State plan under this title may not require, as a condition of coverage or payment for a covered outpatient drug for which Federal financial participation is available in accordance with this section, the approval of the drug before its dispensing for any medically accepted indication (as defined in subsection (k)(6)) unless the system providing for such approval— "(A) provides response by telephone or other telecommunication device within 24 hours of a request for prior authorization; and "(B) except with respect to the drugs on the list referred to in paragraph (2), provides for the dispensing of at least a 72-hour supply of a covered outpatient prescription drug in an emergency situation (as defined by the Secretary). "(6) TREATMENT OF NEW DRUGS. —A State may not exclude for coverage, subject to prior authorization, or otherwise restrict any new biological or drug approved by the Food and Drug Administration after the date of enactment of this section, for a period of 6 months after such approval. "(7) OTHER PERMISSIBLE RESTRICTIONS. —A State may impose limitations, with respect to all such drugs in a therapeutic class, on the minimum or maximum quantities per prescription or on the number of refills, provided such limitations are necessary to discourage waste. Nothing in this section shall restrict the ability of a State to address individual instances of fraud or abuse in any manner authorized under the Social Security Act.

�