107 STAT. 616 PUBLIC LAW 103-66—AUG. 10, 1993 Regulations. (iii) the drug is subject to such restrictions pursuant to an agreement between a manufactiirer and a State authorized by the Secretary under subsection (a)(l) or in effect pursuant to subsection (a)(4); or "(iv) the State has excluded coverage of the drug from its formulary established in accordance with paragraph (4). "(2) LIST OF DRUGS SUBJECT TO RESTRICTION. — The following drugs or classes of drugs, or their medical uses, may be excludedfromcoverage or otherwise restricted: "(A) Agents when used for anorexia, weight loss, or weight gain. "(B) Agents when used to promote fertility. (C) ^ents 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) Barbiturates. "(J) Benzodiazepines. "(3) UPDATE OF DRUG USTINGS. —The Secretary shall, by regulation, periodically update the list of dru^s or classes of drugs described in paragraph (2) or their medical uses, which the Secretary has determined, based on data collected by surveillance and utilization review programs of State medical assistcuice programs, to be subject to clinical abuse or inappropriate use. "(4) REQUIREMENTS FOR FORMULARIES.— A State may establish a formulary if the formulary meets the following requirements: "(A) The formulary is developed by a committee consisting of physicians, pharmacists, and other appropriate individuals appointed by the Governor of the State (or, at the option of the State, the State's drug use review board established under subsection (g)(3)). "(B) Except as provided in subparagraph (C), the formulary includes the covered outpatient drugs of any manufacturer which has entered into and complies with an agreement under subsection (a) (other than any drug excluded from coverage or otherwise restricted under paragraph (2)). "(C) A covered outpatient dru^ may be excluded with respect to the treatment of a specific msease or condition for an identified population (if any) only if, based on the drug's labeUng (or, in the case of a drug the prescribed use of which is not approved under the Federal Food, Drug, and Cosmetic Act but is a medically accepted indication, based on information from the appropriate compendia described in subsection (k)(6)), the excluded drug does not have a significant, clinically meaningful therapeutic advan-
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