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107 STAT. 616 PUBLIC LAW 103-66—AUG. 10, 1993 Regulations. ''(iii) the drug is subject to such restrictions pursuant to £in agreement between a manufactiirer and a State authorized by the Secretary under subsection (aXl) or in effect pursuant to subsection (aX4); or "(iv) the State has excluded coverage of the drug firom its formulary established in accordance with paragraph (4). "(2) LIST OF DRUGS SUBJECT TO RESTRICTION.—The follow- ing drugs or classes of drugs, or their medical uses, may be excluded from coverage 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 inappro- priate use. "(4) REQUIREMENTS FOR FORMULARIES.—A State may estab- lish a formulary if the formulary meets the following requirements: "(A) The formulary is developed by a committee consist- ing of physicians, pharmacists, and other appropriate individuals appointed by the Governor of the State (or, at the option of the State, the Stete's drug use review board established under subsection (gX3)). "(B) Except as provided in subparagraph (C), the for- mulaiy includes tne covered outpatient drugs of any manufacturer which has entered into and complies witn an agreement under subsection (a) (other than any drug excluded from coverage or otherwise restricted under para- graph (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 imder the Federal Food, Drug, and Cosmetic Act but is a medically accepted indica- tion, based on information from the appropriate compendia described in subsection (kX6)), the excluded drug does not have a significant, clinically meaningful therapeutic advan-