Page:United States Statutes at Large Volume 104 Part 2.djvu/565

 PUBLIC LAW 101-508—NOV. 5, 1990 104 STAT. 1388-157 Federal Food, Drug, and Cosmetic Act on a proposed order of the Secretary to withdraw approval of an application for such drug under such section because the Secretary has determined that the drug is less than effective for some or all conditions of use prescribed, recommended, or suggested in its labeling; and "(B) a biological product, other than a vaccine which— "(i) may only be dispensed upon prescription, "(ii) is licensed under section 351 of the Public Health Service Act, and "(iii) is produced at an establishment licensed under such section to produce such product; and "(C) insulin certified under section 506 of the Federal Food, Drug, and Cosmetic Act. "(3) LIMITING DEFINITION.—The term 'covered outpatient drug' does not include any drug, biological product, or insulin provided as part of, or as incident to and in the same setting as, any of the following (and for which payment may be made under this title as part of payment for the following and not as direct reimbursement for the drug): "(A) Inpatient hospital services. "(B) Hospice services. "(C) Dental services, except that drugs for which the State plan authorizes direct reimbursement to the dispensing dentist are covered outpatient drugs. '(D) Physicians'services. "(E) Outpatient hospital services * * * * 39 emergency room visits. "(F) Nursing facility sevices. "(G) Other laboratory and x-ray services. " (H) Renal dialysis. Such term also does not include any such drug or product which is used for a medical indication which is not a medically accepted indication. "(4) NONPRESCRIPTION DRUGS.— If a State plan for medical assistance under this title includes coverage of prescribed drugs as described in section 1905(a)(12) and permits coverage of drugs which may be sold without a prescription (commonly referred to as 'over-the-counter' drugs), if they are prescribed by a physician (or other person authorized to prescribe under State law), such a drug shall be regarded as a covered outpatient drug. "(5) MANUFACTURER.—The term 'manufacturer' means any entity which is engeiged in— "(A) the production, preparation, propagation, compounding, conversion, or processing of prescription drug products, either directly or indirectly by extraction from substances of natural origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis, or "(B) in the packaging, repackaging, labeling, relabeling, or distribution of prescription drug products. Such term does not include a wholesale distributor of drugs or a retail pharmacy licensed under State law. "(6) MEDICALLY ACCEPTED INDICATION. —The term 'medically accepted indication' means any use for a covered outpatient drug which is approved under the Federal Food, Drug, and Cosmetic Act, which appears in peer-reviewed medical lit- •• So in original. Probably should be "services emergency".

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