Page:United States Statutes at Large Volume 106 Part 6.djvu/416

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106 STAT. 4974 PUBLIC LAW 102-585—NOV. 4, 1992 "(A) the non-Federal average manufacturer price of the drug during the 3-month period that ends with the month preceding the month during which a contract goes into e£rect (or, in the case of a covered drug for which sufficient data for determining the non-Federal average manufacturer price during such period is not available, during such period as the Secretary considers appropriate); minus "(B) the non-Federal average manufacturer price of the drug during the 3-month period that ends one year before tihe end of the period described in subpsuragraph (A) (or, in the case of a covered drug for which sufficient data for determining the non-Federal average manufacturer price during such period is not available, during such period precec&ig the period described in subparagraph (A) as the Secretary considers appropriate).

    • (2) The term 'covered drug* means—

"(A) a drug described in section 1927(k)(7)(A)(ii) of the Social Seciuity Act, or that would be described in such section but for the application of the first sentence of section 1927(k)(3) of such Act; "(B) a drug described in section 1927(k)(7)(A)(iv) of the Social Security Act, or that would be described in , such section but for the application of the first sentence of section 1927(k)(3) of such Act; "(C) any biological product identified under section 600.3 of title 21, Code of Federal Regulations; or "(D) insulin certified under section 506 of the Federal / Food, Drug, and Cosmetic Act. "(3) The term 'depot' means a centralized commodity management system through which covered drugs procured by an agency of the Federal Government are— "(A) received, stored, and deHvered through— "(i) a federally owned and operated warehouse system, or "(ii) a commercial entity operating under contract with such agency; or "(B) delivered directly fix)m the commercial source to the entity using such covered drugs. "(4) The term 'manufacturer* means any entity which is engaged 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 retailpharmacy licensed under State law. "(5) The term 'non-Federal average manufacturer price' means, wilii respect to a covered drug and a period of time (as determined by the Secretary), the weighted average price of a single form and dosage unit of the drug that is paid by wholesalers in the United States to the manufacturer, taking