Page:United States Statutes at Large Volume 117.djvu/2261

 117 STAT. 2242

PUBLIC LAW 108–173—DEC. 8, 2003 ‘‘(B) WHOLESALE ACQUISITION COST.—The term ‘wholesale acquisition cost’ means, with respect to a drug or biological, the manufacturer’s list price for the drug or biological to wholesalers or direct purchasers in the United States, not including prompt pay or other discounts, rebates or reductions in price, for the most recent month for which the information is available, as reported in wholesale price guides or other publications of drug or biological pricing data. ‘‘(C) MULTIPLE SOURCE DRUG.— ‘‘(i) IN GENERAL.—The term ‘multiple source drug’ means, for a calendar quarter, a drug for which there are 2 or more drug products which— ‘‘(I) are rated as therapeutically equivalent (under the Food and Drug Administration’s most recent publication of ‘Approved Drug Products with Therapeutic Equivalence Evaluations’), ‘‘(II) except as provided in subparagraph (E), are pharmaceutically equivalent and bioequivalent, as determined under subparagraph (F) and as determined by the Food and Drug Administration, and ‘‘(III) are sold or marketed in the United States during the quarter. ‘‘(ii) EXCEPTION.—With respect to single source drugs or biologicals that are within the same billing and payment code as of October 1, 2003, the Secretary shall treat such single source drugs or biologicals as if the single source drugs or biologicals were multiple source drugs. ‘‘(D) SINGLE SOURCE DRUG OR BIOLOGICAL.—The term ‘single source drug or biological’ means— ‘‘(i) a biological; or ‘‘(ii) a drug which is not a multiple source drug and which is produced or distributed under a new drug application approved by the Food and Drug Administration, including a drug product marketed by any cross-licensed producers or distributors operating under the new drug application. ‘‘(E) EXCEPTION FROM PHARMACEUTICAL EQUIVALENCE AND BIOEQUIVALENCE REQUIREMENT.—Subparagraph (C)(ii) shall not apply if the Food and Drug Administration changes by regulation the requirement that, for purposes of the publication described in subparagraph (C)(i), in order for drug products to be rated as therapeutically equivalent, they must be pharmaceutically equivalent and bioequivalent, as defined in subparagraph (F). ‘‘(F) DETERMINATION OF PHARMACEUTICAL EQUIVALENCE AND BIOEQUIVALENCE.—For purposes of this paragraph— ‘‘(i) drug products are pharmaceutically equivalent if the products contain identical amounts of the same active drug ingredient in the same dosage form and meet compendial or other applicable standards of strength, quality, purity, and identity; and ‘‘(ii) drugs are bioequivalent if they do not present a known or potential bioequivalence problem, or, if

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