Page:United States Statutes at Large Volume 102 Part 1.djvu/751

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PUBLIC LAW 100-360—JULY 1, 1988

102 STAT. 713

they must be pharmaceutically equivalent and bioequivalent, as defined in clause (iii). "(iii) DEFINITIONS.—For purposes of this subparagraph: "(I)

PHARMACEUTICALLY

EQUIVALENT.—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. "(II) BIOEQUIVALENT.—Drugs are bioequivalent if

they do not present a known or potential bioequivalence problem or, if they do present such a problem, are shown to meet an appropriate standard of bioequivalence. "(Ill) SOLD OR MARKETED.—A drug is considered to be sold or marketed during a period if it is listed in the publications referred to in clause (i)(D, unless the Secretary determines that such sale or marketing is not actually taking place. "(B) RESTRICTIVE PRESCRIPTION.—A drug has a 'restrictive prescription' only if— "(i) in the case of a written prescription, the prescription for the drug indicates, in the handwriting of the physician or other person prescribing the drug and with an appropriate phrase (such as 'brand medically necessary') recognized by the Secretary, that the particular drug must be dispensed, or "(ii) in the case of a prescription issued by telephone— "(I) the physician or other person prescribing the drug (through use of such a n appropriate phrase) states that the particular drug must be dispensed, and "(II) the physician or other person submits to the pharmacy involved, within 30 days after the date of the telephone prescription, a written confirmation which is in the handwriting of the physician or other person prescribing the drug and which indicates with such appropriate phrase that the particular drug was required to have been dispensed. "(C) PAYMENT CALCULATION PERIOD.—The term 'payment calculation period' means the 6-month period beginning with January of each year and the 6-month period beginning with July of each year. "(D) OUTLAYS; RECEIPTS.—The terms 'outlays' and 'receipts' mean, with respect to a year or other period, gross outlays and receipts, as such terms are employed in the 'Monthly Treasury Statement of Receipts and Outlays of the United States Government (MTS)', as published by the Department of the Treasury, for months in such year or other period.", (c) PARTICIPATING PHARMACIES; CIVIL MONEY PENALTIES.— (1) PARTICIPATING PHARMACIES.—Section 1842 (42

1395t) is amended—

U.S.C. 42 USC i395u.

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