multiple source drug
Defined in 2 places of the United States Code.
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.
Source
- 2003–present42 U.S.C. § 1395WThe Public Health and Welfare · Use of average sales price payment methodology · in this section
The term "multiple source drug" means, with respect to a rebate period, a covered outpatient drug, including a drug product approved for marketing as a non-prescription drug that is regarded as a covered outpatient drug under paragraph (4), for which there 2 at least 1 other drug product which—
(I) is 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 (B), is pharmaceutically equivalent and bioequivalent, as defined in subparagraph (C) and as determined by the Food and Drug Administration, and
(III) is sold or marketed in the United States during the period.
Source
- 2020–present42 U.S.C. § 1396RThe Public Health and Welfare · Payment for covered outpatient drugs · under this subchapter
The term “multiple source drug” means, with respect to a rebate period, a covered outpatient drug, including a drug product approved for marketing as a non-prescription drug that is regarded as a covered outpatient drug under paragraph (4), for which there 3 at least 1 other drug product which—
(I) is 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 (B), is pharmaceutically equivalent and bioequivalent, as defined in subparagraph (C) and as determined by the Food and Drug Administration, and
(III) is sold or marketed in the United States during the period.
Source
- 2019–202042 U.S.C. § 1396RThe Public Health and Welfare · Payment for covered outpatient drugs · under this subchapter
The term “multiple source drug” means, with respect to a rebate period, a covered outpatient drug (not including any drug described in paragraph (5)) for which there 10 at least 1 other drug product which—
(I) is 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 (B), is pharmaceutically equivalent and bioequivalent, as defined in subparagraph (C) and as determined by the Food and Drug Administration, and
(III) is sold or marketed in the State during the period.
Source
- 2006–200942 U.S.C. § 1396RThe Public Health and Welfare · Payment for covered outpatient drugs · under this subchapter
The term “multiple source drug” means, with respect to a rebate period, a covered outpatient drug (not including any drug described in paragraph (5)) for which there 5 at least 1 other drug product which—
(I) is 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 (B), is pharmaceutically equivalent and bioequivalent, as defined in subparagraph (C) and as determined by the Food and Drug Administration, and
(III) is sold or marketed in the United States during the period.
Source
- 2010–201942 U.S.C. § 1396RThe Public Health and Welfare · Payment for covered outpatient drugs · under this subchapter
The term “multiple source drug” means, with respect to a rebate period, a covered outpatient drug (not including any drug described in paragraph (5)) for which there 6 at least 1 other drug product which—
(I) is 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 (B), is pharmaceutically equivalent and bioequivalent, as defined in subparagraph (C) and as determined by the Food and Drug Administration, and
(III) is sold or marketed in the State during the period.
Source
- 2009–201042 U.S.C. § 1396RThe Public Health and Welfare · Payment for covered outpatient drugs · under this subchapter
The term “multiple source drug” means, with respect to a rebate period, a covered outpatient drug (not including any drug described in paragraph (5)) 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 (B), are pharmaceutically equivalent and bioequivalent, as defined in subparagraph (C) and as determined by the Food and Drug Administration, and
(III) are sold or marketed in the State during the period.
Source
- 1994–200642 U.S.C. § 1396RThe Public Health and Welfare · Payment for covered outpatient drugs · under this subchapter