Sec. 302. DEFINITIONS
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/statute-compilations/comps-15234/sec-302A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
## SEC. 302 DEFINITIONS Section 744A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-41) is amended— ####
(1)in paragraph (1)(B), by striking “ application for a positron emission tomography drug. ” and inserting > “application— > > > ###### “(i) > > for a positron emission tomography drug; or > > > ###### “(ii) > > submitted by a State or Federal governmental entity for a drug that is not distributed commercially.” > ; ####
(2)by redesignating paragraphs
(5)through
(12)as paragraphs
(6)through (13), respectively; and ####
(3)by inserting after paragraph
(4)the following: > > #### “(5) > > The term ‘**contract manufacturing organization facility**’ means a manufacturing facility of a finished dosage form of a drug approved pursuant to an abbreviated new drug application, where such manufacturing facility is not identified in an approved abbreviated new drug application held by the owner of such facility or an affiliate of such owner or facility.” > .
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U.S. Code