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Code · BILL · 115th Congress · H.R. 2430 (Placed on Calendar Senate) — To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs,... · Sec. 302

Sec. 302. Definitions

132 words·~1 min read·/bill/115/hr/2430/pcs/section-302·

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Section 744A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–41 ) is amended— in paragraph (1)(B), by striking application for a positron emission tomography drug. and inserting “application— for a positron emission tomography drug; or submitted by a State or Federal governmental entity for a drug that is not distributed commercially. ; by redesignating paragraphs
(5)through
(12)as paragraphs
(6)through (13), respectively; and by inserting after paragraph
(4)the following: 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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  • 21 USC 379j–41
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Sec. 302
Definitions
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