Sec. 4. Prohibited acts
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/bill/113/hr/3089/ih/section-4A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ) is amended by inserting after paragraph
(bbb)the following: With respect to a drug product to be compounded under section 503A or 503B, the intentional falsification of a prescription, a purchase order, or patient name required under section 503A or 503B. . Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ), as amended by subsection (a), is further amended by inserting after paragraph
(ccc)(as added by such subsection), the following: With respect to any year in which an outsourcing facility is required to register with the Secretary under section 503B(b), the intentional failure of the outsourcing facility to so register. .
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U.S. Code