Sec. 3. Reporting on increases in demand for a drug
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Section 506C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c ) is amended— in the section heading, by inserting after or increase in demand for ; production of in subsection (a), in the matter following paragraph (2), by striking drug, and the reasons for such discontinuance or interruption and inserting drug, or increase in the demand for such drug that is likely to lead to a shortage of the drug, and the reasons for such discontinuance, interruption, or increase in demand ; in subsection (b)— in paragraph (1), by striking ; or and inserting a semicolon; by redesignating paragraph
(2)as paragraph (3); by inserting after paragraph
(1)the following: in the case of an increase in the demand for a drug, not later than 30 days after the manufacture has knowledge of such increase; or ; and in paragraph (3), as so redesignated, by striking paragraph
(1)and inserting paragraph
(1)or
(2); and in subsection (c), by inserting , or increase in demand for, after the manufacture of . Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ) is amended by adding at the end the following: The failure to notify the Secretary as required under section 506C(a). . Section 303 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 333(c) ) is amended— in paragraph (c), by adding before the period at the end the following: ; or
(7)for having violated section 301(jjj) if such person acted in good faith and had a reasonable basis for not notifying as required under section 506C ; and by adding at the end the following: Notwithstanding subsection (a), any manufacturer who violates section 301(jjj) shall be subject to a civil penalty in an amount not to exceed $50,000 per violation. .
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