Sec. 1. Discontinuance or interruption in the production of life-saving devices
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/bill/116/hr/6062/ih/section-1A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 506C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c ) is amended— in the section heading, by striking and inserting life-saving drugs ; life-saving drugs and devices in the matter preceding paragraph
(1)in subsection (a), by striking a drug and inserting a drug or device ; in subsection (a)(1)(C), by striking such drug and inserting such drug or device ; in the matter following paragraph
(2)in subsection (a), by striking the drug each place it appears and inserting the drug or device ; in subsection (c), by striking the drugs and inserting the drugs or devices ; in the matter before paragraph
(1)in subsection (g), by striking a drug shortage of a drug described in subsection
(a)and inserting a drug or device shortage of a drug or device described in subsection
(a); in subsection (g)(1), by striking or a supplement to such an application submitted under section 505(j), that could help mitigate or prevent such shortage and inserting a supplement to such an application submitted under section 505(j), or a submission for clearance of a device under section 510(k), classification of a device under section 513(f)(2), or approval of a device under section 515, that could help mitigate or prevent such shortage ; in subsection (g)(2), by striking such drug shortage and inserting such drug or device shortage ; in subsection (h), by amending paragraph
(2)to read as follows: the term drug or device shortage or shortage , with respect to a drug or device, means a period of time when the demand or projected demand for the drug or device within the United States exceeds the supply of the drug or device; and ; and in subsection (h)(3)(A), by striking a drug and inserting a drug or device . Section 506C–1 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c–1 ) is amended— in the section heading, by striking and inserting drug shortages ; drug and device shortages in subsections
(a)and (b), by striking drug shortages each place it appears and inserting drug and device shortages ; in subsection (a)(2), by striking the staff of the Center for Drug Evaluation and Research's Office of Compliance and Drug Shortage Program and inserting the staffs of the Center for Drug Evaluation and Research's Office of Compliance and Drug Shortage Program and the Center for Devices and Radiological Health ; in subsection (a)(3)(B)(i), by striking applications and supplements and inserting applications, supplements, and submissions ; and in subsections (a)(5) and (c), by striking drug shortage and inserting drug or device shortage .
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- 21 USC 356c–1
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Sec. 1
Discontinuance or interruption in the production of life-saving devices
Cite21 USC 356c–1
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