Sec. 4. Requiring boxed warnings on potentially contaminated drugs
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The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall— issue an order deeming a drug or active pharmaceutical ingredient (or a category thereof) to be misbranded within the meaning of section 502 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 352 ) if such drug or active pharmaceutical ingredient (or category thereof)— is manufactured in a country that the Secretary determines may be producing contaminated drugs or active pharmaceutical ingredients because of systemic problems of supervision in the manufacture of drugs or active pharmaceutical ingredients; and the labeling of such drug or active pharmaceutical ingredient (or category thereof) does not bear a boxed warning of the potential for contamination; make each such order effective for a period of not more than 180 days; and renew each such order each time the preceding order ends and the criteria listed in paragraph
(1)continue to apply. The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs— may waive the requirement to issue or renew an order under subsection
(a)so long as the labeling of the drug or active pharmaceutical ingredient (or category thereof) bears a boxed warning of the potential for contamination; shall make any such waiver effective for a period not to exceed 180 days; and may renew any such waiver one or more times.
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Sec. 4
Requiring boxed warnings on potentially contaminated drugs
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