Sec. 7103. Notification, nondistribution, and recall of adulterated or misbranded drug products
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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 comply with any order issued under section 569D. . Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb et seq.) is amended by adding at the end the following: Upon a determination that the use or consumption of, or exposure to, a drug may present an imminent or substantial hazard to the public health, the Secretary shall issue an order requiring any person who distributes the drug to immediately cease distribution of the drug. An order under paragraph
(1)shall provide the person subject to the order with an opportunity for an informal hearing, to be held not later than 10 days after the date of issuance of the order, on— the actions required by the order; and whether the order should be amended to require a recall of the drug. If, after providing an opportunity for a hearing under paragraph (2), the Secretary determines that inadequate grounds exist to support the actions required by the order, the Secretary shall vacate the order. If, after providing an opportunity for an informal hearing under paragraph (2), the Secretary determines that the order should be amended to include a recall of the drug with respect to which the order was issued, the Secretary shall— amend the order to require a recall; and after consultation with the drug sponsor, specify a timetable in which the recall will occur. An order under this subsection shall require any person who distributes the drug to provide for notice, including to individuals as appropriate, to persons who may be affected by the order to cease distribution of or recall the drug, as applicable. Any person who is subject to an order under paragraph
(1)or
(4)shall immediately cease distribution of or recall, as applicable, the drug and provide notification as required by such order. The Secretary shall, as the Secretary determines to be necessary, provide notice of a recall order under this section to— consumers to whom the drug was, or may have been, distributed; and appropriate State and local health officials. An order to recall a drug under subsection
(a)shall— require periodic reports to the Secretary describing the progress of the recall; and provide for notice, including to individuals as appropriate, to persons who may be affected by the recall. In providing for notice under paragraph (1)(B), the Secretary may allow for the assistance of health professionals, State or local officials, or other individuals designated by the Secretary. An order under this section shall be ordered by the Secretary or an official designated by the Secretary. An official may not be so designated under this section unless the official is the Director of the Center for Drug Evaluation and Research, is an official senior to such Director, or is so designated by such Director. Nothing contained in this section shall be construed as limiting— the authority of the Secretary to issue an order to cease distribution of, or to recall, an drug under any other provision of this Act or the Public Health Service Act; or the ability of the Secretary to request any person to perform a voluntary activity related to any drug subject to this Act or the Public Health Service Act. . The third sentence of subsection
(a)of section 801 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381 ) is amended by inserting or
(5)in the case of a drug, such drug is subject to an order under section 568 to cease distribution of or recall the drug, before then such article shall be refused admission . Sections 301(eee) and 569D of the Federal Food, Drug, and Cosmetic Act, as added by subsections
(a)and (b), shall apply with respect to a drug as of such date, not later than 1 year after the date of the enactment of this Act, as the Secretary of Health and Human Services shall specify.
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Sec. 7103
Notification, nondistribution, and recall of adulterated or misbranded drug products
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