Sec. 4. Quarterly manufacturer reporting with respect to drugs and devices
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Section 510(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(i) ) is amended by inserting at the end the following new paragraph: The requirements of paragraphs
(1)and
(2)shall apply to establishments within a foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of any drug, including the active pharmaceutical ingredient, or device that is required to be listed pursuant to subsection (j). Such requirements shall apply regardless of whether the drug, active pharmaceutical ingredient, or device undergoes further manufacture, preparation, propagation, compounding, or processing at a separate establishment or establishments outside the United States prior to being imported or offered for import into the United States. . Section 510(j)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(j)(1) ) is amended— in subparagraph (D), by striking and at the end; in subparagraph (E), by striking the period at the end and inserting ; and ; and by adding at the end the following new subparagraph: in the case of a drug contained in the applicable list, a certification that the registrant has— identified every other establishment where manufacturing is performed for the drug; and notified each known foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of the drug, including the active pharmaceutical ingredient, of the inclusion of the drug in the list and the obligation to register under subsection (i)(5). . Paragraph
(3)of section 510(j) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(j) ), as amended by the CARES Act ( Public Law 116–136 ), is amended to read as follows: Subject to subparagraph
(C)each person who registers with the Secretary under this section shall submit to the Secretary quarterly reports, in such electronic data format as the Secretary requires, containing the following information, as applicable, with respect to all drugs, drug substances, and devices manufactured, prepared, propagated, compounded, or processed at the establishment, whether for import into the United States or distribution in another country: With respect to a finished drug product— the number of dosage units manufactured at each establishment since the last report, broken down by— the number of dosage units manufactured at each establishment at which final manufacturing occurred, and the unique facility identifier of each such establishment; the number of dosage units from each such establishment that were distributed (or are intended to be distributed) for use in the United States and the number of dosage units that were distributed (or are intended to be distributed) for use outside of the United States; and the sources of drug substances used in the manufacturing of the finished drug product, and, for each such source— the unique facility identifier of each source of drug substance; and the number of dosage units of the finished drug product manufactured using that drug substance from each source of drug substance; and the National Drug Code number. With respect to a drug substance— the amount of drug substance manufactured at each establishment since the last report and the unique facility identifier of each such establishment; the amount of the drug substance manufactured at each such establishment that was distributed (or are intended to be distributed) for use in the United States and the amount that was distributed (or are intended to be distributed) for use outside of the United States; and the National Drug Code number. With respect to a device, the number of units manufactured at each establishment since the last report, broken down by— the number of units manufactured at each establishment at which final manufacturing occurred, and the establishment identification number of each such establishment; and the number of units from each such establishment that were distributed (or are intended to be distributed) for use in the United States and the number of units that were distributed (or are intended to be distributed) for use outside of the United States. By order of the Secretary, certain biological products or categories of biological products may be exempt from some or all of the reporting requirements under subparagraph (A), if the Secretary determines, at the Secretary’s sole discretion, that applying such reporting requirements to such biological products or categories is not necessary to protect the public health. The determination of the appropriate structured electronic data format by the Secretary under subparagraph (A), whether to exempt certain biological products or categories of biological products under subparagraph (B), and the date on which reporting begins under this section shall be exempt from the requirements of section 553 of title 5, United States Code. . The amendments made by this section shall take effect on September 23, 2020. Nothing in the amendments made by this section shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.
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Sec. 4
Quarterly manufacturer reporting with respect to drugs and devices
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