Sec. 70534. Reporting requirement for drug manufacturers
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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, that is required to be listed pursuant to subsection (j). Such requirements shall apply regardless of whether the drug, including the active pharmaceutical ingredient, undergoes further manufacture, preparation, propagation, compounding, or processing at a separate establishment outside the United States prior to being imported or offered for import into the United States. . Section 510(j) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(j) ) is amended— in paragraph (1)— 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. ; by redesignating paragraphs
(3)and
(4)as paragraphs
(4)and (5), respectively; and by inserting after paragraph
(2)the following: Subject to subparagraph (B), each person who registers with the Secretary under this section shall report to the Secretary by electronic means in a form and manner as specified by the Secretary, with regard to drugs, once during the month of March of each year, once during the month of June of each year, once during the month of September of each year, and once during the month of December of each year, on the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed at each establishment registered by such person since the date the person last made a report under this paragraph. Such amount shall include the number of dosage units for each finished drug product intended for distribution in the United States, or amount of active pharmaceutical ingredient intended for distribution in the United States. The Secretary may require information reported under this subparagraph to be further delineated in such manner as the Secretary determines appropriate. Notwithstanding subparagraph (A), the Secretary may issue an order exempting certain biological products or categories of biological products licensed under section 351 of the Public Health Service Act from some or all of the reporting requirements under such subparagraph if the Secretary determines that the application of such requirements to such products (or categories thereof) is not necessary to protect the public health. . Nothing in the amendments made by this section shall be construed— to limit or narrow, in any manner, the meaning or application of the provisions of subsection
(i)or
(j)of section 510 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360 ); or to affect any determination under either such subsection made prior to the date of enactment of this Act. Nothing in the amendments made by this section shall be construed— to limit or narrow the ability of the Secretary of Health and Human Services to share confidential commercial information pursuant to a memorandum of understanding, entered into before, on, or after the date of enactment of this section, between the Food and Drug Administration and another Federal department or agency; or as authorizing the Secretary to disclose any information that is confidential commercial or trade secret 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. 70534
Reporting requirement for drug manufacturers
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