; (2) by redesignating paragraphs (3) and (4) as paragraphs (4) and (5), respectively; and (3) by inserting after paragraph (2) the following: (3) (A) 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. (B) 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. . (c) Rules of construction (1) Nothing in the amendments made by this section shall be construed— (A) 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 )