Improved Transparency of Foreign Drug Manufacturing Act of 2022

To amend the Federal Food, Drug, and Cosmetic Act to clarify reporting requirements for establishments within a foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of an active pharmaceutical ingredient, and for other purposes. 1. Short title This Act may be cited as the Improved Transparency of Foreign Drug Manufacturing Act of 2022 2. Reporting requirement for drug manufacturers (a) Establishments in a foreign country Section 510(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(i) (5) 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 or active pharmaceutical ingredient 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. . (b) Listing of drugs Section 510(j)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(j)(1) (1) in subparagraph (D), by striking and (2) in subparagraph (E), by striking the period at the end and inserting ; and (3) by adding at the end the following: (F) in the case of a drug contained in the applicable list, a certification that the registrant has— (i) identified every other known establishment where manufacturing is performed for the drug; and (ii) 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. . (c) Quarterly reporting on amount of drugs manufactured Section 510(j)(3)(A) of the Federal Food, Drug, and Cosmetic Act (as added by section 3112 of the CARES Act ( Public Law 116–136 annually 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

Summary: Improved Transparency of Foreign Drug Manufacturing Act of 2022 This bill modifies requirements for certain foreign establishments that manufacture drugs (including active pharmaceutical ingredients) to register with the Food and Drug Administration (FDA). Under this bill, if an establishment outside of the United States manufactures (or otherwise processes or prepares) a drug to be imported (or offered for import) into the United States, the establishment must comply with the registration requirements even if the drug undergoes further manufacturing at another non-U.S. establishment prior to importation into the United States. A non-U.S. manufacturing establishment must also file with the FDA a list of drugs manufactured by the establishment. For each drug on the list, the establishment must (1) identify every other known establishment where additional manufacturing is performed, and (2) notify each foreign establishment involved of the listing of the drug and the obligation to register with the FDA. The bill also requires each registered non-U.S. manufacturing establishment to report every three months to the FDA a list of each drug it manufactures for commercial distribution, where currently this report is required once a year.