3.0.0 6483 2023-08-03T14:30:25Z 2023-08-03T14:30:25Z House HR 2022-01-25 117 [Congressional Record Volume 168, Number 16 (Tuesday, January 25, 2022)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Ms. ESHOO:H.R. 6483.Congress has the power to enact this legislation pursuantto the following:Article I, Clause 8[Page H302]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2022-01-26T15:46:26Z Referred to 2022-01-25T15:04:40Z Pharmaceutical Supply Chain Defense and Enhancement Act 117 1366 S 2021-04-26 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS 2022-01-26 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2022-01-25 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2022-01-25 Introduced in House IntroReferral Intro-H 9 Library of Congress 2022-01-25 Introduced in House IntroReferral 1000 9 Library of Congress E000215 Rep. Eshoo, Anna G. [D-CA-18] ANNA ESHOO D CA G. 18 N Health Health 00 2022-01-25 Introduced in House 2023-08-03T14:20:27Z 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.

]]> Improved Transparency of Foreign Drug Manufacturing Act of 2022 Display Title Improved Transparency of Foreign Drug Manufacturing Act of 2022 Short Title(s) as Introduced Improved Transparency of Foreign Drug Manufacturing Act of 2022 Introduced in House IH Official Title as Introduced 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. Introduced in House IH Introduced in House 2022-01-25T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-117hr6483ih/xml/BILLS-117hr6483ih.xml 2022-01-26 Referred to the Subcommittee on Health. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.