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Improved Transparency of Foreign Drug Manufacturing Act of 2022

USA117th CongressHR-6483| House 
| Updated: 1/26/2022
Anna G. Eshoo

Anna G. Eshoo

Democratic Representative

California

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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.
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Timeline
Jan 25, 2022
Introduced in House
Jan 25, 2022
Referred to the House Committee on Energy and Commerce.
Jan 26, 2022
Referred to the Subcommittee on Health.
  • January 25, 2022
    Introduced in House


  • January 25, 2022
    Referred to the House Committee on Energy and Commerce.


  • January 26, 2022
    Referred to the Subcommittee on Health.

Health

Related Bills

  • S 117-1366: Pharmaceutical Supply Chain Defense and Enhancement Act

Improved Transparency of Foreign Drug Manufacturing Act of 2022

USA117th CongressHR-6483| House 
| Updated: 1/26/2022
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.
View Full Text

Suggested Questions

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Timeline
Jan 25, 2022
Introduced in House
Jan 25, 2022
Referred to the House Committee on Energy and Commerce.
Jan 26, 2022
Referred to the Subcommittee on Health.
  • January 25, 2022
    Introduced in House


  • January 25, 2022
    Referred to the House Committee on Energy and Commerce.


  • January 26, 2022
    Referred to the Subcommittee on Health.
Anna G. Eshoo

Anna G. Eshoo

Democratic Representative

California

Health Subcommittee, Energy and Commerce Committee

Health

Related Bills

  • S 117-1366: Pharmaceutical Supply Chain Defense and Enhancement Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted