Title: Improved Transparency of Foreign Drug Manufacturing Act of 2022
Policy area: Health

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.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6483 Introduced in House (IH)]

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117th CONGRESS
  2d Session
                                H. R. 6483

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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            January 25, 2022

  Ms. Eshoo introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Improved Transparency of Foreign 
Drug Manufacturing Act of 2022''.

SEC. 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)) is amended by 
inserting at the end the following:
            ``(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)) is amended--
            (1) in subparagraph (D), by striking ``and'' at the end;
            (2) in subparagraph (E), by striking the period at the end 
        and inserting ``; and''; 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)) is amended by 
striking ``annually'' and inserting ``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''.
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