Title: ABC Safe Drug Act
Policy area: Health

Summary:
Anyone But China Safe Drug Act or the ABC Safe Drug Act
This bill requires the federal government to maintain a registry of certain foreign-sourced drugs, prohibits federal health care programs from purchasing drugs containing ingredients manufactured in China, and requires drugs to be labeled for country of origin.
The Food and Drug Administration shall maintain (1) a list of foreign-sourced drugs and active ingredients that are critical for consumer health and safety, and (2) another list identifying such drugs that are produced exclusively in China or use ingredients produced in China.
The bill phases in a restriction on federal health care programs purchasing drugs with active ingredients manufactured in China. By January 1, 2026, such programs may not purchase a drug with any active ingredients from China. The Department of Health and Human Services may issue a waiver for an agency or program that is unable to meet this requirement, but no waiver may apply to drugs purchased in or after 2027.
Each drug must have labeling listing the country of origin of each active ingredient, and a drug without this labeling shall be deemed misbranded.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 3401 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  1st Session
                                S. 3401

  To require the Secretary of Health and Human Services to maintain a 
   list of the country of origin of all drugs marketed in the United 
   States, to ban the use of Federal funds for the purchase of drugs 
manufactured in the People's Republic of China, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           December 15, 2021

 Mr. Cotton (for himself and Mr. Braun) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
  To require the Secretary of Health and Human Services to maintain a 
   list of the country of origin of all drugs marketed in the United 
   States, to ban the use of Federal funds for the purchase of drugs 
manufactured in the People's Republic of China, 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 ``Anyone But China Safe Drug Act'' or 
the ``ABC Safe Drug Act''.

SEC. 2. COUNTRY OF ORIGIN OF DRUGS.

    (a) In General.--Subchapter A of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at 
the end the following:

``SEC. 524B. REGISTRY OF DRUGS PRODUCED OUTSIDE THE US.

    ``(a) In General.--The Secretary shall compile and maintain a list 
of all drugs approved under subsection (c) or (j) of section 505 of 
this Act or licensed under subsection (a) or (k) of section 351 of the 
Public Health Service Act, and any active ingredients in such drugs, 
that--
            ``(1) are manufactured outside of the United States; and
            ``(2) are determined by the Secretary to be critical to the 
        health and safety of consumers in the United States.
    ``(b) Additional List.--In conjunction with the list described in 
subsection (a), the Secretary shall compile and maintain a list of 
drugs included on such list that are exclusively produced in, or use 
active or inactive ingredients produced in, the People's Republic of 
China.
    ``(c) Requirement.--The list described in subsection (a) shall, 
with respect to each drug included on the list, provide information 
about the supply chain of the drug, including each step in the supply 
chain that occurs prior to importation of the drug into the United 
States.''.
    (b) Federal Health Program Purchase of Drugs.--
            (1) In general.--Notwithstanding any other provision of 
        law, with respect to the purchase of a drug by the Department 
        of Health and Human Services, the Department of Veterans 
        Affairs, the Department of Defense, or any other Federal health 
        care program (as defined in section 1128B(f) of the Social 
        Security Act (42 U.S.C. 1320a-7b(b))), the following shall 
        apply:
                    (A) Beginning on January 1, 2024, such agency or 
                program may purchase only drugs for which 60 percent or 
                more of the active pharmaceutical ingredients are 
                manufactured in countries described in paragraph (2).
                    (B) Beginning on January 1, 2026, such agency or 
                program may purchase only drugs for which 100 percent 
                of the active pharmaceutical ingredients are 
                manufactured in countries described in paragraph (2).
            (2) Countries described.--The countries described in this 
        paragraph are countries--
                    (A) other than People's Republic of China; and
                    (B) that meet the health and safety standards of 
                the Food and Drug Administration.
            (3) Waivers.--The Secretary of Health and Human Services 
        may issue waivers of the requirements under paragraph (1) for 
        any agency or program that is unable to meet such requirements 
        and demonstrates a need for the waiver. No waiver may be issued 
        under this paragraph for drugs that are purchased on or after 
        January 1, 2027.
    (c) Labeling Requirement.--Section 502 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the 
following:
    ``(gg) If it is a drug and its labeling does not specify the 
country of origin of each active ingredient contained in the drug.''.
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