Title: Protecting our Pharmaceutical Supply Chain from China Act of 2021
Policy area: Health

Summary:
Protecting our Pharmaceutical Supply Chain from China Act of 2021
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, requires drugs to be labeled for country of origin, and offers domestic manufacturing facility tax incentives.
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, 2024, 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 2026.
Each drug must have labeling listing the country of origin of each active ingredient, and a drug without this labeling shall be deemed misbranded.
The bill allows 100% tax expensing for qualified pharmaceutical and medical device manufacturing property placed in service between 2020 and 2026.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 2495 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  1st Session
                                S. 2495

  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

                             July 28, 2021

    Mr. Cotton (for himself, Mrs. Blackburn, Mr. Cruz, Mr. Scott of 
 Florida, and Mr. Braun) introduced the following bill; which was read 
             twice and referred to the Committee on Finance

_______________________________________________________________________

                                 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 ``Protecting our Pharmaceutical Supply 
Chain from China Act of 2021''.

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, the Department of Health and Human Services, the 
        Department of Veterans Affairs, the Department of Defense, and 
        any other Federal health care program (as defined in section 
        1128B(f) of the Social Security Act (42 U.S.C. 1320a-7b(b))), 
        with respect to the purchase of a drug by such agency or 
        program, the following shall apply:
                    (A) Beginning on January 1, 2023, 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, 2024, 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, 2026.
    (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.''.

SEC. 3. TEMPORARY 100 PERCENT EXPENSING FOR PHARMACEUTICAL AND MEDICAL 
              DEVICE MANUFACTURING PROPERTY.

    (a) In General.--For purposes of section 168(k) of the Internal 
Revenue Code of 1986, in the case of any qualified pharmaceutical and 
medical device manufacturing property which is placed in service after 
December 31, 2019, and before January 1, 2027--
            (1) such property shall be treated as qualified property 
        (within the meaning of such section),
            (2) the applicable percentage otherwise determined under 
        section 168(k)(6) of such Code with respect to such property 
        shall be 100 percent, and
            (3) paragraph (8) of such section shall not apply.
    (b) Qualified Pharmaceutical and Medical Device Manufacturing 
Property.--For purposes of this section, the term ``qualified 
pharmaceutical and medical device manufacturing property'' means any 
tangible property placed in service in the United States as part of the 
construction or expansion of property for the manufacture of drugs (as 
defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 321(g))) or medical devices (as defined in section 201(h) of 
such Act (21 U.S.C. 321(h))).
                                 <all>