ABC Safe Drug Act

Bill: 117-s-3401
Sponsor: full_name: Sen. Cotton, Tom [R-AR]
Introduced: 2021-12-15
Policy area: Health
Latest action: action_date: 2021-12-15
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Summaries:
action_date: 2021-12-15
action_desc: Introduced in Senate
text: <p><strong>Anyone But China Safe Drug Act or the ABC Safe Drug Act </strong></p> <p>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.</p> <p>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. </p> <p>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.</p> <p>Each drug must have labeling listing the country of origin of each active ingredient, and a drug without this labeling shall be deemed misbranded. </p>

tv_txt: II 117th CONGRESS 1st Session S. 3401 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.

1. Short title This Act may be cited as the Anyone But China Safe Drug Act or the ABC Safe Drug Act . 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: 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. .