Secure Drug Supply Chain Act of 2026

(a) In general. The Secretary of Health and Human Services (referred to in this Act as the Secretary) shall utilize authorities under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) to prevent the importation of drugs, including active pharmaceutical ingredients and key starting materials, that are counterfeit, unapproved, misbranded, or adulterated and manufactured, prepared, propagated, compounded, and processed in a foreign establishment, with particular emphasis on preventing importation of such drugs, including active pharmaceutical ingredients and key starting materials, from the People’s Republic of China and other countries that are designated as adversarial by the Secretary of State.

(b) Enforcement actions. In carrying out subsection (a), the Secretary shall—

(1) conduct compliance and enforcement actions directed at entities involved in the manufacture, preparation, propagation, compounding, processing, or distribution of unapproved, adulterated, or misbranded drugs, including active pharmaceutical ingredients and key starting materials, that are offered for import;

(2) in cooperation with the Attorney General, initiate civil and criminal enforcement actions, including injunctions and seizures, under sections 301, 302, 303, 304, and 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331, 332, 333, 334, 381);

(3) refuse entry into the United States of such drugs, including active pharmaceutical ingredients or key starting materials; and

(4) conduct inspections of, or use alternative tools with respect to, as appropriate, facilities engaged in compounding to monitor for unauthorized receipt, use, or handling of drugs from the People’s Republic of China and other countries designated as adversarial by the Secretary of State that were imported into the United States in violation of applicable laws and regulations.

(c) Annual reporting. Beginning with fiscal year 2027, not later than 180 days after the end of each fiscal year, the Secretary shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, detailing enforcement actions described in subsection (b) that were taken in the previous fiscal year, including information on the number and type of drugs, active pharmaceutical ingredients, and key starting materials that were the subjects of such actions during the previous fiscal year.

(d) Guidance; recommendations. Not later than 180 days after the submission of each report under subsection (c), based on the information compiled in the report, the Secretary shall—

(1) issue or update guidance for importers of drugs to comply with the requirements of this Act, including the amendments made by this Act; and

(2) submit to Congress legislative proposals relating to resources and policies that would facilitate carrying out this Act, including the amendments made by this Act.