The Secure Drug Supply Chain Act of 2026 aims to prevent the unlawful importation of counterfeit, unapproved, misbranded, or adulterated drugs , particularly from the People's Republic of China and other adversarial countries. Its core purposes include increasing visibility into the U.S. pharmaceutical supply chain and reducing dependence on active pharmaceutical ingredients (APIs) and key starting materials (KSMs) sourced from China, thereby strengthening drug supply resilience and national security. The bill directs the Secretary of Health and Human Services to utilize existing authorities to prevent such imports, focusing on drugs manufactured in foreign establishments, especially from China or designated adversarial countries. Enforcement actions include compliance actions, civil and criminal proceedings, refusal of entry, and facility inspections. The Secretary must also submit annual reports to Congress detailing these enforcement actions and subsequently issue guidance for importers and legislative proposals. To enhance transparency, the bill amends the Federal Food, Drug, and Cosmetic Act to require drug manufacturers to report quarterly , instead of annually, on their active pharmaceutical ingredients, key starting materials, and acquired intermediates. This reporting must include the identity, total amount, and country of origin for these components, particularly for drugs on the Essential Medicines List or those sourced from China or other "foreign countries of concern." Based on these reports, the Secretary must issue a confidential annual report to Congress analyzing U.S. vulnerabilities due to dependence on these materials, identifying specific risks to public health and national security. The legislation introduces new prohibitions, banning the import of drugs from establishments known to have used forced labor or violated federal sanctions. It also allows the Secretary to order the destruction of refused articles that present a significant public health concern, without the option for export. Furthermore, it prohibits the registration of foreign establishments involved in forced labor or sanctions violations and mandates the revocation of existing registrations for such entities. New prohibited acts are established, including making materially false statements related to imported drugs, the unauthorized movement of articles ordered for destruction, or the re-importation of drugs previously refused admission. The Secretary is directed to conduct a regulatory gap analysis to identify ways to incentivize sourcing APIs and KSMs from non-Chinese origins and to propose legislative solutions for any deficiencies. Finally, the bill requires the Secretary to issue draft and final guidance defining "key starting material" and to implement regulations for all new provisions within specific timelines.
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Timeline
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Secure Drug Supply Chain Act of 2026
USA119th CongressS-5043| Senate
| Updated: 7/21/2026
The Secure Drug Supply Chain Act of 2026 aims to prevent the unlawful importation of counterfeit, unapproved, misbranded, or adulterated drugs , particularly from the People's Republic of China and other adversarial countries. Its core purposes include increasing visibility into the U.S. pharmaceutical supply chain and reducing dependence on active pharmaceutical ingredients (APIs) and key starting materials (KSMs) sourced from China, thereby strengthening drug supply resilience and national security. The bill directs the Secretary of Health and Human Services to utilize existing authorities to prevent such imports, focusing on drugs manufactured in foreign establishments, especially from China or designated adversarial countries. Enforcement actions include compliance actions, civil and criminal proceedings, refusal of entry, and facility inspections. The Secretary must also submit annual reports to Congress detailing these enforcement actions and subsequently issue guidance for importers and legislative proposals. To enhance transparency, the bill amends the Federal Food, Drug, and Cosmetic Act to require drug manufacturers to report quarterly , instead of annually, on their active pharmaceutical ingredients, key starting materials, and acquired intermediates. This reporting must include the identity, total amount, and country of origin for these components, particularly for drugs on the Essential Medicines List or those sourced from China or other "foreign countries of concern." Based on these reports, the Secretary must issue a confidential annual report to Congress analyzing U.S. vulnerabilities due to dependence on these materials, identifying specific risks to public health and national security. The legislation introduces new prohibitions, banning the import of drugs from establishments known to have used forced labor or violated federal sanctions. It also allows the Secretary to order the destruction of refused articles that present a significant public health concern, without the option for export. Furthermore, it prohibits the registration of foreign establishments involved in forced labor or sanctions violations and mandates the revocation of existing registrations for such entities. New prohibited acts are established, including making materially false statements related to imported drugs, the unauthorized movement of articles ordered for destruction, or the re-importation of drugs previously refused admission. The Secretary is directed to conduct a regulatory gap analysis to identify ways to incentivize sourcing APIs and KSMs from non-Chinese origins and to propose legislative solutions for any deficiencies. Finally, the bill requires the Secretary to issue draft and final guidance defining "key starting material" and to implement regulations for all new provisions within specific timelines.