Secure Drug Supply Chain Act of 2026

The Secure Drug Supply Chain Act of 2026 directs the Food and Drug Administration (FDA) to prevent the importation of counterfeit, unapproved, misbranded, or adulterated drugs from China and other adversarial countries, and to increase transparency and resilience in the U.S. pharmaceutical supply chain.

Sec. 3, Prevention of importation of unlawful counterfeit drugs: The Secretary of Health and Human Services must use existing FDA authorities to stop the import of counterfeit, unapproved, misbranded, or adulterated drugs, especially from China and countries designated as adversarial. This includes enforcement actions, inspections, and annual reporting to Congress on such actions.

Sec. 4, Supply chain transparency and resilience: Drug manufacturers must report quarterly on active pharmaceutical ingredients (APIs) and key starting materials, including their country of origin, for drugs on the Essential Medicines List or sourced from China or other foreign countries of concern. The Secretary must issue regulations and a confidential report to Congress analyzing U.S. vulnerabilities and supply chain dependencies.

Sec. 5, Amendments to the Federal Food, Drug, and Cosmetic Act: The bill bans imports of drugs from establishments using forced labor or violating sanctions, allows destruction of refused drugs that pose significant public health concerns, prohibits registration of foreign establishments using forced labor or violating sanctions, and adds new prohibited acts including false statements and reimportation of previously refused drugs. It also defines adulterated drugs based on inspection frequency and forced labor or sanctions violations.

Sec. 6, Defining key starting material: The Secretary must issue draft and final guidance defining the term "key starting material" within 90 and 180 days of enactment, respectively.