Secure Drug Supply Chain Act

Summary#

This bill directs the Secretary of Health and Human Services and the Food and Drug Administration to prevent the importation of counterfeit, unapproved, misbranded, or adulterated drugs, with a focus on drugs and drug materials coming from the People’s Republic of China and other foreign countries of concern. It requires enforcement actions, inspections, refusals of entry, and civil or criminal actions when appropriate. The bill adds new reporting rules for active pharmaceutical ingredients, key starting materials, and acquired intermediates, including country-of-origin information and recordkeeping for at least 5 years. It allows the FDA to order destruction of refused articles that present a significant public health concern, bans registration of foreign establishments tied to forced labor or sanctions violations, and creates new prohibited acts such as knowingly providing false statements about imported drugs. The bill sets deadlines for the FDA to issue proposed and final regulations and guidance and requires annual and confidential reports to Congress on supply chain vulnerabilities.

What it means for you#

  • If you import or manufacture drugs or drug ingredients that are offered for import, you may face more inspections, reporting requirements, and recordkeeping obligations (including identity, quantities, and country of origin for APIs and key starting materials).
  • Importers and owners of refused shipments may be required to destroy products the FDA determines present a significant public health concern and pay destruction costs after due process.
  • Foreign establishments that used forced labor or violated certain sanctions may be ineligible for FDA registration or have existing registrations revoked.
  • The FDA must make more information available to Congress and issue guidance and regulations on these changes.

Expenses#

No publicly available information.

Proponents' View#

The bill states its purposes as preventing unlawful importation of counterfeit and illicit drugs from the People’s Republic of China and other countries of concern, increasing visibility into the U.S. pharmaceutical supply chain, and reducing dependence on APIs and key starting materials sourced from those countries to strengthen supply resilience and protect public health and national security.

Opponents' View#

No publicly available information.