Industry news

US Drug Quality and Security Act

On 28 November 2025 US President Obama signed the Drug Quality and Security Act into US law.

This Act addresses one of the omissions from FDASIA; the tracking of drug products in the USA. This new law immediately pre-empts all state laws concerning drug product track and trace, including California’s e-pedigree requirement that was scheduled to be effective from 2015.

This Act sets numerous deadlines for pharmaceutical manufacturers:

• By 1 January 2026 manufacturers must establish:
  • A lot-level transaction history that documents each step a product takes from manufacturer to final sale for all finished-dosage forms of prescription drugs (i.e. a supply chain map)
  • A system to quarantine, investigate and validate via the history record a product suspected of being counterfeit, adulterated or stolen

• Four years after enactment manufacturers must:
  • Affix product identifiers to each package and case of a product that includes a numerical identifier, lot number and expiry date
  • If a manufacturer intends to redistribute a returned product they must verify the product identifier on each package

• Ten years after enactment manufacturers must develop an electronic traceability system that identifies products down to the sales-unit level

The Act also requires the US Department of Health & Human Services (HHS) to conduct public and industry consultations on a number of topics, including one on standards for the interoperable and secure electronic exchange of data along the drug product supply chain. They must then produce standards within 18 months of the consultations on the electronic system. HHS must hold at least one pilot project that evaluates unit-level traceability and the use of the product identifier.