The US Food and Drug Administration (USFDA) has unveiled a new program aimed at strengthening the domestic pharmaceutical supply chain by increasing regulatory predictability and facilitating the construction of manufacturing sites in the United States.

The FDA PreCheck program was developed in response to Executive Order 14293, "Regulatory Relief to Promote Domestic Production of Critical Medicines," which directs the FDA to streamline review of domestic pharmaceutical manufacturing and eliminate unnecessary regulatory requirements while maximising review timeliness and predictability.

Currently, more than half of the pharmaceuticals distributed in the US are manufactured overseas. Additionally, the US relies heavily on foreign sources for active pharmaceutical ingredients (APIs). Of the manufacturers that produce APIs used in FDA-approved products, only 11 percent are based in the United States.

 “Our gradual overreliance on foreign drug manufacturing has created national security risks,” said FDA Commissioner Marty Makary.

“The FDA PreCheck initiative is one of many steps FDA is taking that can help reverse America's reliance on foreign drug manufacturing and ensure that Americans have a resilient, strong, and domestic drug supply,” he added.

The PreCheck program introduces an innovative two-phase approach to facilitate new drug manufacturing facilities in the US.

The first, the Facility Readiness Phase, provides manufacturers with more frequent FDA communication during critical development stages, including facility design, construction, and pre-production. This phase also encourages companies to submit a comprehensive, facility-specific Type V Drug Master File (DMF), which includes information such as site layout and operations, elements of the Pharmaceutical Quality System, and Quality Management Maturity practices. This DMF can then be incorporated by reference into a drug application, as appropriate.

The second, the Application Submission Phase, focuses on streamlining the development of the chemistry, manufacturing, and controls (CMC) section of the application through pre-application meetings and early feedback.

The FDA will present the PreCheck draft framework at a public meeting on September 30, 2025, at the FDA White Oak Campus in Silver Spring, Maryland. The meeting will also include stakeholder discussions on the framework’s strengths and opportunities, as well as exploration of additional considerations to address current onshoring challenges relevant to the FDA’s authority.