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# FDA Steps to Boost U.S. Drug Production
- URL: https://www.fdaweb.com/fda-steps-to-boost-u-s-drug-production/
- Published: 2025-08-07T12:00:00.000Z
- Updated: 2026-09-14T15:18:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159643

FDA is launching FDA PreCheck, a new program it says will “strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability and facilitating the construction of manufacturing sites in the U.S.” An agency [announcement](https://www.fda.gov/news-events/press-announcements/fda-announces-new-fda-precheck-program-boost-us-drug-manufacturing?utm%5Fmedium=email&utm%5Fsource=govdelivery) says more than half of the drugs distributed in the U.S. are manufactured overseas, and only 11% of active pharmaceutical ingredient manufacturers are U.S. companies.

“Our gradual overreliance on foreign drug manufacturing has created national security risks,” says FDA commissioner **Martin 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.”

The PreCheck program has two phases:

- Facility Readiness Phase – providing manufacturers with more frequent FDA communication at critical development stages, including facility design, construction, and pre-production, and encouraging companies to provide comprehensive facility information through a Type V drug master file; and
- Application Submission Phase – streamlining development of the Chemistry, Manufacturing, and Controls section of an application through pre-application meetings and early feedback.

FDA says it will host a 9/30 public meeting at its White Oak Campus with virtual participation available to present the PreCheck draft framework and have stakeholder discussions on framework strengths and opportunities, and exploration of additional considerations to overcome current onshoring challenges relevant to FDA authority.