On August 7, 2025, the U.S. Food and Drug Administration (FDA) announced the launch of the PreCheck program, a strategic initiative aimed at strengthening the domestic pharmaceutical supply chain.

The primary objective of this program is to reduce dependence on foreign drug manufacturing, a vulnerability that poses significant risks to national security.

Currently, more than 50% of pharmaceutical products distributed in the U.S. are produced outside the country, and only 11% of FDA-approved active pharmaceutical ingredient (API) manufacturers are domestic.

WHOM DOES IT IMPACT?

The direct impact is on human drug manufacturing facilities, active pharmaceutical ingredient production systems, biological and biotechnological drug plants, software and digital systems, automated production systems, CMC control, and traceability.

CONCLUSION:

The FDA's PreCheck program marks a decisive step toward U.S. pharmaceutical sovereignty by promoting regulatory incentives that facilitate the establishment of domestic drug plants.