Regulatory Relief To Promote Domestic Production Of

The order aims to reduce delays in building or expanding U.S. facilities that produce medicines, active ingredients, and raw materials while increasing oversight of foreign manufacturers.

What the order does ​

• Gives the Food and Drug Administration 180 days to remove unnecessary or duplicative requirements and make reviews of domestic pharmaceutical facilities faster and more predictable.
• Directs the Food and Drug Administration to improve inspections, expand early technical assistance, clarify facility-transfer rules, and strengthen manufacturing-data reporting.
• Gives the Food and Drug Administration 90 days to improve risk-based inspections of overseas facilities, disclose inspection totals by country and manufacturer, and pursue higher foreign-facility fees where legally allowed.
• Gives the Environmental Protection Agency 180 days to streamline environmental reviews for new or expanded domestic pharmaceutical manufacturing capacity.
• Makes the Environmental Protection Agency the lead agency for environmental impact reviews of covered pharmaceutical facilities unless another agency assumes that role.
• Directs the Office of Management and Budget and permitting agencies to coordinate and expedite relevant federal permits.
• Gives the Department of the Army 180 days to consider a nationwide water-related permit tailored to pharmaceutical manufacturing facilities.

Who it affects ​

• U.S. pharmaceutical manufacturers building, expanding, or modifying production facilities.
• Foreign facilities manufacturing medicines for the U.S. market.
• Federal regulators responsible for drug-facility oversight, environmental review, and permitting.
• Companies producing active pharmaceutical ingredients, starting materials, and associated raw materials.