Securing Drug Supply Chains: Transparency and Stricter Foreign Inspections.
This legislation aims to strengthen the US drug supply chain by requiring pharmaceutical manufacturers to disclose the sources of all active and inactive ingredients annually. It tightens the definition of "country of origin" for government drug purchases and directs the FDA to prioritize inspections of facilities located in countries deemed foreign adversaries or those that are the sole global source of essential medicines. This increases transparency and aims to reduce reliance on potentially unstable foreign sources.
Key points
Drug manufacturers must annually report to the FDA the names, addresses, and percentages of all sources for active and inactive drug ingredients.
The FDA must focus inspections on facilities in countries identified as "foreign adversaries" or those that produce essential medicines with few alternative global sources.
New, stricter rules define the country of origin for Active Pharmaceutical Ingredients (APIs) used in government contracts, promoting domestic or secure sourcing.
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