SAFE Drugs Act of 2025
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Summary
The SAFE Drugs Act of 2025 amends federal pharmacy regulations to restrict compounding pharmacies from producing copies of commercially available drugs more than 20 times per month, and requires reporting when pharmacies compound such drugs for out-of-state patients exceeding that threshold. The bill also imposes stricter inspection and registration requirements on large-scale outsourcing facilities (those compounding more than 100 times annually) and authorizes the FDA to set base establishment fees for compounding facilities.
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How your representatives voted
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