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H.R. 6509119th CongressIn committeeLatest action Dec 9, 2025Decoded by AI · checked against the record
The plain-language version leads. The official text is always the reference.
The SAFE Drugs Act of 2025 caps near-copy compounded drugs at 20 monthly and adds FDA reporting and inspections.
45-second read · 4 questions answered below
The bill narrows the definition of an illegal "copy" of a commercial drug and limits pharmacies to 20 near-copies per month for a patient unless a documented medical difference exists. It adds annual FDA reporting for compounders exceeding that limit for out-of-state patients, mandates inspections for large outsourcing facilities before and every two years after making a new drug, removes a registration exemption, and lets the FDA set its own base registration fee instead of a fixed amount.
Affects compounding pharmacies, large-scale drug outsourcing facilities, and prescribing physicians; hospital pharmacies treating their own patients are exempt from the new reporting rule.
The changes give the FDA more oversight and data on large-scale production of drugs resembling existing commercial medications, which could affect how available certain customized medications are to patients.
AI-drafted summary. Verify it against the official text before you act on it. Read the official bill on Congress.gov
Right now: a House committee is reviewing it. If the Senate changes it, it goes back to the House before reaching the President.
Latest action: — Referred to the House Committee on Energy and Commerce.