Bipartisan Bill Would Raise FDA Compounding Copy Limits Fivefold
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H.R.6509, the SAFE Drugs Act of 2025, introduced by Rep. Yakym in December 2025, would raise the monthly limit on pharmacists or physicians compounding drugs that are essentially copies of commercially available drugs from the FDA's current 4 to 20. It would also add reporting requirements for facilities compounding more than 20 such prescriptions monthly for out-of-state patients, and require biennial inspections of large-scale compounders. The bill has drawn bipartisan cosponsors and is gaining traction, but it remains pending in the House Energy and Commerce Committee. Open questions include whether it advances out of committee and how the expanded limits and inspection regime would be implemented.
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H.R.6509, the SAFE Drugs Act of 2025, introduced by Rep. Yakym on 2025-12-09 and pending in the Energy and Commerce Committee, would raise the monthly limit on pharmacists or physicians compounding drugs that are essentially copies of commercially available drugs from FDA's current 4 to 20. It would add reporting requirements for facilities compounding more than 20 such prescriptions monthly for out-of-state patients and biennial inspections of large-scale compounders. The bill has drawn bipartisan cosponsors and remains in committee.
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