A bill in Congress that increases manufacturing limits on Compound Pharmaceuticals is gaining traction

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.