New rules would boost safety for compounded drugs and large drug-making facilities.
This bill would create new rules to make sure compounded drugs are safer for patients. It would set clear limits on how many copies of commercial drugs pharmacies can make and require reports for drugs sent out of state. Large drug-making facilities would also face stricter inspections and registration requirements.
Today, compounding pharmacies have limits on making copies of existing drugs, but the specific number isn't clearly defined. Outsourcing facilities might not need to register, and their inspections are risk-based. Their base fee is a fixed $15,000. If this bill passes, compounding pharmacies could not make copies of commercial drugs more than 20 times a month. Outsourcing facilities would all need to register, and large ones would get mandatory inspections. Their base fee would be set by the Secretary of Health and Human Services, not a fixed $15,000.
HR 6509 · 119th Congress · December 9, 2025 · AI Summary by gemini-2.5-flash · 9/10
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15 filings mentioned this bill
Amounts reflect total quarterly lobbying spend reported to the Senate, not bill-specific spending. Source: Senate LDA filings.