Requires more oversight for pharmacies and facilities that make specialized drugs.
This bill would set new limits on how often pharmacies can make copies of existing drugs. It would also require some pharmacies and facilities to report more information and face stricter inspections. These changes aim to improve the safety of specialized drug products.
Today, compounding pharmacies may have different rules for how often they can make copies of commercially available drug products, and some outsourcing facilities are exempt from certain registration and reporting requirements. This bill would establish a clear limit of 20 times per month for compounding copies of commercially available drugs and require annual reports for out-of-state compounding. It would also remove a registration exemption for all outsourcing facilities and mandate specific inspection schedules for large-scale outsourcing facilities, aiming to increase oversight.
S 3794 · 119th Congress · AI Summary by gemini-2.5-flash · 8/10
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14 filings mentioned this bill
Amounts reflect total quarterly lobbying spend reported to the Senate, not bill-specific spending. Source: Senate LDA filings.