US SB3794

Limits compounding pharmacies to producing copies of commercially available drugs no more than 20 times per month, with exceptions only for patient-specific changes that produce significant therapeutic differences as determined by the prescribing practitioner

Requires pharmacies, facilities, or physicians that compound drugs more than 20 times monthly for out-of-state patients to submit annual reports to the Secretary identifying drug types and monthly compounding totals, beginning in calendar year 2025

Mandates pre-operation inspections and biennial reinspections for "large-scale outsourcing facilities" that compound more than 100 drug products annually, with these requirements taking effect 6 months after enactment

Removes registration exemptions for outsourcing facilities, subjecting them to standard drug establishment registration and reporting requirements under Section 510 of the Federal Food, Drug, and Cosmetic Act

Replaces the fixed $15,000 base establishment fee with a variable amount set by the Secretary to fund compounded drug safety activities