Holt Law April Regulatory Alert: BPC-157 California Sherman Law Risk + Federal Pre-PCAC Compliance Reminders for Compounders
Holt Law's April update on BPC-157 reminded compounders and clinics that the FDA's Category 2 removal does not authorize compounding on its own — the seven-peptide PCAC meeting on July 23–24 is required first, followed by formal rulemaking. The alert flagged California-specific exposure: the state's Sherman Food, Drug and Cosmetic Law prohibits the sale or distribution of new drugs that have not received FDA or state approval, and prescribing or dispensing BPC-157 outside approved pathways could expose physicians to significant legal risks separate from federal enforcement. The piece complements the firm's January 2 critical-status alert and the broader 2026 state-by-state compounding-enforcement divergence between California (30+ Board of Pharmacy actions since 2023) and Texas (more permissive for licensed 503A operations).