fda warning letters bpc-157 compounding pharmacies Content Analysis of US Issued to Regarding Violations of Current Good Manufacturing Practices Between 2017 and 2022 | Journal of Pharmaceutical Innovation Compounding warning letters to 503A

Dose-response studies indicate that BPC-157 at 800 ng/kg produces near-complete ulcer healing with thick granulation tissue formation, demonstrating potent effects at remarkably low doses

A phase I safety study in healthy adults confirmed that subcutaneous MOTS-c injections at doses up to 10 mg produced no serious adverse events, with a pharmacokinetic profile supporting once-daily or every-other-day dosing [3]

Notably, depending on the deficiencys severity, patients may need five (5) to seven (7) shots in their first week of treatment

On April 15, 2026 the FDA removed BPC-157 (and 11 other peptides) from that Category 2 list