BPC-157
ContestedTissue Repair
Our read of public sources: some pharmacies compound it under a legal theory — a differentiated-formulation argument, or in anticipation of a pending committee recommendation — that no court ruling or final FDA rule has settled either way. We're flagging this as actively debated, not as a green or red light. This is not a legal determination; verify independently before relying on it.
Not legal advice. Every status on this page is our own reading of public FDA guidance, shortage listings, and committee materials — it has not been reviewed by an attorney and is not a legal determination. "Contested" means pharmacies and regulators publicly disagree, not that we're resolving the disagreement. Verify independently, and check with counsel, before relying on any entry here.
Current status
Not currently on the permitted 503A bulk substances list, but the Pharmacy Compounding Advisory Committee voted 8–6 (1 abstain) on July 23–24, 2026 to recommend adding it for ulcerative colitis/tissue-healing use — FDA staff opposed, citing insufficient characterization data and unknown immunogenicity risk for an injectable. A PCAC recommendation is not final rulemaking; until FDA acts, it remains outside the permitted list. Frequently sold RUO despite this; FDA treats RUO labeling as immaterial when site context implies human use.
Last changed: 2026-07-24