BPC-157 regulatory note updated for FDA compounding restrictions
We clarified BPC-157's status after the FDA placed it in compounding category 2 — substances that may present significant safety risks — reinforcing its research-chemical grade.
What happened
We updated BPC-157’s regulatory note to reflect the FDA’s evaluation placing it among substances with significant safety concerns for compounding — a category that restricts compounding pharmacies from using it.
Why it matters
This does not change BPC-157’s evidence grades, which remain D — Preclinical for its healing claims and U — Unknown for long-term human safety. It does underline the core point: BPC-157 is not an approved therapeutic, its human evidence is essentially absent, and the regulatory system treats it accordingly. No grade changed; the regulatory context did.
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