FDA places BPC-157 in Category 2 significant safety risks
The September 2024 update to the 503A bulk list keeps BPC-157 off the lawful compounding list because of safety concerns.
As of September 27, 2024, FDA categorizes BPC-157 as a 503A bulk drug substance that raises significant safety concerns (Category 2). It is not on the list of substances that can be used in 503A compounding.
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FDA's September 27, 2024 update to the 503A bulk drug substances list places BPC-157 in Category 2: Bulk Drug Substances that Raise Significant Safety Concerns. The agency also published a safety-risk summary noting concerns about peptide-related impurities, aggregation, and immunogenicity for peptides such as BPC-157.
This status is different from an FDA approval or a final rule adding BPC-157 to the permitted bulk list. Category 2 substances are not on the 503A bulk list and therefore do not have a recognized federal pathway for 503A compounding.
What did not change
BPC-157 was not approved. WADA's S0 prohibition remains in effect. State and federal enforcement against unapproved products can still occur.
Key takeaways
- ✓ BPC-157 is not an FDA-approved drug.
- ✓ Category 2 status means FDA identified significant safety risks.
- ✓ A later advisory committee meeting can make recommendations, but it cannot itself approve BPC-157.
What changed
FDA formally placed BPC-157 in 503A Category 2.
What did not change
BPC-157 remains unapproved; no lawful 503A compounding pathway opened.
Next step
FDA's Pharmacy Compounding Advisory Committee is scheduled to discuss BPC-157-related bulk substances; any recommendation is advisory.
Affected records
Controlling documents
- Bulk Drug Substances Nominated for Use in Compounding Under Section 503A
U.S. Food and Drug Administration · Agency list · FDA-2015-N-3534
- FDA Briefing Document: BPC-157-Related Bulk Drug Substances (PCAC July 2026)
U.S. Food and Drug Administration · Advisory committee briefing · FDA-2026-N-XXXX