FDA removes 12 peptides, including BPC-157, from its Category 2 list, but that does not make them legal to compound
An April update to the FDA's interim 503A bulks list removed 12 peptides from the "significant safety risk" category.
On April 15, the FDA republished its interim 503A bulk drug substances list and said it would remove 12 peptides from Category 2, according to law-firm analyses. One firm reports the removals followed the original nominators formally withdrawing their nominations.
Removal from Category 2 is not placement on a list that permits compounding. Under section 503A, a bulk substance generally needs a USP monograph, must be a component of an FDA-approved drug, or must appear on an approved list. The same analysis concludes BPC-157 still meets none of those criteria, so enforcement risk is unchanged until the agency acts.
The alert we reviewed also covers GHK-Cu. Law firms disagree on how much room the change opens. Treat any claim that BPC-157 is now "legal" with caution and check the date on our legal tracker.
Sources
- D. J. Holt Law: FDA's April 2026 update on BPC-157 and GHK-Cu
- D. J. Holt Law: the legal status of BPC-157 in compounding and clinical practice
Related evidence
Cited Peptides summarizes published reporting and research for education. It is not medical or legal advice, and regulatory situations change; check the date above.