UPDATE: FDA Committee Votes on Popular Peptides for Inclusion on 503A Bulks List

Our healthcare law firm works with many providers and healthcare practices to assist them in complying with federal, state, and local laws. In particular, our med spa clients often ask whether they can offer peptides as part of their practice. Peptides have garnered recent popularity among med spas, but offering peptides also carries legal risk. In a prior blog post, our firm wrote that the Food and Drug Administration (FDA) announced that it would reconsider certain peptides for inclusion on the 503A Bulks List. This blog post discusses the results of this meeting that occurred from July 23-24, 2026. If you need assistance setting up a med spa to offer peptides or would like to discuss this blog post, you may contact our healthcare law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

Background of FDA Announcement

On April 15, 2026, the FDA announced it would hold a meeting from July 23-24, 2026, to discuss popular peptides, including BPC-157, TB-500, KPV, and MOTs-C, for inclusion on the 503A Bulks List. If these peptides are included on the 503A Bulks List, this means that the FDA has reclassified them into Category 1, which means compounding pharmacies can freely compound drugs with these peptides pursuant to a valid prescription without risk of an enforcement action, but it does not mean that these peptides are now FDA-approved. Our firm will continue to monitor the results of this meeting.

FDA Committee Meeting and Its Significance

The FDA’s Pharmacy Compounding Advisory Committee recommended that six of the seven peptides be included on the 503A Bulks List. The peptides recommended to be included are BPC-157, KPV, TB-500, MOTs-C, Epitalon, and Semax, and the only peptide recommended not to be included was Emideltide. The Committee’s recommendation is only a recommendation and does not mean that these six peptides can be used for compounding. The recommendation goes to the FDA for a full vote, and only the FDA has the authority to implement regulations to place these peptides on the 503A Bulks List, which would greenlight compounding pharmacies to use these peptides when compounding drugs. Our Firm will continue to monitor the FDA’s vote.

If you need assistance setting up a med spa that offers peptides, have questions about whether your practice is compliant with the various laws and regulations surrounding peptides, or would like to discuss this blog post, you may contact our healthcare law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

 

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