Little Health Law Blog
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. On April 15, 2026, the Food and Drug Administration (FDA) announced that it will reconsider certain peptides for inclusion on the 503A Bulks List. This blog post discusses the significance of this announcement as it relates to peptides. 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
Peptides are smaller versions of proteins that may provide pro-aging support, anti-inflammatory, or muscle-building properties. Although popular peptides include weight loss drugs such as semaglutide or tirzepatide, certain peptides such as BPC-157 and Sermorelin are currently being used at med spas for therapeutic purposes. Peptides that are used for therapeutic purposes are not FDA-approved, so they are considered off-label use.
Section 503A of the Food, Drug & Cosmetic Act allows licensed compounding pharmacies to compound drugs for patients who have a valid prescription. The FDA has created three categories of bulk drugs substances, each of which carries its own significance. Bulk drug substances in Category 1 are eligible for inclusion on the 503A Bulks List, and compounding pharmacies can compound drugs with bulk drug substances in this category. Bulk drug substances in Category 2 contain “significant safety risks” associated with compounding, which means pharmacies cannot compound drugs containing substances in Category 2 without risking enforcement actions against them. Bulk drug substances in Category 3 have insufficient information for the FDA to evaluate them.
Popular peptides, including BPC-157 and Thymosin Beta-4, are currently in Category 2 because the FDA has cited certain risks that these peptides can invoke an immune response in the body, but the agency also lacks enough information about whether the peptides would harm humans when administered to them.
The FDA has issued warning letters to pharmacies for compounding drugs containing substances in Category 2. Although enforcement has been primarily against pharmacies or manufacturers for compounding and selling drugs with certain peptides in them, we are monitoring whether the FDA will seek enforcement actions against med spas and other practices for offering peptides to patients.
Recently, in February 2026, Secretary of Health and Human Services Robert F. Kennedy, Jr. has admitted to using peptides and has pushed for the FDA to loosen regulations on popular peptides.
FDA Announcement
On April 15, 2026, the FDA announced it will 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.
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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