Nationwide: what the FDA's peptide review means for your med spa

Key facts:

• On February 27, 2026, HHS Secretary Robert F. Kennedy Jr. said the FDA may take new action on about 14 peptides then restricted in Category 2.
• The comments came in a podcast interview, not a formal FDA action.
• In 2023, 19 peptides were placed in Category 2, making them ineligible for compounding by 503A pharmacies.
• Peptides discussed include BPC-157, thymosin beta-4 (TB-500), AOD-9604, and CJC-1295.
• The FDA later removed 12 peptides from Category 2 on April 22, 2026, but removal is not approval (see below).

What did RFK Jr. say about the FDA peptide restrictions?

On February 27, 2026, HHS Secretary Robert F. Kennedy Jr. said in a podcast interview that the FDA was looking at new action on about 14 of the peptides then sitting in Category 2 of the agency's 503A bulk drug substances list. He argued the original designations went through without the safety signal the FDA normally requires. Those were remarks in an interview, not a rule change.

What is Category 2 of the FDA's 503A list?

In 2023, the FDA moved a group of peptide substances into Category 2, the group it reserves for ingredients that raise a significant safety or regulatory concern. Category 2 substances are not eligible for compounding, which means licensed 503A pharmacies cannot legally formulate them for patient-specific prescriptions. You can read the FDA's explanation of these bulk drug substances that may present significant safety risks, and the underlying list in 21 CFR 216.23.

Which peptides are affected?

The peptides discussed include ones some practices know well, such as BPC-157, thymosin beta-4 (TB-500), AOD-9604, and CJC-1295. For a med spa, Category 2 status is the difference between being able to source an ingredient from a licensed compounding pharmacy and not.

Has anything actually changed for med spas?

At the time of the interview, no. Since then, on April 22, 2026, the FDA did remove 12 peptides from Category 2, but because their nominations were withdrawn, not because they were cleared for compounding. Removal is not approval, and the existing Section 503A requirements remain in effect. The safest position is to treat the current rules as the rules and watch for formal FDA action. (We cover the April 22 removal in a separate post.)

What should med spas do now?

• Confirm every peptide in your treatment protocols is currently eligible for compounding under FDA bulk substance guidance.
• Review prescriber documentation so patient evaluations and medical necessity are recorded properly.
• Check that the compounding pharmacies you work with are licensed and supplying under Section 503A.
• Keep your marketing language tied to prescriber authority, and steer clear of therapeutic claims you can't support.

FAQs

Did the FDA remove peptides from Category 2?

When this story broke in February 2026, no. The FDA later removed 12 peptides from Category 2 on April 22, 2026, but that was due to withdrawn nominations, not approval for compounding.

Can my med spa source BPC-157 or CJC-1295 right now?

Not on the basis of these developments. Removal from Category 2 is not approval, and eligibility under Section 503A still has to be confirmed before sourcing.

What is a 503A compounding pharmacy?

A pharmacy that compounds medications for individual patient-specific prescriptions under Section 503A of the Federal Food, Drug, and Cosmetic Act.

Fresh Clinics gives med spa owners the clinical oversight and compliance infrastructure to stay ahead of changes like this one. Learn more about Fresh Clinics membership.