The February 2026 Announcement
On February 27, 2026, HHS Secretary Robert F. Kennedy Jr. announced that approximately 14 of 19 peptides previously restricted from compounding would be expected to return to legal compounding status. The announcement was made during a widely-shared media appearance and later covered by NPR and multiple health publications. This represents a significant potential regulatory shift for patients and clinics who have worked with these compounds under physician supervision.
At Vitality Texas, Dr. Jaqua has monitored this development closely. Our peptide therapy program is structured around physician-supervised protocols that evolve as the regulatory landscape changes. This article explains what the announcement means, what remains pending, and what is currently available through our program.
What “Expected Reclassification” Means
The announcement signals intent — not completion. The formal mechanism for restoring legal compounding access is an FDA publication in the Federal Register. That publication would move specific peptides from the Category 2 bulk drug substance list — the restricted category that prohibited their compounding — back to Category 1, where they are legal for 503A compounding pharmacies to produce with a valid physician prescription.
Updated September 2026.Two things have happened since the February announcement, and neither of them authorises compounding. In April 2026 the FDA's own listing moved BPC-157, TB-500 and CJC-1295 into the “nominated but withdrawn” group, because the parties who nominated them withdrew those nominations. Coming off the Category 2 list is not the same as being placed on the 503A bulks list, so it does not create permission to compound. Then on 23 and 24 July 2026 the FDA's Pharmacy Compounding Advisory Committee voted to recommend BPC-157, TB-500, KPV, MOTS-c, Semax and Epitalon for the 503A bulks list, against the recommendation of FDA's own reviewers. That vote is a recommendation to the agency. It begins a formal rulemaking process rather than concluding one, and rulemaking of this kind typically runs many months.
The 14 peptides expected to return to legal compounding status (pending formal publication) are:
- BPC-157 (Body Protection Compound-157)
- TB-500 (Thymosin Beta-4)
- Thymosin Alpha-1
- AOD-9604
- Ipamorelin
- CJC-1295
- Selank
- Semax
- GHK-Cu
- KPV
- MOTS-c
- Epitalon
- Kisspeptin-10
- DSIP (Delta Sleep-Inducing Peptide)
The 5 peptides expected to remain in Category 2 (restricted from compounding) are: Melanotan II, GHRP-2, GHRP-6, LL-37, and PEG-MGF.
What This Means for Vitality Texas Patients
At Vitality Texas, our peptide program currently includes Sermorelin — a growth hormone secretagogue that was never on the Category 2 restricted list — and NAD+ injectable therapy, which was also not part of the restriction. Both are available via licensed 503A compounding pharmacies with a physician prescription, and both are prescribed off-label at physician discretion rather than under an FDA approval for these uses. For background on each, see what is sermorelin? and NAD+ therapy benefits.
If and when rulemaking completes and these compounds are actually placed on the 503A bulks list, Dr. Jaqua will evaluate which of them can be incorporated into patient protocols through our licensed compounding pharmacy partners. Those decisions will be based on the final rule text, updated pharmacy capabilities, and her clinical assessment for each patient. We are not currently offering compounds that are not authorised for compounding, and you should be cautious of any clinic or vendor telling you otherwise — in August 2026 the FDA issued warning letters to five online peptide sellers over products marketed for human use.
What About BPC-157?
BPC-157 is among the 14 peptides included in the expected reclassification announced by HHS on February 27, 2026. The announcement is a meaningful regulatory signal — it indicates that the FDA is expected to move BPC-157 from Category 2 back to Category 1, restoring legal compounding access.
However, because the formal FDA publication has not been released, BPC-157 cannot yet be prescribed through licensed 503A compounding pharmacies. At Vitality Texas, we are not currently offering BPC-157 through our program until the formal reclassification is published and our legal team has reviewed the updated guidance. Patients who are interested in BPC-157 for tissue recovery or gut health should schedule a consultation — Dr. Jaqua can discuss the anticipated timeline and what the reclassification would mean for their specific protocol once the formal publication is issued.
We will update this article when the formal FDA publication is released. Do not rely on any clinic or pharmacy telling you BPC-157 is “available now” until the formal reclassification has been published and verified.
How to Stay Informed and Next Steps
The regulatory landscape for peptide therapy in 2026 is genuinely evolving. The Kennedy announcement is real and represents a meaningful change in regulatory direction. But the formal FDA publication — the step that actually changes what compounding pharmacies can legally produce — is still pending.
For patients interested in peptide therapy, the appropriate step is a physician consultation. Dr. Jaqua will review your health history, lab results, and goals, and discuss which peptides are currently available through our licensed pharmacy partners, what the expected reclassification timeline looks like, and how your protocol may expand once the formal publication is released. If you are earlier in the process, peptide therapy 101 covers the basics and am I a candidate for peptide therapy? covers who is screened in and out.
Federal classification is only half of the picture. What a patient in Texas can actually be prescribed also depends on state law, on who holds the prescribing licence and on what a 503A pharmacy is permitted to compound — how peptide therapy is prescribed and compounded in Texas sets out that side of it.
Schedule a peptide therapy consultation at Vitality Texas →
Dr. Jaqua reviews each patient's lab results and health history before recommending any peptide protocol. All peptides at Vitality Texas are sourced from licensed compounding pharmacies — not gray market suppliers. Physician-supervised peptide therapy means the right compounds, at the right doses, within the current legal framework.
Frequently Asked Questions
Are peptides legal in 2026?
Some peptides have never been restricted. Sermorelin and NAD+ are available via licensed 503A compounding pharmacies with a physician prescription and were not part of the 2024 restriction that created the Category 2 list. Fourteen other peptides — including BPC-157, TB-500, and CJC-1295 — were announced for expected reclassification by HHS Secretary Kennedy on February 27, 2026, but the formal FDA publication restoring their legal compounding status has not yet been released as of this writing. Until that formal publication is issued, compounding pharmacies cannot legally resume production of those 14 compounds.
Is BPC-157 legal to prescribe now?
Not yet. BPC-157 is among the 14 peptides announced for expected reclassification by HHS on February 27, 2026. However, the formal FDA publication — the mechanism that legally moves a compound from the Category 2 restricted list back to Category 1 — has not been released as of this writing. Until that publication is issued, licensed 503A compounding pharmacies cannot legally compound BPC-157, and physicians cannot prescribe it through those channels. We will update this article when the formal publication is released.
What does 'Category 2' mean in the context of FDA peptide regulations?
The FDA classifies bulk drug substances used in compounding into categories. Category 1 substances are approved for use in 503A compounding pharmacies with a physician prescription. Category 2 substances have been placed on the restricted list due to safety concerns — meaning compounding pharmacies cannot legally produce them. The February 2026 Kennedy announcement signaled intent to move 14 compounds from Category 2 back to Category 1, but that move requires a formal FDA publication to take effect.
Does the Kennedy announcement mean I can get these peptides now?
Not yet. The announcement by HHS Secretary Robert F. Kennedy Jr. on February 27, 2026 signals regulatory intent — it is not itself a regulatory action. The formal mechanism is an FDA publication in the Federal Register moving specific peptides from the Category 2 restricted list. Until that publication is issued, the legal status of these 14 compounds has not changed. Compounding pharmacies operate under federal law and cannot resume production based on an announcement alone.
What peptides are currently available at Vitality Texas?
Vitality Texas currently offers Sermorelin — a growth hormone secretagogue that was never restricted — and NAD+ injectable therapy, which was not on the Category 2 restricted list. Dr. Jaqua evaluates each patient individually based on their lab results, health history, and goals before recommending any peptide protocol. As the regulatory landscape evolves and the formal FDA publication is released, Vitality Texas will evaluate which additional compounds can be incorporated into patient protocols through our licensed compounding pharmacy partners. To discuss what is currently available for your situation, schedule a consultation through our peptide therapy program page.