Regulatory status
Where the compounding question currently stands.
Research peptides are inside an active federal review. This page is a plain summary of that record. Nothing on it changes the research-use-only status of any material we supply, and nothing on it should be read as guidance for any use in humans or animals.
Last revised August 17, 2026
The July 2026 advisory committee votes
On July 23–24, 2026, the FDA's Pharmacy Compounding Advisory Committee reviewed seven peptides nominated for the Section 503A Bulk Drug Substances List — the list that permits licensed pharmacies to compound with a bulk substance that has no USP monograph and is not a component of an approved drug. FDA's own review staff had recommended against adding any of the seven. The committee voted otherwise on six.
| Substance | Session | Vote | Committee outcome |
|---|---|---|---|
| BPC-157 | 23 Jul | 8–6–1 | Recommended |
| KPV | 23 Jul | 8–6–1 | Recommended |
| TB-500 | 23 Jul | 8–6–1 | Recommended |
| MOTS-c | 23 Jul | 7–5–2 | Recommended |
| Semax | 24 Jul | — | Recommended |
| Epitalon | 24 Jul | — | Recommended |
| Emideltide (DSIP) | 24 Jul | 7–6–1 | Not recommended |
Votes reported as yes–no–abstain. Each substance was considered in both free base and acetate forms. Semax and Epitalon were cleared on 24 July by similarly narrow margins; published summaries do not record the individual tallies.
A committee recommendation is not an approval. PCAC advises; it does not decide. For any of these substances to become compoundable under 503A, FDA must accept the recommendation, issue a proposed rule, take public comment, and publish a final rule, with formal approval at the Department level. None of that has happened. None of these substances is an FDA-approved drug, and compounding with them remains outside the 503A framework today.
Category 2 removals, April 2026
Separately, on April 15, 2026, twelve peptides were removed from the FDA's Category 2 restricted list following withdrawal of the underlying nominations. Category 2 identified substances raising significant safety risks in compounding. The removal reflects the withdrawn nominations rather than an affirmative safety finding, and it does not confer approved status on any substance.
What this does not change
Material supplied by Tessellix is for laboratory research use. It is not FDA-approved, not for human or veterinary use, and not for diagnostic or therapeutic use. That is true regardless of how the 503A question resolves, and it will remain the basis on which we supply.
This page records public federal activity. It is not a product list, does not indicate what Tessellix supplies, and does not indicate availability. It is not legal advice; purchasers are responsible for determining what is lawful in their own jurisdiction and for their own institution.
