Are any of the peptides on this tracker FDA-approved drugs?

Sermorelin has a past FDA drug-approval history as Geref, though it was discontinued commercially and current research-chemical Sermorelin is not regulated the way that approved drug was. None of the other 10 compounds on this tracker is or has ever been an FDA-approved drug.

What does it mean that a peptide is 'on the 503A Bulks List'?

Section 503A of the Federal Food, Drug, and Cosmetic Act allows licensed pharmacies to compound medications for individual patients under certain conditions. A substance generally has to be on the 503A Bulks List, have its own U.S. Pharmacopoeia monograph, or be a component of an FDA-approved drug before it can legally be compounded this way. As of this tracker's last review, none of the peptides discussed here are on that list.

How often is this tracker updated?

This tracker is reviewed whenever there's a meaningful regulatory development, such as an FDA advisory committee vote, a Federal Register notice, or a final rule, and at minimum whenever BioStackIQ's other regulatory content is reviewed. Each row shows a last-reviewed date so you can see how current the information is.

Does a peptide being 'research use only' mean it's illegal?

Not automatically. Selling a substance labeled for research use only, and not for human consumption, is a distinct regulatory category from an approved drug or a legally compoundable substance. It generally means the seller isn't making a drug claim, not that possession is illegal, though how it's marketed and used can still raise separate legal questions. This is a general explanation, not legal advice for any specific situation.

FDA Peptide Status Tracker

How to Read This Tracker

Three different things get lumped together when people ask if a peptide is "legal": whether it's an FDA-approved drug, whether it's eligible for a licensed pharmacy to legally compound under Section 503A, and whether it's simply available to buy labeled for research use only. Those are three separate regulatory questions, and this tracker keeps them separate rather than collapsing them into a single yes-or-no answer. See What Is FDA's 503A Bulks List? and What Is a Compounded Peptide? for background on how those categories actually work.

Status Tracker

Compound	FDA-Approved Drug?	503A Compounding Status	Last Reviewed
BPC-157	No	PCAC recommended, Jul 2026 (not final)	Sep 29, 2026
TB-500	No	PCAC recommended, Jul 2026 (not final)	Sep 29, 2026
MOTS-c	No	PCAC recommended, Jul 2026 (not final)	Sep 29, 2026
KPV	No	PCAC recommended, Jul 2026 (not final)	Sep 29, 2026
Semax	No	PCAC recommended, Jul 2026 (not final)	Sep 29, 2026
Epithalon	No	PCAC recommended, Jul 2026 (not final)	Sep 29, 2026
DSIP (Emideltide)	No	PCAC did not recommend, Jul 2026	Sep 29, 2026
CJC-1295	No	Not part of Jul 2026 review	Sep 29, 2026
Ipamorelin	No	Not part of Jul 2026 review	Sep 29, 2026
Sermorelin	Formerly, as Geref	Not part of Jul 2026 review	Sep 29, 2026
Selank	No	Not part of Jul 2026 review	Sep 29, 2026

Source context: the "PCAC recommended" and "PCAC did not recommend" statuses refer to the FDA's Pharmacy Compounding Advisory Committee meeting of July 23-24, 2026, which reviewed seven peptides for possible inclusion on the Section 503A Bulk Drug Substances List. These are nonbinding committee recommendations, not final FDA rules. See What Changed With BPC-157, TB-500 and MOTS-c in 2026? for the full context of that vote.

What "No FDA-Approved Drug" Actually Means

For every compound on this tracker except Sermorelin's discontinued past approval, "No FDA-Approved Drug" means the compound has not gone through the FDA's clinical trial process for safety and effectiveness in the way a prescription medication has. It does not by itself mean the compound is illegal to sell or possess. Most of these peptides are currently sold labeled for research use only, a separate category covered in What Does "Research Use Only" Actually Mean?.

What Would Change a Row on This Tracker

A row would change if the FDA formally adds a substance to the 503A Bulks List through notice-and-comment rulemaking, if a compound receives its own FDA drug approval through a sponsor's clinical trial program, or if a significant enforcement action or public FDA statement changes the practical regulatory picture. Routine research publications, by themselves, do not change regulatory status and are covered separately in BioStackIQ's Evidence Reviews cluster.

For the story behind the six compounds' July 2026 PCAC recommendation, see What Changed With BPC-157, TB-500 and MOTS-c in 2026?. For the broader legal picture around buying and using research peptides, see Are Peptides Legal in the United States? 2026 Guide and FDA-Approved Peptides vs Research Peptides.

Frequently Asked Questions

Disclaimer: This tracker is for informational purposes only and does not constitute legal or medical advice. FDA regulatory status can change quickly; always verify current status directly with the FDA, a qualified attorney, or a healthcare provider before making decisions based on this page. BioStackIQ reviews this tracker periodically but cannot guarantee it reflects the most recent regulatory action at every moment.