Educational resource for licensed providers · Not medical or legal advice · Regulatory status changes frequently — verify independently
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Living reference · updated on review

Peptide Regulatory-Status Tracker

Where each peptide actually sits under U.S. federal compounding rules right now — sortable, filterable, and tied to a dated primary source on every row. This is reference data, not a news article. We check it on a fixed schedule and stamp each entry with the date it was last reviewed, so you always know how current it is.

Last published: — · Next scheduled review: —
How to read this table — the distinction that matters most The FDA's interim "Category 1 / 2 / 3" buckets are being retired; since January 7, 2025 a substance is only compoundable once it is on the final 503A bulks list. Several peptides were removed from Category 2 in April 2026 because their nominations were withdrawn — this made them unlisted, not approved and not authorized for compounding. A July 23–24, 2026 advisory-committee (PCAC) meeting will consider adding seven of them to the bulks list. Category status is never the same as FDA approval, and removal from a do-not-compound list is not permission to compound.

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Tap “What this means” on any card for the full detail and citation. Cards marked ⚑ pending counsel are drafted from credible secondary summaries and held for verification against the underlying Federal Register / docket text before they are treated as published fact.

What "trajectory" tells you

Two opposite things are happening at once, and mixing them up is exactly how a clinic gets caught out:

Research peptides are moving toward access. BPC-157, TB-500, KPV, MOTS-c, DSIP, Epitalon and Semax were pulled off the do-not-compound list and are up for bulks-list consideration in July 2026 — but they are not there yet.

GLP-1s are moving the other way. On April 30, 2026 the FDA proposed to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list, with a comment period through June 29, 2026 — tightening, not loosening, bulk compounding of the approved drugs.

How this tracker stays current

A scheduled review checks the primary sources — the Federal Register, FDA's compounding and bulk-substances pages, PCAC meeting notices, and relevant state legislatures — on a fixed cadence, flags any change against the last-known status, and routes it for human confirmation. No legal-status change is published automatically; a person verifies it against the primary document first, then updates the "last reviewed" date.

Verify before you act. A tracker is a starting point, not a clearance. Confirm current federal and your state's status against the primary source — linked on every row — before making a sourcing or clinical decision.
Important — please read This tracker aggregates publicly available regulatory information and attributes each entry to its dated primary source; it is educational information for licensed providers, not medical, legal, or regulatory advice, and not a clinical opinion of HPD. Regulatory status changes frequently and entries may lag the most recent action — verify current federal and state status independently before acting. "Category 1," or removal from "Category 2," does not mean a substance is FDA-approved or currently authorized for compounding.