Peptide Intelligence
FDA Peptide Tracker every action, dated.
Committee votes are not approvals. Federal Register notices are not final rules. This page keeps the sequence straight so you can tell what has actually changed. Updated 2026-09-02; next review 2026-10-15.
Pending
Rulemaking on the six PCAC-recommended peptides
Expected: 12–24 months from July 2026. Until a final rule, status is unchanged.
Pending
Final decision on the 503B bulks-list exclusion for GLP-1s
Expected: Late 2026. Watch for a supply transition if you use a compounded product.
2026-09-01
FDA updates its 'concerns with unapproved GLP-1 drugs' page
As of May 31 2026 FDA had received 990 adverse-event reports for compounded semaglutide and more than 730 for compounded tirzepatide, including dosing errors of 5–20×.
2026-07-24
PCAC votes to recommend six peptides for the 503A bulks list
The Pharmacy Compounding Advisory Committee voted in favor of BPC-157, TB-500, KPV, MOTS-c, Semax and epitalon. The votes are advisory only. Until FDA completes rulemaking, none of the six is legally compoundable and research-use-only products remain unapproved drugs.
2026-04-30
FDA proposes excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list
The proposal would end outsourcing-facility compounding of the three GLP-1s from bulk substance. Comments closed Jun 29 2026. If finalized, many compounded-GLP-1 users will face a supply transition.
2026-04-15
Federal Register notice updates the peptide 'do not compound' list
FDA published an update to the Category 2 list and opened the process for nominated peptides to be evaluated for the 503A bulks list.
2026-02-27
HHS announces a review of peptide compounding policy
HHS signaled it would revisit the compounding status of several peptides, setting up the April Federal Register notice and the July advisory-committee meeting.
2026-01-13
FDA requests removal of the suicidal-ideation warning from GLP-1 labels
After review, FDA asked manufacturers to remove the suicidal behavior and ideation warning from Wegovy, Saxenda and Zepbound labels. Ozempic never carried it.
2026-01-06
FDA updates General Wellness and Clinical Decision Support guidances
The updated guidances define the lane for consumer health software: general-wellness products show values, trends and wellness ranges and may suggest seeing a clinician, but do not diagnose or direct treatment. Patient-facing decision support is not covered by the CDS carve-out.
2024-07-26
FDA alerts on dosing errors with compounded GLP-1s
FDA warned health-care providers, compounders and patients about dosing errors from multi-dose vials and unit confusion with compounded semaglutide and tirzepatide.
2023-09-01
FDA places several wellness peptides on the Category 2 list
FDA's list of bulk drug substances that may present significant safety risks in compounding grew to include BPC-157, CJC-1295, ipamorelin, AOD-9604 and others. Category 2 substances cannot be used in 503A compounding.
Educational summary of public regulatory actions. Not legal or medical advice. Reviewed 2026-09-02 by Curtis Holder (product); clinical review pending.