FDA approved
FDA has approved a specific product, indication, formulation and label—not every product using a similar name.
Living regulatory tracker
FDA peptide status and regulatory updates
Peptide regulation changes quickly. This page separates FDA approval, investigational status, compounding review, safety signals, proposals, advisory discussions and enforcement actions.
Last checked against FDA sources: . General education only—not legal or medical advice.
How to read an FDA status
Investigational
A substance is being studied. Trial registration or publication does not make it approved.
Compounding review
FDA's 503A/503B process concerns whether bulk substances may be used under specific compounding frameworks; it is not drug approval.
Warning or enforcement
FDA is addressing cited products, firms or claims. Read the underlying letter for its exact scope.
Latest FDA peptide updates
Scheduled—not final
FDA advisory committee to discuss multiple peptide bulk substances
BPC-157TB-500MOTS-cEpitalonSemax
What changed
FDA posted briefing materials for BPC-157, TB-500, MOTS-c, Epitalon, Semax and other substances being considered in the 503A compounding process. Committee discussion and recommendations are not final FDA determinations.
Why it matters
This is the next formal public review point for whether these bulk substances should advance within the 503A compounding framework. It is not an approval event.
Read the FDA sourceFDA safety update
FDA updated concerns involving unapproved GLP-1 products
RetatrutideCagrilintideSemaglutideTirzepatide
What changed
FDA states that retatrutide and cagrilintide cannot be used in compounding under federal law and are not components of FDA-approved drugs. The same update reports adverse-event totals associated with compounded semaglutide and tirzepatide while noting attribution and underreporting limitations.
Why it matters
It sharpens the distinction between approved branded products, lawful patient-specific compounding circumstances, and investigational products that cannot be used in compounding.
Read the FDA sourceProposed—not final
FDA proposed excluding three GLP-1 substances from the 503B Bulks List
SemaglutideTirzepatideLiraglutide
What changed
The proposal concerns semaglutide, tirzepatide and liraglutide. A proposal is not the same as a final rule or a change to the approval status of branded FDA-approved products.
Why it matters
If finalized, the proposal would affect the 503B bulk-substance pathway; it would not withdraw FDA approvals for specific approved drug products.
Read the FDA sourceWarning letter
FDA cited unapproved semaglutide and tirzepatide multidose vials
SemaglutideTirzepatide
What changed
FDA's warning letter to New Life Pharma describes the inspected products as unapproved new drugs and documents manufacturing and legal concerns specific to that firm and inspection.
Why it matters
The letter illustrates why a product bearing the name of an approved active ingredient is not automatically an FDA-approved product.
Read the FDA sourceWarning letter
FDA cited online retatrutide and tirzepatide peptide sales
RetatrutideTirzepatide
What changed
The Gram Peptides letter states that the retatrutide and tirzepatide products FDA reviewed were unapproved new drugs. A warning letter records FDA's position about the cited conduct; it is not a blanket approval decision for unrelated products.
Why it matters
It directly addresses the online 'research peptide' market and reinforces that investigational retatrutide sold online is not an approved medicine.
Read the FDA sourceEnforcement update
FDA announced 30 telehealth warning letters over compounded GLP-1 marketing
SemaglutideTirzepatideCompounded GLP-1 products
What changed
FDA focused on false or misleading comparisons between compounded products and FDA-approved drugs. Compounded drugs are not FDA approved.
Why it matters
Marketing cannot erase the regulatory difference between an approved product and a compounded product that FDA has not reviewed for safety, effectiveness or quality before marketing.
Read the FDA sourceHigh-interest peptide watchlist
Status summaries are intentionally narrow. Open each evidence guide for the supporting studies, formulations and limitations.
BPC-157Not FDA approved; July 2026 PCAC review scheduledEvidence →FDA source
TB-500Not FDA approved; distinct from full-length thymosin beta-4; PCAC review scheduledEvidence →FDA source
MOTS-cNot FDA approved; FDA reports inadequate human exposure information for administered productsEvidence →FDA source
EpitalonNot FDA approved; PCAC review scheduled; not interchangeable with Epithalamin evidenceEvidence →FDA source
SemaxNot FDA approved in the United States; PCAC review scheduledEvidence →FDA source
CJC-1295Not FDA approved; limited clinical data and FDA-identified compounding concernsEvidence →FDA source
IpamorelinNot FDA approved; FDA has evaluated compounding and route-specific safety concernsEvidence →FDA source
GHK-Cu injectionNot FDA approved for injection; do not transfer topical/cosmetic evidence to injectable productsEvidence →FDA source
RetatrutideInvestigational; not FDA approved and cannot be used in compounding under federal lawEvidence →FDA source
What this tracker does not mean
- PCAC discussion does not equal FDA approval or a final compounding decision.
- “Not FDA approved” does not by itself prove that a substance has no biological effect; it means FDA has not approved a specific product as safe and effective for an indication.
- A compounded drug is not FDA approved, even when an FDA-approved drug contains a similarly named active ingredient.
- Availability from a seller does not establish legality, identity, purity, sterility, safety or effectiveness.