Retatrutide
No Legal PathwayGLP-1 / Triple Agonist
Based on public FDA records, we don't see an approval or a shortage-list listing — both are usually preconditions for a 503A/503B exception. From what's publicly available, we don't find a compounding route under any formulation theory, but this is our reading of public sources, not legal advice.
Not legal advice. Every status on this page is our own reading of public FDA guidance, shortage listings, and committee materials — it has not been reviewed by an attorney and is not a legal determination. "Contested" means pharmacies and regulators publicly disagree, not that we're resolving the disagreement. Verify independently, and check with counsel, before relying on any entry here.
Current status
Never FDA-approved and never placed on an FDA drug shortage list — both are preconditions for a 503A/503B compounding exception. No legal compounding pathway currently exists under any formulation theory.
Last changed: 2026-03-31
Enforcement history
- 2026-03-31
FDA warning letter to Gram Peptides for selling unapproved retatrutide, tirzepatide, and bacteriostatic water for injection; RUO labeling rejected as a defense.
Source - 2026-03-01
Multiple vendors (Prime Sciences, Mile High Compounds, Pink Pony Peptides, PekCura Labs) cited for selling retatrutide under coded names (e.g. 'GLP-3 RT') to evade RUO scrutiny.
Source