Cagrilintide
No Legal PathwayAmylin Analog
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
Not FDA-approved as a standalone drug and never placed on an FDA drug shortage list — both preconditions for a 503A/503B compounding exception. FDA sent a letter to the Federation of State Medical Boards flagging compounded drug products containing cagrilintide (some marketed for obesity and other conditions) and asking boards to make licensees aware of its regulatory status; the full FDA letter was not published in detail on the cited page, so this entry will be revisited if the underlying letter surfaces.
Last changed: 2026-01-01