Peptide & GLP-1 compounding status, tracked.

What each status means

Our reading of public sources, not a legal determination — see the notice above.

Compoundable (503A)

Based on public 503A guidance, a compounding pathway appears to exist with a valid, patient-specific prescription. The closest thing to a green light in this dataset — but that's our reading of public sources, not a legal opinion, so confirm with counsel before relying on it.

Contested

Our read of public sources: some pharmacies compound it under a legal theory — a differentiated-formulation argument, or in anticipation of a pending committee recommendation — that no court ruling or final FDA rule has settled either way. We're flagging this as actively debated, not as a green or red light. This is not a legal determination; verify independently before relying on it.

Restricted

Based on public FDA bulk-substance and shortage listings, it appears to be off the permitted bulk substances list, or a shortage-based exception has ended. That's our read that no established pathway currently applies — not a formal legal bar, and not a determination we're qualified to make. Confirm current status with FDA sources or counsel.

No Legal Pathway

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.

FDA-Approved (narrow carve-out)

An FDA-approved commercial product appears to exist. Public guidance suggests compounding is limited to narrow carve-outs for an individual patient (a documented allergy, a needed dosage-form change) rather than open compounding for unapproved uses — again, our reading of public sources, not a legal opinion.