PT-141 (Bremelanotide)
FDA-Approved (narrow carve-out)Sexual Health
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.
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
FDA-approved (Vyleesi) — compounding is restricted to narrow 503A/503B carve-outs (e.g. a medically necessary dosage-form or strength change for an individual patient), not open compounding of the approved drug.
Last changed: 2026-01-01