Is PT-141 with oxytocin legal in the United States?

A 15 mg vial, commonly 10 mg bremelanotide with 5 mg oxytocin, so two thirds of the powder is the melanocortin and one third the hormone. Bremelanotide has two phase 3 trials behind its approval; the oxytocin half has a randomised crossover trial in 30 women where oxytocin and placebo both improved sexual function with no treatment effect. The combination has never been tested.

This vial is sold as a two-part answer to sexual difficulties: one component for desire and arousal, one for connection and bonding. The second half is where the page has to be blunt.

Mechanism: Bremelanotide is a melanocortin receptor agonist acting largely through melanocortin 4 receptor signalling in the central nervous system, which is the desire and arousal pathway. Oxytocin is a nine amino acid posterior pituitary hormone with well characterised roles in labour and lactation and a far less settled role in social and sexual behaviour.

Regulatory history: Bremelanotide is FDA approved for hypoactive sexual desire disorder in premenopausal women. Oxytocin is approved for obstetric use. The combination is not approved and there is no approved oxytocin product for sexual function.

Approves prescription drugs by indication and polices unapproved products, including peptides sold online. Compounding pharmacies may prepare some compounds under a prescription when the FDA places them on a permitted bulk-substances category.

The classification above is the The Longevity Archive reading of U.S. Food and Drug Administration listings for PT-141 with oxytocin at the reviewed date, not a legal opinion. Rules change, and importing, prescribing and possessing a compound can each be treated differently. Check the regulator directly before acting on anything here.