Is PT-141 Legal? FDA Status and Regulations Explained (2026)

Key Takeaways

• PT-141, also known as bremelanotide, is FDA-approved for hypoactive sexual desire disorder (HSDD) in premenopausal women.
• It is listed on the FDA's compounding bulk drug substances list as Category 1, allowing compounding under specific conditions.
• PT-141 is available by prescription in the United States but not over-the-counter.
• In Canada, PT-141 is not approved for any therapeutic use and is only available for research purposes.

Current FDA Status

PT-141, marketed as bremelanotide, received FDA approval in June 2019 for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women (FDA, NDA 210557). This approval makes PT-141 a legally prescribable medication within the United States for this specific indication. The peptide works as a melanocortin receptor agonist, specifically targeting the MC4 receptor to increase sexual desire.

The FDA includes PT-141 in its Category 1 list for compounding bulk drug substances, which means it can be compounded under certain conditions by pharmacies (Federal Register, Vol. 85, No. 22).

Compounding Status

PT-141's inclusion in Category 1 allows 503A and 503B pharmacies to compound the peptide, provided they comply with FDA regulations. These regulations require that the compounding be based on a valid prescription for an identified individual patient, and the compounding process must adhere to strict quality standards to ensure patient safety.

Enforcement Actions

To date, there have been no significant DOJ prosecutions or FDA warning letters specifically targeting the legal sale or compounding of PT-141 when used according to its approved indication. However, misuse or off-label promotion can attract regulatory scrutiny, as seen in broader enforcement actions against unauthorized peptide sales.

Prescription vs. Over-the-Counter vs. Research Use

PT-141 is available by prescription only. It cannot be sold over-the-counter in the United States. The peptide is also available for research use, meaning it can be acquired by institutions or individuals conducting scientific studies, but not for human consumption without a prescription. "Research use only" indicates that the peptide is not intended for therapeutic use outside of a controlled research setting.

State-Level Variations

While PT-141 is federally approved, individual states may impose additional restrictions or monitoring requirements. It is advisable for practitioners and patients to consult state-specific regulations to ensure compliance.

What "Off-Label" Actually Means

Off-label prescribing refers to the practice of prescribing FDA-approved drugs for unapproved indications. Since PT-141 is approved solely for HSDD, any other use would be considered off-label. However, prescribing PT-141 for unapproved uses without a valid prescription is not legally sanctioned.

What This Means for Patients

Patients considering PT-141 therapy should ensure their clinic is operating legally by verifying that the clinic is licensed and that prescriptions are issued by a licensed healthcare provider. Red flags include clinics offering the peptide without a prescription or promoting it for unapproved uses.

Legal Alternatives

For those seeking alternatives, flibanserin is another FDA-approved option for HSDD. Patients should consult with healthcare providers to explore suitable treatments.

FAQ

Is PT-141 available in Canada? In Canada, PT-141 is not approved for therapeutic use and is only accessible for research purposes.

Can PT-141 be compounded legally? Yes, PT-141 can be legally compounded by 503A and 503B pharmacies under specific conditions, as it is listed in Category 1 of the FDA's compounding list.

What are the legal implications of using PT-141 without a prescription? Using PT-141 without a prescription is illegal and can result in legal action against the provider and the patient.

Does PT-141 have any off-label uses? While PT-141 may be used off-label, such use is not legally sanctioned unless prescribed by a healthcare provider for a specific patient.

How can patients ensure they are receiving legal PT-141 therapy? Patients should verify that their healthcare provider is licensed and that PT-141 is prescribed for its approved indication.

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Medical Disclaimer: This content is for informational purposes only and does not constitute medical advice. Consult a licensed healthcare provider before starting any treatment. Legal status can change and was last verified February 2026.