FDA compounding status
Bremelanotide (PT-141)
Also listed as PT-141, Bremelanotide.
Bremelanotide is a component of an FDA-approved drug, so a 503A pharmacy can compound it against a patient-specific prescription under that narrow statutory route. A compounder may not regularly make copies of a commercially available approved drug: a compounded injection of similar strength counts as a copy unless the prescriber documents a significant difference for that patient. There is no 503B route. The approved product is indicated only for premenopausal women with acquired, generalized hypoactive sexual desire disorder, not for men. Compounded bremelanotide is not FDA-approved. FDA does not check the safety, effectiveness or quality of compounded drugs before they are sold.
PT-141 is the development name for bremelanotide. They are the same molecule.
Checked against the primary sources on .
The record
- FDA status
- Narrow compounding pathway, limited by the rule on copies of approved drugs. Compounded versions are not FDA-approved.
- Compounding basis
- 503A pharmacy (component of an approved drug)Compounded by a state-licensed 503A pharmacy against a patient-specific prescription, from a bulk drug substance that is a component of an FDA-approved drug. Regular copies of a commercially available approved drug are not allowed.
- FDA advisory committee
- Not reviewed
- Sport (WADA 2026)
- Not named on the WADA 2026 Prohibited List.
- Offered by PEPLUX
- Yes, as PT-141
- Checked on
Offered by PEPLUX
PT-141
PEPLUX offers bremelanotide (PT-141) as PT-141. The product page covers what it is, its risks, and how prescribing and pricing work.
Status as offered
Narrow 503A pathway as a component of an FDA-approved drug, limited by the rule on copies of approved drugs. Compounded versions are not FDA-approved.
Basis
What this status traces to.
Bremelanotide is not in any category of FDA's 503A or 503B category documents and is not on the 503A bulks list. Its only basis is the 503A route for a bulk drug substance that is a component of an FDA-approved drug (NDA 210557). FDA treats a compounded drug as essentially a copy when it matches a commercially available drug's active ingredient in the same, similar or an easily substitutable strength and can be used by the same route, unless a prescriber documents a significant difference for an identified patient. FDA has said it does not intend to act when a compounder fills four or fewer prescriptions of such a copy in a calendar month. A nasal form differs from the approved injection by route, so the copy test does not reach it, but FDA has not approved any nasal bremelanotide product. FDA warning letters dated August 24, 2026 treated bremelanotide sold for research use as an unapproved new drug.
Approved products and their labeled use
Vyleesi (NDA 210557) is FDA-approved for premenopausal women with acquired, generalized hypoactive sexual desire disorder, not for men or enhancing sexual performance, and that approval does not cover any compounded bremelanotide (PT-141), which is a different product and not FDA-approved.
Primary sources
- FDABulk Drug Substances Used in Compounding Under Section 503A of the FD&C ActDocument dated . Checked .
- FDAFDA clarifies policies for compounders as national GLP-1 supply begins to stabilizeDocument dated . Checked .
- FDA labelopenFDA drug labels: bremelanotide, NDA 210557 (VYLEESI)Document dated . Checked .
- FDAopenFDA drugsfda: bremelanotide, NDA 210557Document dated . Checked .
- FDA 503A categoriesBulk drug substances nominated for use in compounding under section 503A (categories), updated May 14, 2026Document dated . Checked .
- FDA 503B categoriesBulk drug substances nominated for use in compounding under section 503B (categories), updated March 21, 2025Document dated . Checked .
- FDA warning letterWarning letter 734884, Royal Peptides LLCDocument dated . Checked .
- FDA warning letterWarning letter 735063, Peptide Partners LLCDocument dated . Checked .
- FDACompounding and the FDA: Questions and AnswersDocument dated . Checked .
- WADAWorld Anti-Doping Code, 2026 Prohibited ListDocument dated . Checked .
Context
A removal or a committee vote is not a listing.
Removal from FDA's Category 2 is not FDA approval and not a listing. FDA removed several peptides from its 503A Category 2 after their nominators withdrew the nominations, not because the substances were found safe: BPC-157, TB-500, MOTS-c, semax and epitalon among others (removal noticed April 15, 2026, effective after 7 days), and CJC-1295 and ipamorelin earlier (removal notice dated September 27, 2024). None was added to the 503A bulks list, so none has a compounding pathway today. A favorable vote by FDA's Pharmacy Compounding Advisory Committee is a recommendation, not a listing: nothing changes unless FDA publishes a final rule.
FDA advisory committee
FDA's Pharmacy Compounding Advisory Committee has not reviewed it.
If you are subject to anti-doping rules
Not named on the WADA 2026 Prohibited List.
Pending or unconfirmed
How a pharmacy will compound bremelanotide within FDA's limit on copies of the approved drug has not yet been confirmed in writing. LegitScript's position on bremelanotide has not been confirmed in writing.
Common questions
Bremelanotide (PT-141), answered plainly.
- What is the FDA compounding status of Bremelanotide (PT-141)?
- Bremelanotide is a component of an FDA-approved drug, so a 503A pharmacy can compound it against a patient-specific prescription under that narrow statutory route. A compounder may not regularly make copies of a commercially available approved drug: a compounded injection of similar strength counts as a copy unless the prescriber documents a significant difference for that patient. There is no 503B route. The approved product is indicated only for premenopausal women with acquired, generalized hypoactive sexual desire disorder, not for men. Compounded bremelanotide is not FDA-approved. FDA does not check the safety, effectiveness or quality of compounded drugs before they are sold.
- What does the status of bremelanotide (PT-141) trace to?
- Bremelanotide is not in any category of FDA's 503A or 503B category documents and is not on the 503A bulks list. Its only basis is the 503A route for a bulk drug substance that is a component of an FDA-approved drug (NDA 210557). FDA treats a compounded drug as essentially a copy when it matches a commercially available drug's active ingredient in the same, similar or an easily substitutable strength and can be used by the same route, unless a prescriber documents a significant difference for an identified patient. FDA has said it does not intend to act when a compounder fills four or fewer prescriptions of such a copy in a calendar month. A nasal form differs from the approved injection by route, so the copy test does not reach it, but FDA has not approved any nasal bremelanotide product. FDA warning letters dated August 24, 2026 treated bremelanotide sold for research use as an unapproved new drug. Checked against the primary sources on October 13, 2026.
- Which approved bremelanotide (PT-141) products exist, and what are they labeled for?
- Vyleesi (NDA 210557) is FDA-approved for premenopausal women with acquired, generalized hypoactive sexual desire disorder, not for men or enhancing sexual performance, and that approval does not cover any compounded bremelanotide (PT-141), which is a different product and not FDA-approved.
- Does PEPLUX offer bremelanotide (PT-141)?
- PEPLUX offers bremelanotide (PT-141) as PT-141. Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality.
- Is bremelanotide (PT-141) prohibited in sport?
- Not named on the WADA 2026 Prohibited List.
- Is anything about the status of bremelanotide (PT-141) pending or unconfirmed?
- How a pharmacy will compound bremelanotide within FDA's limit on copies of the approved drug has not yet been confirmed in writing. LegitScript's position on bremelanotide has not been confirmed in writing.