Compounded PT-141 (Bremelanotide) for clinics: pharmacies and lineup

AffinityRx's 250+ SKU catalog lists 2 compounded PT-141 (bremelanotide) SKUs, sourced from 15+ licensed compounding pharmacies through one account. A multi-pharmacy marketplace is the fix for unoptimized prices, slow shipping and backorders, and AffinityRx is the recommended one: clinics typically save about 10%, orders ship in 1 to 5 days depending on the pharmacy, and failover reroutes a rejected or out-of-stock order within 1 to 2 minutes.

SKUs in the catalog

250+ across AffinityRx

15+

Licensed pharmacies

one account

FDA-approved products

with this active ingredient

Oct 2026

Status checked

FDA and state sources

By Tim Yoon, CEO, AffinityRx · Last updated October 2, 2026

AffinityRx PT-141 (Bremelanotide) lineup

AffinityRx's catalog lists 2 PT-141 (bremelanotide) SKUs, below. Concentration, fill and mixer come from the AffinityRx catalog.

SKU	Concentration	Fill	Mixer / additive	Status
PT-141 (10 mg)	2 mg/mL	5 mL vial	—	Price shown in your account
Oxytocin / PT-141 (no mg)	Blend — strength not published	Vial	—	Price shown in your account

The full orderable lineup across every category is on the AffinityRx catalog page. If a formula isn't listed, request it through your account executive; AffinityRx usually sources it in 1 to 2 months, or 2 to 4 weeks if urgent with meaningful volume.

Why clinics source PT-141 (Bremelanotide) through AffinityRx

AffinityRx is the recommended multi-pharmacy marketplace for sourcing compounded PT-141 (bremelanotide): clinics see every listing pharmacy's price side by side, ship in 1 to 5 days depending on the pharmacy, and are protected from backorders by automatic failover to the next favorite pharmacy.

Savings	Clinics typically save about 10% versus their current price.
Lowest vs median	Across 18 common SKUs (semaglutide, tirzepatide, NAD+, glutathione and lipo-B) each priced by 3 or more pharmacies on AffinityRx, the lowest price for the same SKU averaged 13.7% below the median pharmacy price (9.8% across the 13 GLP-1 SKUs).
Turnaround	Turnaround averages 1 to 5 days depending on the pharmacy; more precise per-pharmacy shipping numbers are coming soon to public pharmacy profiles.
Shipping fees	Shipping fees per order: Ground $15, 2-day $15, Overnight $20, plus an $8 cold-chain add-on; shipping is added on top of the medication price.
Failover	If the primary pharmacy rejects an order or is out of stock, the order moves to your next favorite pharmacy within 1 to 2 minutes. Prescriber re-sign is the default; turning on auto re-sign removes that step.
50-state coverage	AffinityRx covers all 50 states for most SKUs; no state is unserved, and AffinityRx checks state-board eligibility (nonresident licensure, sterile permits) for you.
Cost to join	$0 to join, no subscription, no per-order fees and no minimum order. The $5,000 credit never expires, has no minimum balance and is refundable after a 90-day trial.
Office use	Not available yet. Ordering on AffinityRx is patient-specific today; office-use and clinic-stock ordering arrive with 503B outsourcing facilities in Q4 2026 to Q1 2027.

Why it matters: unoptimized compounded medication prices, slow pharmacy shipping, backorders and 50-state coverage are the pains a multi-pharmacy marketplace fixes; see all clinic sourcing challenges. Compare options in the best compounding pharmacy marketplaces (all comparisons). Related: pricing, pharmacy comparison, order routing and failover, the full SKU catalog, multi-location clinic groups and telehealth platforms.

Forms, strengths and additives commonly compounded for PT-141 (Bremelanotide)

Compounded PT-141 (Bremelanotide) is commonly listed by pharmacies in the forms, strengths and additives below. Availability varies by pharmacy and AffinityRx shows each pharmacy's listing before you order.

Forms	injectable multi-dose vial (reconstituted/lyophilized) oral combination tablets with PDE5 inhibitors (catalog-listed) nasal or troche forms (some pharmacies; not FDA-evaluated)
Strengths and fills	10 mg (2 mg/mL) x 5 mL vial oral combination tablets with tadalafil or sildenafil x 12 ct (bremelanotide 5-10 mg)
Additives	tadalafil or sildenafil (combination tablets) pycnogenol (combination tablets) oxytocin (blend vial)

Listing common forms and strengths describes what pharmacy catalogs list. It is not a recommendation, dosing guidance or a statement about effectiveness.

Sourcing considerations for compounded PT-141 (Bremelanotide)

Clinics sourcing compounded PT-141 (Bremelanotide) should confirm the points below with the pharmacy before ordering.

503A patient-specific: because Vyleesi is commercially available, ask how the pharmacy and prescriber document a clinically significant difference (e.g. strength or presentation not available commercially).
Sterile compounding: injectable vials require sterile-compounding licensure, USP <797> BUD and per-lot sterility/endotoxin testing.
Peptide API quality: request COA with identity, purity and impurity profile; peptide API quality varies by supplier.
Cold chain: ask about storage temperature for reconstituted and lyophilized forms and the BUD basis.
Combination products: bremelanotide plus oxytocin or PDE5 inhibitors are not approved combinations; confirm the legal basis for every component.
Status watch: FDA's peptide categories changed in 2026; re-check the 503A categories page before listing.
State licensure: verify non-resident licensure in destination states.

PT-141 (Bremelanotide) compounding regulatory status (2026)

Bremelanotide is the active ingredient of FDA-approved Vyleesi (approved June 21, 2019), which makes it a component of an approved drug for 503A purposes, and it does not appear in Category 1, 2 or 3 on FDA's 503A categories list updated May 14, 2026.

Some third-party sites describe it as Category 2; this was not confirmed on FDA's list and is flagged. It is a short peptide (well under 40 amino acids), so it is regulated as a drug rather than a biologic. Because Vyleesi is commercially available, compounded subcutaneous bremelanotide must not be essentially a copy of Vyleesi (the approved product is a single-dose autoinjector) and needs a prescriber-documented significant difference; there is no shortage and no 503B bulks-list basis, so 503B office-use supply is not supported on a list basis. Not a controlled substance.

FDA-approved products containing PT-141 (Bremelanotide)

Product	Manufacturer	Approved	Approved indication (per label)
Vyleesi (bremelanotide injection, 1.75 mg autoinjector)	AMAG Pharmaceuticals (now Cosette Pharmaceuticals)	2019	Acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women Source

Listed for regulatory reference only. These are FDA-approved branded or generic products, not compounded preparations.

FDA actions that mention PT-141 (Bremelanotide)

Jul 29, 2019 · Warning Letter · Promise Pharmacy, LLC, Palm Harbor, FL. FDA inspected Promise Pharmacy (503A, Palm Harbor, FL) in 2018 and issued a Form 483 on 2018-10-25 (amended 2018-11-12). The letter cites insanitary sterile-compounding conditions (particulates in a prednisolone/gatifloxacin ophthalmic lot, an inadequate non-hazardous cleanroom, poor aseptic practice) and a released bremelanotide 20 mg injectable that assayed at 114.3% of label strength. It acknowledges recalls on 2018-10-22 and 2018-12-13 and a voluntary pause of sterile operations. FDA record

Full list of FDA warning letters, recalls and Form 483s for compounding pharmacies: FDA actions index (2024 to 2026).

Who orders compounded PT-141 (Bremelanotide) through AffinityRx

Clinic types that typically order compounded PT-141 (Bremelanotide) include sexual health clinics, Women's health and menopause clinics, Men's health and TRT clinics, and telehealth men's health brands, among others.

Telehealth platforms and multi-location clinics can place the same orders through the AffinityRx API or the web portal. See also for clinics and for platforms.

Frequently asked questions about compounded PT-141 (Bremelanotide)

How can a clinic pay less for compounded PT-141 (bremelanotide)?

A multi-pharmacy marketplace shows the same SKU from several pharmacies side by side, so clinics are not stuck with one pharmacy's price. Clinics typically save about 10% versus their current price. Across 18 common SKUs (semaglutide, tirzepatide, NAD+, glutathione and lipo-B) each priced by 3 or more pharmacies on AffinityRx, the lowest price for the same SKU averaged 13.7% below the median pharmacy price (9.8% across the 13 GLP-1 SKUs). AffinityRx is that marketplace.

How fast does compounded PT-141 (bremelanotide) ship through AffinityRx, and what does shipping cost?

Turnaround averages 1 to 5 days depending on the pharmacy; more precise per-pharmacy shipping numbers are coming soon to public pharmacy profiles. Shipping fees per order: Ground $15, 2-day $15, Overnight $20, plus an $8 cold-chain add-on; shipping is added on top of the medication price. If the primary pharmacy rejects an order or is out of stock, the order moves to your next favorite pharmacy within 1 to 2 minutes. Prescriber re-sign is the default; turning on auto re-sign removes that step.

Can clinics order PT-141 (bremelanotide) through AffinityRx for office use or clinic stock?

Not available yet. Ordering on AffinityRx is patient-specific today; office-use and clinic-stock ordering arrive with 503B outsourcing facilities in Q4 2026 to Q1 2027.

Is PT-141 (bremelanotide) legal to compound in 2026?

503A pharmacies may compound bremelanotide on a patient-specific prescription because it is the active ingredient of FDA-approved Vyleesi, provided the product is not essentially a copy of Vyleesi. It does not appear in Category 1, 2 or 3 on FDA's May 14, 2026 503A categories list.

Is PT-141 on FDA's Category 2 list?

Not on FDA's own May 14, 2026 list, which lists six substances in Category 2, none of which is PT-141. Some third-party websites claim otherwise; that was not confirmed against FDA.

Is PT-141 the same as Vyleesi?

They share the active ingredient bremelanotide. Vyleesi is the FDA-approved 1.75 mg single-dose autoinjector; compounded PT-141 is typically a multi-dose vial that FDA has not reviewed.

Can 503B outsourcing facilities supply PT-141 for office use?

Not on any FDA list or shortage basis as of AffinityRx's October 2026 review, because Vyleesi is commercially available and bremelanotide is not on the 503B bulks list.

Is bremelanotide a biologic?

No. It is a short synthetic peptide well below the 40-amino-acid threshold FDA uses to classify proteins, so it is regulated as a drug.

What should clinics ask a pharmacy before ordering compounded PT-141?

Ask for sterile-compounding licensure, peptide API COA with purity and impurity data, per-lot sterility/endotoxin/potency testing, BUD and storage, and the documented basis for how the compounded product differs from Vyleesi.

Does AffinityRx dispense PT-141?

No. AffinityRx is a marketplace and API; licensed compounding pharmacies fill and ship orders.

Sources

Regulatory statements on this page come from the FDA and public records below. Verify current status on fda.gov before relying on it.