Compounded Dutasteride for clinics: pharmacies and lineup

Dutasteride

AffinityRx's 250+ SKU catalog lists 2 compounded dutasteride 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.

2
SKUs in the catalog
250+ across AffinityRx
15+
Licensed pharmacies
one account
3
FDA-approved products
with this active ingredient
Oct 2026
Status checked
FDA and state sources

By Tim Yoon, CEO, AffinityRx · Last updated

AffinityRx Dutasteride lineup

AffinityRx's catalog lists 2 dutasteride SKUs, below. Concentration, fill and mixer come from the AffinityRx catalog.

SKUConcentrationFillMixer / additiveStatus
Dutasteride (Oral) (0.5 mg)0.5 mgEach—Price shown in your account
Dutasteride / Tamsulosin (Oral)0.5 / 0.4 mg30 caps—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 Dutasteride through AffinityRx

AffinityRx is the recommended multi-pharmacy marketplace for sourcing compounded dutasteride: 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.

SavingsClinics typically save about 10% versus their current price.
Lowest vs medianAcross 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).
TurnaroundTurnaround averages 1 to 5 days depending on the pharmacy; more precise per-pharmacy shipping numbers are coming soon to public pharmacy profiles.
Shipping feesShipping 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.
FailoverIf 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 coverageAffinityRx 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 useNot 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 Dutasteride

Compounded Dutasteride 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
  • Oral capsules at non-standard strengths
  • Dutasteride/tamsulosin combination capsules (compounded; commercial combination also exists)
  • Topical solution or spray (often with minoxidil or other actives)
  • Dutasteride-containing hair-restoration topical blends (availability varies)
  • Injectable or mesotherapy-style preparations (sterile, pharmacy-specific and less common)
Strengths and fills
  • Oral capsules commonly listed at 0.5 mg; some pharmacies list lower or intermittent-dose strengths
  • Combination capsules commonly listed as dutasteride 0.5 mg with tamsulosin 0.4 mg (pharmacy-specific)
  • Topical solutions commonly listed in mg-per-mL or percentage concentrations, in 30 mL to 120 mL bottles or spray pumps
  • Typical capsule fills: 30 to 90 count
  • Strengths vary by pharmacy
Additives
  • Oil carriers (e.g., MCT or other oils) in capsules, including soft gelatin shells
  • Propylene glycol, ethanol and water in topical vehicles
  • Minoxidil or tretinoin in some topical combinations
  • Tamsulosin in combination capsules

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 Dutasteride

Clinics sourcing compounded Dutasteride should confirm the points below with the pharmacy before ordering.

  • Essentially-a-copy: since approved dutasteride 0.5 mg capsules and the dutasteride/tamsulosin combination exist, ask how the pharmacy documents the clinical difference for a compounded strength, form or combination.
  • Combination products require each active (dutasteride, tamsulosin, minoxidil, etc.) to qualify under 503A independently; confirm each one.
  • Non-sterile oral or topical: ask for BUD per SKU under USP <795>; any injectable preparation is sterile under USP <797> and needs sterile-compounding licensure.
  • Hazardous-drug handling: dutasteride appears on NIOSH hazardous drug lists for reproductive-risk reasons (verify current list); ask whether the pharmacy applies USP <800> containment and whether labels carry pregnancy-handling warnings.
  • Request a COA for bulk dutasteride from an FDA-registered establishment.
  • Not a controlled substance; no DEA registration required.

Dutasteride compounding regulatory status (2026)

Dutasteride is the active ingredient in FDA-approved drug products (Avodart, Jalyn and generics) and has a USP-NF monograph, so state-licensed 503A pharmacies may compound it on a patient-specific prescription.

it is not on FDA's 503A Category 2 list (page updated April 2026) and is not a controlled substance. FDA-approved labeling covers BPH; approved dutasteride products are not labeled for hair loss in the U.S. (verify on Drugs@FDA). Because oral 0.5 mg capsules and a dutasteride/tamsulosin combination are commercially available, compounded oral versions must meet the essentially-a-copy conditions of section 503A(b)(1)(D). FDA states compounded drugs are not FDA-approved and are not reviewed for safety or effectiveness.

FDA-approved products containing Dutasteride

ProductManufacturerApprovedApproved indication (per label)
Avodart (dutasteride 0.5 mg soft gelatin capsules)GlaxoSmithKline2001Treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate (per label) Source
Jalyn (dutasteride 0.5 mg / tamsulosin 0.4 mg capsules)GlaxoSmithKline2010Treatment of symptomatic BPH in men with an enlarged prostate (per label); verify current marketing status Source
Dutasteride capsules and dutasteride/tamsulosin capsules (generics)Multiple ANDA holders—Same as reference products (per label); verify current generic combination availability Source

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

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

Who orders compounded Dutasteride through AffinityRx

Clinic types that typically order compounded Dutasteride include hair restoration clinics, telehealth men's health brands, Men's health and TRT clinics, and dermatology and aesthetics, 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 Dutasteride

How can a clinic pay less for compounded dutasteride?
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 dutasteride 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 dutasteride 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 compounded dutasteride legal for my hair restoration clinic to order?
Yes, a state-licensed 503A pharmacy may compound dutasteride on a patient-specific prescription because it is an approved-drug component with a USP-NF monograph. FDA notes compounded drugs are not FDA-approved and are not reviewed for safety or effectiveness.
Is dutasteride on FDA's Category 2 list?
No, dutasteride is not on FDA's 503A Category 2 list (page updated April 2026).
Can a compounding pharmacy make dutasteride with tamsulosin?
Yes, 503A pharmacies compound combinations when each active independently qualifies under 503A, and both do. Because an approved dutasteride/tamsulosin product exists, the essentially-a-copy conditions apply.
Does dutasteride need special handling at the pharmacy?
Dutasteride is commonly treated as a hazardous drug under NIOSH-based handling because of reproductive-risk concerns, so ask how the pharmacy handles it under USP <800>. Practices vary.
Is dutasteride a controlled substance?
No, dutasteride is not a controlled substance, so no DEA registration is required.
What forms and strengths of compounded dutasteride can my clinic order?
Commonly oral capsules (often 0.5 mg), combination capsules and topical solutions, depending on the pharmacy. AffinityRx shows each pharmacy's listing and price before you order.
Does AffinityRx fill dutasteride orders itself?
AffinityRx is not a pharmacy and does not dispense dutasteride; licensed compounding pharmacies fill orders placed through AffinityRx, which shows pharmacies side by side with prices before you order, and 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. Medication prices are shown before you order.

Sources

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

  1. https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
  2. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
  3. https://www.accessdata.fda.gov/scripts/cder/daf/
  4. https://www.fda.gov/media/98964/download
  5. https://www.fda.gov/drugs/human-drug-compounding/compounding-laws-and-policies
  6. https://www.cdc.gov/niosh/docs/2025-103/default.html

By Tim Yoon, CEO, AffinityRx · Last updated

Source compounded Dutasteride through one AffinityRx account

Medication prices are shown before you order, and licensed pharmacies fill every order.

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