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Compounded Testosterone cypionate for clinics: coming Q2 2027

Testosteronecypionate

Compounded testosterone cypionate is not orderable on AffinityRx yet: AffinityRx adds controlled-substance support (testosterone and other scheduled medications) in Q2 2027. When it launches, clinics will source it like every other SKU on AffinityRx, through a multi-pharmacy marketplace with prices side by side, one login and failover within 1 to 2 minutes. AffinityRx clinics can source non-controlled TRT-support medications such as anastrozole, enclomiphene and clomiphene today.

Coming Q2 2027. Testosterone cypionate is a DEA Schedule III controlled substance. AffinityRx adds controlled-substance support (testosterone and other scheduled medications) in Q2 2027. It cannot be ordered through AffinityRx before then.

Q2 2027
Controlled-substance support
not orderable today
12
Testosterone SKUs listed
Coming Q2 2027
5
FDA-approved products
with this active ingredient
Oct 2026
Status checked
FDA and state sources

By Tim Yoon, CEO, AffinityRx · Last updated

AffinityRx Testosterone cypionate lineup

AffinityRx's catalog lists 12 testosterone cypionate SKUs, below. Concentration, fill and mixer come from the AffinityRx catalog.

SKUConcentrationFillMixer / additiveStatus
Testosterone Cypionate (Injectable) (125 mg)25 mg/mL5 mL vial—Coming Q2 2027
Testosterone Cypionate (Injectable) (200 mg)200 mg/mL1 mL vial—Coming Q2 2027
Testosterone Cypionate (Injectable) (500 mg)100 mg/mL5 mL vial—Coming Q2 2027
Testosterone Cypionate (Injectable) (1000 mg)200 mg/mL5 mL vial—Coming Q2 2027
Testosterone Cypionate (Injectable) (2000 mg)200 mg/mL10 mL vial—Coming Q2 2027
Testosterone (Troche) (Up to 75 mg)Up to 75 mg per trocheEach—Coming Q2 2027
Testosterone (Troche) (100 mg)100 mgEach—Coming Q2 2027
Testosterone (Troche) (200 mg)200 mgEach—Coming Q2 2027
Testosterone (Cream) (Up to 250 mg/g x 15 g)250 mg/g15 g—Coming Q2 2027
Testosterone (Cream) (Up to 250 mg/g x 30 g)250 mg/g30 g—Coming Q2 2027
Testosterone Enanthate (Injectable) (1000 mg)200 mg/mL5 mL vial—Coming Q2 2027
Testosterone Enanthate (Injectable) (2000 mg)200 mg/mL10 mL vial—Coming Q2 2027

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 Testosterone cypionate through AffinityRx

AffinityRx is the multi-pharmacy marketplace clinics will use for compounded testosterone cypionate once controlled-substance support launches in Q2 2027: prices side by side across 15+ pharmacies, one login and one invoice, and automatic failover. AffinityRx clinics can source non-controlled TRT-support medications such as anastrozole, enclomiphene and clomiphene today.

StatusComing Q2 2027. AffinityRx adds controlled-substance support (testosterone and other scheduled medications) in Q2 2027. Not orderable today.
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 Testosterone cypionate

Compounded Testosterone cypionate 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 solution (cypionate or enanthate in carrier oil) in multi-dose vials
  • Topical cream or gel (transdermal, often with penetration-enhancing bases)
  • Troche/lozenge (sublingual or buccal)
  • Subcutaneous pellets (compounded or commercial Testopel)
  • Capsules (less common)
Strengths and fills
  • Injectable cypionate commonly listed at 100 mg/mL and 200 mg/mL, in 10 mL and sometimes 1 mL, 2 mL or 5 mL vials
  • Cream/gel commonly listed in mg-per-mL or mg-per-gram concentrations in 30 mL to 60 mL pumps or jars
  • Troches in set mg-per-troche counts (e.g., 30 or 60 count)
  • Exact strengths and fill sizes vary by pharmacy
Additives
  • Carrier oils for injectables (cottonseed, grapeseed, sesame or MCT oil)
  • Benzyl alcohol (preservative)
  • Benzyl benzoate (co-solvent)
  • Transdermal cream bases (e.g., PLO or proprietary vehicle) for topical forms
  • Flavor bases for troches

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 Testosterone cypionate

AffinityRx adds controlled-substance support (testosterone and other scheduled medications) in Q2 2027. The points below are regulatory context for planning your Q2 2027 workflow.

  • Schedule III: the prescriber needs a current DEA registration, and the dispensing pharmacy needs DEA authority plus state controlled-substance licensing; some states add prescription monitoring (PDMP) checks, and rules for shipping controlled substances to patients differ by state.
  • Telehealth prescribing of controlled substances is governed by DEA telemedicine rules in effect at the time; confirm the current rule before building a telehealth workflow.
  • Injectables are sterile compounded drugs: 503A pharmacies must meet USP <797>, with some states requiring separate sterile-compounding permits; 503B outsourcing facilities are limited to the 503B bulks list or FDA shortage-list drugs, so check which pathway applies.
  • BUD varies by sterility, preservative and storage; sterile preparations made without sterility testing carry the shortest USP <797> BUDs, so ask for the BUD per SKU.
  • Request a COA for the bulk substance (from an FDA-registered establishment) and ask whether finished-product potency or sterility testing is performed and by which lab.
  • Compounded forms where an FDA-approved product exists (e.g., commercial cypionate) are subject to the essentially-a-copy limits of section 503A(b)(1)(D), so pharmacies need documented prescriber rationale for a difference.
  • Quantity limits: 503A pharmacies dispense patient-specific prescriptions; office-use (non-patient-specific) compounding is restricted by state law and FDA policy, so confirm before ordering stock for a clinic.

Testosterone cypionate compounding regulatory status (2026)

Testosterone cypionate and testosterone enanthate are components of FDA-approved drug products and testosterone has USP-NF monograph coverage, so a state-licensed 503A pharmacy may compound with them on a patient-specific prescription.

neither is on FDA's 503A Category 2 list (page updated April 2026). Testosterone is a Schedule III controlled substance under the Controlled Substances Act (21 CFR 1308.13), so prescribers need DEA registration and pharmacies must meet DEA and state controlled-substance requirements. Injectables are sterile preparations, while creams, gels and troches are non-sterile.

FDA-approved products containing Testosterone cypionate

ProductManufacturerApprovedApproved indication (per label)
Depo-Testosterone (testosterone cypionate injection)Pfizer—Replacement therapy in males for conditions associated with deficiency or absence of endogenous testosterone (primary hypogonadism, hypogonadotropic hypogonadism) Source
Xyosted (testosterone enanthate autoinjector)Antares Pharma2018Testosterone replacement therapy in adult males with hypogonadism Source
Testosterone enanthate injection (generic of Delatestryl)Multiple—Testosterone replacement in males with hypogonadism; also delayed puberty and certain breast cancers in women per label Source
AndroGel (testosterone gel, topical)AbbVie2000Testosterone replacement therapy in adult males with hypogonadism Source
Testopel (testosterone pellets)Endo (Auxilium)—Testosterone replacement in males with hypogonadism and delayed puberty Source

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

FDA actions that mention Testosterone cypionate

  • May 21, 2025 · Recall · Empower Clinic Services, LLC dba Empower Pharmacy. Empower Clinic Services, LLC dba Empower Pharmacy initiated a recall (recall initiation 2025-05-02; reported in the FDA Enforcement Report 2025-05-21) covering 1 product listing(s). FDA's stated reason: Lack of Assurance of Sterility. Classification: Class II; status: Ongoing. FDA record

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

Frequently asked questions about compounded Testosterone cypionate

Can clinics order compounded testosterone cypionate through AffinityRx today?
Not yet. AffinityRx adds controlled-substance support (testosterone and other scheduled medications) in Q2 2027. Testosterone cypionate SKUs are listed as Coming Q2 2027 and cannot be ordered before then. AffinityRx clinics can source non-controlled TRT-support medications such as anastrozole, enclomiphene and clomiphene today.
Is compounded testosterone cypionate legal for a clinic to prescribe?
Yes, a state-licensed 503A pharmacy may compound testosterone cypionate on a patient-specific prescription because it is a component of FDA-approved products with USP-NF coverage, and the prescriber must hold a DEA registration because testosterone is a Schedule III controlled substance. AffinityRx adds controlled-substance support (testosterone and other scheduled medications) in Q2 2027.
What DEA schedule is testosterone?
Testosterone is a Schedule III controlled substance under the Controlled Substances Act (21 CFR 1308.13). All forms, including cypionate, enanthate, creams and troches, carry that schedule.
Is testosterone cypionate on the FDA 503A Category 2 list?
No, testosterone cypionate is not on FDA's Category 2 list of bulk drug substances with significant safety risks as of the page updated April 2026.
What is the difference between testosterone cypionate and enanthate for sourcing?
Both are testosterone esters in approved products and are sourced and scheduled the same way; they differ in the ester and typically the carrier oil. Pharmacies list each as a separate SKU, so sourcing considerations such as DEA, sterility and BUD apply to both.
Can a clinic order compounded testosterone cream, troches or injections through AffinityRx?
Not yet. Testosterone cream, troches and injections are DEA Schedule III controlled substances, and AffinityRx adds controlled-substance support (testosterone and other scheduled medications) in Q2 2027. Testosterone SKUs are listed as Coming Q2 2027 and cannot be ordered before then.
When will AffinityRx support controlled substances like testosterone?
AffinityRx adds controlled-substance support (testosterone and other scheduled medications) in Q2 2027. Until then testosterone is not orderable. AffinityRx is not a pharmacy and does not ship medications itself; licensed pharmacies fill every order.
Are pharmacies allowed to compound testosterone injections as an outsourcing (503B) product?
503B outsourcing facilities may use bulk substances only if they are on FDA's 503B bulks list or the drug is on FDA's shortage list, so 503B availability depends on those conditions. Most clinic-sourced testosterone injectables come from 503A pharmacies on patient-specific prescriptions.
How does a clinic get started ordering compounded medications through AffinityRx?
A clinic joins AffinityRx for $0 and preloads a $5,000 credit that is applied 100% to orders. Onboarding runs from demo to loading credit, then API integration or clinic account setup, a test order, and live ordering.

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.fda.gov/media/94155/download
  4. https://www.accessdata.fda.gov/scripts/cder/daf/
  5. https://www.ecfr.gov/current/title-21/chapter-II/part-1308/subpart-B/section-1308.13
  6. https://www.fda.gov/drugs/human-drug-compounding/compounding-laws-and-policies
  7. https://www.deadiversion.usdoj.gov/schedules/

By Tim Yoon, CEO, AffinityRx · Last updated

Get ready for Testosterone cypionate on AffinityRx in Q2 2027

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

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