To start an online TRT (testosterone replacement therapy) clinic, you launch a telehealth brand built on three things: prescribers with DEA registrations, lab testing before the first prescription, and a pharmacy registered to dispense controlled substances. Testosterone is a Schedule III controlled substance. Through December 31, 2026, DEA and HHS rules let a registered clinician prescribe it after an audio-video visit with no in-person exam, and DEA's permanent rule is still under review, so plan for both outcomes. thimblehub sets up and runs your checkout, intake, patient and admin portals and site, fully managed, on a clinician network and pharmacy that handle controlled substances. We set up lab testing too. Bring your network and pharmacy, or we introduce them.
The same steps apply to any TRT business or virtual testosterone clinic. Many states limit who can own a medical practice and add their own telehealth prescribing rules, so have a healthcare attorney check your plan before you launch.
Where TRT telehealth rules stand on October 12, 2026
- Schedule III. Federal rules list testosterone among the Schedule III anabolic steroids (21 CFR 1308.13).
- Telehealth prescribing runs through December 31, 2026. Under the fourth DEA and HHS extension, published December 31, 2025, DEA-registered practitioners can prescribe Schedule II to V medications by audio-video telemedicine without a prior in-person evaluation.
- The permanent rule is pending. DEA proposed a special registration for telemedicine on January 17, 2025. The final rule has been under review at the White House Office of Management and Budget since August 25, 2026, and the federal agenda targets November 2026. It had not been published.
- Labels changed. FDA asked makers to update testosterone labels in June 2026, including removing the limitation of use for age-related low testosterone.
What DEA rules change for a TRT clinic
Testosterone's Schedule III status touches four parts of your clinic.
- Prescribers. Each prescribing clinician needs a DEA registration covering Schedule III and a license in each patient's state. Your clinician network keeps these in place.
- The visit. The Ryan Haight Act requires at least one in-person medical evaluation before a controlled substance is prescribed over the internet, unless an exception applies (21 U.S.C. 829(e)). The current flexibilities are that exception through 2026. Our Ryan Haight Act guide covers the history.
- Prescriptions. An electronic prescription for a controlled substance has to come from software that meets DEA's EPCS rules (21 CFR 1311). A Schedule III prescription can't be filled more than six months after it was written, or refilled more than five times (21 CFR 1306.22).
- The pharmacy. The pharmacist shares responsibility for every controlled-substance prescription they fill (21 CFR 1306.04). Use a DEA-registered pharmacy that fills telehealth TRT prescriptions and is licensed to ship to your patients' states.
If the flexibilities lapse
If December 31, 2026 passes with no new extension and no final rule, the Ryan Haight Act's in-person rule applies again. A prescriber would need at least one in-person medical evaluation of a patient before prescribing testosterone online, with narrow exceptions. Patients a prescriber has already seen in person can keep getting prescriptions by telehealth, and new patients would need an in-person visit first.
If DEA finalizes its 2025 proposal instead, expect a special registration for prescribing Schedule III to V medications by telemedicine, a DEA state telemedicine registration for each state where patients are, audio-video visits and prescription drug monitoring program checks. Ask your clinician network how it will handle both cases before you launch.
Labs first: what the guidelines ask for
Two clinical guidelines cover testing before TRT. Both ask for symptoms plus repeated morning testosterone tests before a first prescription, and the American Urological Association treats a total testosterone below 300 ng/dL as a reasonable cutoff. Your clinicians set the protocol.
| Check | Endocrine Society (2018) | AUA (2018, confirmed 2024) |
|---|---|---|
| Diagnosis | Symptoms and signs of low testosterone, plus consistently low levels | Low total testosterone, plus symptoms or signs |
| Testosterone tests | A fasting morning total testosterone, confirmed by a repeat morning test | Two early-morning total testosterone tests on separate occasions |
| Blood count | Don't start if baseline hematocrit is above the upper limit of normal | Measure hemoglobin and hematocrit before offering therapy |
| Prostate | Assess prostate cancer risk, including PSA, before starting | Measure PSA in men over 40 before starting |
Sources: Bhasin et al., Endocrine Society clinical practice guideline, J Clin Endocrinol Metab 2018; AUA, Evaluation and Management of Testosterone Deficiency (2018, validity confirmed 2024). Checked October 12, 2026.
We set up lab testing for your patients three ways: an at-home collection kit, a walk-in draw at a lab near them, or a mobile phlebotomist who comes to them. Your clinicians choose the panel and when repeat tests happen.
Clinicians and a pharmacy for controlled substances
Bring your clinician network, or we introduce one that runs controlled-substance programs such as TRT. Networks we work with include MDI, OpenLoop, Beluga, Wizlo and Arora, and we connect any other network during setup. You agree terms with the network directly.
For the pharmacy, use your network's pharmacy or one you contract, and we can introduce pharmacies too. Adding TRT to an ED or hair loss brand? Our men's health launch guide covers the rest of the category.
Steps to launch, and who does each
thimblehubYour plan, checked by an attorney
You walk a healthcare attorney through your plan: your company structure, your launch states, the DEA rules above, and what you'll do if the flexibilities lapse.
DEA-registered prescribers
You bring a clinician network whose prescribers hold DEA registrations in your launch states, or we introduce one and you agree terms directly.
A labs-first protocol
Your network's clinicians set the protocol: who qualifies, which labs come first, and how doses and follow-up labs are scheduled. We shape your intake around it and set up lab testing.
A Schedule III pharmacy
You use your network's pharmacy or one you contract, or we introduce one. For TRT it needs a DEA registration to dispense Schedule III medications.
Your brand, set up and connected
thimblehub sets up your site, checkout and intake, and patient and admin portals on your brand, your domain and your own payment processor, such as Stripe. Then we connect your network and pharmacy and turn on dispatch.
A test order, together
You and our team run a test order together, through every step a patient takes, before you go live.
See a men's health brand's checkout and portal
Open the demo set to men's health and click through the checkout, intake and patient portal your patients would use.
Open the men's health demoHow long a TRT launch takes
| Where you are when you sign | When you can go live | What we do |
|---|---|---|
| A network that prescribes testosterone, a Schedule III pharmacy and your lab protocol | As fast as 3 days after you sign | Set up your site, checkout, intake, lab testing and portals, connect your network and pharmacy, and run a test order with you |
| No network or pharmacy for controlled substances yet | Longer. Setup finishes once your terms are signed and prescribers are ready in your launch states. | Introduce ones we work with. You agree terms with them directly. |
| Waiting on LegitScript certification for paid ads | When your certification and marketing are ready. A recent brand went live the morning after. | Support your certification with site changes, reviewer access and answers |
| Design revisions, marketing with us, or custom builds | Each adds time | Scope the work with you on the first call |
Launch times count from your signed contract. Controlled-substance launches take longer when prescribers still need DEA registrations in your launch states or the pharmacy still needs licenses to ship there.
Keeping TRT patients on their plan
TRT is ongoing care, so refills carry the business. We built refills on thimblehub to keep patients on plan with little effort from them or your team.
- Refill check-ins. Before each refill, patients answer a short check-in in their portal on how they're doing, side effects and anything that's changed. You choose whether it's required, optional or off. A hospital stay or a dose change request is flagged to the clinician.
- Renewals on time. A Schedule III prescription runs out after six months or five refills, whichever comes first. When one runs out or expires, the renewal goes back to your clinician network automatically, with the patient's check-in attached.
- A save flow. When a patient goes to cancel, the portal asks why and offers a pause or a skipped month that fits the reason.
- Failed cards. The patient updates the card in the portal, and the refill ships once payment clears. Your team sees every held refill in the admin portal's refill queue.
More in how refills work on thimblehub.
What one call to thimblehub gets you
Tell us your launch states and what you already have. One call covers the rest:
- Your site, checkout and intake, lab testing, and patient and admin portals, set up and run by us on your brand and your domain.
- Your clinician network and pharmacy connected, or introductions to ones that handle controlled substances.
- Ad tracking set up with your site, and campaigns run for you if you want them, as an added engagement.
- People we trust for anything we don't do in house, such as legal work and LegitScript prep.
- Your patients, data, domain and payment processor stay yours, and every customer gets a signed BAA.
Frequently asked questions
- Can a telehealth company prescribe testosterone in 2026?
- Its clinicians can, through December 31, 2026. Under the fourth DEA and HHS extension, a DEA-registered clinician can prescribe testosterone after an audio-video visit without a prior in-person exam. After that date it depends on DEA's final special registration rule, which has been under White House review since August 25, 2026, or another extension. thimblehub sets up your brand on a clinician network whose prescribers hold DEA registrations in your launch states.
- Do I need a DEA registration to start a TRT clinic?
- Your prescribing clinicians do, and so does the pharmacy. Today the registrations sit with prescribers and pharmacies. DEA's 2025 proposal would add a registration for some online telemedicine platforms, so ask your attorney whether it would cover your company if it's finalized.
- What labs do TRT patients need before starting?
- The Endocrine Society and the AUA both call for repeated morning total testosterone tests plus symptoms before diagnosing low testosterone, and the AUA asks for hemoglobin, hematocrit and, for men over 40, PSA before starting. Your clinicians set the panel. We set up at-home kits, walk-in draws and mobile phlebotomy.
- What happens if the DEA telehealth rules expire?
- If December 31, 2026 passes with no extension and no final rule, the Ryan Haight Act's in-person rule returns. New patients would need an in-person evaluation with a prescriber before testosterone can be prescribed online, apart from narrow exceptions, while patients already seen in person can continue by telehealth.
- How fast can I launch an online TRT clinic?
- As fast as 3 days after you sign. It takes longer if you still need a pharmacy or clinicians, are waiting on LegitScript certification, want website design revisions, are planning marketing with us, or need custom builds. For TRT, plan on prescribers with DEA registrations in your launch states and a pharmacy with its own DEA registration and a license to ship to each of them.
Questions, or a topic you'd like us to cover? Book a call or email hello@thimblehub.com.
Sources
- Federal Register: DEA and HHS fourth temporary extension of telemedicine flexibilities, 90 FR 61301 (Dec 31, 2025)
- DEA Diversion Control Division: Telemedicine flexibilities extended for 2026 (Jan 2026 newsletter)
- Federal Register: DEA special registrations for telemedicine, proposed rule, 90 FR 6541 (Jan 17, 2025)
- OMB OIRA: Special registration final rule under review since Aug 25, 2026 (RIN 1117-AB40)
- Unified Agenda: DEA special registrations for telemedicine, final action Nov 2026 (RIN 1117-AB40)
- 21 U.S.C. 829(e), Ryan Haight Act in-person evaluation rule
- eCFR: 21 CFR 1308.13, Schedule III
- eCFR: 21 CFR 1306.22, refilling Schedule III and IV prescriptions
- eCFR: 21 CFR 1306.04, purpose of issue of prescription
- eCFR: 21 CFR 1311.100, electronic prescriptions for controlled substances
- Endocrine Society: Testosterone therapy in men with hypogonadism, clinical practice guideline (2018)
- AUA: Evaluation and management of testosterone deficiency guideline
- FDA: Testosterone information (updated Jun 23, 2026)