Short answer: To start a TRT digital clinic, you build the brand and patient experience while licensed providers evaluate each patient, confirm the diagnosis with labs and decide whether testosterone is appropriate. Because testosterone is a Schedule III controlled substance, your providers also need DEA registration in each state they serve, a plan for the Ryan Haight Act and the DEA telemedicine rules, PDMP checks and EPCS-certified prescribing.
If you want to start a TRT digital clinic, you are building in a category with real demand and real rules. Testosterone is not like most telehealth medications. It is a controlled substance, which brings federal DEA requirements, state controlled substance laws and prescription monitoring into every part of the workflow. Founders who understand that from day one build brands that last. Founders who treat TRT like any other subscription product run into trouble.
WellieMD’s founder, Jessica Lynne White, BS, MSPT, spent 27 years as a licensed physical therapist, and her own brands, KIN Meds, PauseRx, Octane Rx and Naked Rx, run on WellieMD. This guide is the founder-level playbook: why testosterone is regulated differently, where the DEA telemedicine rules stand as of 2026, what screening and monitoring look like, and the business steps to launch.
Why testosterone is different: Schedule III
Testosterone and other anabolic steroids are listed in Schedule III of the Controlled Substances Act. That classification means any practitioner who prescribes testosterone must hold a DEA registration, must follow federal rules for controlled substance prescriptions and must comply with the controlled substance laws of each state where patients are located. It also means pharmacies dispensing testosterone apply extra scrutiny, and your marketing and patient communications need to reflect that this is a regulated medication, not a wellness product.
The federal telemedicine rules for controlled substances
The Ryan Haight Act
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 generally requires at least one in-person medical evaluation before a practitioner prescribes a controlled substance through the internet, with limited exceptions for certain forms of telemedicine. For years this was the central obstacle for any telehealth company offering controlled substances.
The DEA telemedicine flexibilities
During the COVID-19 public health emergency, DEA and HHS allowed DEA-registered practitioners to prescribe controlled substances through telemedicine without a prior in-person evaluation. Those flexibilities have been extended several times. Here is where they stand, based on the Federal Register.
| Date | Action | What it means for a TRT clinic |
|---|---|---|
| 2008 | Ryan Haight Act enacted | In-person evaluation generally required before prescribing controlled substances via the internet, with limited exceptions |
| March 2020 | Public health emergency telemedicine flexibilities begin | DEA-registered practitioners permitted to prescribe via telemedicine without a prior in-person visit |
| January 17, 2025 | DEA publishes the proposed rule on Special Registrations for Telemedicine and Limited State Telemedicine Registrations | A proposed permanent framework, including new registration types and PDMP check requirements. It was a proposal, not a final rule. |
| January 1, 2026 through December 31, 2026 | Fourth temporary extension of the telemedicine flexibilities is in effect | DEA-registered practitioners may prescribe Schedule II through V medications via audio-video telemedicine encounters without a prior in-person evaluation, if all other requirements are met |
| After December 31, 2026 | Uncertain | Depends on whether DEA publishes a final special registration rule, another extension, or neither. Confirm with counsel before year end. |
Two details matter for TRT founders. First, the flexibilities describe audio-video telemedicine encounters for most controlled substances. Audio-only prescribing under the flexibilities is limited to certain medications for opioid use disorder, so a questionnaire alone should not be treated as a qualifying encounter for testosterone. Second, the current extension ends December 31, 2026. At the time of writing, we could not confirm a published final special registration rule. Build a plan for each scenario, including in-person evaluation options, and review it with a healthcare attorney as the deadline approaches.
DEA registration in each state
The Controlled Substances Act requires a separate DEA registration for each principal place of business or professional practice where controlled substances are dispensed. DEA’s regulations include an exception for locations where a registered practitioner only prescribes, but DEA has explained that this exception applies within the same state as the practitioner’s registration. In practice, a provider prescribing testosterone to patients in several states generally needs a DEA registration in each of those states.
On top of DEA, many states require a separate state controlled substance registration, and every state has its own rules for controlled substance prescribing. Your provider network needs to track DEA and state registrations for each prescriber, by state, with renewal dates. This is one of the biggest operational differences between a TRT clinic and a non-controlled telehealth brand.
PDMP checks
Every state operates a prescription drug monitoring program (PDMP) that tracks controlled substance prescriptions. Many states require prescribers to check the PDMP before prescribing certain controlled substances, and the requirements vary by state, by schedule and by circumstance. DEA’s January 2025 proposed rule also included PDMP check requirements for practitioners who would prescribe under a special registration. Your workflow should make PDMP checks a documented step before a testosterone prescription is issued, following the rules in each state you serve.
EPCS: electronic prescribing of controlled substances
DEA permits electronic prescriptions for controlled substances only through applications that meet its requirements, including third-party certification, identity proofing of the prescriber and two-factor authentication for signing. Many states now require controlled substance prescriptions to be sent electronically, and Medicare requires electronic prescribing for most Part D controlled substance prescriptions. Before launch, confirm that your prescribers can send testosterone prescriptions through an EPCS-compliant workflow to the pharmacies you plan to use.
Screening, labs and monitoring
Confirming the diagnosis
The Endocrine Society’s clinical practice guideline on testosterone therapy recommends diagnosing hypogonadism only in men with symptoms and signs consistent with testosterone deficiency and consistently low serum testosterone levels, measured in the morning and confirmed with repeat testing. That makes labs central to a TRT clinic. Your platform should make lab ordering, results routing and provider review simple and well documented.
Contraindications from the labeling
The labeling for testosterone cypionate injection lists contraindications including known hypersensitivity, men with carcinoma of the breast, men with known or suspected carcinoma of the prostate, and use in women who are pregnant, because testosterone may cause fetal harm. FDA’s class-wide labeling changes also retain a Limitation of Use statement explaining that safety and efficacy have not been established for age-related hypogonadism. Your marketing should never position testosterone as a general anti-aging product.
Labeling changes in 2025
In February 2025, FDA announced class-wide labeling changes for testosterone products after reviewing the TRAVERSE trial and postmarket ambulatory blood pressure studies. FDA is removing language from the Boxed Warning about an increased risk of adverse cardiovascular outcomes, adding TRAVERSE results to labeling, and adding or updating warnings about increased blood pressure. Blood pressure is therefore an ongoing monitoring topic for providers.
Ongoing monitoring
| Monitoring topic | Why it matters | Who decides the schedule |
|---|---|---|
| Testosterone levels | Confirms the diagnosis and guides dose decisions | Licensed provider, informed by guidelines |
| Hematocrit | Testosterone can raise red blood cell counts; the labeling and the Endocrine Society guideline address it | Licensed provider |
| Prostate health | Prostate cancer is a labeled contraindication, and the guideline discusses prostate monitoring for certain patients | Licensed provider |
| Blood pressure | FDA’s 2025 class-wide labeling changes added blood pressure warnings | Licensed provider |
| Fertility goals | The guideline recommends against testosterone therapy for men planning fertility in the near term | Licensed provider, with the patient |
The guideline also lists other situations where testosterone therapy is not recommended, such as elevated hematocrit, untreated severe obstructive sleep apnea and uncontrolled heart failure. Your intake should surface these clearly. The provider makes every decision.
Compounded testosterone
Some TRT clinics use compounded testosterone preparations from licensed 503A pharmacies alongside FDA-approved products. Compounded drugs are not FDA-approved, and compounders face legal limits on making copies of commercially available approved drugs. If your formulary includes compounded options, confirm the legal basis with your pharmacy and your attorney, and describe those products accurately in your copy.
Marketing a TRT brand responsibly
- Talk about evaluation, not outcomes. “See if you may be a candidate” is safer and more honest than any promise about energy, strength or body composition.
- No guaranteed prescriptions. Never imply that every patient will receive testosterone.
- No anti-aging framing. FDA labeling retains a Limitation of Use for age-related hypogonadism.
- Never call compounded products FDA-approved.
- Plan for LegitScript. Advertising prescription and controlled products generally requires certification, and controlled substance programs face extra review.
How to start a TRT digital clinic: step by step
- Get legal guidance on controlled substances. Work with a healthcare attorney on entity structure, state rules and your plan for the DEA telemedicine deadline. Our guide on how to start a telehealth business without being a doctor covers the ownership basics.
- Choose your launch states. Start with states where your providers hold state licenses, DEA registrations and any required state controlled substance registrations.
- Secure licensed provider coverage. Confirm providers are experienced with hypogonadism evaluation, labs and long-term monitoring.
- Set up EPCS and PDMP workflows. Confirm certified electronic prescribing and documented PDMP checks for each state.
- Build a lab-first intake. Capture symptoms, history, medications, fertility goals, sleep apnea, cardiovascular history and prostate history.
- Choose pharmacy pathways. Decide on FDA-approved products and any compounded options, and confirm each pharmacy’s controlled substance handling.
- Plan follow-up and refills. Controlled substance refills and ongoing labs need a clear, provider-led schedule.
- Budget for the extra layers. See How Much Does It Cost to Start a Telehealth Business? for the categories to plan for.
- Start merchant processing and LegitScript early. Controlled substance programs often take longer to approve.
- Test the full patient journey, then launch. Run test orders from intake to lab review to delivery before real patients arrive.
How WellieMD helps
WellieMD is a white-label telehealth platform, also called a digital clinic platform, that connects your men’s health brand to licensed providers, licensed 503A compounding pharmacies and brand-name pharmacy pathways. It supports branded intake, licensed provider review, e-prescribing, subscriptions, refills and lab workflows in one place. Controlled substance programs add DEA, EPCS and PDMP requirements that depend on your providers and states, so we walk through those specifics during your demo. All clinical decisions stay with licensed providers.
Visit the white-label telehealth platform page for the full platform view. If you want a done-for-you team to build your brand and website, GrowPro has launched 80+ telehealth brands. We build it with you.
Frequently asked questions
Is testosterone a controlled substance?
Yes. Testosterone is a Schedule III controlled substance under federal law. Providers who prescribe it need DEA registration and must follow federal and state controlled substance rules, including rules for telemedicine prescribing, PDMP checks and electronic prescribing.
Can testosterone be prescribed through telehealth without an in-person visit?
Under the DEA telemedicine flexibilities, DEA-registered practitioners may prescribe controlled substances via audio-video telemedicine without a prior in-person evaluation through December 31, 2026. What happens after that date is uncertain, so confirm the current rules with a healthcare attorney.
Does a provider need a DEA registration in every state?
Generally, yes. DEA requires a separate registration in each state where a practitioner handles controlled substances, and its prescribing-only exception applies within the same state. Many states also require their own controlled substance registration.
Are labs required for TRT?
The Endocrine Society guideline recommends confirming low testosterone with morning lab tests, repeated to confirm, in men with consistent symptoms and signs. Ongoing monitoring, including hematocrit and blood pressure, is also part of responsible care. The licensed provider sets the schedule.
Who should not take testosterone?
Testosterone labeling lists contraindications including men with breast cancer or known or suspected prostate cancer, known hypersensitivity, and use in pregnant women. The guideline describes other situations to avoid. A licensed provider reviews these and other factors during evaluation.
Your next step toward a TRT digital clinic
When you start a TRT digital clinic with DEA-registered providers in every state you serve, EPCS and PDMP workflows, lab-first screening and honest marketing, you build a brand that can hold up in a heavily regulated category. The DEA telemedicine rules are on a clock, so build your plan with counsel now. If you are ready to map out your TRT brand, book a demo with WellieMD and we will walk through it together.
This guide is general information, not legal or medical advice. Prescription products require evaluation by a licensed provider. Compounded medications are not FDA-approved.
Sources
- Federal Register: Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications
- Federal Register: Special Registrations for Telemedicine and Limited State Telemedicine Registrations (proposed rule)
- Federal Register: Clarification of Registration Requirements for Individual Practitioners
- Electronic Code of Federal Regulations: 21 CFR Part 1311, Requirements for Electronic Orders and Prescriptions
- U.S. Food and Drug Administration: FDA issues class-wide labeling changes for testosterone products
- DailyMed: Depo-Testosterone (testosterone cypionate) injection labeling
- Endocrine Society: Testosterone Therapy in Men with Hypogonadism clinical practice guideline