How do I start an online testosterone (TRT) or hormone therapy practice?
An online testosterone (TRT) or hormone therapy practice needs the same base as any telehealth brand, plus a set of controlled-substance rules, because testosterone is a Schedule III controlled substance under federal law. The base is licensed providers in the states you serve, a legal structure where clinicians own the medical practice, and a pharmacy. The controlled-substance rules add prescribers with DEA registrations for each state they prescribe into, electronic prescribing that meets the DEA's EPCS standard (identity-proofed prescribers and two-factor signing), a check of the state's prescription drug monitoring program (PDMP) where required, and lab testing before and during treatment. Through December 31, 2026, federal rules let providers prescribe controlled medications by telehealth without a prior in-person visit; the permanent rule is still pending. The founder needs no medical license and no DEA registration. On Tessic Health, hormone therapy runs on providers licensed in all 50 states with EPCS and controlled-substance coverage, PDMP checks inside the prescribing workflow, labs, and pharmacy at 0% markup.
Reviewed September 11, 2026 · 7 min read
In short
- Testosterone is Schedule III, so every prescriber needs a DEA registration for the patient's state.
- Prescriptions go through EPCS software, with PDMP checks where the state requires them.
- Telehealth prescribing without an in-person visit is allowed through December 31, 2026.
- Labs before and during treatment set the program's rhythm and its billing schedule.
- The founder needs no medical license and no DEA registration.
On this page
What makes a TRT practice different
Most telehealth categories need a licensed provider, a pharmacy, and a legal structure. Testosterone adds federal controlled-substance law. The DEA lists testosterone and other anabolic steroids in Schedule III, so every prescription has to come from a practitioner registered with the DEA, be signed through software that meets the DEA's electronic prescribing rules, and be filled by a pharmacy registered to dispense controlled substances.
States add their own requirements. Many require prescribers to check the prescription drug monitoring program (PDMP), the state database of controlled-substance prescriptions, before prescribing, and some require a separate state controlled-substance registration. A national TRT practice has to meet every one of those rules in every state it serves.
Women's hormone therapy is a different case. Estradiol and progesterone are not controlled substances, so a menopause or HRT program without testosterone runs like any other prescription category. Testosterone prescribed to women is controlled, the same as for men. Can a white-label brand prescribe controlled substances? covers those rules in full.
Start here
Do I need a medical license to start a telehealth company?
No. Licensed clinicians own the medical practice and the founder's company owns the business. Here is exactly who needs which license, and how the two companies fit together.
Read the guideThe launch sequence
Set up the legal structure
The founder's company owns the brand and the business, and a physician-owned professional corporation employs the prescribers. The DEA registrations belong to the prescribers, never the brand. Do I need a medical license? explains the split.
Line up DEA-registered prescribers
Each prescriber needs a state license and a DEA registration for every state they prescribe into, plus a state controlled-substance registration where the state requires one.
Prescribe through EPCS
EPCS (electronic prescribing of controlled substances) requires identity proofing for each prescriber and two-factor signing on every controlled prescription, through software certified to the DEA's standard.
Build PDMP checks into the workflow
Where a state requires a PDMP check, it has to happen before the prescription is signed, every time. A check that depends on someone remembering it will eventually be skipped.
Write the lab protocol
TRT protocols order labs before the first prescription and at set intervals during treatment. The clinical lead decides which tests and how often; the clinic needs a lab network near its patients, with results that land in the chart.
Contract a pharmacy that fills controlled prescriptions
The pharmacy needs a DEA registration, a license in every state it ships into, and a willingness to fill controlled-substance prescriptions from telehealth providers. Not every pharmacy has all three.
Price the program on the lab schedule
Bill the program monthly, with follow-up visits and labs built into the schedule, so a lab reminder and a renewal arrive together. From visits to recurring care covers why this keeps patients enrolled.
Clear claims and ad approvals
An ad that promotes testosterone is a prescription drug ad, so Meta and Google require LegitScript certification first. See how to get approved on Meta and Google.
The in-person rule and the 2026 deadline
A federal law called the Ryan Haight Act requires an in-person medical evaluation before a controlled substance is prescribed over the internet, with limited exceptions. Temporary rules have set that requirement aside for telehealth, and the current extension from the DEA and HHS runs through December 31, 2026. Until then, a DEA-registered provider can prescribe testosterone by telehealth after a proper evaluation, without first seeing the patient in person.
The permanent answer is a DEA special registration for telemedicine. The final rule entered White House review on August 25, 2026, and the Justice Department's forecast expects it in November 2026. Its final terms are not public yet.
Build the practice so it keeps running whatever the rule says: keep a way to arrange an in-person exam for patients who need one, track which state each patient is in, and keep prescribing records clean enough to support any new registration. A practice that can add an in-person step quickly will keep treating patients however the final rule reads.
Build it yourself or launch on Tessic Health
| What the practice needs | Build it yourself | On Tessic Health |
|---|---|---|
| Legal structure | Counsel forms the MSO and PC and drafts the agreements: one to three months | MSO and friendly-PC structure drafted for the client's ownership during setup |
| Prescribers | Recruit providers, then license and DEA-register them state by state | Providers licensed in all 50 states, with controlled-substance coverage |
| EPCS | License certified software and identity-proof every prescriber | Built in: identity-proofed prescribers and two-factor signing on every controlled prescription |
| PDMP checks | Add a check to the workflow for each state that requires one | Enforced inside the prescribing workflow |
| Labs | Contract a lab network and connect results to the chart | Labs included, with results flowing into the patient record |
| Pharmacy | Find a DEA-registered pharmacy willing to fill telehealth controlled prescriptions in every state | Contracted pharmacy with controlled-substance coverage, billed at wholesale with 0% markup |
| Time to first patient | Six months or more | Days |
Build-it-yourself timelines follow The real cost of launching a telehealth clinic.
What regulators ask about a TRT practice
These are the questions a state board or the DEA asks about a telehealth practice that prescribes testosterone:
- Did a provider licensed in the patient's state evaluate the patient before the first prescription?
- Does the prescriber hold a DEA registration for that state, and a state registration where one is required?
- Was the PDMP checked where the state requires it, and is the check recorded?
- Were labs ordered and reviewed as the protocol requires, before and during treatment?
- Was each prescription signed through EPCS, with records kept as federal rules require?
- Did anyone on the business side set targets for how many patients get approved?
Hormone programs run for the long haul
TRT patients often stay on treatment for months or years, which makes hormone therapy a natural subscription business. That length is also why the fee model matters: a platform that takes a percentage of revenue or a markup on every fill collects it for as long as the patient stays. On Tessic Health, medication is billed at wholesale with 0% markup and there is no revenue share. See what 0% pharmacy markup means and flat fee vs revenue share.
COMMON QUESTIONS
What founders ask next.
- Do I need a DEA license to start a TRT clinic?
- No. The DEA registration belongs to each provider who prescribes testosterone, for every state they prescribe into. The founder's company owns the brand and the business, never holds a DEA registration, and never makes the prescribing decision. Do I need a medical license? explains how the two sides fit together.
- Can telehealth providers prescribe testosterone without an in-person visit?
- Yes, through December 31, 2026. A temporary extension from the DEA and HHS lets DEA-registered providers prescribe controlled medications, including testosterone, by telehealth after a proper evaluation without an in-person visit first. State rules still apply, and some states add requirements of their own.
- What happens when the telehealth flexibilities end?
- The DEA plans to replace them with a special registration for telemedicine. The final rule entered White House review on August 25, 2026 and is forecast for November 2026, but its terms are not public yet. Practices should be ready to add an in-person exam or a new registration, and should watch for the final rule before the end of the year.
- Do TRT patients need lab work?
- Yes. TRT protocols order labs before the first prescription and at intervals during treatment, and the clinical lead sets which tests and how often. The lab schedule also sets the program's rhythm, so billing, follow-ups, and reminders should follow it. Tessic Health includes labs, with results flowing into the patient record.
- Is women's hormone therapy a controlled substance?
- Estradiol and progesterone are not controlled substances, so a menopause or HRT program built on them follows ordinary prescription rules. Testosterone is Schedule III for every patient, so a women's program that includes testosterone follows the same DEA, EPCS, and PDMP rules as TRT for men.
- Can a TRT practice serve all 50 states?
- Yes, if its prescribers are licensed and DEA-registered in every state and its pharmacy can ship controlled prescriptions into each one. Some states add registrations or PDMP rules of their own. On Tessic Health, providers are licensed in all 50 states, with controlled-substance coverage and PDMP checks inside the prescribing workflow.
KEEP READING
The next questions on the list.
- Read the answer
Start here
Do I need a medical license to start a telehealth company?
- Read the answer
Compliance
Can a white-label telehealth brand prescribe controlled substances?
- Read the answer
Launch by treatment
How do I launch a peptide therapy brand?
- Read the answer
Launch planning
What do I need before my telehealth clinic sees its first patient?
- Read the answer
Advertising
How do I get my telehealth brand approved for Meta and Google ads?
- Read the answer
Compliance
What does HIPAA require of a telehealth brand owner?
SOURCES
- Federal Register: DEA and HHS extend telemedicine flexibilities through December 31, 2026
- Telehealth.org: DEA telemedicine special registration rule enters final review
- McDermott: DEA extends telemedicine flexibilities for controlled substances for 2026
- DEA Diversion Control: Controlled substances by name and schedule (PDF)
- DEA Diversion Control: EPCS questions and answers
Reviewed September 11, 2026. Tessic Health guides are general information for founders, not legal advice. Laws, agency guidance, and ad platform policies change; confirm the specifics for your business with health-care counsel. Tessic Health claims restate what tessichealth.com publishes on its pricing, platform, and security pages.