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How to start a men’s health clinic.

Testosterone is a controlled substance, sexual health ads have their own rules and telehealth prescribing is in flux. Here is what to get right before you open a TRT, ED and men’s wellness clinic.

7 min readUpdated October 2026

The rules that shape it

  • TestosteroneSchedule III
  • DEA registration$888 for 3 years
  • Telehealth flexibilitiesThrough Dec 31, 2026
  • ED ads on Meta18+ and health focused
Sources: DEA, DOJ OIG, Federal Register, Meta. Linked below.

Testosterone is a controlled substance

Short answer: to start a men’s health clinic you need an ownership structure your state allows, licensed prescribers with DEA registration and any state controlled substance registration, lab and monitoring protocols, a plan for telehealth prescribing rules, and marketing that stays within sexual health and prescription drug ad rules.

The DEA lists testosterone in Schedule III, placed there with other anabolic steroids by Congress in 1990 and 2004. DEA DEA fact sheet Every prescriber needs DEA registration, $888 for three years, and many states add their own controlled substance registration and prescription monitoring checks. DOJ OIG Each state guide covers the state side.

What the FDA label says

The FDA approves testosterone for men with low testosterone caused by certain medical conditions, and has said its benefit and safety are not established for low testosterone due to aging. FDA In February 2025 it updated testosterone labels across the class: adding results from the TRAVERSE trial, removing boxed warning language on cardiovascular outcomes, adding a warning about increased blood pressure and keeping the limitation for age-related low testosterone. FDA Build your evaluation, lab and monitoring protocols around that labeling.

Telehealth prescribing in 2026

The fourth temporary extension of the DEA telemedicine flexibilities lets DEA-registered practitioners prescribe Schedule II to V controlled substances by telemedicine without a prior in-person visit through December 31, 2026, as long as other requirements are met. Federal Register A permanent special registration rule went to White House review in August 2026 and was still unpublished in early October 2026. WCH Service Bureau If your model depends on telehealth TRT, plan for the rules to change in 2027 and check the Federal Register before launch.

Advertising rules

  • Meta allows erectile dysfunction ads only to people 18 and over and only when focused on health, not sexual pleasure or enhancement. Meta
  • Meta does not allow ads that assert or imply a viewer’s health condition. Meta
  • Promoting prescription drugs needs Meta authorization, and Google requires certification for prescription drug services. Meta Google
  • Google does not allow hCG promoted in conjunction with anabolic steroids. Google

How to start a men’s health clinic, step by step

  1. Confirm ownership and prescriber rules in your state guide.
  2. Register to prescribe: DEA registration for every prescriber, plus state controlled substance registration and prescription monitoring enrollment.
  3. Write clinical protocols for evaluation, labs, treatment options, monitoring and follow-up, aligned with FDA labeling.
  4. Get a CLIA certificate if you will run lab tests in the clinic.
  5. Decide your telehealth model and how it changes if the federal rules change after 2026.
  6. Set clear pricing for the consult, labs and ongoing care.
  7. Build private online booking and text-first follow-up.
  8. Launch with discreet, compliant creative.

Marketing a men’s health clinic

Men research privately and put off the first call, so private booking, clear pricing and fast, respectful follow-up matter more than clever ads. See how we do it on our men’s health marketing page, or plan your opening with us.

Important. General information, checked October 2026. Controlled substance and telehealth rules change. Confirm your model with a healthcare attorney licensed in your state.
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Common questions, answered.

Is testosterone a controlled substance?
Yes. The DEA lists testosterone in Schedule III, so prescribers need DEA registration and must follow controlled substance rules, including any state registration and monitoring requirements.
Can you prescribe testosterone through telehealth?
Under the DEA’s temporary telemedicine flexibilities, DEA-registered practitioners can prescribe Schedule III drugs without a prior in-person visit through December 31, 2026. A permanent rule was still under review in October 2026, so check the current position before relying on it.
Can men’s health clinics advertise ED treatment on Facebook?
Yes, to adults 18 and over, focused on health rather than sexual pleasure, and without implying the viewer has a condition. Prescription drug promotion needs Meta authorization.
Who can own a men’s health clinic?
That depends on your state’s corporate practice of medicine rules. Some states require physician ownership or an MSO structure. Check your state guide and confirm with a healthcare attorney.