How to start a hormone replacement therapy clinic

To start a hormone replacement therapy clinic, define the clinical population and services first, then match the license, training, prescribing rules, insurance, and follow-up to that plan. Menopause care and testosterone prescribing raise different operational questions. Review your employment agreement before leaving your job, and complete the usual private-practice setup. A service menu should explain what patients can expect without promising a prescription or a particular result.

This is a practice-planning guide for licensed clinicians, not a treatment protocol. The regulatory and credential sources below were checked October 12, 2026; state rules and individual clinical decisions need their own review.

How do you start a hormone replacement therapy clinic?

Start with a service map that distinguishes the populations you serve and the decisions each visit supports. For each service, write down the clinical lead, relevant training, prescribing authority, follow-up process, and referral route. That map lets your lawyer, insurer, and operational partners review the same concrete plan.

1. Define whether the clinic provides menopause care, testosterone-related care, or both.
2. Confirm scope, ownership, prescribing authority, and any collaboration requirements in the states you will serve.
3. Review your employment agreement before resigning or contacting patients about the new clinic.
4. Confirm controlled-substance requirements for any planned testosterone prescribing.
5. Decide whether you perform testing or send specimens to an outside laboratory.
6. Arrange malpractice coverage, records, results routing, and backup coverage.
7. Complete the entity, identifiers, and payment steps in the private-practice guide.

How do menopause and testosterone services differ operationally?

Create a separate review for each service instead of assuming one hormone-clinic protocol covers everything. The difference affects the credentials you describe, the prescribing requirements you check, and the follow-up you organize. The table is a planning aid; it does not determine whether any patient should receive treatment.

Service	Operational questions to settle
Menopause consultation	Who assesses suitability, discusses hormone and nonhormonal options, and coordinates follow-up?
Testosterone-related care	Who confirms prescribing authority, controlled-substance compliance, monitoring, and referrals?
Testing	Which tests are performed in-house, who receives outside results, and who covers absences?
Telehealth	Which states can you serve, and when will an in-person assessment be arranged?
Medication questions	Who responds to an adverse-effect report, a refill request, or a change in the patient's other medicines?

A useful rehearsal is a patient who calls with a question after starting a treatment. Test how the message reaches the responsible clinician and what happens when that clinician is away.

What changes when the clinic prescribes testosterone?

Testosterone is listed in Schedule III under 21 CFR 1308.13. The federal registration rule in 21 CFR 1301.11 applies to controlled-substance activities, subject to its exemptions. Confirm the registration, state authority, and any additional requirements before offering the service.

For remote visits, check the telehealth practice guide and the underlying rules before building a prescribing workflow. A general telehealth consent or a website statement does not settle controlled-substance requirements.

Have the insurer review the actual service list, including procedures and locations. If the clinic changes that list, revisit coverage and the operating process before promoting the new service.

How should the clinic present menopause care and credentials?

Describe the clinician's license, actual certification, and experience clearly. “Hormone replacement therapy” is not a specialty certificate on the ABMS chart. The Menopause Society MSCP credential is a separate exam-based credential for licensed professionals. The menopause clinic guide covers the visit design and current application resources.

FDA notes that hormone therapy may help menopause symptoms, but it has benefits and risks and is not appropriate for everyone. Product choice and follow-up should reflect the individual assessment and current labeling. Use FDA's menopause guidance as background, alongside current clinical guidance; do not turn a business plan into a standard prescription package.

What should you say about compounded products?

Compounded medications are made by licensed pharmacies for individual patients and are not FDA-approved.

Explain the actual product and why it is being considered. FDA's compounding questions and answers explains that compounded drugs do not receive FDA's premarket review for safety, effectiveness, and quality. Do not describe a compounded product as an approved equivalent or imply approval through the clinic's branding.

Ask counsel and the responsible pharmacy to review the legal basis for the specific product. Document the patient discussion and follow-up plan. Compounding is a patient-specific clinical and regulatory question, not a reason to build the whole clinic around one advertised formula.

How do labs, fees, and follow-up fit together?

List what the consultation fee includes and what the patient may pay separately for laboratory work, medication, procedures, and follow-up. At the same time, assign responsibility for every result and message. Pricing and operations need to agree: if the fee includes a results discussion, the schedule must have room to deliver it.

If your site performs tests, review the CLIA requirements described in the functional medicine practice guide. Collecting specimens for an outside lab is a different activity from performing tests in the clinic. The startup-cost guide helps separate equipment, staff, insurance, and recurring expenses.

Before accepting a first patient, have these items ready: a service-specific consent process, result ownership, coverage for absences, a referral route, a written fee explanation, and the insurer's confirmation. Test them with a fictional patient from booking through follow-up.

Where can Vye Health help?

Vye Health helps providers launch, run, and grow private practices. Vye manages licensing, credentialing, malpractice insurance, and your website, and payer contracts if you want them.

Bring your service map and intended states of practice. Apply to Vye Health.