A compliant telehealth weight-loss program has a real clinician evaluation before any prescription, signed protocols with labs and follow-up for each drug, a pharmacy arrangement that fits approved or compounded products after the shortages ended, marketing that never implies FDA approval of compounded drugs, no ad tracking on intake pages, and clear subscription terms.
A compliant telehealth weight-loss program has six parts that hold up to scrutiny: a real clinical evaluation before any prescription, protocols for each medication including monitoring labs, a pharmacy arrangement that fits the product (approved or compounded), accurate marketing, privacy controls on the intake and checkout pages, and subscription terms that are clear before payment. Each has drawn enforcement in the last three years.
This describes the operational and regulatory requirements; counsel and your medical director decide how they apply to your program.
1. Is there a real clinical evaluation?
- A licensed clinician in the patient's state reviews history, current medications, contraindications and goals, and decides whether to prescribe. Intake forms inform that decision; they do not make it.
- Several states prohibit prescribing based on a questionnaire alone or require a minimum interaction. See where questionnaire-only prescribing is prohibited.
- Whether an asynchronous visit can establish the patient relationship depends on the state. See asynchronous telehealth by state.
- Document why the patient qualifies under the protocol, using the criteria in the medication's labeling or the protocol your medical director has signed.
2. Are there protocols for each medication?
- GLP-1 receptor agonists (approved or compounded): eligibility, contraindications, dose titration, follow-up interval, side-effect escalation, and when to stop.
- Phentermine and other controlled weight-loss drugs: phentermine is a Schedule IV controlled substance, so DEA registration in the patient's state, the DEA telemedicine rules, and state limits all apply. DEA's temporary flexibilities (90 FR 61301) run through December 31, 2026; the special registration rule proposed in January 2025 is not final. Some states restrict controlled weight-loss drugs further. See our DEA telemedicine rules hub.
- Labs: baseline and monitoring labs where the protocol calls for them, with a lab partner that can reach every patient. See lab partners for telehealth.
- Follow-up: scheduled clinician check-ins, not only automated refills. Refills without clinician review were central to the Justice Department's case against Done Global in a different drug class. See the Done Global case.
3. Does the pharmacy arrangement fit the product?
Approved products go through any licensed pharmacy, including manufacturers' direct-to-consumer channels where they exist.
Compounded products are narrower than they were. FDA declared the tirzepatide shortage resolved on December 19, 2024 and the semaglutide shortage resolved on February 21, 2025, and the compounding grace periods ended in 2025. A 503A pharmacy may not regularly compound drugs that are essentially copies of a commercially available product unless the prescriber determines that a change produces a significant difference for the individual patient (21 U.S.C. 353a(b)). If you prescribe compounded GLP-1s:
- the prescriber, not the company, documents the patient-specific reason;
- the pharmacy is licensed in every state you ship to and can show its inspection history;
- no payment flows from the pharmacy to the practice based on prescription volume.
See compounded GLP-1s after the shortages ended and choosing a pharmacy partner.
4. Is the marketing accurate?
FDA sent warning letters to telehealth companies over compounded GLP-1 marketing in September 2025, March 2026 and June 2026, citing the misbranding provisions of sections 502(a) and 502(bb) of the Food, Drug, and Cosmetic Act. The letters objected to implied FDA approval, implied equivalence to brand-name approved drugs, and company names on labels of products the companies did not compound.
- Describe compounded products as compounded and not approved by FDA, and name the pharmacy.
- Do not use brand-name drug trial results to sell a compounded product.
- Do not promise a prescription or a specific amount of weight loss.
- Substantiate any outcome claims for your own program.
See marketing after FDA's warning letters and the advertising claims checklist.
5. What leaves the site through tracking code?
A weight-loss intake asks about weight, conditions and medications. If a pixel on that page sends identifiers and events to an advertising platform, the program has the same exposure the FTC charged in its orders against BetterHelp, Cerebral, Monument and GoodRx, plus state consumer health data laws such as Washington's. Keep advertising tags off intake, checkout and patient pages, and do not name events after drugs or conditions. See tracking pixels on telehealth sites.
6. Are subscription terms clear?
- Show the full monthly price, what it includes (visits, medication, labs), and what costs extra.
- Disclose the renewal interval and how to cancel before taking payment, as the Restore Online Shoppers' Confidence Act and state automatic renewal laws require.
- Make cancellation as easy as sign-up. The FTC's 2024 Cerebral order included refunds tied to cancellation practices.
- Decide in advance what happens to a medication shipment already in transit when a patient cancels.
Documents a reviewer will ask for
- A sample of charts showing evaluation, eligibility, prescribing decision, labs and follow-up.
- Signed protocols for each medication.
- Prescriber licensure and DEA registrations by state, reconciled to patient locations.
- Pharmacy contracts, licenses, and any payments between the pharmacy and the practice.
- Current and past ads, landing pages and product pages.
- A tracking inventory for the site and app.
- Checkout flow screenshots and cancellation data.
Our Service-Line Pivot Package ($3,950) reviews an existing weight-loss program against these six areas and maps the changes, for your counsel's review. New programs start with the Telehealth Launch Blueprint ($4,950). See pricing.
Common questions
- Can a telehealth company prescribe weight-loss drugs from a questionnaire?
- A licensed clinician must evaluate the patient and decide, and several states prohibit prescribing based on a questionnaire alone. Whether an asynchronous visit can establish the relationship depends on the patient's state.
- Is phentermine a controlled substance for telehealth purposes?
- Yes. Phentermine is a Schedule IV controlled substance, so the prescriber needs a DEA registration in the patient's state and must follow DEA's telemedicine rules, which allow prescribing without a prior in-person evaluation only through December 31, 2026 under the current extension, plus any state limits.
- Can a weight-loss program still use compounded semaglutide?
- Only within narrower limits since the shortage ended. A 503A pharmacy may not regularly compound essentially copies of a commercially available drug unless the prescriber documents a change that makes a significant difference for the individual patient. Counsel and the pharmacy should review the program.
- What did FDA object to in weight-loss telehealth marketing?
- Its warning letters cited implied FDA approval of compounded products, implied equivalence to brand-name approved drugs, and company names on labels of products the company did not compound, under the misbranding provisions of the Food, Drug, and Cosmetic Act.
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