Seller record · Telehealth service

RoenRx

By Paul Harris, Standards EditorRecorded September 2026 · Standard v1.1 · How checks are performed

Fails 4 of 8 criteria. S3, pharmacy identification: No filling pharmacy is named. The terms and answers refer only to partner pharmacies and third-party pharmacies. 3 more criteria also fail; see the table below.

At a glance

RoenRxTelehealth service

4/8criteria passed
Price
Compounded semaglutide from $151 a month on a 3-month supply, plus a membership at $39 the first month, then $135
Sells
compounded semaglutide, compounded tirzepatide, Ozempic, and 7 more
FDA letters
1 on file
Visit RoenRxSee all eight dispositions

Telehealth service. Passes 4 of 8 criteria. Recorded against Standard v1.1.

A telehealth membership selling compounded semaglutide and tirzepatide and helping members get brand-name GLP-1s covered by insurance, beside birth control, hair loss, erectile dysfunction, skin care and mental health treatment. Care comes from an outside medical group after an online questionnaire, and an FDA warning letter from June 2026 names the company.

Operating entity Roen Health, Inc.

Dispositions

CodeCriterionDispositionWhere it appears
S1Prescriber requirementPASSRoenRx's website; RoenRx's telehealth consent; RoenRx's returns and refunds page
S2Prescription gatingPASSRoenRx's weight loss page; RoenRx's weight loss FAQ
S3Pharmacy identificationFAILRoenRx's terms of use page; RoenRx's weight loss FAQ
S4Compounding disclosureFAILRoenRx's weight loss page; RoenRx's website
S5Analytical documentationFAILRoenRx's weight loss page; RoenRx's weight loss FAQ; RoenRx's terms of use page
S6Business addressFAILRoenRx's website; RoenRx's privacy policy; RoenRx's terms of use page
S7Price disclosurePASSRoenRx's weight loss FAQ; RoenRx's FAQ; RoenRx's weight loss page
S8Enforcement statusPASSFDA warning-letter index

Evidence, criterion by criterion

The evidence behind each disposition in the table above, where it appears, and its date.

S1PASSA provider licensed in the patient's state reviews each questionnaire and decides whether to prescribe. The telehealth consent and membership terms name Bruno Health, P.A. and its affiliated medical groups as the providers.Source: RoenRx's website; RoenRx's telehealth consent; RoenRx's returns and refunds page.
S2PASSThe weight-loss page lists answering eligibility questions as the first step and the provider's review of those answers as the second, and the answers say medication is charged only if it is prescribed.Source: RoenRx's weight loss page; RoenRx's weight loss FAQ.
S3FAILNo filling pharmacy is named. The terms and answers refer only to partner pharmacies and third-party pharmacies.Source: RoenRx's terms of use page; RoenRx's weight loss FAQ.
S4FAILThe weight-loss page sells semaglutide without calling it compounded, says a clinician might prescribe FDA-approved medications like Wegovy or its active ingredient, semaglutide, and carries no statement that compounded products are not FDA-approved. Only the home page footer says so.Source: RoenRx's weight loss page; RoenRx's website.
S5FAILNo certificate of analysis or lot document is published on the weight-loss page, the answers or the terms.Source: RoenRx's weight loss page; RoenRx's weight loss FAQ; RoenRx's terms of use page.
S6FAILThe seller prints two different addresses. The footer and privacy policy give 800 North State Street, Suite 304, Dover, Delaware 19901, while the terms of use give Roen Health, Inc at 767 Broadway #1235, New York, NY 10003.Source: RoenRx's website; RoenRx's privacy policy; RoenRx's terms of use page.
S7PASSCompounded semaglutide from $151 a month and compounded tirzepatide from $216 a month when a 3-month supply is bought, shipping included. Medication is not part of the membership, which the answers price at $135 a month and discount to $39 for the first month for a limited time. Bundles with care and medication cost $217 for the first month, then $297 a month for semaglutide, and $349, then $449 for tirzepatide. Brand-name GLP-1s with insurance from $25 a month.Source: RoenRx's weight loss FAQ; RoenRx's FAQ; RoenRx's weight loss page.
S8PASSFDA warning letter 728293, June 2026, names Roen Health, Inc. doing business as RoenRx, reviews this website and writes to the support address it prints. It says the labels pictured name RoenRx as the compounder and that claims such as semaglutide being the active ingredient in Wegovy and Ozempic present the compounded products as FDA-approved. No FDA action has halted the business, and the seller still trades.Source: FDA warning-letter index.

Products shown on the seller's own pages at the recorded date: compounded semaglutide, compounded tirzepatide, Ozempic, Wegovy, Zepbound, Mounjaro, birth control, hair loss and erectile dysfunction treatments, enclomiphene, anxiety and depression treatment.

Other sellers of the same products

Who sells semaglutideWho sells tirzepatide

Enforcement documents on file: 1 warning letter

FDA warning letter 728293, issued June 2026, to Roen Health, Inc. dba RoenRxPictured labels identify RoenRx as the compounder of semaglutide products when it is not, and claims that semaglutide is the active ingredient in Wegovy and Ozempic represent the compounded products as FDA-approved when they are not.

A warning letter alleges violations and requests a response. It does not halt a business, and it does not remove a seller from this ledger. Every letter recorded here.

Visit RoenRx

Dispositions recorded against Standard v1.1. Method and null semantics: how checks are performed. This record is not a review and contains no medical advice.