White-label sermorelin program for clinics
Run a sermorelin program under your own brand, with licensed prescribers deciding every patient and a licensed pharmacy compounding each prescription.
A white-label sermorelin program lets a clinic run sermorelin under its own brand while licensed prescribers decide who receives it. MDLaunchr supplies the intake, prescriber review, labs where the prescriber orders them, and coordination with licensed 503A compounding pharmacies. No FDA-approved sermorelin product is sold today, so every prescription is compounded and must be described that way.
Who it's for: Men's health, hormone and longevity clinics, med spas, and wellness brands adding sermorelin to an existing program.
What the program covers, and what you own
Clinical review
MDLaunchr provides: Licensed prescribers review each patient and decide whether sermorelin is appropriate.
You own: Nothing clinical. Eligibility and every protocol are the prescriber's decision.
Labs
MDLaunchr provides: Lab ordering and results routed to the prescriber when the prescriber asks for them.
You own: Explaining what testing is for without promising what it will show.
Pharmacy coordination
MDLaunchr provides: Prescriptions sent to licensed 503A pharmacies that compound sermorelin for the individual patient.
You own: Never calling sermorelin FDA-approved, or the same as a growth hormone product.
Follow-up
MDLaunchr provides: Scheduled check-ins that go back to a prescriber before each continuation.
You own: The program or membership structure patients sign up for.
Brand
MDLaunchr provides: Your name, look and domain on every screen the patient sees.
You own: Your brand, your website and your marketing.
Advertising claims
MDLaunchr provides: Program pages written to the same rules this page follows.
You own: Every ad and post, which must not promise muscle, fat-loss, sleep or anti-aging results without evidence.
How a patient moves through the program
- 1A patient finds your brand and starts intake on your site.
- 2They complete a health history and telehealth consent.
- 3A licensed prescriber reviews it and may order labs before deciding.
- 4If prescribed, a licensed 503A pharmacy compounds sermorelin for that patient and ships it.
- 5Follow-up check-ins and any repeat labs go back to a prescriber.
How a launch runs, step by step
- 1Decide whether sermorelin stands alone or joins a hormone, men's health or longevity program. (You)
- 2Confirm the pharmacy's basis for compounding sermorelin under section 503A. (MDLaunchr, with the pharmacy)
- 3Set up the brand, the domain and the program pages. (You and MDLaunchr)
- 4Have your claims reviewed before anything runs. (You, with counsel)
- 5Confirm prescriber licensing in each launch state. (MDLaunchr)
- 6Set up lab ordering and the follow-up schedule. (MDLaunchr)
- 7Launch, then review intake, labs and follow-up every week. (You and MDLaunchr)
Claims review is the step most sermorelin programs underestimate: much of the category's marketing language promises results regulators treat as health claims.
The compliance limits for this program
No FDA-approved sermorelin is sold today
Sermorelin acetate was once sold as an FDA-approved drug, Geref. Its maker discontinued it, and in 2013 FDA determined it was not withdrawn from sale for reasons of safety or effectiveness. No approved sermorelin product is marketed now, so what patients receive is compounded and must not be described as FDA-approved.
Compounding under section 503A
A 503A pharmacy compounds for an individual patient on a prescription, from a bulk substance that has a USP or NF monograph, is a component of an FDA-approved drug, or is on FDA's 503A bulks list. Confirm the pharmacy's basis in writing before launch.
Other growth hormone secretagogues are a different case
Some growth hormone secretagogues sold online are on FDA's list of bulk substances that may present significant safety risks in compounding. A sermorelin program should not add them.
Muscle, sleep and anti-aging claims need evidence
The FTC expects health claims to be backed by competent and reliable scientific evidence. Promises of muscle gain, fat loss, better sleep or slower aging are health claims, and so are results in testimonials.
Licensing follows the patient
A prescriber generally must be licensed in the state where the patient is located at the time of the visit.
Questions operators ask
Is sermorelin FDA-approved?
Not as a product sold today. Sermorelin acetate was approved as Geref, which was discontinued, and FDA determined in 2013 that it was not withdrawn for safety or effectiveness reasons. Sermorelin prescribed now is compounded and is not FDA-approved.
Can a clinic prescribe sermorelin through telehealth?
Yes, when a licensed prescriber in the patient's state decides it is appropriate and a licensed 503A pharmacy compounds it for that patient. The marketing has to follow FDA and FTC rules.
Is sermorelin the same as growth hormone?
No, and your pages must not present it as one. Sermorelin is a growth hormone-releasing hormone analog, a different substance from growth hormone itself, and growth hormone products are regulated separately.
Can a 503A pharmacy compound sermorelin?
503A pharmacies compound sermorelin under individual prescriptions. Confirm in writing the basis your pharmacy relies on under section 503A, and recheck it when FDA updates its bulk substance lists.
Can a med spa or men's health clinic add sermorelin?
Yes. It is often added to a hormone, men's health or longevity program. Each patient still goes through a prescriber's review, and the clinic's marketing needs its own claims review.
What can I say in sermorelin ads?
Describe the program: who reviews patients, the labs and follow-up, and what is included. Claims about muscle, fat loss, sleep or aging need competent and reliable scientific evidence.
Do I need to be a clinician to run a sermorelin program?
No. The brand owner makes no clinical decisions. How the business is owned is set by each state's corporate practice of medicine rules, so confirm the structure with counsel.
Guides for this program
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View allLaunch a sermorelin program under your brand
Clinician review, pharmacy fulfillment and compliant intake are already in place. You bring the brand.