The first question decides most of the rest: is there an FDA-approved product containing this molecule, and is that the thing being offered? Approved, compounded, and unapproved are three different purchases with three different guarantees. Everything below is designed to establish which one is on the table before money moves.
Question one: what exactly would arrive, in regulatory terms
Ask for the molecule, the product name if one exists, and the approval status of the item that would ship. A good answer is specific and unembarrassed. Compounded semaglutide is not FDA-approved, and a service that says so directly is more trustworthy than one that describes the same product as pharmacy grade.
The answer that should stop the conversation is a category noun standing in for a product. Peptide therapy, restorative protocol, and optimization stack are descriptions of a service. They are not descriptions of a drug, and they cannot be looked up.
Question two: what human evidence exists for this compound
Ask what was measured, in whom, and against what comparison. Approved peptide medicines have this on file by definition. Liraglutide, teriparatide, and bremelanotide each cleared trials with named endpoints in named populations, and those endpoints are printed on the label.
For unapproved compounds the honest answer is usually that the evidence is preclinical. That answer is acceptable when given plainly. What is not acceptable is animal data presented in human language, because the reader then has no way of knowing that no one has measured the outcome being promised.
Question three: is this substance on the FDA safety-risk page
| Compound | Regulatory status | Evidence class |
|---|---|---|
| Liraglutide (Saxenda) | FDA-approved for chronic weight management | Randomized placebo-controlled trials with weight endpoints |
| Teriparatide (Forteo) | FDA-approved peptide for osteoporosis in patients at high fracture risk | Randomized trials with fracture outcomes |
| Bremelanotide (Vyleesi) | FDA-approved melanocortin agonist for hypoactive sexual desire disorder in premenopausal women | Randomized trials in that indication |
| Sermorelin | No current US label; the former product was discontinued, leaving compounded preparations only | Older diagnostic and pediatric literature; no current approved product to inherit it |
| GHRP-6 | Category 2 under the 503B interim policy | FDA describes limited safety information, with concerns on cortisol and insulin sensitivity |
| Ibutamoren mesylate | Category 2 under both the 503A and 503B interim policies | A randomized trial in hip fracture recovery was terminated early over a potential congestive heart failure signal |
| Kisspeptin-10 | Category 2 under the 503A interim policy | FDA reports no, or only limited, safety information for the proposed routes |
| Semax and selank | No approved US product; nominations withdrawn | Largely rodent work and regional clinical use outside the US |
Read the entry, not just the presence of a name. The agency writes a specific reason for each substance, and the reasons differ enormously. Some describe documented harm. Others describe an absence of data so complete that no judgment is possible either way.
Question four: who is the prescriber, and where are they licensed
Ask for the clinician’s name, credential, and licensing state, and ask whether the same person is available for follow-up. State boards publish searchable license registers, so the answer is checkable in a few minutes. A service that treats this as an unusual request has told you something about how the visit works.
Ask a second question alongside it: what would make this clinician decline? A prescriber who cannot describe a patient they would turn away is describing an order form.
Asking the same of each provider sorts them fast. Ro, Hims and Hers, LillyDirect, and HealthRX all present themselves in this space, and the ones worth more attention describe the clinician model and licensing rather than resting on a brand line. HealthRX ties its peptide therapy pages to a prescriber-reviewed process, which at least gives a reader a fact to confirm. A service that will not name who signs the prescription has answered the prescriber question before it is put to them.
Question five: what monitoring is planned and what would end treatment
For approved metabolic medicines the answer is fairly standard: baseline assessment, periodic weight and tolerability review, and defined criteria for stopping if the response is inadequate. Current obesity pharmacotherapy guidance sets out that structure and is worth having in mind as the benchmark.
For unapproved compounds there is no established monitoring standard, because there is no approved use to monitor against. A service offering one should be able to say what it is watching and why. Silence on this point usually means nothing is being watched.
Question six: what does a full year cost, and what happens if I stop
Ask for the annualized figure rather than the introductory month, and ask separately about consultation charges, lab work, shipping, supplies, and dose changes. Compounded and unapproved preparations are generally not covered by insurance or Medicare Part D, so the number on the page is usually the number paid.
Several cash-pay services publish per-month pricing that can be annualized before any intake form is completed, including Hims, LifeMD, and FormBlends, which makes cost comparison possible without handing over a medical history first. Ask the exit question in the same breath. Weight regain after stopping a GLP-1 medication is well documented in trial extensions, and a plan that has no answer for the stopping point is a plan for indefinite spending.
Question seven: what happens when something goes wrong
Ask who to call about a warm shipment, a suspected reaction, or a lot that looks wrong. Approved products have adverse event reporting attached to them. Compounded preparations have a named pharmacy that can be reached. Research chemicals have neither, and that gap is the practical difference the tier system creates.
Frequently asked questions
Is sermorelin approved for adult use?
There is no current US label for it. The brand product that once existed was discontinued, so any sermorelin available today is a compounded preparation rather than an approved drug. Older literature describes its diagnostic and pediatric use, but that record does not transfer to a preparation with no approval behind it.
If a clinic runs blood work, does that make the compound evidence-based?
No. Testing produces numbers, and numbers make a service feel clinical, but a biomarker moving is not the same as an outcome improving. The relevant question is whether any trial has shown that changing that marker with this compound changes something a patient would notice.
Are approved peptide medicines interchangeable with each other?
No. Each label names its own indication and population. Tesamorelin is approved for HIV-associated lipodystrophy and explicitly not for weight loss. Setmelanotide is approved for named genetic and hypothalamic causes of obesity. Sharing a chemical class says nothing about whether one drug does another one’s job.
What if a provider will not answer these questions?
Then the answer has been given. Approval status, pharmacy identity, prescriber license, and total cost are all facts the service already holds. Declining to state them is a choice, and it usually means at least one of those facts would cost the sale if disclosed.
