Read This First
This page is not built on clinical evidence. It is built on the approved product's label, the FDA's compounding rules, and the regulatory record. What tesamorelin does in people is covered on the library entry; this page is about the difference between the approved product and everything else sold under its name.
Tesamorelin is unusual in this library because a fully characterised, approved, manufacturer-supplied version exists and can be prescribed. That does not simplify sourcing; it splits it. There is the approved product, there is compounded tesamorelin operating under a rule most of it does not meet, and there is research-labelled powder in vial sizes the approved product has never come in.
The Approved Product
What Is It?
Egrifta, approved by the FDA on 10 November 2010, now supplied as Egrifta SV (2 mg vial, reconstituted daily) and Egrifta WR (11.6 mg vial, reconstituted weekly for seven daily 1.28 mg doses, approved 25 March 2025). The label states the two "are not substitutable" and that they differ in dose, number of vials, reconstitution and storage.1 Both are dispensed by prescription, typically through specialty pharmacy, with the manufacturer's diluent and supplies in the box.
The manufacturer, Theratechnologies, was acquired in 2025 by an affiliate of Future Pak, a contract manufacturer.2 Supply continues under the same product names.
What Does "Approved" Guarantee?
Identity, content, sterility, endotoxin limits, stability through the labelled shelf life under the labelled storage, a validated manufacturing process, and a label that says what it is for and who should not take it. Those are the things a certificate of analysis on a gray-market vial is trying to imitate, and the approved product has all of them without a certificate.
What approval does not guarantee is that the product is being prescribed for its indication. Egrifta is approved for excess abdominal fat in adults with HIV who have lipodystrophy.1 A prescription for anything else is off-label. Off-label prescribing of an approved product is lawful and common; it is also the point at which the evidence stops and the label's cautions still apply.
Compounded Tesamorelin
Is It Legal?
Sometimes, and rarely in the way it is sold.
Tesamorelin is the active ingredient of an approved drug, which makes it eligible for compounding by 503A pharmacies without appearing on any bulks list. That is the one respect in which it differs from every unapproved peptide sold beside it. But the same law forbids compounding what is "essentially a copy of a commercially available drug product." The FDA's guidance treats a compounded product as essentially a copy when it has the same active ingredient in the same, similar or easily substitutable strength, by the same route, unless the prescriber documents a change for an identified patient that "will produce a significant difference for that patient." The guidance is explicit that a lower price is not such a difference.3
A pharmacy supplying subcutaneous tesamorelin at 1 or 2 mg a day to a person who could take Egrifta is making a copy. A pharmacy supplying it because Egrifta is unaffordable is making a copy for a reason the rule does not accept. The lawful cases are narrow: a documented allergy to an excipient, a dose the approved product cannot deliver, a shortage.
Why Does the Rule Matter to a Buyer?
Because it explains the product. Compounded tesamorelin exists commercially because it is cheaper than Egrifta, and it is cheaper because it does not carry the manufacturing standard, the stability data or the label. A pharmacy operating inside the copy rule has every incentive to document a patient-specific reason; a telehealth service dispensing it by the thousand does not have thousands of them.
The FDA has issued waves of warning letters to telehealth companies and compounders over misleading promotion of compounded peptide drugs, most visibly in the GLP-1 market.4 ONPEPS has not identified a warning letter naming compounded tesamorelin specifically, and says so rather than implying one. The rule exists regardless of whether it has been enforced against a particular seller.
What Should a Compounded Product Come With?
A prescription from a named prescriber, and a stated reason the approved product is not being used
A pharmacy label with the pharmacy's name, licence state, lot number and beyond-use date
A stated strength per millilitre, not per vial, so that a dose can be drawn without arithmetic on a guess
Instructions for storage and for discarding after first use
A product lacking any of these is not a compounded prescription drug. It is a vial with a pharmacy's name on it, and the FDA has documented fabricated pharmacy names on gray-market peptide products.4
Research-Labelled Product
What Is Being Sold?
Lyophilised powder, commonly in 5 mg and 10 mg vials, labelled for research use only, from the same vendors that sell CJC-1295 and ipamorelin. The approved product has never been supplied in those sizes.1 A 10 mg vial of "tesamorelin" is not Egrifta repackaged; it is a peptide synthesised elsewhere to an unverified standard, with no connection to the manufacturer.
It is also frequently sold in blends with CJC-1295 and ipamorelin, which the FDA documented when it reviewed CJC-1295 in 2024.5 No study has tested any such combination.
Does "Research Use Only" Change Anything?
No. It is a liability position adopted by the seller, not a regulatory category. The FDA has held in warning letters that the disclaimer does not survive product copy establishing human use.6 For tesamorelin the position is stranger than usual: the seller is disclaiming human use of a molecule whose human use is approved, on a page that usually cites the approval.
Purity Testing Versus Identity Testing
| Test | Question it answers | Question it cannot answer |
|---|---|---|
| HPLC purity | What proportion of the sample is one substance | Whether it is tesamorelin, unmodified GHRH 1-44, or a truncated fragment |
| Mass spectrometry identity | Whether the mass matches | How much of the sample it represents; whether the hexenoyl group is intact |
| Endotoxin assay | Whether bacterial cell-wall fragments are present | Identity or content |
| Sterility | Whether viable organisms are present | Anything about the peptide |
Tesamorelin is a 44-residue peptide, long for synthetic manufacture, and the N-terminal modification is the whole difference between it and native GHRH, which the body destroys in minutes. A product missing that group has the right sequence and almost none of the activity. A purity figure would not show it.
Certificates of Analysis
A laboratory report on one batch. Read it for the laboratory's independence from the seller, the lot number and whether it matches the vial, the date, and which tests were run rather than mentioned. It cannot establish that the vial in hand came from the batch tested; that rests on a chain of custody the buyer cannot inspect. A certificate is a PDF, and nothing about the format prevents reuse or fabrication.
Storage and Handling
What the Label Says
This is the one compound in this group with a validated specification. Egrifta WR vials are stored at room temperature, 20 to 25°C, in the original box to protect from light, and not frozen. After reconstitution with the supplied bacteriostatic water, one vial provides seven daily doses and unused solution is discarded seven days after mixing. The reconstituted solution should be clear, colourless and free of particles, and used only if it is.1
Those figures were generated for that formulation, in that vial, with that diluent. They do not transfer to a compounded product or a research vial, which have their own excipients, concentrations and unknowns. A gray-market seller quoting the Egrifta stability data for a 10 mg vial is quoting a different product.
Multi-Dose Use
The approved product is designed for seven days from one vial with a new needle and syringe each time.1 The FDA's general guidance for compounded injectables is to discard a multi-dose vial within 28 days of first use regardless of what remains.4 A 10 mg research vial at a daily 1 to 2 mg dose runs past that.
Signs to Stop Rather Than Proceed
Reconstituted solution that is cloudy, coloured or contains particles, which the label itself says not to inject
Injection-site redness, itching or swelling that grows with successive doses; these are the most common labelled reactions and also the pattern of an immune response to an impure product1
Swelling of the hands or feet, joint pain, or numbness in the hands, which are the labelled signs of fluid retention and carpal tunnel
Any sign of hypersensitivity, which the label says warrants immediate medical attention
A vial size, label or certificate that does not correspond to any approved presentation, sold as if it did
Community Language
Tesa, Tesamorelin
The compound. Approved as Egrifta.
Egrifta, Egrifta SV, Egrifta WR
The approved products, in three formulations over fifteen years. WR is the current one; SV remains marketed; the two are not interchangeable.1
Compounded tesamorelin
Tesamorelin made by a pharmacy. Lawful only where it is not essentially a copy of the approved product, which most of it is.3
Tesa/CJC/Ipa blend
A research-vendor mixture of tesamorelin with CJC-1295 and ipamorelin. Untested as a combination; one component has been rejected for compounding and another sits on the FDA's safety-risk list.
Essentially a copy
The legal test for whether a compounded version of an approved drug is permitted. Cost is not a qualifying difference.3
Certificate of analysis
A laboratory report on one batch. The approved product does not need one; a research vial cannot be trusted with one.
Related ONPEPS Coverage
Tesamorelin library entry: the trials, the label and the off-label market
Tesamorelin cost and access: a specialty drug with one indication
Compounded, gray market and counterfeit semaglutide: what the regulators have documented
Sources
Theratechnologies Inc. EGRIFTA WR (tesamorelin) for injection: prescribing information. Revised March 2025. DailyMed. dailymed.nlm.nih.gov
Theratechnologies Inc. Theratechnologies enters into definitive agreement to be acquired by CB Biotechnology, an affiliate of Future Pak. Press release, 3 July 2025. globenewswire.com
US Food and Drug Administration. Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry. January 2018. fda.gov
US Food and Drug Administration. FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss. Drug Alerts and Statements. Cited for the agency's guidance on telehealth warning signs, fabricated labels and multi-dose vials. fda.gov
US Food and Drug Administration. CJC-1295-related bulk drug substances: FDA review for the December 4, 2024 meeting of the Pharmacy Compounding Advisory Committee. Docket FDA-2024-N-4777. Documents tesamorelin blends on sale. fda.gov
US Food and Drug Administration. Warning Letter: Gram Peptides. MARCS-CMS 721806, 31 March 2026. fda.gov
Not Medical Advice
Tesamorelin is a prescription medicine with a label that sets out who should not take it and what should be monitored. If you are using a product obtained outside a pharmacy, the route back to oversight is a clinician who knows what you have taken; the label's monitoring of IGF-1 and glucose applies whatever the vial said.
Label and regulatory sources verified 16 September 2026. Compounding enforcement and product availability change frequently. Re-verify before relying on any statement here.