The short answer. Tesamorelin is FDA-approved as Egrifta, and since March 23, 2020 FDA has regulated it as a biologic. FDA’s 503A guidance says biologics are not eligible for 503A compounding. As of September 25, 2026, compounded tesamorelin has no pathway, whatever the vendor says.
| FDA approved | Yes. Egrifta (Nov 10, 2010), Egrifta SV, Egrifta WR (Mar 25, 2025). Reducing excess abdominal fat in adults with HIV and lipodystrophy. |
|---|---|
| Regulatory class | Biologic. Deemed a BLA on Mar 23, 2020. |
| 503A pharmacy | No pathway. FDA excludes biologics approved under section 351 of the PHS Act from 503A. |
| 503B outsourcing facility | No pathway. |
| Latest FDA action | Warning letters to five research-peptide sellers naming tesamorelin, Aug 24, 2026. |
| MDside position | The approved product only, for its approved use. We do not order compounded tesamorelin. |
| Last verified | 2026-09-25 |
The 2020 transition is what the market missed
In March 2020 a group of protein products approved as drugs moved to the biologics framework, and FDA’s transition list includes Egrifta and Egrifta SV. From that date they are deemed biologics license applications. Most pages describing tesamorelin as “503A compoundable with a prescription” were written before the transition or never noticed it.
Why a biologic cannot go through 503A
Section 503A exempts compounded drugs from certain requirements. FDA’s January 2025 interim policy on 503A bulk substances states that biological products subject to approval in a BLA are not eligible for the 503A exemptions and will not be considered for the 503A bulks list. Tesamorelin does not appear in any 503A or 503B category.
One point of honesty: FDA’s August 2026 warning letters cite tesamorelin under the drug approval provision, section 505(a), rather than the biologics statute. As of September 25, 2026 FDA has not issued a tesamorelin-specific statement on compounding. Both routes lead to the same result, which is no lawful compounded product.
Egrifta is on the market, which closes the other door too
Even setting the biologic question aside, Egrifta is commercially available. A compounded version at a similar strength by the same route would be essentially a copy under FDA’s guidance.
What this means for you
Remove compounded tesamorelin, including blends with ipamorelin. If a pharmacy you use supplies it, ask it in writing how it reconciles the 2020 transition with FDA’s 503A guidance. Tesamorelin’s approved use is narrow, so it rarely fits a wellness menu at all. For growth hormone axis options, see the sermorelin page.
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Frequently asked questions
Can tesamorelin be compounded?
No. Tesamorelin has been regulated as a biologic since March 23, 2020, and FDA’s 503A guidance says biologics are not eligible for 503A compounding. It is in no 503A or 503B category. As of September 25, 2026 compounded tesamorelin has no lawful pathway.
What is Egrifta approved for?
Egrifta is approved to reduce excess abdominal fat in adults with HIV who have lipodystrophy. Its label states it is not indicated for weight loss management. Egrifta WR, a newer formulation, was approved on March 25, 2025. Prescribing it for body composition in other patients is off-label.
Why do some pharmacies still sell compounded tesamorelin?
Most vendor descriptions predate the 2020 biologics transition or ignore it. FDA sent warning letters naming tesamorelin to five research-peptide sellers on August 24, 2026. A supplier’s confidence is not a legal basis, and the clinic that administers the product carries its own exposure.
Primary sources. Last verified September 25, 2026. Corrections are welcome: contact us.
- Egrifta WR prescribing information (2025)
- FDA, list of approved NDAs for biological products deemed to be BLAs on March 23, 2020
- FDA, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A (Jan 2025)
- FDA, 503A bulk drug substance categories (updated May 14, 2026)
- FDA, 503B bulk drug substance categories (updated Mar 21, 2025)
- FDA guidance, Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A (Jan 2018)
- FDA warning letter, NuScience Peptides (Aug 24, 2026)
- FDA warning letter, Royal Peptides (Aug 24, 2026)
- FDA warning letter, Peptide Partners LLC (Aug 24, 2026)
This is general information, not legal advice. Rules vary by state and change. Confirm your own facts with counsel.