FDA compounding status
Tesamorelin
Tesamorelin is a biological product, and federal law gives compounding pharmacies and outsourcing facilities no pathway to make it. A branded tesamorelin product is licensed for one labeled use, the reduction of excess abdominal fat in adults with HIV who have lipodystrophy, and it is not for weight loss. Compounded tesamorelin is not that product and is not FDA-approved.
Checked against the primary sources on .
The record
- FDA status
- Cannot be compounded.
- Compounding basis
- Branded product onlyNo pharmacy may compound it. Only the branded product exists, for its labeled use.
- FDA advisory committee
- Not reviewed
- Sport (WADA 2026)
- Prohibited at all times under WADA class S2.2.4 (growth hormone releasing factors).
- Offered by PEPLUX
- No
- Checked on
Basis
What this status traces to.
Tesamorelin's approved application was deemed a biologics license application (BLA 022505) on March 23, 2020, under FDA's transition of biological products. FDA states that biological products are not eligible for the compounding exemptions in sections 503A and 503B. The essentially-a-copy test does not apply, because compounding is barred outright. FDA's warning letters of August 24, 2026 to two online peptide sellers named tesamorelin products as unapproved new drugs.
Approved products and their labeled use
Egrifta SV and Egrifta WR (BLA 022505) is FDA-approved for reduction of excess abdominal fat in adults with HIV who have lipodystrophy, not for weight loss, and that approval does not cover any compounded tesamorelin, which is a different product and not FDA-approved.
Biological product status: List of approved NDAs for biological products that were deemed to be BLAs on March 23, 2020 (corrected April 2, 2020) (dated )
Primary sources
- FDAList of approved NDAs for biological products that were deemed to be BLAs on March 23, 2020 (corrected April 2, 2020)Document dated . Checked .
- FDACompounding and the FDA: Questions and AnswersDocument dated . Checked .
- FDA labelopenFDA drug labels: tesamorelin, BLA 022505 (EGRIFTA SV and EGRIFTA WR)Document dated . Checked .
- FDAopenFDA drugsfda: tesamorelin, BLA 022505Document dated . Checked .
- FDA warning letterWarning letter 734884, Royal Peptides LLCDocument dated . Checked .
- FDA warning letterWarning letter 735063, Peptide Partners LLCDocument dated . Checked .
- WADAWorld Anti-Doping Code, 2026 Prohibited ListDocument dated . Checked .
Context
A removal or a committee vote is not a listing.
Removal from FDA's Category 2 is not FDA approval and not a listing. FDA removed several peptides from its 503A Category 2 after their nominators withdrew the nominations, not because the substances were found safe: BPC-157, TB-500, MOTS-c, semax and epitalon among others (removal noticed April 15, 2026, effective after 7 days), and CJC-1295 and ipamorelin earlier (removal notice dated September 27, 2024). None was added to the 503A bulks list, so none has a compounding pathway today. A favorable vote by FDA's Pharmacy Compounding Advisory Committee is a recommendation, not a listing: nothing changes unless FDA publishes a final rule.
FDA advisory committee
FDA's Pharmacy Compounding Advisory Committee has not reviewed it.
If you are subject to anti-doping rules
Prohibited at all times under WADA class S2.2.4 (growth hormone releasing factors).
Common questions
Tesamorelin, answered plainly.
- What is the FDA compounding status of Tesamorelin?
- Tesamorelin is a biological product, and federal law gives compounding pharmacies and outsourcing facilities no pathway to make it. A branded tesamorelin product is licensed for one labeled use, the reduction of excess abdominal fat in adults with HIV who have lipodystrophy, and it is not for weight loss. Compounded tesamorelin is not that product and is not FDA-approved.
- What does the status of tesamorelin trace to?
- Tesamorelin's approved application was deemed a biologics license application (BLA 022505) on March 23, 2020, under FDA's transition of biological products. FDA states that biological products are not eligible for the compounding exemptions in sections 503A and 503B. The essentially-a-copy test does not apply, because compounding is barred outright. FDA's warning letters of August 24, 2026 to two online peptide sellers named tesamorelin products as unapproved new drugs. Checked against the primary sources on October 13, 2026.
- Which approved tesamorelin products exist, and what are they labeled for?
- Egrifta SV and Egrifta WR (BLA 022505) is FDA-approved for reduction of excess abdominal fat in adults with HIV who have lipodystrophy, not for weight loss, and that approval does not cover any compounded tesamorelin, which is a different product and not FDA-approved.
- Does PEPLUX offer tesamorelin?
- Compounded tesamorelin is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established. PEPLUX does not offer, prescribe or sell it. This page explains its regulatory status and is not a recommendation to use it. Tesamorelin is a biological product. Federal law gives compounding pharmacies no pathway to make it.
- Is tesamorelin prohibited in sport?
- Prohibited at all times under WADA class S2.2.4 (growth hormone releasing factors).