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Informational listing

Tesamorelin / Ipamorelin Injection

A combination of tesamorelin and ipamorelin. This informational listing describes the ingredients and their regulatory records; it is not offered for ordering.

FDA status

Cannot be compounded.

Checked on October 13, 2026.

This page provides product and regulatory information. Ordering is not available for this product.

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This information is educational and is not medical advice. It does not establish a provider–patient relationship.

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FDA status for Tesamorelin / Ipamorelin Injection.

Each record below links to the primary sources and shows when the information was last checked.

Tesamorelin

Cannot be compounded.

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.

View the full FDA status record

Primary sources

  1. FDAList of approved NDAs for biological products that were deemed to be BLAs on March 23, 2020 (corrected April 2, 2020)Document dated . Checked .
  2. FDACompounding and the FDA: Questions and AnswersDocument dated . Checked .
  3. FDA labelopenFDA drug labels: tesamorelin, BLA 022505 (EGRIFTA SV and EGRIFTA WR)Document dated . Checked .
  4. FDAopenFDA drugsfda: tesamorelin, BLA 022505Document dated . Checked .
  5. FDA warning letterWarning letter 734884, Royal Peptides LLCDocument dated . Checked .
  6. FDA warning letterWarning letter 735063, Peptide Partners LLCDocument dated . Checked .
  7. WADAWorld Anti-Doping Code, 2026 Prohibited ListDocument dated . Checked .

Ipamorelin acetate

No compounding pathway today.

Ipamorelin is not FDA-approved, and there is no pathway for a US pharmacy or a 503B outsourcing facility to compound it today. FDA removed it from its 503A Category 2 under a notice dated September 27, 2024, after the nominations were withdrawn, and FDA's Pharmacy Compounding Advisory Committee voted against it on October 29, 2024. Ipamorelin acetate is still in FDA's 503B Category 2, the category for substances that may present significant safety risks.

View the full FDA status record

Primary sources

  1. FDA 503A categoriesBulk drug substances nominated for use in compounding under section 503A (categories), updated May 14, 2026Document dated . Checked .
  2. FDA 503B categoriesBulk drug substances nominated for use in compounding under section 503B (categories), updated March 21, 2025Document dated . Checked .
  3. FDA503B Bulk Drug Substances ListDocument dated . Checked .
  4. eCFR21 CFR 216.23, Bulk drug substances that can be used to compound drug productsDocument dated . Checked .
  5. FDA 503A categoriesBulk drug substances nominated for use in compounding under section 503A (categories), updated September 27, 2024Document dated . Checked .
  6. FDACertain Bulk Drug Substances for Use in Compounding that May Present Significant Safety RisksDocument dated . Checked .
  7. FDA advisory committee minutesPharmacy Compounding Advisory Committee, October 29, 2024: final minutesDocument dated . Checked .
  8. FDA warning letterWarning letter 734884, Royal Peptides LLCDocument dated . Checked .
  9. WADAWorld Anti-Doping Code, 2026 Prohibited ListDocument dated . Checked .
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