Source comparison
Tesamorelin FDA Approved Status: Branded vs Compounded Comparison
FDA Approval Yes. Approved drug product for HIV lipodystrophy No. Prepared under USP standards but not FDA-approved as finished product No. Not intended for human consumption Egrifta is the only FDA-reviewed option; compounded versions use identical peptide bu
This comparison does not assign a generated winner or score.
- FDA Approval
- Yes. Approved drug product for HIV lipodystrophy
- No. Prepared under USP standards but not FDA-approved as finished product
- No. Not intended for human consumption
- Egrifta is the only FDA-reviewed option; compounded versions use identical peptide but lack batch-level FDA oversight
- Prescription Required
- Yes. DEA unscheduled but Rx-only
- Yes. Must be prescribed by licensed physician
- No. Sold for research use only
- All clinical use requires prescription; research-grade cannot be legally prescribed
- Cost (Typical)
- $4,000–$6,000/month retail (often insurance-covered for approved use)
- $300–$800/month (not typically covered by insurance)
- Variable. Bulk pricing for institutional research
- Compounded versions are 80–90% less expensive but require out-of-pocket payment
- Quality Assurance
- FDA-mandated batch testing, cGMP manufacturing
- USP <797> sterile compounding standards, 503B facility oversight
- cGMP synthesis with COA (certificate of analysis) provided
- Branded product has highest regulatory oversight; 503B compounding is second; research-grade depends on supplier verification
- Legal Use Context
- On-label prescription for HIV lipodystrophy
- Off-label prescription for any legitimate medical purpose
- Laboratory research and preclinical studies only
- Prescribers assume liability for off-label use; research-grade use in humans violates federal law