Is Tesamorelin Legal? FDA Status and Regulations Explained (2026)

Key Takeaways

• Tesamorelin is not FDA-approved and is available for research purposes only.
• It is not listed on the FDA's compounding bulk drug substance list.
• Tesamorelin cannot be legally compounded by 503A or 503B pharmacies.
• Prescribing Tesamorelin is considered prescribing an unapproved drug, not off-label use.
• Patients should verify clinic legality and watch for red flags when considering peptide therapy.

Current FDA Status

As of February 2026, Tesamorelin is not approved by the U.S. Food and Drug Administration (FDA) for any therapeutic use. It is classified as a research-only peptide, primarily used in preclinical and investigational settings. The FDA has not included Tesamorelin on its compounding bulk drug substance list, which categorizes substances into three categories based on their suitability for compounding. The absence of Tesamorelin from Category 1, 2, or 3 indicates that it is not permitted for compounding (FDA Federal Register Notice, 2023).

Compounding Status

Tesamorelin cannot be compounded by either 503A or 503B pharmacies. The FDA's exclusion of Tesamorelin from its bulk drug substances list means that it is not considered safe or effective for compounding purposes. The FDA has expressed concerns about the safety and efficacy of compounding peptides that have not undergone rigorous clinical testing (FDA Guidance for Industry, 2023).

Enforcement Actions

There have been several enforcement actions related to the illegal distribution and compounding of Tesamorelin. Notably, in 2024, the Department of Justice (DOJ) prosecuted a compounding pharmacy in California for illegally compounding and distributing Tesamorelin without proper authorization. The case resulted in significant fines and the revocation of the pharmacy's license (DOJ Press Release, 2024).

Prescription vs. Over-the-Counter vs. Research Use

Tesamorelin is not available over-the-counter or by prescription for therapeutic use. It is legally available for research purposes only, meaning it can be used in controlled laboratory settings for scientific studies. The designation "research use only" indicates that Tesamorelin can be utilized for investigational purposes but not for treating or diagnosing any medical conditions in humans (21 CFR 312.2).

State-Level Variations

While federal regulations govern the overall status of Tesamorelin, some states have implemented additional restrictions. For instance, New York and California have stringent regulations prohibiting the possession and distribution of research peptides without appropriate licenses. It is crucial for practitioners and researchers to be aware of both federal and state regulations when handling Tesamorelin.

What "Off-Label" Actually Means

Off-label prescribing refers to the use of an FDA-approved drug for an indication not specified in its approved labeling. Since Tesamorelin is not FDA-approved, prescribing it does not constitute off-label use but rather the prescribing of an unapproved drug. This distinction is critical for healthcare providers to understand to avoid regulatory violations (FDA Guidance on Off-Label Use, 2023).

What This Means for Patients

For patients, the legal status of Tesamorelin means that it should not be offered as a therapeutic option by legitimate clinics. Patients should verify that any clinic offering peptide therapy is operating within legal boundaries. Red flags include clinics offering Tesamorelin as a treatment for conditions without FDA approval or without a clear research protocol in place.

Legal Alternatives

For individuals seeking alternatives to Tesamorelin for similar therapeutic goals, legal options include FDA-approved growth hormone therapies such as somatropin. These alternatives have undergone extensive clinical testing and are approved for specific indications.

FAQ

Is Tesamorelin FDA-approved?

No, Tesamorelin is not FDA-approved for any therapeutic use. It is designated for research purposes only.

Can Tesamorelin be compounded legally?

No, Tesamorelin is not on the FDA's list of approved bulk drug substances for compounding.

What does "research use only" mean for Tesamorelin?

"Research use only" means Tesamorelin can be used in controlled laboratory settings for scientific research but not for treating or diagnosing medical conditions in humans.

Are there legal consequences for using Tesamorelin therapeutically?

Yes, using Tesamorelin therapeutically without FDA approval can result in legal actions, including fines and license revocations.

What should I look for in a legal peptide therapy clinic?

Ensure the clinic adheres to FDA regulations, does not offer unapproved peptides like Tesamorelin for therapeutic use, and operates with transparency regarding their practices.

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This content is for informational purposes only and does not constitute medical advice. Consult a licensed healthcare provider before starting any treatment. Legal status can change, and this information was last verified in February 2026.