Is Tesamorelin FDA Approved?

When someone asks your practice about tesamorelin, start with the named product and its FDA record. The answer for Egrifta is yes. The next question is what that specific record says about its application and marketing status.

Keep your review focused on those documents. This guide explains the Egrifta listing, FDA's statements about biologics and compounding, research-product labeling, and the FDA records for sermorelin. It also gives your team a short checklist for reviewing regulatory language before answering questions or publishing copy.

Is tesamorelin FDA approved?

Yes, tesamorelin is FDA-approved as Egrifta (tesamorelin acetate), listed under BLA 022505 with an approval date of November 10, 2010, and Prescription marketing status.

Drugs@FDA names Theratechnologies as the company. It also states that the former NDA was deemed a BLA on March 23, 2020. These dates describe different entries in the record: the original approval and the later application designation. Keep both dates attached to their respective descriptions when summarizing the record for your team.

For an internal reference, record the product name, ingredient, application number, application type and marketing status together. This gives the person reviewing your copy a specific FDA entry to check. An ingredient name alone leaves out the application details that make this answer precise.

Use the linked Drugs@FDA record as the reference for Egrifta's approval. If a question concerns another product description, identify that description separately and ask your reviewer to check the corresponding documentation.

Why does Egrifta's BLA status matter for compounding?

Egrifta's BLA status matters because FDA says biological products are not eligible for the compounding exemptions under sections 503A and 503B.

FDA also states that federal law provides no legal pathway for marketing biologics prepared outside the scope of an approved biologics license application. Read that statement alongside the Drugs@FDA listing of Egrifta under BLA 022505. These are the agency's statements and application record; your own attorney should review how they apply to any specific proposal before your practice acts.

FDA separately explains that compounded drugs are not FDA-approved and that it does not verify their safety, effectiveness or quality before marketing. Its general guidance says compounded drugs should only be used when an FDA-approved drug cannot meet a patient's medical needs. Keep that general statement alongside, rather than separate from, FDA's specific statements about biological products.

For background on the two compounding categories, see our 503A and 503B regulatory guide. When preparing questions for counsel, include the Egrifta application record and the relevant FDA statements together. Ask for a review of the specific product and proposed activity before turning that review into practice policy.

What about tesamorelin sold as a research product?

A research-use-only label is not enough to settle the regulatory question: FDA has found products intended as drugs for human use despite that labeling.

In its June 17, 2026 warning letter (opens in a new tab), FDA said research-use-only and not-for-human-consumption statements did not prevent that finding. The agency pointed to evidence in the product labeling, including the website. This is an example of FDA's treatment of those statements, not a determination about every product carrying similar wording.

The HHS peptide enforcement policy document (opens in a new tab) states an aim of discouraging widespread use of certain research-use-only peptides from foreign manufacturers that pose a safety risk to US patients. Appendix A lists six peptides: BPC-157, epitalon, KPV, MOTS-c, semax and TB-500. Tesamorelin is not on that list.

For your review, keep the label wording and the policy's named substances separate. Ask your attorney to examine the actual product representations and the cited policy text. If a claim about tesamorelin relies on this six-peptide list, ask the person making it to identify where tesamorelin appears. Appendix A does not include it.

How is tesamorelin different from sermorelin in FDA status?

Drugs@FDA lists Egrifta with Prescription marketing status, while both GEREF (sermorelin acetate) applications are listed as Discontinued.

The GEREF NDA 019863 application record (opens in a new tab) gives an approval date of December 28, 1990. The GEREF NDA 020443 application record (opens in a new tab) gives an approval date of September 26, 1997. Both records therefore contain historical approval information as well as a Discontinued listing.

In a March 4, 2013 Federal Register determination (opens in a new tab), FDA stated that the GEREF products were not withdrawn from sale for safety or effectiveness reasons. The determination followed a citizen petition dated October 12, 2012. Preserve both parts of the record when explaining the comparison: the products are listed as Discontinued, and FDA made that specific determination about the reason for withdrawal.

A status comparison should keep historical approval, the listed marketing status and the withdrawal determination distinct. If your team receives a question about a compounded product, document that question separately. FDA's statement that compounded drugs are not FDA-approved remains a separate part of the review.

What should a practice check?

Your practice should check the exact product record, the claimed regulatory basis, promotional wording and the oversight questions to raise with your state boards and attorney.

Use the following checklist to prepare that review. Keep the supporting documents with the wording you want reviewed, so your advisers can see the claim and its source together.

• Identify the product record. For Egrifta, check the name, ingredient, BLA 022505 and Prescription status. Write down any difference between the product description presented to your team and the FDA entry.
• Check the claimed regulatory basis. Bring FDA's statements about biological products and the 503A and 503B exemptions to your attorney. Ask how those statements apply to the specific activity under consideration.
• Review promotional wording. FDA says prescription drug promotion by or for manufacturers, including compounders, must be truthful, non-misleading and accurate. Ask who is responsible for the proposed copy and what supports each regulatory claim.
• Check the evidence standard. FTC's Health Products Compliance Guidance (opens in a new tab) says health benefit or safety claims for health-related products require competent and reliable scientific evidence. Have the relevant evidence reviewed before approving such claims.
• Confirm the oversight questions. FDA says state boards of pharmacy generally have primary day-to-day oversight of state-licensed pharmacies that are not FDA-registered outsourcing facilities. FDA primarily oversees and inspects registered 503B outsourcing facilities, which are subject to current good manufacturing practice requirements. Ask your state boards and your own attorney what your practice must verify.

Related reading

• Are Peptides Legal? FDA Status and Compounding Rules
• Telehealth Regulation News: How to Ensure Virtual Compliance
• How to Pick the Right Medical Spa Lawyer for Your Clinic
• Med Spa Laws by State: Ownership and Licensing

Sources

• Drugs@FDA: Egrifta, BLA 022505 (opens in a new tab), checked November 6, 2026.
• FDA: Compounding Questions and Answers (opens in a new tab), checked November 6, 2026.
• FDA: June 17, 2026 Warning Letter (opens in a new tab), checked November 6, 2026.
• HHS: Peptide Compounding Enforcement Discretion Policy (opens in a new tab), checked November 6, 2026.
• Drugs@FDA: GEREF, NDA 019863 (opens in a new tab), checked November 6, 2026.
• Drugs@FDA: GEREF, NDA 020443 (opens in a new tab), checked November 6, 2026.
• FDA: GEREF Withdrawal Reasons Determination (opens in a new tab), checked November 6, 2026.
• FTC: Health Products Compliance Guidance (opens in a new tab), checked November 6, 2026.