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Egrifta (Tesamorelin) Compounding Pharmacy: 503A vs 503B for This Peptide

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Key numbers

  • 0.35 mLEgrifta SV dose given immediately after reconstitution, per its labelSource: dailymed.nlm.nih.gov, as cited 2026-11-07
  • 7 daysHow long unused Egrifta WR solution is kept after mixing, per its labelSource: dailymed.nlm.nih.gov, as cited 2026-11-07
  • 6.5%HbA1c level at or above which the label's glucose intolerance warning appliesSource: dailymed.nlm.nih.gov, as cited 2026-11-07

At a glance

  • FDA approval / Egrifta (tesamorelin acetate) approved November 10, 2010, application BLA 022505 [7]
  • Current labels / Egrifta SV (2 mg vial) and Egrifta WR (11.6 mg vial), both dated July 29, 2026 [8][9]
  • Approved use / excess abdominal fat in HIV-infected adults with lipodystrophy only [8]
  • Significant-safety-risk list / tesamorelin not listed, content dated April 22, 2026 [1]
  • FDA lists for pharmacies and outsourcing facilities / tesamorelin in no category of either [2][3]
  • HHS peptide policy / covers six other peptides, not tesamorelin [4][5]
  • Outsourcing-facility status / voluntary category added by the DQSA in 2013, subject to CGMP and FDA inspection [6]

What Is Tesamorelin and What Is It Approved For?

Tesamorelin is a synthetic analog of human growth hormone-releasing factor (GHRF, also called GHRH): the 44-amino-acid human sequence with a hexenoyl group on the N-terminal tyrosine, molecular weight about 5,135.9 Da [8]. It is a peptide, not growth hormone. It binds and stimulates GRF receptors on pituitary somatotroph cells, so the pituitary releases more of the body's own GH, which raises IGF-1 and IGFBP-3 [8].

FDA approved Egrifta under application BLA 022505 on November 10, 2010 [7]. The only approved use is reduction of excess abdominal fat in HIV-infected adults with lipodystrophy [8]. The label adds limits: long-term cardiovascular safety has not been established, it is not indicated for weight loss management because its effect on weight is neutral, and there are no data that it improves adherence to antiretroviral therapy [8].

Two formulations are currently labeled. Egrifta SV is a 2 mg vial given as 1.4 mg (0.35 mL) subcutaneously once daily. Egrifta WR is an 11.6 mg vial given as 1.28 mg (0.16 mL) once daily. The labels state the two are not substitutable [8][9].

What FDA's Compounding Lists Say About Tesamorelin

Tesamorelin does not appear on FDA's page of bulk drug substances that may present significant safety risks, content dated April 22, 2026 [1]. It appears in no category of FDA's list for state-licensed pharmacies and physicians, updated May 14, 2026, or of FDA's list for outsourcing facilities, updated March 21, 2025 [2][3]. So FDA has made no category-based statement about compounding it. It is not one of the six peptides named in HHS's draft enforcement-discretion policy for compounding, filed October 28, 2026 as Federal Register document 2026-22192; that draft names BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500 [4][5]. Tesamorelin is also already a component of an FDA-approved drug, Egrifta [7].

Pharmacy vs Outsourcing Facility: What Differs Under Federal Law

FDA describes the pharmacy-compounding section of the FD&C Act as setting out the conditions under which compounded human drug products are exempt from the provisions on approval before marketing, current good manufacturing practice, and labeling with adequate directions for use. One of those conditions is that the drugs be compounded on receipt of valid patient-specific prescriptions [6].

The Drug Quality and Security Act, enacted November 27, 2013, added a voluntary category of compounders called outsourcing facilities. Unlike pharmacy compounders under the first section, outsourcing facilities are subject to CGMP requirements, are inspected by FDA on a risk-based schedule, must report adverse events, and must give FDA certain information about the products they compound. They may distribute compounded drugs either pursuant to a patient-specific prescription or in response to an order from a health care provider, such as a hospital, that is not for an identified individual patient, for office stock for example [6].

Neither pathway makes a product FDA-approved. Compounded drugs are not FDA-approved, and FDA does not review them for safety, effectiveness or quality before they reach patients [6].

Questions worth asking

Choose the questions you want to keep

What the Egrifta Labels Specify

The labels for the approved products carry specific instructions and warnings. The Egrifta SV label says to reconstitute with 0.5 mL of the supplied Sterile Water for Injection, give 0.35 mL immediately, and discard what is left [8]. The Egrifta WR label says to reconstitute with 1.3 mL of Bacteriostatic Water for Injection; one vial supplies 7 daily doses, and unused solution is discarded 7 days after mixing [9].

The label directs IGF-1 monitoring and says to consider discontinuing with persistent elevations, for example above 3 SDS. Among patients treated 26 weeks, 47% had IGF-1 above 2 SDS and 36% above 3 SDS; among those treated 52 weeks, 34% and 23% [8]. The label lists glucose intolerance as a warning: HbA1c of 6.5% or higher developed in 5% on tesamorelin versus 1% on placebo by week 26, with a hazard ratio of about 3.3 [8]. Hypersensitivity reactions occurred in 4% of patients in trials, and injection-site reactions in 25% versus 14% on placebo over the first 26 weeks [8].

Contraindications are disruption of the hypothalamic-pituitary axis, active malignancy, known hypersensitivity to tesamorelin or its excipients, and pregnancy [8][9].

GerWynn on why tesamorelin's label argues with its marketing

The host argues that tesamorelin is the one genuine approved drug in the growth hormone secretagogue family, approved for one narrow job: reducing excess visceral abdominal fat in people with HIV-associated lipodystrophy. He points out that its own label says it is not indicated for weight loss management, that weight did not change in its trials, and that the fat only redistributed. In his view, the gym and biohacking uses advertised for it are off-label extrapolation that the label itself argues against. He also notes that tesamorelin is named as a banned substance in competition by the World Anti-Doping Agency, and that none of the growth hormone secretagogues appeared on the FDA's interim access list.

Who is speaking?

GerWynn. Host of the GerWynn peptide education series, as described on the channel Background

Episode notes and full video

One Further Regulatory Point

WADA's Prohibited List names tesamorelin in section S2.2.4 among growth hormone releasing factors and prohibits it at all times, in and out of competition [10]. It is on the 2026 List, in force since January 1, 2026, and remains on the 2027 List [10][11].

Check what you know

5 quick questions. Pick an answer to see what this article says.

1. On what date did FDA approve Egrifta under application BLA 022505?
2. According to the article, what is the only approved use of Egrifta?
3. Which requirement does the article say applies to outsourcing facilities?
4. How much Sterile Water for Injection does the Egrifta SV label say to use to reconstitute the vial?
5. In the trial, what share of tesamorelin patients developed HbA1c of 6.5% or higher by week 26?

Score: 0 right, 0 of 5 answered

Frequently asked questions

Is tesamorelin FDA-approved?
Yes, as Egrifta, for reducing excess abdominal fat in HIV-infected adults with lipodystrophy. The current products are Egrifta SV, given as 1.4 mg once daily, and Egrifta WR, given as 1.28 mg once daily, and the labels state the two are not substitutable [7][8][9].
Is tesamorelin on FDA's significant-safety-risk list for compounding?
No. Tesamorelin does not appear on FDA's page of bulk drug substances that may present significant safety risks, content dated April 22, 2026 [1].
Which peptides does the HHS draft enforcement-discretion policy cover?
Six: BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500. Tesamorelin is not among them [4][5].
Does an outsourcing facility need a patient-specific prescription?
Not necessarily. FDA says outsourcing facilities may distribute compounded drugs either pursuant to a patient-specific prescription or in response to an order from a health care provider that is not for an identified individual patient, such as office stock [6].
Does a compounding pharmacy need a prescription?
The pharmacy-compounding exemption FDA describes requires that the drugs be compounded on receipt of valid patient-specific prescriptions [6].
What does the Egrifta label say to monitor?
IGF-1 and glucose. The label says to consider discontinuing with persistent IGF-1 elevations, for example above 3 SDS, and to evaluate glucose before and during therapy. HbA1c of 6.5% or higher developed in 5% on tesamorelin versus 1% on placebo by week 26 [8].

References

  1. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA
  2. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  3. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  4. Official web page. Official web page
  5. Official web page. Official web page
  6. Human Drug Compounding Laws | FDA. Human Drug Compounding Laws | FDA
  7. Drugs@FDA: FDA-Approved Drugs. Drugs@FDA: FDA-Approved Drugs
  8. U.S. National Library of Medicine, DailyMed. Egrifta SV (tesamorelin) for injection, 2 mg vial prescribing information. Egrifta SV (tesamorelin) for injection, 2 mg vial label
  9. U.S. National Library of Medicine, DailyMed. Egrifta WR (tesamorelin) for injection, 11.6 mg vial prescribing information. Egrifta WR (tesamorelin) for injection, 11.6 mg vial label
  10. World Anti-Doping Agency. World Anti-Doping Agency
  11. World Anti-Doping Agency. World Anti-Doping Agency
  12. GerWynn. GH Secretagogues: One Real Drug, a Halted Trial, and a Number That Isn't an Outcome. Accessed 2026-11-11.
Evidence overview for Egrifta (Tesamorelin) Compounding Pharmacy: 503A vs 503B for This Peptide