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Egrifta (Tesamorelin) Compounding Pharmacy Quality Red Flags to Avoid

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Key numbers

  • 1.4 mgLabeled daily dose of Egrifta SV, given once daily under the skinSource: dailymed.nlm.nih.gov, as cited 2026-11-07
  • 1.28 mgLabeled daily dose of Egrifta WR, which differs from Egrifta SV's 1.4 mgSource: dailymed.nlm.nih.gov, as cited 2026-11-07
  • 36%Share of patients treated for 26 weeks on tesamorelin whose IGF-1 rose above 3 SDSSource: dailymed.nlm.nih.gov, as cited 2026-11-07

At a glance

  • Approved products / Egrifta SV 2 mg vial and Egrifta WR 11.6 mg vial, once-daily subcutaneous injections [3][4]
  • Approved use / excess abdominal fat in HIV-infected adults with lipodystrophy; not for weight loss [3]
  • FDA high-risk bulk list / tesamorelin is not on it [5]
  • FDA lists for state-licensed pharmacies and for outsourcing facilities / no category for tesamorelin [6][7]
  • HHS peptide draft policy / covers six other peptides, not tesamorelin [1]
  • Compounded status / not FDA-approved; no FDA premarket quality review [1][2]
  • Sport / WADA names tesamorelin in S2.2.4, prohibited at all times [8][9]

What the approved Egrifta products are

Tesamorelin is a synthetic analog of human growth hormone-releasing factor. Its only approved use is reduction of excess abdominal fat in HIV-infected adults with lipodystrophy; the label states it is not indicated for weight loss because its effect on weight is neutral [3].

Egrifta SV is a 2 mg vial dosed at 1.4 mg (0.35 mL) subcutaneously once daily into the abdomen. Egrifta WR is an 11.6 mg vial dosed at 1.28 mg (0.16 mL) once daily. The labels state the two are not substitutable [3][4]. Egrifta is an FDA-approved prescription drug, and the current products are Egrifta SV and Egrifta WR [10][3][4].

Questions worth asking

Choose the questions you want to keep

Red flag: an FDA position that does not exist

FDA keeps a list of bulk substances that may present significant safety risks when compounded; tesamorelin is not on it [5]. FDA's lists for state-licensed pharmacies and physicians (updated May 14, 2026) and for outsourcing facilities (updated March 21, 2025) do not place tesamorelin in any category [6][7]. HHS filed a draft enforcement-discretion policy for compounded peptides on October 28, 2026; it names six peptides, BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500, and not tesamorelin [1]. Absence from these lists is not an FDA approval or endorsement of any compounded product.

Peptide Search on why tesamorelin's FDA approval is so narrow

The channel argues that tesamorelin is the first compound it covers that is genuinely FDA approved, so a doctor can prescribe it and a pharmacy can legally make it. It stresses that the approval is very narrow, covering only the reduction of deep belly fat in people living with HIV. In its view, the terminated and withdrawn trials in other areas show that an approval is not a general endorsement of a compound. It also says the fifteen research chemical sellers are mostly serving buyers who want the drug for uses it was never approved for, where no prescription, monitoring, or verified source applies.

Who is speaking?

Peptide Search. Host of the Peptide Search channel, as the channel presents itself Background

Episode notes and full video

Red flag: silence about anti-doping status

For anyone subject to anti-doping rules, WADA names tesamorelin in S2.2.4 and prohibits it at all times, in and out of competition. It is on the 2026 List and stays on the 2027 List [8][9].

What the label says to monitor

The Egrifta labels name two areas of monitoring [3][4].

  • IGF-1: the label says to monitor IGF-1 during therapy and to consider discontinuing if levels stay persistently elevated (for example above 3 SDS), particularly if the efficacy response is not robust. Among patients treated for 26 weeks, 36% had IGF-1 above 3 SDS [3].
  • Glucose: HbA1c of 6.5% or higher developed in 5% on tesamorelin versus 1% on placebo by week 26 (hazard ratio about 3.3, 95% CI 1.4 to 9.6). The label says to evaluate glucose before and during therapy [3].

Frequently asked questions

Is compounded tesamorelin FDA-approved?
No. Compounded drugs are not FDA-approved, and FDA does not review their safety, effectiveness or quality before they are marketed [1][2]. The approved tesamorelin products are Egrifta SV and Egrifta WR [3][4].
Does FDA put tesamorelin on any compounding list?
Tesamorelin is not on FDA's list of bulk substances that may present significant safety risks, and FDA's lists for state-licensed pharmacies and physicians and for outsourcing facilities place it in no category [5][6][7].
What are the approved Egrifta doses?
Egrifta SV is 1.4 mg (0.35 mL of the reconstituted solution) once daily subcutaneously into the abdomen; Egrifta WR is 1.28 mg (0.16 mL) once daily. The labels state the two are not substitutable [3][4].
Is tesamorelin banned in sport?
Yes. WADA names tesamorelin in S2.2.4 (growth hormone releasing factors) and prohibits it at all times, in and out of competition; it is on the 2026 List and stays on the 2027 List [8][9].

What people actually ask

What does a red flag mean at pharmacy?

A red flag is a warning sign in a compounding pharmacy's claims or omissions that suggests quality or legitimacy problems. For tesamorelin, one sign is a claim that compounded product is FDA-approved or FDA quality-checked, which is false. Another is treating Egrifta SV and Egrifta WR as interchangeable, since their labeled daily doses are 1.4 mg and 1.28 mg. Silence about anti-doping status is a third.

Can you legally compound tesamorelin?

Tesamorelin is not on FDA's list of bulk substances that may present significant safety risks, and FDA's lists for state-licensed pharmacies and physicians and for outsourcing facilities place it in no category. Compounded drugs are not FDA-approved, and absence from these lists is not an FDA approval or endorsement of any compounded product.

How to check if a compounding pharmacy is legit?

Watch for claims that compounded tesamorelin is FDA-approved or FDA quality-checked, since it is neither. Question any seller that treats Egrifta SV and Egrifta WR as interchangeable, because their labeled daily doses are 1.4 mg and 1.28 mg. If you are subject to anti-doping rules, also check that the seller addresses this, since WADA prohibits tesamorelin at all times.

References

  1. Official web page. Official web page
  2. Official web page. Official web page
  3. 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
  4. 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
  5. 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
  6. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  7. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  8. World Anti-Doping Agency. World Anti-Doping Agency
  9. World Anti-Doping Agency. World Anti-Doping Agency
  10. Drugs@FDA: FDA-Approved Drugs. Drugs@FDA: FDA-Approved Drugs
  11. Peptide Search. Tesamorelin: What The Research Actually Shows. Accessed 2026-11-11.
Evidence overview for Egrifta (Tesamorelin) Compounding Pharmacy Quality Red Flags to Avoid