
Fact:
These products are reviewed by the FDA for quality, safety, and effectiveness.
Myth:
Compounded GLP-1s are just cheaper versions of the same thing
Fact:
They are not FDA-approved, can contain impurities, and may not have the right dose.
GLP-1 medications have been studied extensively, and the evidence supporting their effectiveness is compelling. Clinical trials show that these therapies can lead to average weight loss of 5–15% of body weight over several months when combined with lifestyle interventions. Some dual-action medications, such as tirzepatide, which targets both GLP-1 and another hormone called GIP, have demonstrated even greater reductions in weight compared to single-target agents like semaglutide.
Beyond weight loss, GLP-1 medications offer significant health benefits. Research, including the SELECT trial published in the New England Journal of Medicine, has shown that semaglutide can reduce the risk of major adverse cardiovascular events—such as heart attacks and strokes—by up to 20% in individuals with obesity or overweight who also have cardiovascular disease but do not have diabetes. This finding has prompted new FDA approvals and expanded coverage for some GLP-1 medications based on cardiovascular indications.
By contrast, compounded versions of these drugs are not FDA-approved, may use alternative ingredients, and often lack safety data. Products containing unverified compounds or salt forms, such as “semaglutide sodium,” are particularly concerning, as they are not equivalent to approved formulations and may alter how the medication functions in the body. Using underregulated or counterfeit products puts patients at unnecessary risk and undermines the proven benefits of these therapies.
Fake products can contain the wrong ingredient or the wrong amount of drug, be contaminated by poor manufacturing practices, and come with vague or misleading labels that make safe dosing impossible. Multi‑use vials that require you to self‑measure doses are especially risky and have led to overdoses and hospitalizations. If anything about the product, packaging, or seller feels off, do not inject it—contact a licensed pharmacist or your prescriber right away and report the incident to FDA MedWatch.
Fake products can contain the wrong ingredient or the wrong amount of drug, be contaminated by poor manufacturing practices, and come with vague or misleading labels that make safe dosing impossible. Multi‑use vials that require you to self‑measure doses are especially risky and have led to overdoses and hospitalizations. If anything about the product, packaging, or seller feels off, do not inject it—contact a licensed pharmacist or your prescriber right away and report the incident to FDA MedWatch
Fake products can contain the wrong ingredient or the wrong amount of drug, be contaminated by poor manufacturing practices, and come with vague or misleading labels that make safe dosing impossible. Multi‑use vials that require you to self‑measure doses are especially risky and have led to overdoses and hospitalizations. If anything about the product, packaging, or seller feels off, do not inject it—contact a licensed pharmacist or your prescriber right away and report the incident to FDA MedWatch
Fake products can contain the wrong ingredient or the wrong amount of drug, be contaminated by poor manufacturing practices, and come with vague or misleading labels that make safe dosing impossible. Multi‑use vials that require you to self‑measure doses are especially risky and have led to overdoses and hospitalizations. If anything about the product, packaging, or seller feels off, do not inject it—contact a licensed pharmacist or your prescriber right away and report the incident to FDA MedWatch
Oct 2024:
FDA determined the tirzepatide shortage resolved, with short grace periods for compounders.
Feb 2025:
FDA determined the semaglutide shortage resolved and set grace periods to prevent treatment disruption.
April–May 2025:
Grace periods ended (503A pharmacies/physicians by April 22, 2025; 503B outsourcing facilities by May 22, 2025). After these dates, routine compounding of “essentially copies” of approved semaglutide/tirzepatide is no longer permitted.
Sept 2025:
FDA launched a “Green List” import alert to block illegal/poor‑quality GLP‑1 APIs from unverified foreign sources while allowing compliant API manufacturers.
Compounded GLP‑1s may only be prepared under narrow conditions (e.g., a specific medical need not met by an approved product).
Bulk API from unverified foreign suppliers can be detained at the border; products labeled “research use only/not for human use” are not appropriate for patients.
Using salt forms (e.g., semaglutide sodium/acetate) is not equivalent to approved drugs and should not be used for compounding.