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The Danger of Compounded Medications

COMPOUNDED RISKS

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FDA WarningCompounded GLP-1 is not FDA-approved
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The Real Risks ofCompounded Knockoffs

### Some compounded products can be risky Many are sourced from overseas suppliers and may contain unverified or harmful ingredients.¹ ²

### Wondering why unapproved knockoffs pose serious health risks? Read on to learn more about toxic impurities, unverified dosages, and the legal warnings from healthcare authorities.

Why Compounded GLP-1 Is Risky

01

Toxic Impurities and Illegal Substances

Compounded “semaglutide” may include harmful impurities, salt formulations (semaglutide sodium or acetate), and illegal substances not recognized by the FDA.

02

Unneeded Ingredients

Unregulated compounding pharmacies frequently add untested additives, vitamins, or preservatives that alter medication stability and safety.

03

Unverified Dosages

Compounded vials often suffer from inconsistent potency and unpredictable dosages, leading to accidental overdoses or ineffective treatment.

Harmful Compounding Facts

33%
01

Impurities

Testing revealed up to 33% impurities in unauthorized compounded semaglutide products analyzed across independent laboratories.*

5-20x
02

Accidental Overdoses

Poison control centers reported a 5-20x increase in adverse calls related to dosing confusion and compounding errors.*

0%
03

Semaglutide Content

In several seized samples, test results showed 0% active semaglutide content, leaving patients with counterfeit placebos.*

Compounded weight loss injections are not approved by the FDA

Not ApprovedBy The FDA

Compounded weight loss injections are not approved by the FDA

Not Reviewed: Despite misleading claims, the FDA has not evaluated these products for safety, effectiveness, or quality.¹
Not Guaranteed Safe: Without FDA oversight, compounded medications are made by pharmacies not required to track, test, or report side effects or adverse events.¹
Not Proven Effective: Because they lack FDA approval, their true benefits and risks remain unknown.¹²
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Hear It FromThe Experts

The U.S. Food and Drug Administration, World Health Organization, and many other authorities are cautioning patients and healthcare providers about the dangers of counterfeit “semaglutide.”¹,¹⁴,¹⁵

“Noncompliant healthcare providers are selling fraudulently compounded drugs claiming to contain semaglutide..., in combination with other ingredients.”16 — Federal Bureau of Investigation (FBI)

“…there can be errors in compounding or contamination of the product because compounding pharmacies are not held to the same standards of larger drug manufacturers.”17 — National Capital Poison Center

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References

1. U.S. Food and Drug Administration (FDA). FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss. Accessed May 2025. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss. May 16, 2025 2. Partnership for Safe Medicines. New report reveals illegal ingredients for knockoff weight loss drugs flooding into U.S. from foreign sources, endangering patient safety. Accessed May 2025. https://www.safemedicines.org/2025/02/new-report-reveals-illegal-ingredients-for-knockoff-weight-loss-drugs-flooding-into-u-s-from-foreign-sources-endangering-patient-safety.html. February 20, 2025. 5. U.S. Food and Drug Administration (FDA). FDA Drug Shortages: Semaglutide Injection. Accessed May 2025. https://dps.fda.gov/drugshortages/activeingredient/semaglutide-injection. February 21, 2025. 6. Hach M, Dorthe Kot Engelund, Mysling S, et al. Impact of manufacturing process and compounding on properties and quality of follow-on glp-1 polypeptide drugs. Pharmaceutical Research. Published online October 8, 2024. 10.1007/s11095-024-03771-6 7. U.S. Food and Drug Administration (FDA), Safety Risks Associated with Certain Bulk Drug Substances Nominated for Use in Compounding. Accessed May 2025. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks. September 27, 2024. 8. U.S. Food and Drug Administration (FDA). FDA alerts health care providers, compounders and patients of dosing errors associated with compounded injectable semaglutide products. Accessed May 2025. https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-patients-dosing-errors-associated-compounded. July 26, 2024. 9. Novo Nordisk, Novo Nordisk escalates legal actions to safeguard patients from potentially harmful compounded “semaglutide” drugs. Accessed May 2025. https://www.novonordisk-us.com/media/news-archive/news-details.html?id=168519. May 30, 2024. 10. Wu J, Zhu C, Fan W, et al. Systemic delivery of proteins using novel peptides via the sublingual route. J Control Release. 2024;368:290-301. 11. Jenny K.W. Lam et al., Oral transmucosal drug delivery for pediatric use, 73 Advanced Drug Delivery Reviews 50 (2014). 12. U.S. Food and Drug Administration (FDA). Draft Guidance for Industry: Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act. Accessed May 2025. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/current-good-manufacturing-practice-guidance-human-drug-compounding-outsourcing-facilities-under. January 7, 2021. 13. U.S. Food and Drug Administration (FDA). Compounding and the FDA: Questions and Answers. Accessed May 2025. https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers. November 17, 2024. 14. World Health Organization. Medical product alert N°2/2024: Falsified Ozempic (semaglutide). June 19, 2024. https://www.who.int/news/item/19-06-2024-medical-product-alert-n-2-2024--falsified-ozempic-(semaglutide). Accessed March 31, 2025. 15. National Association of Attorneys General. State and Territory Attorneys General Urge FDA to Take Action Against Counterfeit and Illegally Sold GLP-1 Drugs. Feb. 19, 2025. https://www.naag.org/press-releases/state-and-territory-attorneys-general-urge-fda-to-take-action-against-counterfeit-and-illegally-sold-glp-1-drugs/. Accessed March 31, 2025. 16. Federal Bureau of Investigation (FBI). Safety Concerns Related to Fraudulent Compounding Practices Associated with Weight Loss Drug. Accessed May 2025. https://www.ic3.gov/PSA/2025/PSA250228. February 28, 2025. 17. National Capital Poison Control Center. What is Ozempic? Accessed May 2025. https://www.poison.org/articles/can-ozempic-help-me-lose-weight.