This drug was first approved in 2017 by the brand name Ozempic® for the treatment of diabetes. Due to its effects on weight loss, semaglutide was also approved in 2021 for weight management under the name Wegovy®. The sheer popularity of this drug has resulted in supply shortages, prompting some people to seek out compounded versions of the drug instead.
In general, federal regulations prohibit compounding pharmacies from producing identical copies of commercially available drugs unless the FDA places a commercial drug on its official shortage list. Currently, semaglutide is on the list, and some compounding pharmacies and healthcare professionals are capitalizing on this loophole and the demand for the drug. They are offering compounded semaglutide (sometimes even marketed as “generic” Ozempic) at lower prices and easier access.
Concerns regarding compounded Semaglutide
There are several risks associated with compounded semaglutide. The most concerning aspect is that the source of the semaglutide is unknown or whether what they sell is even semaglutide at all. Novo Nordisk is the only FDA-approved supplier of the drug and they do not sell it for compounding purposes. Furthermore, semaglutide is patent protected in the United States for at least until 2026. As a result, it is unclear where pharmacies and healthcare professionals are obtaining the semaglutide, but it is certainly not from an FDA approved manufacturer.
Where are compounding pharmacies obtaining the Semaglutide?
There are reports that some compounding pharmacies are obtaining a sodium salt of semaglutide from sources outside the United States. Semaglutide Sodium is a research product that can be purchased online. The Alliance for Pharmacy Compounding (APC) has issued a warning to its members that semaglutide sodium “should not be used in human drug compounding”. This salt is not used in FDA-approved products and it has not been evaluated for safety and effectiveness in clinical trials. While different salts of active pharmaceutical ingredients are frequently considered pharmaceutical alternatives by the FDA, there are currently no therapeutic equivalents to semaglutide listed in the FDA's Orange Book.
Furthermore, some compounding pharmacies are also thought to be purchasing brand-name versions of the drug in their highest-dose formats. The medication is then diluted and mixed with other ingredients such as Vitamin B6, Vitamin B12, and L Carnitine. These combinations have not been evaluated in clinical trials for safety and effectiveness. This practice also carries risks such as loss of sterility and stability of the drug, which can compromise its safety and cause contamination.
Legal Issues regarding Compounded Semaglutide
Obtaining semaglutide from a non-FDA-approved source not only jeopardizes the patient's health, but may also lead to litigation, as semaglutide is patent protected in the United States. Novo Nordisk has already issued cease-and-desist letters to some compounding pharmacies, claiming that selling compounded semaglutide infringes on its intellectual property.
Recommendation to Health Care Specialists
Healthcare providers, particularly endocrinologists, and obesity medicine specialists, must be cautious when considering prescribing compounded semaglutide because of the potential hazards associated with its preparation and ingredient sourcing. It is crucial to prioritize patient safety by avoiding medications that have not undergone rigorous testing for efficacy and safety.
The FDA provides guidance on human drug compounding, including guidelines for compounding pharmacies and healthcare providers on the appropriate use of compounded drugs and regulatory requirements to ensure their safety and effectiveness. The Alliance for Pharmacy Compounding also provides resources and information for compounding pharmacies, including warnings about the dangers of using semaglutide sodium. Providers can consult with Novo Nordisk, the FDA-approved supplier of semaglutide, for more information on the drug and its proper usage.
Conclusion
Compounded semaglutide poses significant risks to patients, as there are considerable questions about its preparation and the source of the active ingredient. Compounding pharmacies and healthcare professionals who offer this medication may be jeopardizing their patients’ health and infringing on Novo Nordisk's intellectual property rights. Therefore, MC-Rx recommends that healthcare specialists exercise caution when prescribing compounded semaglutide, as its efficacy, safety, and quality cannot be guaranteed. Ultimately, the risks of compounded semaglutide outweigh the potential benefits. Keeping up with drug safety and efficacy information can assist providers in making responsible decisions about their patients' health and well-being.
References:
Alliance for Pharmacy Compounding. (n.d.). Tempted to compound semaglutide sodium? Don't. APC Website. Retrieved February 22, 2023, from https://web.archive.org/web/20221105070430/https://a4pc.org/2022-11/tempted-to-compound semaglutide-sodium-dont/
Center for Drug Evaluation and Research. (n.d.). Bulk drug substances used in compounding. U.S. Food and Drug Administration. Retrieved February 22, 2023, from https://www.fda.gov/drugs/human-drug-compounding/bulk-drug substances-used-compounding
Center for Drug Evaluation and Research. (n.d.). Human Drug Compounding. U.S. Food and Drug Administration. Retrieved March 1, 2023, from https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding
Novo Nordisk. (n.d.). Updates about Wegovy®. Wegovy supply. Retrieved February 22, 2023, from https://www.novonordisk us.com/products/product-supply-update.html
Putka, S. (2022, July 7). Demand rising for 'bootlegged' weight-loss drug. Medical News. Retrieved February 22, 2023, from https://www.medpagetoday.com/special-reports/exclusives/99625
Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. [Rockville, Md.]: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Office of Generic Drugs
VLS Pharmacy. (2022, September 23). The Potential Risks Associated with Compounded Semaglutide: What Medical Professionals Should Know. New Drug Loft and VLS Pharmacy. Retrieved February 22, 2023, from https://newdrugloft. com/the-potential-risks-associated-with-compounded-semaglutide/ FDA Drug Shortages. Food and Drug Administration (FDA). (2023) from https://www.access.fda.gov/