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/