Although we mentioned the potential dangers of compounded semaglutide several months ago and have noted that there are several semaglutide alternatives for weight loss, we continue to receive requests to compound semaglutide. Due to reports of adverse events, the FDA has recently issued a statement highlighting concerns about compounded semaglutide, which we’d like to reiterate here.
Update: On Tuesday, June 20, 2023, Novo Nordisk, the manufacturer of Ozempic® and Wegovy®, announced that it was taking action against certain medical spas, medical weight loss clinics, and pharmacies that, they allege, have been unfairly competing with and falsely marketing and advertising their drugs.
Overprescription of semaglutide-containing drugs has led to a drug shortage—again!
The FDA has approved three drugs with semaglutide as the API (Ozempic®, Wegovy®, and Rybelsus®), but only Wegovy® is indicated for weight loss in obese patients or in overweight patients with a weight-related comorbidity. Ozempic®, which is indicated to help manage type 2 diabetes, is being used as an off-label prescription for weight loss due to Wegovy® shortages. This has led to many diabetic patients having difficulty obtaining Ozempic®, which helps them manage their disease.
The only FDA-approved manufacturer of semaglutide, Novo Nordisk, has issued another statement that they are once again facing supply issues, less than six months after they originally noted these issues had been resolved. Because of this shortage, some prescribers may turn to compounding pharmacies to obtain compounded semaglutide preparations for their patients.
Here’s why we won’t compound semaglutide.
Although both Ozempic® and Wegovy® currently appear on the FDA’s Drug Shortages list, which may technically make them eligible for compounding under the FD&C Act, we will not compound semaglutide.
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- The APIs used in compounded preparations must be sourced from an FDA-approved supplier. Because Novo Nordisk, the only FDA-approved supplier of these semaglutide drugs, is currently facing a shortage, any compounded semaglutide is not being sourced from them. Furthermore, they’ve explicitly stated they do not provide semaglutide for compounding.
- There are some reports of patients receiving compounded preparations using semaglutide salts, which are not eligible for compounding. Because the salt forms of semaglutide are not FDA-approved, they have not been the subject of clinical trials to demonstrate their safety or effectiveness and should not be used in compounded preparations as a semaglutide substitute. This is especially important because these “semaglutide” compounded preparations are administered as injections, allowing any unknown substances to enter systemic circulation immediately.
- The substances (whatever they are) in these preparations are being sourced from a non-FDA-approved supplier, possibly from outside the USA. If the providers of these semaglutide compounded preparations are skirting one regulation, they may be violating others as well.
- The FDA has received numerous adverse event reports involving compounded semaglutide preparations, some of which have been serious. Injecting unknown and untested substances into patients is not worth the risk.
Are there semaglutide alternatives?
Yes! At VLS Pharmacy and New Drug Loft, we offer several alternatives to semaglutide. It’s important to note that none of these alternatives will provide overnight weight loss, but they can help patients lose weight as part of a weight loss and weight management plan with long-term lifestyle changes.
Please comment below with any thoughts or questions. Reach out to our team to learn about best practices and to partner with our experts on custom, non-semaglutide compounded weight loss medications for your patients. All medications from VLS Pharmacy and New Drug Loft are prepared in a lab that follows safety and quality standards per our status as a 503A pharmacy.
- Learn about the potential risks of compounded semaglutide
- It’s never been easier to submit your prescriptions! Place your order today
- Tips for choosing a compounding pharmacy
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