Due to the blockbuster weight loss drugs Ozempic, Wegovy and Mounjaro going on the FDA Shortage List, compounding pharmacies are legally allowed to make duplicates of these name brand drugs without risk of patent infringement. And even though NovoNordisk, the maker of Ozempic and Wegovy, admits they can’t keep up with demand, they’re trying everything in their power to protect their investment with litigation and possibly behind the scenes lobbying of the FDA.
Below, we discuss an alert by the FDA and two other recent actions taken against compounding pharmacies and providers who offer semaglutide, the active ingredient found in Ozempic and Wegovy. Of note, the alerts, bulletins and press releases often have titles that suggest very nefarious actions on the part of compounding pharmacies and providers. But after careful reading of said statements, the warnings, restrictions and legal pitfalls can be easily overcome with simple solutions, suggesting that if compounding pharmacies and providers follow the law, they will only be guilty of upholding the standard of care.
FDA Warning
The FDA recently issued a notice to consumers to be wary of purchasing semaglutide online without a prescription and of the possibility that some semaglutide may not be the exact same ingredient found in the name brand versions of Ozempic and Wegovy.
In the case of Ozempic and Wegovy, the active ingredient is semaglutide. However, semaglutide can come in two forms, the pure base or the salt version (which includes an additional sodium ion attached to the semaglutide amino acid sequence). According to the provisions set forth by the FDA, any duplication of a medication on the shortage list must truly be a duplicate. NovoNordisk’s original formulation is a semaglutide base, not semaglutide salt.
Several compounding pharmacies I spoke with state that the difference between the base and salt form are negligible, but indeed, the salt form is technically not a duplicate. Therefore, this is a reasonable alert by the FDA stating that the semaglutide salt has not been tested for safety and efficacy in the way the semaglutide base has. This seems to be a non-issue because if your compounding pharmacy is providing you with the semaglutide salt, switch to a pharmacy that has access to the semaglutide base! How can you tell the difference?
Request a Certificate of Analysis (CoA) from your compounding pharmacy and they will (hopefully) provide you with a document similar to the one below. This CoA was provided to our practice by our compounding pharmacy on behalf of the manufacturer that provided them with the semaglutide base. If this was the salt version, an ‘Na’ would follow the sequence at the top of the document.
Lastly, the FDA alert rightly states that consumers should be wary of medication bought online without a prescription. Hardly an unreasonable recommendation.
NovoNordisk lawsuits against providers
The cease and desist orders issued by NovoNordisk to providers in the US has very little to do with the legal use of compounded versions of semaglutide. At first, it would seem NovoNordisk is suing over the use of semaglutide itself. But as stated previously, compounding pharmacies creating a duplicate of a medication are protected by the FDA rules during shortages.
If you read the press release fully, you recognize the issue is the unlawful use of the name brands Ozempic and Wegovy in marketing materials. Using the brand name is understandably confusing to the consumer if the practice is actually offering the compounding version of the active ingredient.
This Instagram post provides an example of what not to do. I don’t believe this is one of the clinics that received a cease and desist order but the use of the brand name is infringing on the NovoNordisk trademark. So what do you do? Stop using the brand names in your marketing, promote that your practice offers the compounded version of semaglutide and keep treating and providing your patients with amazing weight loss results. Not a bad tradeoff.
NovoNordisk lawsuits against compounding pharmacies
These suits, according to NovoNordisk, against four compounding pharmacies relates to the compounding of “an unauthorized version of their active ingredient semaglutide.” Ostensibly these pharmacies are offering the semaglutide salt rather than a duplicate semaglutide base. In a sense, NovoNordisk is enforcing FDA regulations on behalf of the FDA. And while NovoNordisk would like to push the narrative that this is about safety, based on the suits, this is clearly a campaign of harassment to protect their interests.
So what is a provider to do?
Dos and Don’ts
- Do use a compounding pharmacy offering the semaglutide base
- Do check your state’s Board of Pharmacy (BOP) website to ensure your compounding pharmacy is licensed for sterile compounding
- Don’t advertise that you are offering “compounded Ozempic or Wegovy,” but rather Do present it as “compounded semaglutide” or simply “semaglutide”
- Do collect weight loss data on your patients so that you can publish your program’s results on your website, and in the process, dispel any suggestion that the semaglutide you are offering is not safe or effective
In the end, if you can ensure your entire supply chain is FDA or BOP-approved in the sense that the manufacturer creating the compound is FDA approved and following current Good Manufacturing Practices (cGMP) and is then providing that compound along with a CoA to a compounding pharmacy with a license in your state, then, really, what more could a regulator ask of you?!
