FDA statement on semaglutide (generic form of Wegovy and Ozempic)
Everyone has heard about the new weight loss medication Wegovy (Ozempic for diabetes). As reviewed in our previous newsletters and blog, semaglutide is part of a new class of medications that have revolutionized obesity medicine. They are all over social media with tweets by Elon Musk and the Kardashians. And for a good reason! These medications can help you be successful where other treatments have failed. And, although the publicity is amazing, it has created a worldwide shortage of these medications. Because this medication is essential in the management of type 2 diabetes, the shortage is leaving many people with diabetes unable to obtain treatment.
The shortage has prompted the FDA to allow companies to manufacture generic semaglutide formulas as stated on the FDA website:
“When a drug is in shortage, compounders may be able to prepare a compounded version of that drug if they meet certain requirements in the Federal Food, Drug, and Cosmetic (FD&C) Act. As of May 2023, Ozempic and Wegovy are both listed on FDA’s Drug Shortages list.”
The good news about compounded generic medication is that they cost a fraction of the brand name. For example, our compounded generic semaglutide at Sound Medical Weight Loss costs in the neighborhood of $100-$200 per month, whereas the brand-name typically costs $1200 per month or more if your insurance doesn’t cover the brand name medications.
The downside of compounded medication when coming from an unknown source is that they may be unsafe, untested, or even fake.
The FDA warns that not all generic forms of semaglutide are safe and effective. Here’s why:
- Semaglutide can be made as a chemical salt (sodium or acetate) or as a chemical base.
There have been reports of serious side effects from the salt compounds and there are no studies to show that the salt forms even work. Yet the salt forms are being widely sold online and by unlicensed pharmacies and companies.
- The approved base forms need to be manufactured under very stringent guidelines and conditions, which are inspected by the US FDA.
- These medications must be prepared in a completely sterile environment.
How do I know if the semaglutide I am getting is safe?
Authentic compounded medication must be prescribed by a doctor and purchased from legitimate and licensed compounding pharmacies who obtain their products from FDA approved companies around the world, and whose physical sites have been inspected and approved for sterility by the US FDA.
Our commitment to safety
Our preference, of course, is to prescribe the brand name medications when insurance coverage is available. However, because we believe everyone should have access to the best treatment, at Sound Medical Weight Loss we use only Washington state licensed compounding pharmacies that can provide us with documents verifying that their semaglutide comes from an FDA approved facility. Then we confirm that the medication is made with a base solution by requesting the authenticated and FDA stamped formula. We also confirm that all injectable medications are prepared under strict sterile conditions as required by the Washington Department of Health.
Avoiding scams and fake or unsafe semaglutide
We are aware that there are many online sources and even local practitioners selling forms of semaglutide that do not to meet the above three mandatory requirements.
Make sure that the source of your medication is coming only from Washington state licensed pharmacies. If you’re purchasing direct from a provider, make sure that they are adhering to the Department of Health’s standards for sterile procedures (ie, using a sterile room) to compound injectable formulas. Do not buy semaglutide from online pharmacies or from providers that are not approved and licensed by the state of Washington.