Threats of legal action have been made by a growing number of states against pharmacies making or dispensing unauthorized, copycat versions of the two weight-loss medications Ozempic and Wegovy.
Both Ozempic and Wegovy are injections containing the active ingredient semaglutide. Ozempic is approved to treat Type 2 diabetes in adults. Used along with diet and exercise, the drug improves glycemic control. Wegovy is a higher-dose version that’s approved specifically for the treatment of obesity. However, they’re not interchangeable, especially if taking Ozempic for Type 2 diabetes. Wegovy isn’t approved for that.
With an ongoing shortage of semaglutide, some U.S. compounding pharmacies are using a different form of the drug that’s not FDA approved. The FDA sent a letter to states informing them the ingredient is approved for use only in its “base form,” and pharmacists can only get it from Novo Nordisk, the patent holder of Ozempic and Wegovy. Therefore, it isn’t possible to make because Novo Nordisk doesn’t share the drug ingredients with compounding pharmacies.
What’s concerning regulators is that some medications are made using semaglutide sodium salt, which is a cheaper and modified version of the compound that’s used for scientific research and not intended for human use. In fact, no FDA-approved drugs contain semaglutide salt because the salt version of semaglutide isn’t regulated, monitored, or tested by the FDA. So, patients really don’t know what they’re getting.
The warning by state regulators means compounding pharmacists who are making unauthorized versions of Ozempic and Wegovy could face a fine, be put on probation, or lose their license to dispense medications. However, no pharmacies have been fined so far.
As of now, no one has reported if any consumers have been harmed by the compounded versions. But states are cracking down and telling compounding pharmacies to stop making the unapproved versions of the drug. If they don’t, they will face legal or regulatory consequences.
Wegovy and Ozempic: Who is Eligible?
Candidates for Wegovy:
- Must have a body mass index (BMI) of 30 or above. If BMI is 27 or higher and they have additional health risks, then they’re eligible to get a prescription.
If they don’t meet the criteria, they would be using it off label. However, if their healthcare provider believes they need it, it’s okay.
Candidates for Ozempic:
- Must have Type 2 diabetes
- A1C level is uncontrolled with other interventions
- At high risk of having or developing cardiovascular disease
- Have kidney disease or heart failure
From the Magazine
This article was published in our quarterly print magazine, which covers relevant topics in greater depth featuring leading experts in the industry. Subscribe to receive the quarterly print issue in your mailbox. All registered independent pharmacies in the U.S. are eligible to receive a free subscription.
More articles from the June 2023 issue:
- Leveraging Non-Pharmacy Assets
- Diagnostic Testing
- Diabetes Management
- Mental Health Care
- Arthritis Care
- Mentoring a Junior Partner
- Quit for Good
- Cracking Down on Copycats
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