As the demand for weight loss medications like Ozempic and Mounjaro has skyrocketed, many have found it challenging to get their hands on their prescriptions, prompting a rise in compounding pharmacy utilization.
Compounding pharmacies do not manufacture medications in bulk. They manufacture small amounts, and typically work directly with physicians to provide their patients with compounded products of brand name medications, like Ozempic and Mounjaro, helping to fill the gap between supply and demand for the drugs.
Compounding pharmacies have also helped to increase access to weight loss drugs by allowing patients to pay reduced out-of-pocket cash prices and bypass the red tape involved in insurance approvals.
The popularity of these pharmacies has grown as weight loss medications have become more widely prescribed. And while many of these pharmacies are safe and legitimate, the questionable practices of some compounders have prompted the Food and Drug Administration to urge caution among consumers.
On October 31, the FDA, which does not regulate compounded drugs, warned consumers that the agency had received numerous adverse event reports from people who had taken a compounded version of semaglutide — the generic version of Ozempic and Wegovy. The report alleges that some compounding pharmacies were using salt-based versions of semaglutide that are not the same as the FDA approved version, which caused users to have adverse reactions.
“Patients should be aware that some products sold as ‘semaglutide’ may not contain the same active ingredient as FDA-approved semaglutide products and may be the salt formulations,” the FDA noted. “Products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective.”
Sue Decotiis, M.D., a weight management specialist based in New York City, tells The Messenger that the generic versions of Ozempic and Mounjaro — semaglutide and tirzepatide — are the same ingredients used in the branded versions of the drugs. But when compounded, the drugs have a slightly different formulation to their branded counterparts. Patients should be aware of where the compounded versions come from, and there are issues to consider when it comes to having prescriptions filled at compounding pharmacies.
Here’s what anyone considering getting weight loss medications from a compounding pharmacy needs to know:
Weight loss medications require a prescription from a licensed healthcare provider. If an online platform offers to give you the medication without a prescription, that is a sign that it is a scam. It’s also illegal, Dr. Decotiis notes.
While the branded versions of these drugs can be filled and picked up at standard pharmacies, the process is a little different when it comes to compounding pharmacies. If a physician prescribes you medication through a compounding pharmacy, you can sometimes take it home with you from their clinic. In some cases, you will have to go to the pharmacy yourself to get it and in others you might be able to have it mailed to you.
Regardless, it is important that the provider prescribing the medication has a relationship with the compounding pharmacy distributing it.
“These pharmacies — if they’re legitimate — they have accounts with physicians. They have relationships with the physicians prescribing these medications,” Dr. Decotiis notes, adding that this relationship helps to ensure that the medications are safe and effective, and that patients are getting the products that they are paying for, not counterfeit versions with undisclosed ingredients.
Legitimate compounding pharmacies are designated as 503a pharmacies, which is something that can be verified online via the Pharmacy Compounding Accreditation Board (PCAB).
Compounding pharmacies must also be licensed through the state and registered with the FDA, though the agency does not regulate compounded drugs. All of this information can be verified online.
Dr. Decotiis says that legitimate compounding pharmacies do not advertise their services online.
“No good compounding pharmacy is advertising online. They have websites, but they’re not advertising these medications. That’s a big red flag,” she warns.
She adds that even an online platform that is appropriately licensed and registered and has providers who can legally prescribe weight loss medications might not be able to follow through with ensuring that the prescription is filled.
Many of these online platforms collect payment for services up front before consultation. While this is standard practice for in-person consultations, there is more of a risk with online visits because there is no guarantee that a prescription will actually be filled.
“These platforms will suggest that they can get their hands on these medications, but sometimes they’re not going to be able to get it because of the shortages. And then a month later when you still don’t have the drug, they’re going to say ‘You paid for our services — we didn’t promise you a drug,’” Dr. Decotiis cautions.
Although there are numerous online platforms that can legally and legitimately provide weight loss services and prescribe medications, Dr. Decotiis suggests that in-person visits will provide better results.
“When you go on these online platforms, you could get a legitimate prescription that isn’t bogus and that is prescribed by a physician. But that physician is not going to be able to examine you and you’re not going to be put on a body composition scale, so they won’t be able to monitor your actual fat loss.”
At her practice, Dr. Decotiis uses body composition scales to monitor her patients’ progress. Body composition scales go beyond measuring weight, they assess the overall composition of the body, including how much of a person’s weight is body fat.
When losing weight, the goal is to lose excess fat, not muscle, so a body composition scale will help to determine whether weight is being lost in an appropriate and healthy manner.
“You might lose 20 pounds but if it wasn’t fat that you lost, then you really aren’t at your ideal weight,” Dr. Decotiis notes. “Even if these platforms are technically legitimate, you’re not going to get the best care.”