Should you consider compounded weight loss medications?
Semaglutide (Ozempic/Wegovy) and Tirzepatide (Mounjaro/Zepbound) are in high demand. These medications are FDA approved for diabetes and/or obesity and are not covered by some insurance formularies. With this, patients are looking for alternative sources of the medications.
Medical spas, online companies and unfortunately physicians are offering "generic" versions of these popular medications. Obviously, as they don't have generics, one must consider how this is legal. Compounding pharmacies are allowed to create varying versions of medications as long as the follow the rules outlined below.
A compounding pharmacist must comply with the following rules.
The commercially available product is modified to produce a significant difference, in the professional judgment of the prescriber, between the compounded product for the patient and the comparable commercially available product; or
The commercially available product is not available from normal distribution channels in a timely manner to meet the patient’s needs, and the dispensing of the compounded product has been approved by the prescriber and the patient.
A pharmacist who compounds a commercially available product consistent with the requirements of above and shall maintain documentation of the reason for such compounding.
Semaglutide was found to be "in short supply" and many compounding pharmacist took this to mean they could offer their own versions. Normally, pharmacists would obtain the active pharmaceutical ingredient (API) from a FDA regulated distributor as this is in short supply, many pharmacists are using a salt version that has never been tested. Let me repeat, semaglutide salt is not FDA-approved. Anyone that is prescribing compounded semaglutide is offering a product that is not FDA-approved. I have seen people use words such as "generic Ozempic" or "FDA approved semaglutide." These are not accurate statements.
This means that the sources of these ingredients are coming from a non-FDA approved supplier, most likely outside of the US. I highly doubt these suppliers are doing liquid chromatography to ensure the product is indeed there. This is not a safe choice and therefore, we will not be offering it in our office.
We will happily offer services that are safe and effective to help lessen the cost to our patients. This is not one of them,
Bottom line: You do not know what you are getting when you buy from an unknown company. We work closely with compounding pharmacies and continue to inquire if this could be done safely for those patients that can't afford the medication. At this time, we do not suggest this method as it can not be proven to be safe at this time.