CNN
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U.S. Food and Drug Administration announced caveat Tuesday will discuss a conjugated form of semaglutide, which has been approved for the treatment of diabetes and overweight.
Compounding is “the process of combining, mixing, or modifying ingredients to create a drug product that is tailored to individual patient needs,” the FDA said. “Formulation involves combining two or more drugs.”
Semaglutide, a class of drugs called GLP-1 agonists, is FDA-approved as Ozempic and Rybelsus for the treatment of type 2 diabetes and Wegovy for the treatment of overweight and obesity.
Ozempic and Wegobee have been on the FDA’s drug shortage list since last year.
“If a drug is in short supply, a formulator may be able to prepare a compounded version of that drug if it meets certain requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act,” the FDA said. However, the FDA has not confirmed the safety, efficacy and quality of these combined versions.
The FDA has received reports of adverse events in people who have used the combination semaglutide, stating that patients “should not use the combination when an approved drug is available.”
Some formulators may also use salt forms of drugs such as semaglutide sodium and semaglutide acetate that contain different active ingredients than the approved drug. “Government agencies are unaware of the rationale for formulating with salt forms that meet FD&C requirements. Not proven.”
The FDA says patients and health care providers should be aware of these differences in the drugs being formulated.
“Patients should obtain drugs containing semaglutide only by prescription from a licensed healthcare provider and only from nationally licensed pharmacies or FDA-registered referral facilities.”
Dispensing pharmacy alliance statement As for semaglutide, last week it advised consumers not to buy semaglutide online unless they have a prescription and cannot verify that the seller is a licensed US pharmacy.
According to the group, people who have been prescribed compound semaglutide and want to know for sure what it contains can ask their pharmacist for a certificate of analysis and lab results.
