Semaglutide (Wegovy and Ozempic) and tirzepatide (Zepbound) have become some of the most sought-after weight-loss medications in history. Due to overwhelming demand, both drugs were placed on the FDA's official drug shortage list for several years. Under federal law, this shortage status allowed compounding pharmacies to legally produce their own versions of the medications. The pharmacies purchase what is supposed to be the raw active pharmaceutical ingredient, often from overseas chemical suppliers. They then mix it with other substances, such as bacteriostatic water and vitamins like B12, in their sterile compounding facilities to create an injectable product that they sell to patients.

The FDA does not review compounded drugs for safety, effectiveness, or quality and has issued warnings against their use. The agency has received reports of adverse events in patients using compounded semaglutide. Furthermore, the FDA has warned that the active ingredients used by many compounding pharmacies are not the same as those in the brand-name products. For instance, instead of using semaglutide base, pharmacies often use salt forms, such as semaglutide sodium or semaglutide acetate. These salt forms have different chemical structures and have not been shown to be safe or effective in humans. There is no way for a patient or a prescriber to know the exact ingredients, purity, or sterility of a compounded product.

For these reasons, I do not prescribe compounded versions of semaglutide or tirzepatide. My primary concern is safety. These specific compounded formulations have never been tested in rigorous clinical trials, so their short-term and long-term side effects are unknown. There are also significant concerns about the consistency of these products. A dose from one vial may not be the same as a dose from the next, and the product from one pharmacy may be entirely different from another. This lack of standardization makes it impossible to ensure proper dosing and exposes patients to unnecessary risks. The brand-name medications have undergone years of extensive testing in thousands of patients to prove they are safe and effective, a standard that compounded drugs do not meet.

Tirzepatide and semaglutide were removed from the FDA's drug shortage list in December 2024 and February 2025, respectively. This change means that, according to federal law, pharmacies should no longer be compounding these medications. Despite this, many compounding pharmacies and telehealth companies continue to produce and market their own versions. Given the potential risks and the lack of regulatory oversight, I strongly advise patients to use the brand-name drugs. Prices have come down significantly since they were first introduced, and with oral GLP-1 drugs on the horizon, they will likely continue to decline.