FDA Lifts Compounding Restrictions on Weight-Loss Drugs

The FDA has lifted its restrictions on compounding GLP-1 weight-loss drugs, but with some conditions. The agency allows compounding in cases of “clinical need,” such as when a patient is allergic to a certain dye or can’t take the drug in its current form.

However, this decision does not apply to making or selling unauthorized copies of these drugs, known as “knockoffs.” Novo stated that under compounding laws, such actions are illegal with rare exceptions.

The focus now shifts to Hims, which has been selling personalized doses of GLP-1 weight-loss medications. The company’s argument to keep its business model intact is being closely watched.

As more clinicians warn patients about the side effects and risks associated with GLP-1 weight-loss drugs, including Wegovy and Ozempic, the luster on these treatments is starting to wear off. Research has shown that these drugs not only aid in obesity but also lower the risk of heart attacks, stroke, certain cancers, and even Alzheimer’s disease.

Despite their effectiveness, the substantial cost of these medications and the fact that many patients struggle to stay on them are major concerns.

Source: https://www.axios.com/2025/02/22/ozempic-wegovy-weight-loss-drugs