WASHINGTON, D.C. - A new federal enforcement deadline is set to reshape access to some of the country’s most in-demand weight-loss drugs. Starting May 22, the U.S. Food and Drug Administration (FDA) will prohibit most pharmacies and providers from producing or distributing compounded versions of GLP-1 medications semaglutide and tirzepatide, active ingredients in blockbuster drugs including Ozempic, Wegovy, Mounjaro, and Zepbound.

The move follows months of mounting pressure on regulators to tighten control over the rapidly expanding market for GLP-1-based therapies used for diabetes management and weight loss. 

Demand has soared in recent years, creating temporary shortages that allowed compounding pharmacies to fill the gap with cheaper, unbranded alternatives. During the shortage period, the FDA tolerated compounding GLP-1 drugs as a temporary workaround. 

However, Novo Nordisk and Eli Lilly informed the FDA that the supply had improved. In February, the FDA determined that the supply from both companies had indeed stabilized, ending the emergency provision. 

Most compounded versions of the drugs will no longer be allowed unless they are made for a specific individual with a valid prescription and a medical need that cannot be met with a commercially available product.

Under federal law, drug compounding is allowed in limited cases when medications must be tailored to meet a patient’s unique clinical needs, such as when a patient is allergic to an ingredient in the brand-name version. However, producing compounded drugs in bulk or for general use, especially when FDA-approved versions are available in sufficient supply, is not permitted.

Novo Nordisk is the sole manufacturer of FDA-approved medications containing semaglutide. Its products, Ozempic and Wegovy, have become household names. Eli Lilly manufactures FDA-approved tirzepatide-based drugs such as Mounjaro and Zepbound, which have similarly gained traction.

Some compounders challenged the change, filing legal motions, but the federal courts have ruled against them, clearing the way for full enforcement of the ban on copycats, starting May 22.

FDA Revises COVID-19 Vaccine Policy, Limiting Access for Healthy Individuals Under 65

In a significant policy shift, the FDA announced on May 20 that updated COVID-19 vaccines will now be primarily recommended for adults aged 65 and older and individuals aged six months and older with at least one high-risk health condition. 

This marks a departure from the previous federal policy, which recommended annual COVID-19 shots for all Americans aged six months and older. Under the new guidelines, vaccine manufacturers must conduct randomized, controlled trials with robust outcome data before the FDA approves boosters for healthy individuals under 65.

On May 20, FDA Commissioner Marty Makary and U.S. vaccine regulator Vinay Prasad wrote in the New England Journal of Medicine that the benefit of repeated annual shots for healthy adults was uncertain.