In an April 24, 2025, decision, a U.S. judge denied compounding pharmacies the ability to continue compounding semaglutide, the active ingredient in Novo Nordisk’s popular diabetes and medical weight loss medications Ozempic and Wegovy.

The U.S. Food and Drug Administration (FDA) announced in February 2025 that the shortage of semaglutide was over, thus beginning the end of compounding. In response, the Outsourcing Facilities Association (OFA), a trade group that represents FDA-sanctioned compounding pharmacies, filed a lawsuit against the FDA’s decision marking the shortage as resolved. By denying the injunction request, the FDA’s timeline for large compounders remains in place. 

Larger outsourcing facilities, which make compounded drugs in bulk and are regulated by the FDA, will have until May 22 to stop producing and dispensing semaglutide. Smaller compounding pharmacies, which make drugs to fill prescriptions for individual patients and are primarily overseen by U.S. states, must immediately cease making copies of semaglutide. The FDA has previously said it would not take any enforcement action against compounders until after the court ruled. 

Tirzepatide, the active ingredient in Mounjaro and Zepbound, has been regulated in the same way, with the shortage listed as resolved in August 2024. On March 5, 2025, a U.S. judge denied an injunction that would have allowed certain compounding pharmacies to continue producing compounded versions of tirzepatide. Larger facilities had a deadline of March 19, 2025, to stop producing and dispensing tirzepatide.

Notable exception

As of March, only semaglutide could still be compounded. With the April 24 decision, compounding will soon come to a close.

There is, however, a limited exception for medical necessity. This exception must be patient-specific, wherein a patient must meet all the criteria for the exception; the exception should not be used if the patient does not meet all the criteria for the exception. Specifically, the exception does not apply broadly to a general population.

Importantly, the medical necessity exception shifts the compounding determination and risk to the provider, who assesses the needs of a patient and communicates the need to a pharmacy.

An authorized provider must determine that a patient needs personalized medication for a specific, medically necessary reason. Then, they must document this on the prescription submitted to a compounding pharmacy and in the patient’s medical records. This exception can only be utilized when a patient’s medical needs cannot be met by an available FDA-approved drug. For example, a patient may be allergic to an ingredient in an approved formulation of medication, so the compounding pharmacy could create a version without the allergen; or, if a patient cannot swallow pills and the drug is only available in pill form, a liquid solution could be compounded for that patient.

Drug cost is an insufficient reason to claim a medical necessity exception, per FDA guidance. Simply adding another substance (e.g. vitamin B12) would be pharmacy- and population-driven and would not comply with the exception. Speak with your legal counsel for further guidance on what medical needs will comply with this patient-specific medical exception.

AmSpa continues to follow the regulation of medical weight loss medication. Visit the Medical Weight Loss resource page for additional resources and further reading.