What action is the FDA taking regarding compounded drugs?

The FDA announced its intention to restrict GLP-1 ingredients used in compounded drugs that have not received agency approval, citing quality, safety, and potential legal violations.

Which companies are affected by the FDA's new restrictions?

Companies marketing non-FDA-approved compounded drugs using GLP-1 ingredients, such as Hims & Hers, are subject to these new restrictions and investigations.

Home / Health / FDA Cracks Down on Unapproved Compounded Drugs

FDA Cracks Down on Unapproved Compounded Drugs

Q: What are the concerns behind the FDA's crackdown on compounded GLP-1 drugs?

The FDA's concerns revolve around the quality, safety, and potential violations of federal law associated with these compounded products, as well as misleading advertising.

7 Feb

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Summary

FDA plans to restrict GLP-1 ingredients in non-approved compounded drugs.
Concerns cited include quality, safety, and potential legal violations.
Hims & Hers faces investigation and stock decline.

The U.S. Food and Drug Administration announced on Friday, February 6, 2026, its intention to restrict GLP-1 ingredients used in compounded drugs not approved by the agency. This action targets companies like Hims & Hers that have been marketing these alternatives to authorized treatments.

The FDA cited significant concerns regarding the quality, safety, and potential violations of federal law associated with these compounded products. Companies will be prohibited from claiming that non-FDA-approved compounded products are generic versions or equivalent to approved drugs.

In response to these developments, shares of Hims & Hers Health experienced a notable decline in after-hours trading. Additionally, the U.S. Department of Health and Human Services has referred Hims & Hers to the Department of Justice for an investigation into potential violations.