Home / Health / FDA Cracks Down on Unapproved Compounded Drugs
FDA Cracks Down on Unapproved Compounded Drugs
7 Feb
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.
Previously, on Thursday, Hims and Hers had announced plans to offer copies of Novo Nordisk's Wegovy at a reduced price. Novo Nordisk had stated its intention to pursue legal action against the telehealth company regarding this plan. The FDA also noted steps to combat misleading direct-to-consumer advertising.
