Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistCVS Health was cited for selling unapproved ophthalmic drug products, specifically "CVS Health Pink Eye Relief Drops," in violation of sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act. The product's labeling and website claims—including statements that it "relieves redness, burning, watery discharge, and gritty sensation" and "stimulates the body's ability to relieve" these symptoms—established it as a drug requiring FDA approval before marketing. The FDA emphasized particular concern regarding the safety risk posed by unapproved ophthalmic drugs, which bypass the body's natural defenses due to direct eye administration.