US FDA Enforces OTC Monograph With Seizure of Hand Sanitizer as an Unapproved New Drug
On July the United States Food and Drug Administration (FDA) seized $ 230,000 worth of an over-the-counter (OTC) hand sanitizer gel product made and distributed in Puerto Rico charging the large quantity of product as unapproved New Drugs under the Food Drug and Cosmetic Act (“FDCA”). All products that are marketed as OTC drugs must [...]