The U.S. Food and Drug Administration (FDA) is warning manufacturers, exporters, importers and distributors: Methanol is not an acceptable active ingredient for hand sanitizers and must not be used due to its adverse events including deaths.
The U.S. Food and Drug Administration encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program.
Hand sanitizers are regulated as over-the-counter (OTC) drug products. Therefore, manufacturers are required to register their establishments with the U.S. Food and Drug Administration, and list their products annually.
All establishments currently registered with the FDA are expected to renew their registration before December 31, 2021.
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