US Consumers' Hand Sanitizer Resources Expand: FDA Allows Compounding During Pandemic
Agency says compounding pharmacies are more familiar with standards and methods for producing drug products than “untrained consumers.” It will allow operations that might otherwise get sanctioned for marketing adulterated drugs because their products likely are better than some remedies consumers are making. It is aware consumers are experiencing difficulties accessing alcohol-based hand sanitizers and are concocting their own hand sanitizers.
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Four warnings, like previous letters FDA submitted to Mexican firms making methanol-containing hand sanitizers, which have been linked to deaths and other adverse events, indicate the targeted firms apparently entered US market for the products after the agency loosened manufacturing controls.
Action responds to methanol contamination in hand sanitizers manufactured in Mexico and marketed in the US under numerous brands that followed a loosening standards for the products to drive a swift increase in production and meet surging demand during the coronavirus pandemic.