US FDA’s ‘Narrow Path’ Squeezes Some Firms New To Sanitizer Space Under Enforcement Discretion
Among firms entering the sanitizer space during COVID-19 pandemic, those adhering to FDA’s GMPs could remain in the market expected to reach $3.65 by 2025. Shook, Hardy and Bacon attorneys say companies should determine whether they realistically can follow FDA’s “narrow path” of regulation.
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In addition to a large and growing number of products made in Mexico and found to contain methanol on recall, sanitizers made by a Washington state dental whitening product firm contain ethanol at below labeled levels and the presence of undeclared isopropyl alcohol. Recent recalls also include injectable CBD formulations a Seattle firm marketed OTC and a New Jersey’s firm dandruff shampoo produced with water that failed US Pharmacopeia specifications
Trade group also compiled website with information and resources to help members "stay up to date and take any necessary steps to mitigate the risks associated with COVID-19." Its members also got a chance to describe potential supply chain disruptions in survey for USDA.
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.