In 2020, even the hand sanitizer is potentially suspect. Retailers, distributors and corporate purchasers are now grappling with the added problem of clearing their shelves of it and stopping employees from using the Food and Drug Administration (FDA) recalled product.

Earlier this year, to combat the novel coronavirus, the FDA issued temporary guidance to streamline regulatory processes for manufacturing alcohol-based hand sanitizer (typically ethanol or isopropyl alcohol) to get product quickly to market. Many manufacturers (generally foreign manufacturers), however, then distributed toxic or defective product to U.S.-based distributors. As such, the FDA issued a recall for certain hand sanitizer products beginning in June 2020. Over the following months, it has expanded this recall, citing risks that some products pose a risk of poisoning users with methanol and wood alcohol or leaving customers exposed to COVID-19 as a result of either adulteration or ineffective ingredients.. The FDA has advised importers, consignees, distributors, retailers and others not to distribute or sell certain hand sanitizers, even if the manufacturer of the product has not recalled it, due to the dangers of methanol contamination, including death.


Continue Reading Sanitizing Hand Sanitizer — Managing FDA-Recalled Hand Sanitizer

The onset of the public health crisis caused by the spread of the coronavirus (COVID-19) has led to a global shortage of hand sanitizer. Businesses attempting to cope with new challenges presented by COVID-19 may be interested in retooling current manufacturing or other processes to begin developing hand sanitizer for external distribution or even internal use. In support of these efforts, the federal Food and Drug Administration (FDA) has issued guidance for both companies that are not currently authorized by the FDA to manufacture hand sanitizer companies and pharmacists in state-licensed, federal, or registered outsourcing facilities compounders that may be interested in producing hand sanitizer. Companies that adhere to this guidance and maintain sufficient documentation should be able to manufacture hand sanitizer for external distribution or internal use without enforcement exposure from the FDA.

Continue Reading FDA Authorizes Temporary Production of Hand Sanitizer