Pharma and Regulatory Publication Reports on Complexities of Hand Sanitizer Production

HBW Insight spoke to Shook Attorney John Johnson about the challenges companies face when pivoting to a new business line such as hand sanitizer production. Reporter Eileen Francis explored the various issues for the article, “US FDA’s ‘Narrow Path’ Squeezes Some Firms New to Sanitizer Space Under Enforcement Discretion.”

“Firms considering hand sanitizer production during the pandemic should first assess their manufacturing capabilities and determine whether they can realistically meet the standards of the FDA,” said Johnson, who represents clients before the FDA and other government agencies.

Regulations and requirements vary from country to country. In the UK and EU, hand sanitizers are regulated in various ways: as a cosmetic, a biocide or a pharmaceutical product. Each has its own regulatory requirements. Failure to comply with regulations may result in enforcement action; competitor complaints; and consumer claims

“Understanding and following the rules at the outset helps companies avoid risk and develop potentially long term products,” said Shook Partner Eva Weiler, who focuses on a variety of industries including cosmetics and personal care and leads the firm’s Orange County office.

Shook has created a series of infographics to easily explain some of the necessary requirements for manufacturing hand sanitizer in various jurisdictions.