December 3, 2021

Volume XI, Number 337

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November 30, 2021

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FDA Withdraws Temporary Hand Sanitizer Policies

  • FDA is withdrawing a trio of temporary policies implemented in the beginning of the COVID pandemic which allowed certain businesses that are not regulated as drug manufacturers, including pharmacies and alcohol producers, to produce alcohol-based hand sanitizers. See Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer ProductsTemporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products, and Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products.

  • The policies were intended to provide temporary regulatory flexibility and encourage increased production of alcohol-based hand sanitizer to keep pace with the demand for these products experienced during the pandemic. FDA is withdrawing the policies because it has determined there is no longer a shortage of hand-sanitizer.

  • After December 31, 2021, manufacturers of these products will no longer be able to rely on the temporary policies and instead must meet all regulatory requirements, including the tentative final monograph for over-the-counter (OTC) topical antiseptics and cGMP requirements. Furthermore, manufactures may not distribute alcohol-based hand sanitizers produced under the temporary after March 31, 2022. However, there is no cut-off date for retailers who may continue to sell their stock of hand sanitizer produced under the temporary guidance even after March 31, 2022. See Q&A.

  • Manufacturers who will no longer produce hand sanitizers must deregister their facilities and delist their products in FDA’s Drug Registration and Listing System by following the instructions on FDA’s webpage.

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 299
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About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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