FDA requires companies that manufacture drugs to register their manufacturing facilities and list their drug products with FDA. This includes companies that are manufacturing drugs to address the COVID-19 pandemic.
For those companies only registering and listing for the duration of the crisis, FDA is offering assistance with creating and submitting data on their behalf to expedite the process and allow them to begin production and distribution sooner.
FDA intends to withdraw three guidances originally issued in March 2020 outlining temporary policies for manufacturers that were not drug manufacturers before the public health emergency to produce certain alcohol-based hand sanitizer and alcohol for use in hand sanitizers. Effective December 31, 2021, companies manufacturing alcohol-based hand sanitizers under the temporary policies must cease production of these products. Hand sanitizers manufactured before or on December 31, 2021, and produced under the temporary guidances can no longer be sold or distributed by manufacturers after March 31, 2022.
After that date, manufacturers wishing to continue producing hand sanitizer can do so provided they comply with the tentative final monograph for over-the-counter topical antiseptics and other applicable requirements, including the FDA’s Current Good Manufacturing Practice requirements. Manufacturers who no longer plan to produce these products are able to deregister by following the instructions on the Electronic Drug Registration and Listing Instructions page.
- Electronic Drug Registration and Listing Instructions
- CDER Direct application for creating and submitting R&L files: Application Login
- Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)
- Federal Register Notice of Withdrawal of Temporary Guidances for Hand Sanitizer Production During the Public Health Emergency
- Q&A For Industry – Withdrawal of Temporary Hand Sanitizer Guidances
- For more guidances on this topic and a comprehensive list, see COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders.
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