Registration and Listing Assistance for Non-Traditional Manufacturers of Hand Sanitizer and Related COVID-19 Drugs
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.
Contact Us
Email eDRLS@fda.hhs.gov
Resources
- 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)
- Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)
- Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency
- For more guidances on this topic and a comprehensive list, see COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders.
More information on Coronavirus (COVID-19) | Drugs