U.S. Food & Drug Administration (FDA) COVID-19 Guidance

Hand Sanitizers

PCPC has been actively engaged with FDA on behalf of our members who are willing to help increase the supply of hand sanitizers, given the ongoing shortage during this public health crisis. PCPC was successful in securing guidance from FDA that will allow non-traditional drug manufacturers to manufacture hand sanitizers to the standards set forth in the following FDA guidance, assuming the entity registers with the Agency: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19). More information can be found here.

Temporary Policy for Manufacture of Alcohol for Incorporation Into 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

Inspections

On March 18, FDA announced it would be suspending all domestic routine facility inspections due to COVID-19. They had announced earlier in the month postponing all foreign facility inspections. While cosmetics are not specifically mentioned, we can assume this applies to our sector as well. More information can be found here.