COVID-19 Guidance from Federal Agencies
U.S. Food & Drug Administration (FDA)
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
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.
Critical Infrastructure and Security Agency (CISA)
Guidance on the Essential Critical Infrastructure Workforce
The Critical Infrastructure and Security Agency (CISA) (part of The U.S. Department of Homeland Security (DHS)) updated its COVID-19 guidance on Friday, April 17 identifying Critical Infrastructure.
The updated guidance now includes personal care products, including manufacturers and distribution workers (e.g., ingredient suppliers, technicians, logistics and warehouse operators, printers, packagers, distributors). The previous CISA COVID-19 Guidance included producers of hygiene products which also remains in this updated guidance in addition to personal care products.
While the guidance is not legally binding, many state and local orders have been referencing the DHS/CISA COVID-19 guidance and outlining specific measures for the particular jurisdiction. Members should continue to check the applicable orders for your relevant jurisdiction(s).
We see this as an improvement to the previous guidance as PCPC had been advocating for continued consumer access to these essential products. We will continue to advocate for personal care and hygiene products to be considered critical infrastructure across all jurisdictions around the globe.
If you have any questions, please contact Meredith Simpson at firstname.lastname@example.org.