Sometimes things take longer than planned and new due dates impact other commitments. That happened to the FDA, but they prevented a regulation from disappearing with just five days to spare.
Current Good Manufacturing Practice (cGMP) regulations for food go back to 1986 (21 CFR Part 110), and a lot has changed since then. Thus, as part of implementing the Food Safety Modernization Act (FSMA) regulations for the Preventive Controls rule (aka Hazard Analysis and Risk-Based Preventive Controls), FDA took the opportunity to update cGMP regulations too. It also located the updated cGMP regulations to one place (21 CFR Part 117).
As with most FSMA regulations, FDA included a staggered set of compliance dates based on business size. So a food facility was subject to the 1986 regulations in Part 110 until their compliance date and would shifted over to the new regulations in Part 117. FDA originally wanted this shift to be completed for everyone by September 2018, and so on September 17, 2018, the old cGMPs (Part 110) would be deleted, never to be seen again.
Problem: FDA extended the compliance dates for several operations beyond September 2018, which means that the operations remain subject to the regulation in Part 110. However, these regulations were to be deleted; so what is a facility to do? There would be no regulation to follow.
With 5 days to spare, FDA stopped the printer from erasing the old regulations in Part 110 so that these operations with extended compliance dates still had cGMPs to follow.
It’s a good reminder to everyone to check your work. And because regulatory compliance is always on our minds, we encourage manufacturers and importers to check your work and make sure there aren’t any gaps in your food safety plan. Need a seasoned professional’s eye on your FSMA compliance plans? Contact us today.
