Key Takeaways

• The FDA has issued a Federal Register notice explaining how the end of the COVID-19 Public Health Emergency (PHE) declaration will impact the Agency’s 72 COVID-related guidance documents.
• Of the 72 guidance documents, 22 will no longer be in effect when the PHE declaration expires, 22 will be revised to continue in effect for 180 days after the expiration, 24 will be retained with revisions after the 180 days, and four will remain in effect after the declaration expires.
• All FDA-regulated industries should review the categorization of FDA guidance documents related to COVID-19 and assess whether their practices are compliant with current FDA guidance.
• Firms continuing to operate under FDA guidance that is no longer in effect risk FDA enforcement actions.

On March 13 the FDA officially issued a Federal Register notice to explain how the end of the COVID-19 PHE declaration will impact the Agency’s 72 COVID-related guidance documents currently in effect. The notice comes as the Biden administration plans to end the PHE phase of the pandemic response on May 11.

Of the 72 COVID-19-related guidance documents, 22 will no longer be in effect when the PHE declaration expires, 22 will be revised to continue in effect for 180 days after the expiration, 24 will be retained with revisions after the 180 days, and four will remain in effect after the declaration expires.

Notably, temporary policies for compounding drugs by outsourcing facilities and pharmacy compounders as well as requirements to notify the Center for Devices and Radiological Health of interruptions to medical device manufacturing are among the guidances that will no longer be in effect when the emergency declaration ends. The Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples is also ending with the end of the PHE. The FDA intends to extend certain guidances for an additional 180 days. Guidances that will be extended for 180 days include many guidances on medical devices such as remote ophthalmic assessments, ventilators, fetal monitoring devices and remote digital pathology devices. Additionally, food manufacturers should continue to monitor the temporary policy on certain food labeling requirements, because this policy will be extended for 180 days. Policies related to emergency use authorizations for vaccines and the development of drugs and biologics for treating and preventing the virus are slated to be extended subject to further revisions.

Lastly, four guidance documents are not tied to the COVID-19 PHE declaration and will remain in effect indefinitely according to the FDA, including FDA’s Policy for Coronavirus Disease-19 Tests.

All FDA-regulated industries should review the listings and categorization of FDA guidance documents related to COVID-19. Firms should assess and confirm that practices are compliant with current FDA guidance. Firms continuing to operate under FDA guidance that is no longer in effect risk FDA enforcement actions.

Authored by: Winston D. Kirton; Lee H. Rosebush; Francis Palumbo; Laura E. Macherelli and Marc N. Wagner