The Food and Drug Administration has issued a notice detailing the COVID-19-related guidances that will expire when the public health emergency (PHE) ends as scheduled on May 11, and which guidances will remain in effect.
The Department of Health and Human Services announced the PHE’s end date in January, and the notice is intended to clarify which guidance documents are tied to the duration of the PHE declaration and those that are being revised to remain in effect, the FDA explained.
In addition, some of the PHE guidances and policies will merit an additional 180-day “wind-down period” in order to ensure an orderly transition, the FDA stated. These will expire by Nov. 7.
The Centers for Medicare & Medicaid Services has urged long-term care facilities to prepare for the end of industry-specific PHE waivers and flexibilities, and has phased out many over the past two years. Key items now on the chopping block for May 11 include the three-day stay provision and temporary nurse aide statewide waivers.
The FDA’s PHE guidances, meanwhile, have totaled 84 from 2020 through 2022, and address a wide variety of medical products and public health issues that faced the United States during the pandemic, the agency stated.
To be withdrawn, wound down or kept
According to a report by Inside Health Policy, guidances that will be withdrawn include those that allow outsourcing of drug compounding, and allow manufacturers to mail prescription drug samples directly to a patient’s home upon clinician’s orders. Guidance that requires manufacturers to notify the FDA of expected disruptions in the medical device supply chain also will be withdrawn.
As part of a 180-day wind-down policy on other guidance, the agency will reinstate restrictions on the distribution and use of personal protective equipment, loosened in some cases to help alleviate pandemic shortages.
Guidances that will remain in place — with revisions — include those that cover the emergency use authorization, development and licensing of COVID-19 vaccines. The FDA also will retain guidance for drug and biologics sponsors to enable continued monitoring for the effect of new variants on product performance, the news outlet reported.
Certain guidance will be kept in place for the longer term under an emergency use declaration that is separate from the PHE and does not include an expiration date, Inside Health Policy noted. These include guidance related to chloroquine and hydroxychloroquine in order to support the development of generics for these COVID-19 treatments, and guidance related to COVID-19 diagnostic testing.
The complete list of FDA COVID-19-related guidance documents that are currently in effect can be found on the agency’s website.
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