The Food and Drug Administration (FDA) has provided guidance to healthcare facilities and providers looking to use certain drugs beyond their labeled “in-use times” due to supply issues related to the coronavirus disease 2019 (COVID-19) pandemic. 

The Agency released the information following reports from providers indicating the need to discard a medication before it was fully administered because of the “in-use time” specified on the product labeling. The in-use time is defined as the maximum amount of time that can be allowed to elapse between penetration of a container-closure system containing a sterile drug product, or after a lyophilized drug product has been reconstituted, and before patient administration.

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Given the challenges of maintaining an adequate supply of these critical care drugs, specifically medications required for the care of ventilated patients, the FDA recommends the following:

  • If there is a need to use products beyond the labeled in-use time, that period should be as short as possible, and for a maximum of:
    • Four hours for a refrigerated storage condition (if any), or
    • Two hours for any labeled room temperature in-use time (if any).
  • Extended use applies to either the refrigerated or the room temperature in-use storage condition and not both storage conditions even if both refrigerated and room temperature in-use life times are provided in the labeling.
  • While these recommendations may minimize the likelihood of physiochemical degradation or microbial proliferation, the Agency has not necessarily evaluated data to support a longer in-use time.

Based on reports from healthcare facilities and providers, the following agents have been considered for use beyond the in-use times indicated on the product labeling:

Healthcare providers seeking additional information on the use of products beyond labeled in-use times due to supply issues can email the FDA at [email protected]. According to the Agency, submissions will be evaluated as quickly as possible.

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1. Information for health care facilities and providers on “in-use time” | COVID-19. Accessed August 5, 2020.