FDA issues guidance on extending ‘in-use time’ for shortage drugs

Health care facilities or providers facing inadequate supplies of certain drugs needed to treat patients with COVID-19 should not use the products more than four hours beyond the labeled “in-use time” for refrigerated storage or two hours beyond the labeled “in-use time” for room temperature storage, the Food and Drug Administration announced yesterday. The guidance applies to 10 specific drug products.

“FDA is aware that some health care facilities and providers are facing challenges in maintaining adequate supplies of certain drugs needed to treat patients with COVID-19,” the agency said. “In particular, health care facilities and providers have reported that care of ventilated patients can be complicated by the need to discard containers of medications before they are fully administered because of the in-use time specified on the FDA-approved label.”

The “in-use time” is the maximum amount of time allowed before administering a sterile drug product after penetrating its container-closure system or a lyophilized drug product after it has been reconstituted.

Facilities or providers seeking information on the potential to use other specific FDA-approved drugs for injection beyond the labeled in-use time in COVID-19 patients due to supply issues may email requests for information to CDER-OPQ-Inquiries@fda.hhs.gov.