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

Healthcare 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, according to the Food and Drug Administration announcement this week. The guidance applies to 10 specific drug products.

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.