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.
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:
- Cisatracurium besylate EQ 2mg base/mL, EQ 10mg base/mL
- Phenylephrine hydrochloride 0.1mg/mL, 10mg/mL (10mg/mL), 50mg/5mL (10mg/mL), 100mg/10mL (10mg/mL)
- Bumetanide 0.25mg/mL
- Midazolam hydrochloride EQ 1mg base/mL, EQ 5mg base/mL
- Succinylcholine chloride 20mg/mL
- Famotidine 10mg/mL
- Hydromorphone 0.2mg/mL, 1mg/mL, 2mg/mL, 4mg/mL, 10mg/mL
- Rocuronium bromide 50mg/5 mL (10mg/mL), 100mg/10mL (10mg/mL)
- Epinephrine EQ 1mg base/mL (EQ 1mg base/mL) and EQ 30mg base/mL (EQ 1mg base/mL)
- Heparin sodium 1000 units/mL, 5000 units/mL, 10000 units/mL (NDCs: 0069-0058-01, 0069-0059-01, 0069-0059-03, 0069-0137-03, 0069-0043-01)
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.
For more information visit fda.gov.
1. Information for health care facilities and providers on “in-use time” | COVID-19. https://www.fda.gov/drugs/coronavirus-covid-19-drugs/information-health-care-facilities-and-providers-use-time-covid-19. Accessed August 5, 2020.