FDA issues guidance on using medications beyond their “in-use time”

Aug. 6, 2020

Responding to shortages of certain medications to treat COVID-19 patients, the U.S. Food and Drug Administration (FDA) described in a guidance how healthcare organizations can use these products beyond their “in-use time.”

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.

The FDA said healthcare facilities should not use these products more than four hours beyond their “in-use time” if in refrigerated storage or more than two hours beyond their “in-use time” if in room-temperature storage. The guidance applies to 10 products:

·        Cisatracurium besylate EQ 2 mg base/mL, EQ 10 mg base/mL

·         Phenylephrine hydrochloride 0.1 mg/mL, 10 mg/mL (10 mg/mL), 50mg/5mL (10 mg/mL), 100 mg/10mL (10 mg/mL)

·         Bumetanide 0.25 mg/mL

·         Midazolam hydrochloride EQ 1 mg base/mL, EQ 5 mg base/mL

·         Succinylcholine chloride 20 mg/mL

·         Famotidine 10 mg/mL

·         Hydromorphone 0.2 mg/mL, 1 mg/mL, 2 mg/mL, 4 mg/mL, 10 mg/mL

·         Rocuronium bromide 50 mg/5 mL (10 mg/mL), 100 mg/10mL (10 mg/mL)

·         Epinephrine EQ 1mg base/mL (EQ 1 mg base/mL) and EQ 30 mg base/mL (EQ 1 mg base/mL)

·         Heparin sodium 1,000 units/mL, 5,000 units/mL, 10,000 units/mL (NDCs: 0069-0058-01, 0069-0059-01, 0069-0059-03, 0069-0137-03, 0069-0043-01)

Visit the FDA for more news