Had a report last week where remdesivir IV study doses were compounded with twice the amount of medication. Initial doses are loading dose of 200 mg, or 2 vials. Subsequent doses are 100 mg or 1 vial. The subsequent doses were compounded with 2 vials though the dose was 100 mg.

Like many investigational drug container labels, this one is not clearly labeled. USP <7> requires that approved drugs list total amount of drug per container volume, followed in close proximity by amount per mL. The remdesivir vials are 100 mg, 20 mL vials, but labeled as 5 mg/mL in one location, away from elsewhere on the label where it is mentioned that the unreconstituted powder is 100 mg. Away from the 5 mg/mL statement and lower on the vial label it does also mention that 21.2 mL is contained, but this additional information was missed. Some facilities have received this drug under compassionate use phase, and now through an expanded emergency use authorization program.

ISMP previously published a 2-part article on serious problems with investigational drug labeling here https://www.ismp.org/resources/investigational-drugs-product-related-iss... and here https://www.ismp.org/resources/investigational-drugs-strategies-sponsors.... We've been working with some investigational drug pharmacists on this issue and have also interacted with FDA.

Mike, ISMP