The U.S. Food and Drug Administration approved a dedicated syringe for the administration of Humulin R U-500 insulin, which is now the only device approved for use with U-500 insulin vial.
Humulin R U-500 insulin vial has been available with no dedicated device for delivery since 1994. To administer the insulin, healthcare practitioners and patients had to make dose conversions to deliver the appropriate dose using a U-100 insulin syringe or a tuberculin (volumetric) syringe. Since conversions are no longer needed with this new device, the Humulin R U-500 insulin vial label will be updated to remove the dose conversion information for U-100 and tuberculin syringes.
Helene Clayton-Jeter, O.D.
Office of Health and Constituent Affairs
Food and Drug Administration