Recently, the U.S. Food and Drug Administration (FDA) provided guidance on certain drugs that can be used beyond the manufacturer's labeled expiration date. At this time, the drugs listed below can be used during the shortage or while available. Per the FDA, to ensure patient safety, these products should have been—and should continue to be—stored as per labeled conditions. >> Click for FDA information on drug shortage.
The medications included in this expiration date waiver include the following drugs manufactured by Hospira Inc, a Pfizer company:
- Epinephrine Injection, USP 0.1 mg/mL; 10 mL ABBOJECT syringe (NDC 0409-4921-34)
Dextrose 50% Injection, USP, 50 mL ABBOJECT Syringe (NDC 0409-4902-34)
Atropine Sulfate Injection, USP 0.1 mg/mL; 10 mL ABBOJECT syringe (NDC 0409-4911-34)
- Atropine Sulfate Injection, USP 0.1 mg/mL; 5 mL ABBOJECT syringe (NDC 0409-4910-34
The Wisconsin EMS Office recommends practitioners work with their local medical director to determine the most appropriate response to these drug shortages. In addition, the Department of Health Services and Department of Transportation (DOT) discussed these shortages and the DOT ambulance inspector will not cite for these identified expired medications. However, all other expired medication dates will be subject to DOT enforcement action. EMS services will not be required to submit drug shortage protocols but will need to follow FDA recommendations.
The memo issued on this will be in effect until December 31, 2017. >> Click to read memo 17-04.