By Renee Arbet, Pharmacy Manager, Riddle Hospital
Due to extreme shortages of several critical injectable drugs, the U.S. Food and Drug Administration (FDA) has extended expiration dates on certain lots of critical drugs.
Pfizer, the primary manufacturer of these critical drugs, reports that the shortages are caused by both manufacturing and distribution. The FDA is working closely with Pfizer to resolve these critical shortages in the long-term. For the short-term critical need, the FDA has approved extended expiration dates based on stability data provided by Pfizer and reviewed by the FDA for certain lots of emergency syringes/vials, so that healthcare professionals can continue to use these specific lots during the shortage.
The critical injectable drugs which have been approved for possible extension of expiration dating are:
- sodium bicarbonate (vials and syringes)
- dextrose 50% injection (vials and syringes)
- calcium chloride
- atropine sulfate
These new expiration dates are published in a table updated by the FDA.
The MLH Pharmacy Department will continue to review the published FDA table for affected lots.
Using the table published by the FDA, the MLH Pharmacy Department will update expiration dating on affected critical syringes/vials by placing a new extended expiration date over top of the old expiration date with a special sticker.
- Syringes: New extended date stickers will be placed on the EXTERIOR of the un-opened packaging of affected syringes, thus, the interior syringe will NOT have the extended dating. Please use the new extended date on the exterior of the package as the “true” expiration date.
- Vials without packaging: New extended date sticker will be placed directly on the vial over the old expiration date.
If you have any questions or require assistance, please contact your respective MLH Pharmacy Department.