FDA has worked with companies to support expiration date extensions for “critical” drugs on the FDA’s drug shortage list. The current list (here) contains 343 entries Most products have had their expiration dates extended by one year from the labeled expiration date.
The list provides information to providers to verify that the firm had submitted substantiating data to support the extended expiration dating. The list provides the NDC number of the specific SKUs and the lots for which the expiration dating has been extended. The overwhelming number of lots with extended expiration dates include epinephrine injection and (by far) the most listings are for propofol injection.
The Agency notes that it “is not requiring or recommending that the identified lot numbers in the following table be relabeled with their new use dates. However, if replacement product becomes available during the extension period, then the agency expects the lots in these tables will be replaced and properly disposed of as soon as possible.”
As the pandemic winds down and more supplies become available, the list should shorten. It should be noted that not all drugs on the FDA’s shortage list have qualified for extended expiration dating, and it also appears that the word “critical” plays a big part of how the Agency uses this tool to reduce the impact of shortages of these specific critical drugs.
