October 15, 2022

Shelf-life extension Paxlovid® – the rationale alternative to discarding expired batches

Do the Paxlovid® packs already delivered to pharmacies and medical practices need to be discarded timely or by the beginning of 2023 at the latest if the printed shelf-life has been expired? Media reports revealed that the federal government had stockpiled large quantities of the product at the end of 2021 as a precaution in order to avoid a bottleneck in the supply of the patients. However, the prescription rate fell short of expectations in the first nine months, with the result that a number of packs will expire in November 2022 or early 2023.

However, discarding is not inevitable. Rather, a shelf-life extension would be possible in case of proven longer stability in “follow-up” stability tests. Against this background, the Frankfurt Foundation Quality of Medicines initiated investigations into the stability of Paxlovid® tablets collected from the market. The results did not indicate a decrease in the labelled content of active drug ingredient nirmatrelvir or increased levels of degradation products. Therefore, in a published statement, we have suggested extending the expiry date for the packs that have already been delivered, based on the results of follow-up stability investigations conducted by the manufacturer.

The long version of the FFQM statement is published in DAZ No. 41, October 2022.

In the meantime, the professional groups have been informed by a letter from Pfizer that a corresponding extension of the deadline has been agreed with the BfArM (see PZ No. 41 of October 13, 2022). After that, re-labeling is not considered necessary.