CBER gives guidance for handling temperature-sensitive pharmaceticals in local storage


Recommendations help pharmacies, healthcare providers and patients deal with natural disasters or power outages

Although it’s more for pharmacies or others storing biologic drugs, rather than manufacturers or shippers, some general guidance that came from FDA’s Center for Biologics Evaluation and Research (CBER) might provide some useful information on storing, using or discarding biologics in the event of power outages, floods or storms. Potentially, the situation could become especially dire when a natural disaster creates the need for more pharma products, yet the products were put at risk by the disaster itself: “While people should not be put at risk by using a product that may be unsafe due to the conditions under which it was stored, shortages should not be created by discarding product simply because of power failures that may not adversely affect the product,” says CBER.

The info, posted on CBER’s web page, states:

1. Follow label instructions in all cases where the situation is obvious—such as wetted product from a flood. Refrigerated or frozen product might still be good after a short-duration power outage; check with manufacturers’ label for permissible excursions.

2. Minimize opening refrigerators doors until after power is restored. Refrigerators and freezers should be equipped with internal thermometers to measure temperature excursions.

3. For locations with backup power, record high temperatures and the cool-down pace after power is restored, then check with the manufacturer.

CBER also notes that many vaccine manufacturers have filed data with it to support the stability of their products at somewhat elevated temperatures and related duration of storage.

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