FDA Biological Products Agency Issues New Recommendations for Emergency Weather Response

With another hurricane season wreaking havoc, the FDA’s Center for Biologics Evaluation and Research (CBER), which regulates biological products for human use, is calling on labs to pay attention to its guidelines for the storage and use of temperature-sensitive biological products that have been involved in a temporary electrical power failure or flood conditions. While most labs have emergency procedures for human safety, product safety can sometimes get overlooked.

Recommendations for Non-Blood Biologicals Requiring Refrigeration

• Note the time of the power outage;
• Do not open refrigerators and freezers until power is restored to keep the temperature low for a longer period of time;
• Once power is restored, record the temperature in the refrigerator or freezer as soon as possible and before the temperature begins to drop again;
• Continue recording the temperature at periodic intervals until it reaches the temperature range indicated on the product labeling as appropriate for product storage;
• Record the duration of increased temperature exposure. Example: Freezer temperature of 0° F at noon on day 1 when the power failed; 15° at 6 pm on day 2; and 0° at 7 am on day 3. This data enables the product manufacturer, in consultation with the FDA as necessary, to make calculations about the continued potency of the products.

Recommendations for Blood Products & Plasma Derivatives
Establishments that collect and store blood and blood components typically have written emergency response procedures. Problems or issues affecting the blood supply should be brought to the attention of the FDA. Blood establishments should contact their consumer safety officers if they need assistance with handling products impacted by power failures.

As for health facilities without emergency backup power, CBER notes that there’s evidence that lyophilized coagulation products such as Factor VIII and Factor IX may be stored at room temperature for a fairly long period without loss of factor potency. If you’re concerned about the exposure or efficacy of a particular product, call the supplier or manufacturer’s customer service department.

Many immune globulin products are licensed for storage at 36° to 46° F, and some products may be stored at room temperature for all or part of the time before expiration. Because storage temperatures and times are specific to each product, CBER recommends following the package insert recommendations for Immune Globulin Intravenous (IGIV), intramuscular IG (IG), and subcutaneous IG (IGSC) products. Products requiring lower temperatures can be stored on wet ice. All of these products should not be frozen. If you have any questions about the storage of these products, you should consult the package inserts.

General Recommendations for Floods
The following CBER flood recommendations apply to facilities with either or both categories of biological products mentioned above:

• Elevate biological products on warehouse floors off the ground, e.g., on pallets;
• Make sure shelves containing products that must be kept dry are securely anchored;
• Elevate refrigerators used to store products above floor level using wheels, platforms or other methods;
• Discard blood components and other products that are exposed to flood waters even if they’re kept in vials.