| Public health departments and healthcare providers and institutions involved in reallocating influenza vaccine this year should be aware of the following information from the FDA.
Anticipated shortages of influenza vaccine this flu season constitute emergency medical reasons, within the meaning of Section 503(c)(3)(B)(iv) of the Food, Drug, and Cosmetic Act (FDC Act), as determined by FDA. It is therefore permissible under the FDC Act for a hospital or health care entity to redistribute influenza vaccine to alleviate shortages this flu season.
When redistribution occurs, the hospital or health care entity that is redistributing influenza vaccine, should document and maintain the following information:
- vaccine brand name
- manufacturer and distributor
- lot number
- number of doses transferred
- recipient's name and address
In any such redistribution, the influenza vaccine and its transfer must comply with FDA's current good manufacturing requirements. Information on proper handling, storage, and shipping can be found at http://www.cdc.gov/nip/publications/vac_mgt_book.htm#flu.
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