What are the guidelines for redistributing 2009 H1N1 vaccine?
Under Section 503(c)(3)(B)(iv) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), a health care entity may redistribute or trade (or offer to do the same with) Influenza A (H1N1) 2009 Monovalent Vaccine to alleviate a shortage if there is a reasonable basis to conclude that a shortage of Influenza A (H1N1) 2009 Monovalent Vaccine exists or will actually occur. A “shortage” includes a temporary shortage arising from delays in or interruptions of regular distribution schedules. Health care entities that experience a shortage or have a reasonable basis to conclude that they will experience a shortage, which would constitute an “emergency medical reason” for redistributing Influenza A (H1N1) 2009 Monovalent Vaccine under section 503(c)(3)(B)(iv) of the FD&C Act, may obtain Influenza A (H1N1) 2009 Monovalent Vaccine from other health care entities to the extent necessary to alleviate or prevent the shortage. Providers are encouraged to contact their local health departments if they fin
