Reallocating Influenza A (H1N1) 2009 Monovalent Vaccine

October 23, 2009, 6:30 PM ET

Public health departments and health care providers and institutions that consider reallocating/redistributing Influenza A (H1N1) 2009 Monovalent Vaccine should be aware of the following FDA-related information.

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.   As 21 CFR 203.3(m) states, "Emergency medical reasons include, but are not limited to, transfers of a prescription drug between health care entities or from a health care entity to a retail pharmacy to alleviate a temporary shortage of a prescription drug arising from delays in or interruption of regular distribution schedules…" 

Health care entities should keep in mind, however, that "emergency medical reasons" for redistributing Influenza A (H1N1) 2009 Monovalent Vaccine do not include "regular and systematic sales to licensed practitioners..." (21 CFR 203.3(m)).  Such sales would include agreements that hospitals will resell Influenza A (H1N1) 2009 Monovalent Vaccine to doctors in pre-set amounts, even though those doctors neither received a communication from their distributors that their vaccine delivery will be delayed, nor have any other reason to believe that they will not receive the Influenza A (H1N1) 2009 Monovalent Vaccine they ordered on time.

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 A (H1N1) 2009 Monovalent Vaccine and its transfer must comply with FDA's current good manufacturing requirements.  Information on proper handling, storage, and shipping can be found at Recommendations for Storage & Handling of Selected Biologicals.