Guidance on reallocating influenza vaccine
CDC answers questions on sharing, transferring, and selling
vaccine.
The CDC webpage Reallocating
influenza vaccine provides guidance to pharmacists and other
health providers regarding sharing, transferring, and selling vaccine
amongst themselves. Public health departments and health care providers
and institutions that are considering reallocating influenza vaccine
should be aware of the following information from FDA:
Under Section 503(c)(3)(B)(iv) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act), a health care entity may sell, purchase, or
trade (or offer to do the same with) influenza vaccine to alleviate a
shortage if a reasonable basis exists for concluding that a shortage of
influenza vaccine has occurred or will 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 vaccine under section
503(c)(3)(B)(iv) of the FD&C Act, may obtain influenza vaccine from
other health care entities to the extent necessary to alleviate or
prevent the shortage. Health care entities should keep in mind, however,
that emergency medical reasons for redistributing influenza vaccine do
not include "regular and systematic sales to licensed practitioners" [21
C.F.R. 203.3(m)]. Such sales would include agreements that hospitals
will resell influenza vaccine to doctors in preset 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 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 vaccine and its transfer
must comply with FDA’s current good manufacturing requirements.
Information on proper handling, storage, and shipping can be found
at this
website.
Pharmacies can also offer to collaborate with providers (e.g.,
long-term care facilities) that do not have vaccine supply to vaccinate
their patient populations on site.
Web links
Posted by Joe Sheffer (jsheffer@aphanet.org)
November 17, 2009
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