EMERGENCY RULE

DEPARTMENT OF HEALTH

RULE TITLE: RULE NO.:

Distributions of 2004-05 Flu Vaccines 64FER04-5

SPECIFIC REASON FOR FINDING AN IMMEDIATE DANGER TO THE PUBLIC HEALTH,
SAFETY OR WELFARE:  Influenza, commonly called "the flu" is an infection
of the respiratory tract caused by the influenza virus.  Most people who
get the flu recover completely in one to two weeks, but some people
develop serious and potentially life-threatening medical complications
such as pneumonia.  In an average year, influenza is associated with
more than 36,000 deaths nationwide according to the U.S. Centers for
Disease Control and Prevention, and more than 100,000 hospitalizations. 
Much of the illness and death caused by influenza can be prevented by
annual influenza vaccinations.  The 2004-2005 influenza vaccine is
specifically recommended for people who are at high risk for developing
serious complications as a result of influenza infection.   These
priority groups include: all children aged 6 -- 23 months, adults 65
years or older, people aged 2 to 64 with underlying chronic medical
conditions, women who will be pregnant during this influenza season,
residents of nursing homes and long-term care facilities, children 6
months -- 18 years of age on chronic aspirin therapy, health-care
workers with direct patient care, and out-of-home caregivers and
household contacts of children aged less than 6 months. \
On October 5, 2004, it was announced that approximately 50% of the
anticipated 100 million doses of flu vaccine planned to be distributed
in the United States, approximately 46-48 million doses manufactured by
Chiron, would not be released.  A shortage in the availability of the
vaccine is therefore anticipated in Florida for the 2004-2005 flu
season.  It is expected that there will be fewer than 60 million doses
of vaccine available in the United States which is a significant
decrease from the approximately 86 million doses available the prior
year when demand was not fully met. 

REASONS FOR CONCLUDING THAT THE PROCEDURE USED IS FAIR UNDER THE
CIRCUMSTANCES:   Normal distribution channels for prescription drugs,
which includes influenza vaccines, is from the manufacturer to a
wholesaler to the end-user practitioner (health care entity).  As a
general rule, both federal and Florida law prohibit the distribution or
redistribution of prescription drugs by health care entities such as
hospitals and licensed medical practitioners. One exception to the
prohibition against the wholesale distribution of prescription drugs by
health care entities is for "emergency medical reasons".  In prior years
when conditions warranted, the federal Food and Drug Administration
authorized health care providers, under the "emergency medical reasons"
exemption of Section 503(c)(3)(B)(IV) of the Food, Drug, and Cosmetic
Act, to sell or transfer influenza vaccine to other health care
providers.

The Florida Drug and Cosmetic Act, Chapter 499, Florida Statutes, has a
similar provision in s. 499.012(1)(a)2.b., F.S., for the "emergency
medical reasons" exemption to the prohibition against the wholesale
distribution of prescription drugs by health care entities if the
distribution is conducted in accordance with rules established by the
department.  Rule authority appears in s. 499.05(1)(i), F.S., to
implement an emergency medical reason exemption.  The emergency rule
provides the mechanism to allow for health care entities in Florida with
vaccine surpluses to distribute their excess usable product to health
care entities in Florida experiencing vaccine shortages because of the
demand and current shortage at the manufacturer level so that persons in
the priority groups have access to the influenza vaccine during the
2004-05 flu season.

SUMMARY OF THE RULE:  This emergency rule authorizes the distribution of
surplus influenza vaccine by health care entities in Florida to other
health care entities in Florida during the 2004-05 flu season.

THE PERSON TO BE CONTACTED REGARDING THE EMERGENCY RULE IS:  Jerry Hill,
Chief, Bureau of Statewide Pharmaceutical Services, Department of
Health, 2818-A Mahan Drive., Tallahassee, Florida  32308.

THE FULL TEXT OF THE EMERGENCY RULE IS:

[64FER04-5     Distributions of 2004-05 Flu Vaccines.]{.underline}

[Due to demands for influenza vaccinations and shortages for the 2004-05
influenza season that could impact availability to persons identified in
the priority groups in paragraph (4) below, from October 6, 2004 through
January 4, 2005, health care entities, as defined in s. 499.003(21),
F.S. in Florida are authorized under the emergency medical reasons
exemption in s. 499.012(1)(a)2.b., F.S., to sell or transfer influenza
vaccine to other health care entities in Florida under the following
conditions:]{.underline}

(1) (1)   [All influenza vaccine sold or transferred under this
    authorization must not be adulterated.  All storage and handling
    requirements of the vaccine must have been maintained at all times,
    including periods of shipment and transit.]{.underline}

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(1) (2)   [Influenza vaccine is to be stored and shipped at 35 to 46 F
    (2 - 8 C), or as otherwise indicated in the labeling.  Influenza
    vaccine cannot be frozen.]{.underline}

(2) (3)   [Records of the receipt and subsequent sale or transfer of the
    vaccine must be maintained by the health care entity and be readily
    available and readily retrievable as defined in Rule
    64F-12.001(2)(o), Fla. Admin. Code, for a period of two years after
    the distribution.  At a minimum these records should include:\
    (a)  Vaccine brand;]{.underline}

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(b) (b)   [Manufacturer; ]{.underline}

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(b) (c)   [Number of doses transferred by lot number;]{.underline}

(c) (d)   [The person from whom the doses were received, including the
    address and permit or license number;]{.underline}

(d) (e)   [The person to whom the doses were sold or transferred,
    including the address and permit or license number;]{.underline}

(e) (f)     [Date of the sale or transfer; and]{.underline}

(f) (g)   [The full cost of the sale or transfer.]{.underline}

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(3) (4)   [Influenza vaccine transferred pursuant to this emergency rule
    is to be used on persons in the following priority groups:  all
    children aged 6 -- 23 months, adults 65 years or older, persons aged
    2 to 64 with underlying chronic medical conditions, women who will
    be pregnant during this influenza season, residents of nursing homes
    and long-term care facilities, children 6 months -- 18 years of age
    on chronic aspirin therapy, health-care workers with direct patient
    care, and out-of-home caregivers and household contacts of children
    aged less than 6 months.]{.underline}

[Specific Authority 499.05(1)(i), FS. ]{.underline}

[Law Implemented 499.012(1)(a)2.b., FS. ]{.underline}

[History -- New \_\_\_\_\_\_.]{.underline}

THIS RULE SHALL TAKE EFFECT IMMEDIATELY UPON FILING WITH THE DEPARTMENT
OF STATE UNLESS A LATER TIME AND DATE IS SPECIFIED IN THE RULE.