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The state of Florida took a big step
forward last year by recognizing that veterinary distributors can and
should be regulated differently than human drug distributors.
"That’s a good first step” said Jackie King, Executive Director of AVDA.
“However, AVDA members believe there is a need to create another
animal-health wholesaler license in Florida to allow veterinary
distributors, selling human drugs directly to veterinarians to be exempt
from passing pedigree on those drugs.”
In an effort to accomplish this task,
Capital Ideas, has been hired by AVDA to pursue legislation which will
allow veterinary distributors to sell human drugs to veterinarians
without passing pedigree on those drugs.
In 2003, Florida passed sweeping statutory
changes in its licensing procedures for human drug wholesalers. These
changes also affected wholesalers who sell animal-health labeled
products and human labeled products sold to veterinarians and subjected
them to the same regulations as those imposed on human drug wholesalers.
In 2006, that chain of ownership
documentation is to be passed through the chain of distribution from the
manufacturers to the pharmacy. Thus, this means the “pedigree” would go
from the manufacturer all the way to the veterinary clinic. This will
result in the veterinarian and distributor being forced to, not only
maintain this paper trail, but also to make certain they can certify,
under threat of perjury, that any product returned to the wholesaler is
the very same vial which was purchased from that
wholesaler.
The original law applied to
distribution of all prescription drugs, whether or not they were sold in
the human distribution channel or the animal-health distribution
channel.
However, in 2004 Capital Ideas, the
lobbying firm recently hired by AVDA, convinced the Florida legislature
modify the act to create a new license for animal-health wholesalers who
sell only animal-health labeled pharmaceuticals. These wholesalers are
now exempt from all background checks, bond requirements, the mandate to
pass a test on human drug laws, passing pedigree on animal-health
products and the $2 million liability insurance requirement.
While this was a good first step, those
wholesalers who also sell human- labeled drugs to veterinarians
still must comply with all the human drug provisions including
the passage of pedigree papers to veterinarians Thus, these wholesalers
and the veterinarians to whom they sell, must maintain these enormous
records and store their inventory accordingly.
In addition, these wholesalers must
continue to keep a bond in force, maintain liability insurance against
passing adulterated doses of drugs they don’t even purchase, pass the
human drug rules test and subject their families to having personal
information available to the general public.
HB 895 and SB 1654 have been introduced in
to the Florida Legislature. The Legislature convened March 8 and will
extend through May 5. AVDA members are urged to contact the legislators
listed in this article to show their support for this important
legislation.
The legislation states: in section 2,
paragraph 3, “The pedigree paper requirements in this paragraph do not
apply to …… veterinary legend drugs, or approved human drugs sold
directly to veterinarians.”
Suggested Message of support to HB 895/SB
1654.
“Last session the Florida Legislature
created a unique license for wholesalers selling veterinary products to
veterinarians. This year, the American Veterinary Distributors
Association is seeking to expand that license to allow certain human
drugs to be sold to veterinarians without passing pedigree on those
drugs.
AVDA is comprised of both veterinary
wholesalers and pharmaceutical manufacturers who believe safeguards can
be put in place which will allow human drugs to be sold directly to
veterinarians without pedigree. If pedigree is passed with the drugs,
veterinarians will be forced to keep all drugs they purchase in separate
locations with the paperwork attached. not only is this cumbersome for
the vet, it is costly and will require additional storage space to be
created by vets. The drugs purchased by vets are not the ones which have
been counterfeited, adulterated or diverted and there is no need to pass
pedigree on these few human drugs which are sold to vets.”
House Health Care
Committee list:
(you will note that all House members'
addresses have the same format:
firstname.lastname@myfloridahouse.gov
CHAIRMAN: Rene Garcia
rene.garcia@myfloridahouse.gov
Eleanor Sobel
eleanor.sobel@myfloridahouse.gov
Dorothy Bendross-Mindingall
dorothy.bendross.mindingall@myfloridahouse.gov
Gus Bilirakis
gus.bilirakis@myfloridahouse.gov
Marty Bowen
marty.bowen@myfloridahouse.gov
Larry Cretul
larry.Cretul@myfloridahouse.gov
Bob Henriquez
bob.henriquez@myfloridahouse.gov
Ed Homan
ed.homan@myfloridahouse.gov
Ralph Poppell
ralph.poppell@myfloridahouse.gov
Bill Proctor
bill.proctor@myfloridahouse.gov
Yolly Roberson
yolly.roberson@myfloridahouse.gov
Senate Health Care
Committee
All Senate addresses have the same format:
last name.firstname.web@flsenate.gov
Durrell Peaden
peaden.durrell.web@myflsenate.gov
Mandy Dawson
dawson.mandy.web@flsenate.gov
Jeff Atwater
atwater.jeff.web@flsenate.gov
Mike Fasano
fasano.mike.web@flsenate.gov
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