Protecting your practice and the food animal industry


Gloyd, J.S.

Journal of the American Veterinary Medical Association 190(1): 32-34

1987


Editorial
Protecting
your
practice
and
the
food
animal
industry
"
. .
.
it
appears
that
increased
FDA
regulation
is
here
to
stay
. . .
"
I
n
the
past
4
years,
FDA
has
become
increasingly
stringent
in
its
regulation
of
the
practice
of
veterinary
medicine.
This
stepped-up
regulatory
activity
would
seem
to
be
anathema
to
a
federal
administra-
tion
dedicated
to
less
and
less
government
interference.
Nevertheless,
it
appears
that
increased
FDA
regulation
is
here
to
stay,
and
it
will
be
up
to
veterinary
practitioners
to
assume
the
responsibility
to
protect
themselves
and
their
practices,
despite
regulations
that
are
or
seem
to
be
inexact,
unclear,
contradictory,
or
unusually
complex.
Extra-label
use
policy
Prior
to
1983,
it
was
FDA
policy
that
veterinarians
in
the
course
of
normal
practice
could
use
any
drug
they
could
legally
obtain,
provided
that
they
accepted
the
responsibility
for
preventing
residues
in
food-
producing
animals
and
understood
that
they
were
responsible
for
potential
adverse
reactions
following
use
of
a
drug
for
purposes
not
stated
on
the
label.
In
August
1983,
FDA
declared
that
food
animal
veterinarians
could
use
drugs
only
in
the
exact
manner
stated
on
the
label.
Through
cooperation
with
producer
groups
and
FDA,
the
AVMA
was
able
to
negotiate
a
compromise
that
allowed
veterinarians
practicing
within
a
veterinarian-client-patient
relationship
to
use
FDA-
approved
drugs
for
extra-label
purposes
in
food-producing
animals
when
no
FDA-approved
product
is
available
or
when
approved
drugs
are
clinically
ineffective.
Chloramphenicol
ban
The
ink
on
that
policy
was
barely
dry
when
FDA,
in
March
1984,
issued
a
ban
on
the
use
of
chloramphenicol
in
food-producing
animals.
The
FDA
contended
that
the
drug
had
never
been
approved
for
food
animal
use
and
that
it
or
its
residues
could
cause
aplastic
anemia
in
man.
Most
veterinarians
realized
that
only
adverse
publicity
would
result
if
AVMA
disputed
FDA's
contention
or
if
veterinarians
continued
to
use
chloramphenicol
in
food-producing
animals.
Many
were
perplexed,
however,
to
learn
that
FDA
continues
to
approve
tablet
formulations
of
chloramphenicol
for
use
in
dogs
and
cats.
Some
believed
that
oral
administration
of
a
chloramphenicol
tablet
by
veterinarians
or
animal
owners
would
have
about
the
same
potential
for
human
exposure
to
chloramphenicol
as
would
administering
the
drug
in
any
formulation
to
food-producing
animals.
Several
veterinarians
who
had
chloramphenicol
liquid
on
hand
elected
to
keep
their
supply
for
use
in
non-food
animals.
Unfor-
tunately,
more
than
a
few
of
them
were
investigated
by
FDA
compliance
officers,
who
either
confiscated
the
drug
or
persuaded
them
to
dispose
of
the
product.
Rumors
persist
that
a
few
veterinarians
may
be
using
chloram-
phenicol
in
food-producing
animals,
despite
the
ban.
If
those
rumors
are
true,
the
publicity
that
could
result
would
be
devastating
to
the
livestock
industry
as
well
as
the
profession.
One
of
the
best
ways
to
"One
of
the
best
ways
to
destroy
a
practice
would
be
to
continue
to
use
chloramphenicol
in
food-producing
animals."
32
Editorial
JAVMA,
Vol
190,
No.
1,
January
1,
1987
destroy
a
practice
would
be
to
continue
to
use
chloramphenicol
in
food-producing
animals.
Two
food
animal
veterinarians
in
California
are
presently
being
prosecuted
by
FDA,
through
the
Justice
Depart-
ment,
for
allegedly
using
chloramphenicol
after
the
ban.
. . .
most
of
the
maldistribution
and
misuse
takes
place
without
any
involvement
by
a
veterinarian."
Prescribing
and
dispensing
Following
the
chloramphenicol
ban,
FDA
issued
a
July
1984
proposal
that
would
have
established
prescribing
and
dispensing
requirements
for
veterinary
practitioners.
Although
AVMA
supports
good
prescribing
and
dispensing
practices,
it
objected
strongly
to
direct
FDA
involvement
in
veterinary
practice.
AVMA
believes
that
regulation
of
veterinary
prescribing
and
dispensing
practices
is
clearly
the
responsibility
of
state
boards
of
veterinary
medicine.
In
the
face
of
seemingly
overwhelming
opposition,
FDA
finally
dropped
its
prescribing/dispensing
proposal.
Most
veterinarians
realize
that
there
is
widespread
maldistribu-
tion
of
prescription
drug
products
and
misuse
of
prescription
as
well
as
over-the-counter
(oTc)
products
by
laymen.
They
also
realize
that
most
of
the
maldistribution
and
misuse
takes
place
without
any
involvement
by
a
veterinarian.
Paradoxically,
FDA
has
recognized
the
problem
and
is
attempting
to
rectify
it
by
investigating
veterinary
practitioners,
but
generally
ignoring
the
many
other
sources
of
animal
drugs.
Bulk
drugs
The
concept
that
bulk
drugs
should
be
available
to
veterinarians
for
cost-effective
treatment
of
herds
or
flocks
seems
to
have
its
roots
in
the
Midwest.
It
took
AVMA
almost
7
years
to
hammer
out
a
policy
on
bulk
drug
availability
that
could
be
recommended
to
FDA.
The
policy
proposed
by
FDA
in
1985
closely
paralleled
the
one
recommended
by
AVMA,
but
the
proposal
met
with
considerable
opposition,
primarily
from
drug
research
and
development
firms.
Thus
far,
FDA
has
taken
no
further
action
on
the
bulk
drug
proposal.
Few,
if
any,
of
the
bulk
drugs
presently
available
have
been
through
the
FDA
approval
process.
Therefore,
veterinarians
who
purchase
and
use
unapproved
bulk
drugs
are
leaving
themselves
vulnerable
to
regulatory
action
by
FDA,
and
may
be
inadvertently
accepting
responsibility
for
residues
or
adverse
reactions
that
could
result
from
use
of
such
drugs.
Some
veterinarians
believe
that
the
patent
term
restoration/
generic
drug
approval
legislation
presently
before
Congress
will
provide
the
legal
pathway
needed
to
allow
FDA-approved
bulk
drugs
to
be
marketed.
However,
until
approved
drugs
in
bulk
form
are
available,
practitioners
should
think
of
the
consequences
before
purchasing,
selling,
or
distributing
bulk
drugs.
Prescription
vs
over-the-counter
use
The
Durham-Humphrey
Amendment
to
the
Food,
Drug,
and
Cosmetic
Act
mandates
that
animal
drugs
must
be
marketed
for
arc
use
unless
adequate
directions
cannot
be
written
to
allow
the
drug
to
be
used
by
a
layman.
Therefore,
the
drugs
commonly
referred
to
as
prescription
(Rx)
drugs
are
labeled
"For
use
by
or
on
the
order
of
a
licensed
veterinarian."
Products
that
do
not
have
those
words
on
their
labels
may
be
sold
to
anyone.
Some
drugs
are
labeled
"For
sale
to
veterinarians
only."
That
label
indicates
only
the
company's
sales
policy
and
has
no
bearing
on
whether
the
drug
is
OTC
or
Rx.
Many
drugs
have
both
arc
and
Rx
labels,
depending
on
the
species
or
other
indications
on
the
label.
There
are
inconsistencies.
For
example,
long-acting
penicillin
is
labeled
for
arc
use
if
it
is
sold
for
food
animals
and
for
Rx
use
if
it
is
to
be
used
in
companion
animals.
Oxytetracycline
injectable
is
labeled
for
Rx
use
if
the
label
includes
indications
for
treatment
of
"
. . .
veterinarians
who
purchase
and
use
unapproved
bulk
drugs
are
leaving
themselves
vulnerable
to
regulatory
action
by
FDA
. .
"
JAVMA,
Vol
190,
No.
1,
January
1,
1987
Editorial
33
"When
called
upon
to
do
favors
for
clients,
practitioners
should
ask
themselves,
Will
this
put
me
or
my
practice
in
jeopardy?"
anaplasmosis
and
blackleg,
but
is
labeled
orc
for
all
other
conditions
and
species.
These
types
of
regulations
are
particularly
hard
for
veterinarians
to
understand.
What
to
do?
What
must
veterinarians
do
to
practice
effectively
and
responsibly
under
the
conditions
just
mentioned?
The
first
priority
should
be
to
protect
themselves
and
their
practices.
When
called
upon
to
do
favors
for
clients,
practitioners
should
ask
themselves,
"Will
this
put
me
or
my
practice
in
jeopardy?"
If
veterinarians
use
bulk
drugs
not
approved
by
FDA
or
sell
Rx
drugs
in
the
absence
of
a
veterinarian-client-patient
relationship,
and
are
subsequently
subjected
to
regulatory
actions,
will
their
clients
come
to
the
rescue?
If
the
drug
the
veterinarian
uses
is
not
FDA-approved
and
an
adverse
reaction
occurs,
will
the
supplier
of
the
product
assist
in
defending
the
veterinarian
against
a
civil
suit?
If
a
drug
is
used
for
extra-label
purposes
and
violative
residues
are
found
when
the
treated
animals
are
sent
to
slaughter,
will
the
client
assume
exclusive
responsibility?
If
it
is
not
a
present
management
procedure,
veterinarians
should
inventory
drugs
on
hand
and
separate
those
labeled
"For
use
by
or
on
the
order
of
a
licensed
veterinarian."
Employees
and
practice
col-
leagues
should
be
carefully
instructed
that
such
drugs
are
to
be
sold
only
when
a
veterinarian-client-patient
relationship
has
been
estab-
lished.
A
veterinarian-client-patient
relationship
means
that
a
veteri-
narian
in
the
practice
has
seen
the
animals
to
be
treated,
is
familiar
with
the
premises
and
management
system,
and
has
established
a
tentative
diagnosis
for
the
condition
to
be
treated.
Records
should
be
kept
of
all
Rx
drugs
dispensed,
who
received
the
drugs,
and
for
what
purposes,
and
who
ordered
the
drugs
to
be
dispensed.
Controlled
substances
should
be
kept
under
lock
and
key
and
separate
records
kept.
A
veterinarian
should
not
allow
clients
to
purchase
Rx
products
if
the
animals
to
be
treated
have
not
been
seen
by
a
veterinarian
in
the
practice.
If
a
non-client
attempts
to
purchase
Rx
drugs
for
a
regular
client,
a
telephone
call
to
the
client
will
assure
that
he
or
she
has
knowledge
of
the
situation.
If
the
"client'
of
another
veterinarian
wants
to
buy
Rx
drugs,
a
telephone
call
to
the
person's
veterinarian
will
confirm
that
there
is
an
appropriate
veterinarian-client-patient
rela-
tionship
before
the
drugs
are
dispensed.
If
the
person
who
attempts
to
make
the
purchase
is
not
who
he
or
she
claims
to
be,
call
local
law
enforcement
officials
and
report
the
incident
to
the
state
board
of
veterinary
medicine.
Other
things
can
be
done
to
combat
misuse
and
maldistribution
of
Rx
drugs.
If
clients
or
non-clients
are
obtaining
Rx
drugs
from
questionable
sources,
or
distributors
are
selling
Rx
drugs
to
laymen
when
a
veterinarian-client-patient
relationship
does
not
exist,
write
or
call
Dr.
William
Bixler,
Associate
Director
for
Surveillance
and
Compliance,
Center
for
Veterinary
Medicine,
Food
&
Drug
Adminis-
tration,
5600
Fishers
Lane,
Rockville,
MD
20857.
Dr.
Bixler's
tele-
phone
number
is
(301)
443-3400.
When
notified,
AVMA
also
is
willing
to
assist
in
following
up
on
veterinarians'
concerns.
There
are
many
regulatory
realities
that
are
a
source
of
confusion
to
veterinary
practitioners,
but
those
regulations
have
the
force
of
law.
Practitioners
not
only
must
practice
to
the
best
of
their
ability,
they
also
must
make
sure
that
actions
taken
are
defensible.
Unless
and
until
regulations
and
laws
are
changed,
it
beh000ves
practitioners
to
abide
by
these
laws
and
regulations.
The
profession's
reputation
for
integrity
as
well
as
the
livestock
and
poultry
industries'
reputation
for
providing
wholesome
food
products
may
well
depend
on
sound
advice
rendered
by
veterinarians.—Joe
S.
Gloyd,
Assistant
Director,
Division
of
Scientific
Activities.
"Practitioners
not
only
must
practice
to
the
best
of
their
ability,
they
also
must
make
sure
that
actions
taken
are
defensible."
34
Editorial
JAVMA,
Vol
190,
No.
1,
January
1,
1987