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* The following report from the FDA outlines drugs that are banned from food
animals. The underlined sections show those that are routinely used on horses.
DRUGS PROHIBITED ON FOOD ANIMALS
(NOTE: The new FDA regulations approved on Feb 13, 2003 include as well
phenylbutazone, aka bute)
Some drugs may not be used to treat food-producing animals, even in an
extra-label manner. These include: CHLORAMPHENICOL, CLENBUTEROL,
DIETHYLSTILBESTROL (DES), DIMETRIDAZOLE, IPRONIDAZOLE,OTHER NITROIMIDAZOLES,
AND NITROFURANS-FURAZOLIDONE AND NITROFURAZONE (EXCEPT FOR TWO (2) TOPICALS
LABELED FOR USE IN CATTLE THAT WERE NOT AFFECTED BY FDA'S WITHDRAWAL OF
APPROVAL OF NITROFURAZONE AND FURAZOLIDONE)
In addition, all sulfonamides, except the three (3) sulfonamides approved for
use in lactating dairy cattle, are excluded from any use in female dairy cattle
20 months of age or older. The three (3) approved sulfonamides for lactating
dairy cattle are; sulfadimethoxine (not the sustained release boluses),
sulfabromomethazine, and sulfaethoxypyridazine.
TOPICAL ANTISEPTICS AND WOUND DRESSINGS:
This category includes creams, salves, ointments, sprays, wound dressings,
some foot products, teat dips, tincture of iodine and others. The following
is a list of commonly used topical antiseptics and wound dressings that are
exempt from the labeling requirements of the PMO. They should be used as
topicals only and be stored so as not to contaminate the milk or product
contact surfaces.
Iodine.
Alcohol.
Hydrogen peroxide.
Teat dips.
Clorox.
Formalin (for cattle foot baths).
Blue Coat.
Granulex Spray.
Trypzyme Aerosol.
Kopertox
Furazolidone aerosol powder (trade names such as Topazone and Furox aerosol
(labeled for use in cattle).
Nitrofurazone topical powder for pinkeye and wounds (trade names such as NFZ
Puffer and P.E. 7).
Chlorhexidine (Nolvasan) solutions, ointments, and creams for topical use only.
NOTE: The Nolvasan (chlorhexidine) Cap-Tabs and the Nolvasan Suspension for
intrauterine treatments are no longer labeled for use in cattle. They are approved
for use in horses only. [Note that horses are not refered as cattle]
NITROFURAN DRUGS, FURAZOLIDONE AND NITROFURAZONE:
The withdrawal by FDA of 10 approvals for nitrofurans (furazolidone and
nitrofurazone) on August 23, 1991, affected products that were approved for a
variety of uses in swine and poultry. On July 20, 1992, FDA revised Compliance
Policy Guide 7125.06 "Extra-Label Use of New Animal Drugs in Food-Producing
Animals" to reflect the Commissioner's conclusion that the nitrofuran drugs
are unsafe for oral or parenteral use in food animals.
Nitrofuran drugs are listed with those of highest priority for regulatory attention
regarding extra-label use in food-producing animals. The use of furazolidone,
nitrofurazone or other nitrofurans in food-producing animals in any form, EXCEPT
for the two (2) topical preparations labeled for use in cattle, is not allowed.
There are only two topical nitrofurans labeled by FDA for use in cattle. They were
not affected by the withdrawals and remain as legal products for their labeled indications.
They are:
(1) Furazolidone aerosol (spray) powder (Trade names such as Topazone and
Furox aerosol).
(2) Nitrofurazone topical powder for pinkeye and wounds (Trade names such as NFZ
Puffer and P.E. 7).
The two topicals labeled for cattle as discussed above do not violate item 16r.
There are solutions, ointments, salves, sprays, and creams that contain furazolidone or
nitrofurazone labeled for topical use in horses, dogs, and cats and for intrauterine use
in horses. They were not withdrawn by FDA and remain as legal products for their intended
uses in non-food-producing animals. The use or storage on dairy farms of any withdrawn
nitrofuran or the use of sprays, powders, solutions, ointments, salves, and creams labeled
for use in horses, dogs, and cats violates item 16r.
SYSTEMICALLY ACTING DRUGS THAT ARE APPLIED TOPICALLY:
The following list of drugs are applied as topicals for their systemic effect against
internal parasites or cattle grubs. They are not topical antiseptics or wound dressings
and they are not labeled for use in lactating dairy cattle and therefore they are not
exempt under the Item 16r footnote.
| DRUG |
|
TRADE NAME |
|
EXAMPLES |
| Fenthion |
|
Spotton Cattle Insecticide |
|
Tiguvon Pour On |
| Famphur and Xylene |
|
Purina Grub Kill |
|
Warbex Famphur Pour On |
| Phosmet |
|
Star Bar GX-118 |
|
Prolate 1-E |
| Ivermectin |
|
|
|
Ivomec Pour On |
| Levamisole |
|
Tramisol Pour On |
|
Totalon |
Because of their potential to cause residues in milk, the use of these drugs on
lactating dairy cattle or their storage with the lactating cattle drugs is a
violation of item 16r.
DIMETHYLSULFOXIDE (DMSO):
DMSO is a by-product of the paper industry and is able to carry some drugs rapidly
through the skin and other tissues. There are no FDA approved uses for DMSO in
food-producing animals. Approvals do exist for uses in horses and dogs. Industrial
grade DMSO is widely available for various non-medical uses such as paint remover
and other solvent uses. DMSO is often found stored on dairy farms or mixed with other
drugs intended for use in dairy animals. Such use may lead to an increased chance of
drug residues, off odor and off flavor milk.
FDA considers the use of DMSO for any veterinary purposes other than approved uses in
dogs and horses to be illegal. DMSO is an unapproved new animal drug which is unsafe
to use in food-producing animals.
The storage or use of DMSO is a violation of itme 16 r.
PESTICIDES/RODENTICIDES; INSECTICIDE SPRAYS, DUSTS, POWDERS AND POUR- ONS:
Pesticides/rodenticides/insecticides are usually regulated by the Environmental Protection
Agency (EPA). Ordinarily, an EPA regulated product can be identified by an EPA registration
number on the label. Only products labeled for use on or around dairy cattle or milking
equipment should be used and only according to their labels. EPA regulated
pesticides/rodenticides/insecticides are not controlled under 16r but the improper use
or storage of pesticides or rodenticides violates section 21r of the PMO.
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