extra-label

extra-label

use of a drug in a way or for a purpose not specified on the label, or more practically the documents provided by the manufacturer. In the case of an adverse reaction the responsibility for any loss incurred rests with the veterinarian, not the manufacturer. Extra-label use is common in veterinary practice because of the large number of animal species being treated and because many of the diseases encountered in companion animals require drugs which have been registered for use only in humans.
References in periodicals archive ?
Although [beta]-lactams and aminoglycosides, including neomycin, gentamicin and streptomycin, have a great use for the treatment of Gram-negative bacteria in mastitis, low residues levels might appear in the edible animal products due to extra-label use of veterinary drugs or noncompliance withdrawal periods (PONTES NETTO et al.
Even though samples do not remain hazardous concentrations, the presence of low levels of residues of veterinary drugs may be linked to extra-label use or noncompliance withdrawal periods.
Once we gain FDA approval, copper sulfate can be prescribed for extra-label use on other fish species.
This new report provides insights into Extra-label Drug Use (ELDU), its application in the veterinary setting and other guidelines and regulations followed by professionals in the animal health industry.
Federal extra-label drug use regulations specifically permit compounding from FDA-approved drugs when a veterinarian believes there is a need to alter the approved drug to adequately medicate a non-food animal with a diagnosed medical condition," says Lisa Penny, R.
The VDD has established a policy recommending against the extra-label use of Category I antimicrobial drugs in food-producing animals (7); however, Canada does not have legislation restricting this extra-label use.
However, extra-label use and unintended contamination of poultry feed continue to be a persistent problem.
The agency is prohibiting these extra-label uses in food-producing major species because we believe such uses in these animals will likely cause an adverse event in humans and, therefore, present a risk to the public health," the agency said in a notice that appears in the Jan.
Food and Drug Administration's Center for Veterinary Medicine (CVM) advised veterinarians about a recall of a human drug, phenobarbital, which is used extra-label for pets.
It also has FDA approval for extra-label use as a feline oral contraceptive to postpone estrus (heat) in cats.
Although extra-label use of enrofloxacin is prohibited, microbiologic culture of either of the cited bacteria is not required before administration (2).

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