Under provisions of the Animal Medicinal Drug Use Clarification Act (AMDUCA)
and 21 CFR part 530,
FDA can prohibit use of an entire class of drugs in selected animal species if FDA determines that:
(I) an acceptable analytical method needs to be established and such a method has not or cannot be established; or
(II) the extra-label use of the drug or drug class presents a public health risk. FDA can also limit the prohibition on extra-label use to specific species,
indications, dosage forms, routes of administration, or a combination of these.
GROUP I. Drugs with No Allowable Extra-Label Uses in Any Food-Producing Animal Species
- DIETHYLSTILBESTEROL (DES)
- FLUOROQUINOLONE–CLASS ANTIBIOTICS
- GLYCOPEPTIDES – all agents, including VANCOMYCIN
- MEDICATED FEEDS
- NITROIMIDAZOLES – all agents, including DIMETRIDAZOLE, IPRONIDAZOLE, METRONIDAZOLE and others
- NITROFURANS – all agents, including FURAZOLIDINE, NITROFURAZONE and others
GROUP II. Drugs with Restricted Extra-Label Uses in Food-Producing Animal Species
- ADAMANTANE & NEURAMINIDASE INHIBITORS
– Extra-label use (ELDU) of these drugs is prohibited in poultry including chickens,
turkeys and ducks in the United States. Although these drugs are not approved for use in animals in the United States,
some of these drugs are used in other countries for the treatment or prevention of avian influenza in chickens, turkeys and ducks.
– ELDU of all cephalosporin antibiotics, except CEPHAPIRIN, is restricted in the United States.
– ELDU restrictions differ for Major vs. Minor Food Animal Species as noted below:
- Major Food Animal Species (Cattle, Pigs, Chickens and Turkeys): ELDU is permissible only
for therapeutic indications that are not included on the product label. However, ELDU of cephalosporin antibiotics is prohibited
in all of the following situations:
a) the intended use of the product deviates from the approved dose, treatment duration, frequency or administration route on the product label,
b) the intended use of a product in an unapproved major species or animal production class,
c) the intended use of the product for the purpose of disease prevention.
- Minor Food Animal Species (all species that are not major species): ELDU of cephalosporin antimicrobial
agents is permitted in these species.
- GENTIAN VIOLET – use is prohibited in food or feed of all food-producing animal species (details)
- INDEXED DRUGS (view here)
– ELDU of these drugs is prohibited in all food producing animals, with some exceptions for minor-use animal species that are not used as food for humans or other animals.
- PHENYLBUTAZONE – all uses of this drug is prohibited in female dairy cattle greater than 20 months of age.
- SULFONAMIDE–CLASS ANTIBIOTICS
– USE of all sulfonamide drugs is prohibited in lactating dairy cattle,
except for approved uses of sulfadimethoxine, sulfabromomethazine, and sulfaethoxypyridazine.
GROUP III. Drugs with Special Restrictions for Grade "A" Dairy Operations
Based upon recommendations by the National Conference on Interstate Milk Shipments (NCIMS),
the FDA publishes a set of minimum standards and requirements for the production of Grade "A" milk.
These standards, which are published collectively as the Grade A Pasteurized Milk Ordinance (Grade "A" PMO),
provide applicable CFR references and can be used as an inspectional guide to cover specific operations in the dairy industry,
including pasteurization equipment, packaging, quality control and record keeping requirements.
Although the PMO does not have the force of regulations, it provides procedures and standards of general applicability that are acceptable to FDA.
Owing to human food safety concerns, certain drugs including non-medical grade dimethylsulfoxide (DMSO), dipyrone and colloidal silver, are not to be used or not to be stored on dairy operations or fed to lactating dairy cattle.