Compounding
Under the FD&C Act, an animal drug that is
compounded using an unapproved drug or bulk drugs as the starting material is
adulterated. An animal drug that is compounded using an approved human or animal
drug as the starting material is not adulterated, and using such a drug is
considered a legal extra-label use as long as all other conditions required by
law are met. You can find these requirements in Sections 512(a)(4) and (5) of the FD&C Act8 and Title 21 of the CFR, Part 530.139. It’s important to note that Part
530.13 specifically states, “Nothing in this part shall be construed as
permitting compounding from bulk drugs.”
Drugs Prohibited from Extra-Label Uses in Animals
Under the AMDUCA provisions, FDA has the right to prohibit extra-label uses of certain drugs in animals. The following drugs (both human and animal), families of drugs, and substances are prohibited from extra-label uses in all food-producing animals, including horses intended for human food:
- Chloramphenicol
- Clenbuterol
- Diethylstilbestrol (DES)
- Dimetridazole
- Ipronidazole and other nitroimidazoles
- Furazolidone and nitrofurazone
- Sulfonamide drugs in lactating dairy cattle, except for the approved use of sulfadimethoxine, sulfabromomethazine, and sulfaethoxypyridazine
- Fluoroquinolones
- Glycopeptides
- Phenylbutazone in female dairy cattle 20 months of age or older
- Cephalosporins (not including cephapirin) in cattle, swine, chickens, or
turkeys:
- For disease prevention purposes;
- At unapproved doses, frequencies, durations, or routes of administration; or
- If the drug is not approved for that species and production class.
The following drugs, or classes of drugs, that are approved for treating or preventing influenza A are prohibited from extra-label uses in chickens, turkeys, and ducks:
- Adamantane
- Neuraminidase inhibitors
The above list can be found at Title 21 of the CFR, Part 530.4110. Currently, no approved drugs are
prohibited from extra-label uses in companion animals.
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