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Definitions of Drug Labeling Terms

Label: A display of written, printed, or graphic matter upon the immediate
container of the article. [201(k) of the F.D.,&C Act] An example is the
immediate container label.

Labeling: All labels and other written, printed, or graphic matter upon any
article or any of its containers or wrappers or accompanying such article.
[201(m) of the F.D.,&C Act]. The package insert, box or carton are examples
of labeling.

Veterinary Prescription Drug (Rx Drug): A drug intended for veterinary use
which because of toxicity, other potential for harmful effect, or the method of
its use; the drug is not safe for animal use except under the supervision of a
licensed veterinarian. Adequate directions for use by the lay person cannot be
prepared, as such, the drug is restricted to use by or on the order of a
licensed veterinarian. In other words, the drug is one for which adequate
directions for lay use cannot be written and as such requires the supervision
and knowledge of a veterinarian to ensure its safe and effective use. All
veterinary prescription drugs are required to bear the statement:

"CAUTION: Federal (USA) Law restricts this drug to use

by or on the order of a licensed veterinarian."

Over-The-Counter Drug (OTC): A drug which can be purchased and used by
a layperson without the supervision of a veterinarian. The label of an OTC
drug bears adequate directions for use by a layperson and is written to be
understood by a layperson. (Ref. 21CFR 201.5).

NOTE: When used by a layperson in the absence of a veterinarian's
order, an OTC drug must be used in accordance with its
labeling.

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