Page 112 - Microsoft Word -Cow Book 10-06-09 final update.doc

WHAT IS A DRUG?

A drug is defined in the PMO, Section 1, and Section 201(g) of the Federal Food,
Drug and Cosmetic Act (the Act), as follows:

A. Articles recognized in the official United States Pharmacopoeia,
official Homeopathic Pharmacopoeia of the United States, or
official National Formulary, or any supplement to any of them; and

B. articles intended for use in the diagnosis, cure, mitigation, treat-
ment, or prevention of disease in man or other animals; and

C. articles (other than food) intended to affect the structure or function
of the body of man or other animals; and

D. articles intended for use as a component of any articles specified in
clause (A), (B), or (C); but does not include devices or their compo-
nents, parts or accessories.

I. Vaccines and Other Biologics

Certain drugs are regulated as biologics under the Virus, Serum, and Toxin Act
(VST Act) administered by the United States Department of Agriculture (USDA),
Animal and Plant Health Inspection Service (APHIS), Veterinary Services,
through their Biologic Staff licensing, Biologic Laboratories, and Biologic
Operations.

The VST Act prohibits the production for sale or interstate movement of worth
less, contaminated, dangerous or harmful biologics intended for use in the
diagnosis or treatment of animal diseases. Ordinarily, a biologic can be identified
by the USDA License number on the label. Vaccines and biologics are exempt
from the labeling provisions of the PMO. In general, biologics can be classified as
the following:

Antigens Vaccines Bacterin Toxoids Antitoxins

Some biologics contain antibiotics as preservatives. The antibiotics are added to
biologic products in accordance with the Code of Federal Regulations (CFR), Part
9 CFR 114.10. The concentrations of antibiotics used in the biologics are well
below the levels that are capable of producing a residue in milk or meat.

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