We are an internationally recognized public health organization responsible for the evaluation, approval and/or surveillance of animal drugs, food additives, feed ingredients, and animal devices.

We are proactive in our efforts to increase the availability and diversity of safe and effective products that relieve animal pain and suffering, sustain their health, improve animal productivity and do not compromise public health.

We foster open and collegial partnerships with our constituencies to respond to concerns and needs.

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The Center for Veterinary Medicine is a public health organization that enables the marketing of effective animal drugs, food additives, feed ingredients, and animal devices that are safe to animals, humans and the environment.

We, in partnership with federal and state agencies and other center customers, ensure animal health and the safety of food derived from animals.

We make timely, quality decisions and take regulatory actions to ensure that these products provide for quality health care of animals, minimize the transmission of zoonotic diseases, and increase efficiency of production of animal-derived food and fiber.

To support our decisions, we perform research, monitor product safety and efficacy, and continually strive to improve the quality of our processes.

The legislation is intended to codify the provisions of the FDA Compliance Policy Guide on Extra-Label Use.

The legislation is not intended to address the problem of insufficient drug approvals.

Although the Act provides a sequence of actions leading to the prohibition of an extra-label use, the FDA is not required to take each step before imposing such a constitutes a violation of the FDCA if a safe level has not been established.

Notice and comment rulemaking, or formal rulemaking, are not required for the establishment of a safe level.

FDA can, in its implementing regulations, provide generally for access to veterinarians’ records upon a finding that the extra-label use of a particular drug may present a risk to the public health.

FDA’s authority to require sponsors to monitor, and report on, extra-label uses is limited to that which is already provided in section 512(l), the "records and reports" subsection.

Notice and comment rulemaking is not required as a prerequisite to prohibiting an extra-label use.

Extra-label uses that FDA has prohibited through its existing CPG can be prohibited under the implementing regulation without following the notice procedure under the new law.

Withdrawal of the underlying approval, on the basis of extra-label use, remains an option to the agency but only through the withdrawal procedures contained in section 512(e).

Congress apparently intended to allow use of a human drug in animals even if a suitable approved animal drug is available.

Extra-label use includes use of an approved drug in compounding.

Does not permit extra-label use of drugs in animal feed.