Regulatory Brief

 Unapproved Animal Drugs

Formal title: Docket Number [FDA-2010-N-0528] Unapproved Animal Drugs

The Food and Drug Administration solicited comments from stakeholders on strategies to address the prevalence of animal drug products marketed in the United States without approval or other legal marketing status.

Brief Description:

The FDA is concerned that the safety and effectiveness of actively-marketed products has not been demonstrated. Therefore, the FDA has requested comments on approaches for increasing the number of legally-marketed animal drug products, as well as on the use of enforcement discretion for some unapproved animal drug products in certain limited circumstances.

AVMA Response:

The AVMA commends the FDA on its pursuit of methods by which numbers of legal animal drugs could be increased. The AVMA is committed to the continued availability of medicinal products that are pure, safe, potent and efficacious for animals. The AVMA provided the following suggestions on ways the FDA can address the prevalence of unapproved animal drugs: utilizing the AVMA's expertise as the FDA considers ways forward, preservation of medically necessary drugs for the prevention and relief of animal suffering, active enforcement by FDA of egregious unapproved animal drugs, labeling of animal drug products that illustrate a drug's respective legal or illegal status, and increasing numbers of approved animal drugs and drug uses.

Background Documents:

View Federal Register document (PDF)


The AVMA responded on April 19, 2011. (PDF)