Takhar

Santokh Takhar, a California-licensed veterinarian with a large-animal practice, challenges two Food and Drag Administration (FDA) Compliance Policy Guides (CPG) as exceeding the agency’s statutory mandate by regulating veterinarians’ extra-label drag use. He claims they contravene Congressional intent to exempt the practice of veterinary medicine from the Food, Drag and Cosmetic Act (FDCA). He also challenges the CPGs as substantive rales that were adopted without the notice-and-eomment procedures required by the Administrative Procedure Act. The district court dismissed Takhar’s suit for lack of standing and ripeness. We have jurisdiction under 28 U.S.C. § 1291 and affirm.

BACKGROUND

A. Extra-Label Drag Use in Animals

“Extra-label” drag use consists of using a drag in a maimer not indicated on the FDA-approved manufacturer’s label; this can include the use of a drag for a condition, in a dosage, or in an animal species for which the drag has not received FDA approval. The plaintiff asserts that extra-label drag use is common in veterinary medicine because no FDA-approved drags exist for many diseases in many species; about 30,000 drags have been approved for human…