Regulatory Information

AMDUCA
Subpart D—Extralabel Use of Human and Animal Drugs in Animals Not Intended for Human Consumption

Sec. 530.30 Extralabel Drug Use in Nonfood Animals.
(a) Because extralabel use of animal and human drugs in nonfood-producing animals does not ordinarily pose a threat to the public health, extralabel use of animal and human drugs is permitted in nonfood-producing animal practice except when the public health is threatened. In addition, the provisions of Sec. 530.20(a)(1) will apply to the use of an approved animal drug.
(b) If FDA determines that an extralabel drug use in animals not intended for human consumption presents a risk to the public health, the agency may publish in the Federal Register a notice prohibiting such use following the procedures in Sec. 530.25. The prohibited extralabel drug use will be codified in Sec. 530.41.