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.