C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS › PART 530—EXTRALABEL DRUG USE IN ANIMALS › Subpart D—Extralabel Use of Human and Animal Drugs in Animals Not Intended for Human Consumption

21 C.F.R. § 530.30

Extralabel drug use in nonfood animals

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(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 § 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 § 530.25. The prohibited extralabel drug use will be codified in § 530.41.

Notes of Decisions
Cited in 1 case, 2011–2011 · leading case: United States v. Franck's Lab, Inc., 816 F. Supp. 2d 1209 (M.D. Fla. 2011).
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United States v. Franck's Lab, Inc., 816 F. Supp. 2d 1209 (M.D. Fla. 2011). · cites it 2× “a) ("FDA may prohibit the extralabel use of an approved new animal or human drug or class of drugs in food-producing animals if FDA determines that: (1) [a]n acceptable analytical method needs to be established and such method has not been established or cannot be established;…”
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