GroundRules
21 CFR 530.11: Limitations.
Where this section sits in the code
- Title 21—Food and Drugs
- 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 B—Rules and Provisions for Extralabel Uses of Drugs in Animals
In addition to uses which do not comply with the provision set forth in § 530.10, the following specific extralabel uses are not permitted and result in the drug being deemed unsafe within the meaning of section 512 of the act:
(a) Extralabel use in an animal of an approved new animal drug or human drug by a lay person (except when under the supervision of a licensed veterinarian);
(b) Extralabel use of an approved new animal drug or human drug in or on an animal feed;
(c) Extralabel use resulting in any residue which may present a risk to the public health; and
(d) Extralabel use resulting in any residue above an established safe level, safe concentration or tolerance.
Collected 2026-08-27T02:24:47Z. Source file · JSON