21 C.F.R. § 530.11

Limitations.

Last amended: 2016Year: 2026Length: 120 wordsSubsections: 4Official source

Cite as 21 C.F.R. § 530.11 (2026)

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.
Cross-references to the CFR
530.10
21 C.F.R. § 530.11: Limitations. | Justis AI