21 CFR 530.11 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (Subpart A To Parts 590-599) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Subpart A To Parts 590-599) — Animal Drugs, Feeds, And Related Products (Subpart A To Parts 590-599) — Extralabel Drug Use In Animals (§ 530.1 To § 530.41) — Rules And Provisions For Extralabel Uses Of Drugs In Animals (§ 530.10 To § 530.13) — Limitations.

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.