§530.11. Limitations.
21 C.F.R. § 530.11
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:
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);
Extralabel use of an approved new animal drug or human drug in or on an animal feed;
Extralabel use resulting in any residue which may present a risk to the public health; and
Extralabel use resulting in any residue above an established safe level, safe concentration or tolerance.
Notes, amendments, and revision history
Authority
Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 351, 352, 353, 355, 357, 360b, 371, 379e.
Source
Source: 61 FR 57743, Nov. 7, 1996, unless otherwise noted.