---
kind: "section"
citation: "21 C.F.R. § 530.11"
title: "21"
number: "530.11"
heading: "Limitations."
url: "https://uscodex.org/cfr/21/530.11"
---

# §530.11. Limitations.


In addition to uses which do not comply with the provision set forth in [§ 530.10](/cfr/21/530.10.md), the following specific extralabel uses are not permitted and result in the drug being deemed unsafe within the meaning of [section 512](/cfr/21/512.md) 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.

## Notes

### 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.