21 CFR § 530.11 - Limitations.

---
identifier: "/us/cfr/t21/s530.11"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 530.11 - Limitations."
title_number: 21
title_name: "Food and Drugs"
section_number: "530.11"
section_name: "Limitations."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "530"
part_name: "EXTRALABEL DRUG USE IN ANIMALS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 351, 352, 353, 355, 357, 360b, 371, 379e."
regulatory_source: "61 FR 57743, Nov. 7, 1996, unless otherwise noted."
cfr_part: "530"
---


# 530.11 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.