21 CFR 530.11
§ 530.11 Limitations.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 530.11, § 530.11 Limitations, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87711
- Permanent ID
ys:prov:87711@1- SHA-256
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Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.