21 CFR 530.11: Limitations
Prohibits extralabel animal drug use by lay persons without veterinary supervision, use in or on animal feed, and use leaving residues that risk public health or exceed established safe levels, concentrations, or tolerances.
Part 530, Extralabel Drug Use in Animals · Subpart B, Rules and Provisions for Extralabel Uses of Drugs in Animals
Recent 483s citing 530.11
- Scenic View Dairy, LLC · Fennville, MichiganCausing a residue of an approved human or animal drug above an established safe… Sep 18, 2009
- Scenic View Dairy, LLC · Freeport, MichiganCausing a residue of an approved human or animal drug above an established safe… Aug 11, 2009
- Scenic View Dairy, LLC · Fennville, MichiganUse of an animal drug in a manner contrary to label directions without benefit of a… Jan 7, 2008
The regulation text
§ 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.
Questions
What does 21 CFR 530.11 require?
Prohibits extralabel animal drug use by lay persons without veterinary supervision, use in or on animal feed, and use leaving residues that risk public health or exceed established safe levels, concentrations, or tolerances.