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e-CFR data is current as of February 24, 2021

Title 21Chapter ISubchapter EPart 530Subpart B → §530.11


Title 21: Food and Drugs
PART 530—EXTRALABEL DRUG USE IN ANIMALS
Subpart B—Rules and Provisions for Extralabel Uses of Drugs in Animals


§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.

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