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

Title 21Chapter ISubchapter EPart 530Subpart C → §530.23


Title 21: Food and Drugs
PART 530—EXTRALABEL DRUG USE IN ANIMALS
Subpart C—Specific Provisions Relating to Extralabel Use of Animal and Human Drugs in Food-Producing Animals


§530.23   Procedure for setting and announcing safe levels.

(a) FDA may issue an order establishing a safe level for a residue of an extralabel use of an approved human drug or an approved animal drug. The agency will publish in the Federal Register a notice of the order. The notice will include:

(1) A statement setting forth the agency's finding that there is a reasonable probability that extralabel use in animals of the human drug or animal drug may present a risk to the public health;

(2) A statement of the basis for that finding; and

(3) A request for public comments.

(b) A current listing of those drugs for which a safe level for extralabel drug use in food-producing animals has been established, the specific safe levels, and the availability, if any, of a specific analytical method or methods for drug residue detection will be codified in §530.40.

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