Current through October 31, 2024
Section 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 .