21 C.F.R. § 530.23

Current through September 30, 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 .

21 C.F.R. §530.23