§ 530.23. Procedure for setting and announcing safe levels.
142 words·~1 min read·
/us/cfr/t21/s§ 530.23·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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.