§530.23. Procedure for setting and announcing safe levels.
21 C.F.R. § 530.23
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:
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;
A statement of the basis for that finding; and
A request for public comments.
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.
Notes, amendments, and revision history
Authority
Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 351, 352, 353, 355, 357, 360b, 371, 379e.
Source
Source: 61 FR 57743, Nov. 7, 1996, unless otherwise noted.