Section R68-2-10 - Drugs and Additives in Feed(1) Before the approval of a registration application or approval of a label for commercial feed that contains additives, including drugs, other special purpose additives, or non-nutritive additives, the distributor may be required to submit evidence to prove the safety and efficacy of the commercial feed when used according to the directions furnished on the label.(2) Satisfactory evidence of safety and efficacy of a commercial feed include:(a) the commercial feed contains additives, the use of which conforms to the requirements of the applicable section in Title 21, Code of Federal Regulations, or which are "prior sanctioned", "informal review sanctioned", or "generally recognized as safe" for use;(b) the commercial feed is itself a drug as defined in 21 CFR 510.3 (January 3, 2017) and is generally recognized as safe and effective for the labeled use or is marketed subject to an application approved by the Food and Drug Administration under 21 CFR 584 (August 2, 2024);(c) one of the purposes for feeding a commercial feed is to impart immunity, and the constituent's imparting immunity has been approved for the purpose through the Federal Virus, Serum and Toxins Act of 1913 21 USC Ch. 5;(d) the commercial feed is a direct fed microbial product, which includes; (i) the product meets the particular fermentation product definition;(ii) the microbial content statement, as expressed and appears on the labeling, is limited to the following: "Contains a source of live, viable, naturally occurring microorganisms."; and(iii) the source is stated with a corresponding guarantee expressed in accordance with Subsection R68-2-6(6); and(e) the commercial feed is an enzyme product, which includes:(i) the product meets the particular enzyme definition defined by AAFCO; and(ii) the enzyme is stated with a corresponding guarantee expressed in accordance with Subsection R68-2-6(7).Utah Admin. Code R68-2-10
Adopted by Utah State Bulletin Number 2024-21, effective 10/24/2024