Section 355IAC6-1-9. Drug and feed additives

   (a) A labeler of a commercial feed that contains additives (including drugs, other special purpose additives, or nonnutritive additives) 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.

  (b) Satisfactory evidence of safety and efficacy of a commercial feed may be any of the following:

(1) When the commercial feed contains such additives, the use of which conforms to the requirements of the applicable regulation in 21 CFR, or are prior sanctioned, informal review sanctioned, or generally recognized as safe for such use.

(2) When the commercial feed is itself a drug as defined in Section 1(7) 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 U.S.C. 360(b).

(3) When one (1) of the purposes for feeding a commercial feed is to impart immunity (that is to act through some immunological process) the constituents imparting immunity have been approved for that purpose through the federal Virus, Serum, and Toxins Act of 1913, as amended.

(4) When the commercial feed is a direct fed microbial product, including the following:

(A) The product meets the particular fermentation product definition.

(B) The microbial content statement, as expressed in the labeling, is limited to the statement, "Contains a source of live (viable) naturally occurring micro-organisms.". This statement shall appear on the label.

(C) The source is stated with a corresponding guarantee expressed in accordance with section 4 of this rule.

(5) When the commercial feed is an enzyme product, including the following:

(A) The product meets the particular enzyme definition defined by the Association of American Feed Control Officials.

(B) The enzyme is stated with a corresponding guarantee expressed in accordance with section 4 of this rule.

(State Chemist of the State of Indiana; 355 IAC 6-1-9; filed Apr 4, 2002, 9:26 a.m.: 25 IR 2453; readopted filed Nov 12, 2008, 11:24 a.m.: 20081203-IR-355080677RFA; readopted filed Oct 17, 2014, 9:27 a.m.: 20141112-IR-355140344RFA)