Mich. Admin. Code R. 285.635.13 - Drug and feed additives

Rule 13.

(1) Prior to approval of a license application, or approval of a label for commercial feed which contains additives (including drugs, other special purpose additives, or nonnutritive additives, or both), the manufacturer 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 is achieved when:

(a) The commercial feed contains such additives, the use of which conforms to the requirements of the applicable regulation in the food additives regulations, 21 C.F.R. part 121, chapter 1, or which are "prior sanctioned" or "generally recognized as safe" for such use.

(b) The commercial feed is itself a drug as defined in section 3(h) of the act 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. S512.

Notes

Mich. Admin. Code R. 285.635.13

1979 AC