Section 71.8. Drug and feed additives

(a) Prior to approval of a facility registration for commercial feed which contains additives, including drugs, other special purpose additives or nonnutritive 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.

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

(1) When the commercial feed contains such additives, the use of which conforms to the requirements of the applicable regulation in Title 21 of the Code of Federal Regulations, or which are ‘‘prior sanctioned’’ or ‘‘generally recognized as safe’’ for such use.

(2) When the commercial feed is itself a drug as defined in section 3(16) of the act (3 P. S. § 58.3(16)) and is generally recognized as safe and effective for the labeled use or is marketed subject to an application approved by the United States Food and Drug Administration under the Federal Food, Drug and Cosmetic Act, section 302, 76 Stat. 794, 21 U.S.C.A. § 360(b).