(b) Prior to approval of a facility registration for pet foods which contain 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 pet food, when used according to directions furnished on the label. Evidence of the safety and efficacy of a pet food is not required under the following conditions:
- (1) The pet food contains additives which conforms to the requirements of Federal standards set forth at 21 CFR 121.101(a)—(h), or which are prior sanctioned or generally recognized as safe for that use.
- (2) The pet food itself is a drug as defined in section 3 of the act (3 P. S. § 58.3) and is generally recognized as safe and effective for use or is marketed subject to an application approved by the United States Food and Drug Administration under the provisions of sections 505 and 507 of the Food, Drug and Cosmetic Act of 1938 (21 U.S.C.A. § § 355 and 357).