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Title 012 | Chapter 003 | Regulation 037


12 KAR 3:037.Drugs and pet food additives.

Section 1.

An artificial color may be used in a pet food or specialty pet food only if it has been shown to be harmless to pets or specialty pets. The permanent or provisional listing of an artificial color in 21 C.F.R. Part 70, 71, 73, 74, 80, 81, or 82, or 501.22 as safe for use, together with the conditions, limitations, and tolerances, if any, shall constitute evidence that the color is harmless to pets or specialty pets.

Section 2.

Before approval of a label and a registration application, the distributor of a pet food, containing an additive including a drug, another special purpose additive, or a nonnutritive additive shall, upon request of the director, submit evidence to prove the safety and efficacy of the pet food if used according to label directions. Evidence of the safety and efficacy of a pet food or specialty pet food shall be:

(1)

If the pet food or specialty pet food contains an additive that conforms to 21 C.F.R. 570.3(1), 570.30, or Part 582; or

(2)

If the pet food or specialty pet food is a drug as defined by KRS 250.501(7) and is generally recognized by the Food and Drug Administration as safe and effective for its labeled use or is marketed subject to an application approved by the Food and Drug Administration under 21 U.S.C. 360(b).

Section 3.

If a drug is included in a pet food or specialty pet food, the medicated labeling format recommended by the Association of American Feed Control Officials in its 2018 Official Publication shall be used to insure that adequate labeling is provided.

Section 4.

Incorporation by Reference.

(1)

"2018 Official Publication", (2018 Edition), Association of American Feed Control Officials, is incorporated by reference.

(2)

This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Division of Regulatory Services, 103 Regulatory Services Building, College of Agriculture, University of Kentucky, Lexington, Kentucky 40546-0275, Monday through Friday, 8 a.m. to 4:30 p.m.

HISTORY: (AES-2(1973)-PF 7; 1 Ky.R. 1003; eff. 6-11-1975; 23 Ky.R. 1618; eff. 1-10-1997; 25 Ky.R. 900; 2364; eff. 4-14-1999; 45 Ky.R. 119, 638; eff. 9-28-2018.)

7-Year Expiration: 9/28/2025

Last Action: 12/15/2021


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