The medicated feed CGMPs ensure a pure, safe drug product through requiring specific preventive measures during manufacturing, processing, packing, and holding. In general, the CGMPs in part 225 do not apply to the manufacturing, processing, packing, and holding of non-medicated animal food, even if manufactured in the same facility. However, non-medicated feed would be deemed adulterated under section 402(a)(2)(C)(ii) of the FD&C Act if contaminated with a new animal drug.
6. Animal Food Labeling
FDA regulations that establish animal food labeling standards in part 501 (21 CFR part 501) include requirements for a statement of identity, net quantity statement, manufacturer's name and address, and proper listing of ingredients. In addition, the FDAAA required
7. Generally Accepted as Safe (GRAS) Lists and GRAS Notifications
GRAS is an acronym for the phrase Generally Recognized as Safe. Under section 201(s) of the FD&C Act (21 U.S.C. 321(s)), a substance is not a food additive if it is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive. A listing of substances that are considered by the Agency to be generally recognized as safe for specific intended uses in animal food is found in 21 CFR parts 582 and 584.
Under section 201(s) of the FD&C Act and 21 CFR 570.30, a substance may be deemed to be GRAS if it is generally recognized as having been adequately shown to be safe under the conditions of its intended use in food through scientific procedures or, for a substance used in food before 1958, through experience based on common use in food.
A GRAS substance is not subject to premarket review and approval by
Although not required to do so, firms that have determined that the intended use of a substance in animal food is GRAS may petition
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