subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "558"
part_subject: "NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS"
subpart_code: "B"
subpart_subject: "Specific New Animal Drugs for Use in Animal Feeds"
section_number: "558.500"
section_subject: "Ractopamine."
cfr_reference: "21 CFR 558.500"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 500 to 599"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)Specifications. Type A medicated articles containing 9 or 45.4 grams of ractopamine hydrochloride per pound.
(b)Approvals. See Nos. 054771 and 058198 in § 510.600(c) of this chapter.
(c)Related tolerances. See § 556.570 of this chapter.
(d)Special considerations. (1) Labeling of Type B and Type C feeds shall bear the following: “Not for animals intended for breeding.”
(2)Labeling of Type B and Type C swine feeds shall bear the following:
(i)“No increased benefit has been shown when ractopamine concentrations in the diet are greater than 4.5 g/ton.”
(ii)“Ractopamine may increase the number of injured and/or fatigued pigs during marketing.”
(3)Labeling of Type B and Type C tom turkey feeds shall bear the following: “No increased benefit has been shown when ractopamine concentrations in the diet are greater than 4.6 g/ton.”
(5)Ractopamine liquid Type B cattle feeds may be manufactured from dry ractopamine Type A articles. The liquid Type B feeds must be maintained at a pH of 4.5 to 7.5 or, if in combination with monensin and/or tylosin, at a pH of 4.5 to 6.0. Mixing directions for liquid Type B feeds requiring recirculation or agitation: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.