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Code of Federal Regulations (Last Updated: May 6, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter E - Animal Drugs, Feeds, and Related Products |
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Part 510 - New Animal Drugs |
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Subpart F - XXX |
§ 510.515 - Animal feeds bearing or containing new animal drugs subject to the provisions of section 512(n) of the act.
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Animal feeds that bear or contain penicillin, chlortetracycline, feed grade zinc bacitracin, and bacitracin methylene disalicylate, with or without added suitable nutritive ingredients are exempt from the certification requirements of section 512 of the act provided they are the subject of and in compliance with regulations for their use in this subchapter E, part 558 of this chapter, or any one of the paragraphs of this section:
(a) Where indicated in paragraph (b) of this section it is manufactured with or without one, but only one, of the following ingredients in a quantity, by weight of feed, as hereinafter indicated:
(1) Arsanilic acid: Not less than 0.005 percent and not more than 0.01 percent.
(2) Sodium arsanilate: Not less than 0.005 percent and not more than 0.01 percent.
(3) 3-Nitro-4-hydroxyphenylarsonic acid: Not less than 0.0025 percent and not more than 0.0075 percent except in chicken or turkey feed which shall contain not less than 0.0025 percent and not more than 0.005 percent.
(b) It is intended for use in any one of the following conditions set forth in this paragraph:
(1) It is intended for use solely in the treatment of chronic respiratory disease (air-sac infection), infectious sinusitis, and blue comb (nonspecific infectious enteritis) in poultry and/or bacterial swine enteritis; its labeling bears adequate directions and warnings for such use; and it contains, per ton of feed, the equivalent of 100 grams of penicillin. When intended for uses specified in this paragraph, it may also contain, in the amount specified, one, but only one, of the ingredients prescribed by paragraph (a) of this section.
(2) It is intended for use solely in the treatment of chronic respiratory disease (air-sac infection) and infectious sinusitis in poultry; its labeling bears adequate directions and warnings for such use; and it contains not less than 0.1 percent para-aminobenzoic acid or the sodium or potassium salt or para-aminobenzoic acid.
(3)-(29) [Reserved]
(c) It is intended for use as follows:
Product Species Use levels Indications for use 1. Nicarbazin Chickens - ......do
0.01 to 0.02 percent - 2.4 to 50 g/ton
For use in the prevention of outbreaks of coccidiosis in poultry flocks; growth promotion and feed efficiency. 2. Nicarbazin ......do 0.01 to 0.02 percent Do. Bacitracin methylene disalicylate ......do 4 to 50 g/ton 3. Nicarbazin ......do 0.01 to 0.02 percent For use as an aid in the prevention of coccidiosis in poultry flocks; growth promotion and feed efficiency; improving pigmentation. Bacitracin methylene disalicylate ......do 4 to 50 g/ton 3-Nitro-4-hydroxyphenylarsonic acid ......do 0.0025 to 0.005 percent 4. Nicarbazin ......do 0.01 to 0.02 percent Do. Procaine penicillin ......do 2.4 to 50 g/ton 3-Nitro-4-hydroxyphenylarsonic acid ......do 0.0025 to 0.005 percent 5. Chlortetracycline Swine 10 to 50 g/ton Enhancement of growth and feed efficiency. Arsanilic acid ......do 0.005 to 0.01 percent Effective Date Note: At 71 FR 16221, Mar. 31, 2006, subpart F, consisting of § 510.515 was removed and reserved, effective May 1, 2006.