[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR510.515]

[Page 46-47]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 510--NEW ANIMAL DRUGS--Table of Contents
 
    Subpart F--Animal Use Exemptions From Certification and Labeling 
                              Requirements
 
Sec. 510.515  Animal feeds bearing or containing new animal drugs subject to the provisions of section 512(n) of the act.


    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

[[Page 47]]

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................  0.01 to 0.02 percent.....  For use in the prevention
                                ......do................  2.4 to 50 g/ton..........   of outbreaks of
                                                                                      coccidiosis in poultry
                                                                                      flocks; growth promotion
                                                                                      and feed efficiency.
2. Nicarbazin.................  ......do................  0.01 to 0.02 percent.....      Do.
  Bacitracin methylene          ......do................  4 to 50 g/ton............
   disalicylate.
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          ......do................  4 to 50 g/ton............
   disalicylate.
  3-Nitro-4-                    ......do................  0.0025 to 0.005 percent..
   hydroxyphenylarsonic acid.
4. Nicarbazin.................  ......do................  0.01 to 0.02 percent.....      Do.
  Procaine penicillin.........  ......do................  2.4 to 50 g/ton..........
  3-Nitro-4-                    ......do................  0.0025 to 0.005 percent..
   hydroxyphenylarsonic acid.
5. Chlortetracycline..........  Swine...................  10 to 50 g/ton...........  Enhancement of growth and
                                                                                      feed efficiency.
  Arsanilic acid..............  ......do................  0.005 to 0.01 percent....
----------------------------------------------------------------------------------------------------------------


[41 FR 8299, Feb. 25, 1976, as amended at 41 FR 11011, Mar. 15, 1976; 42 
FR 18614, Apr. 8, 1977; 47 FR 42102, Sept. 24, 1982; 47 FR 51563, Nov. 
16, 1982; 56 FR 41912, Aug. 23, 1991; 58 FR 30119, May 26, 1993; 61 FR 
35950, July 9, 1996]