[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR558.62]

[Page 383-384]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS--Table of Contents
 
      Subpart B--Specific New Animal Drugs for Use in Animal Feeds
 
Sec.  558.62  Arsanilic acid.

    (a) Approvals. Type A medicated articles to sponsors in Sec.  
510.600(c) of this chapter as follows:
    (1) To 015565: 20, 50, and 100 percent for use as in the table in 
paragraph (c)(1), entry (ii), item 1; entry (ii), item 2; entry (iv); 
entry (vi); and entry (vii) of this section.
    (2) To 015565: 20 percent for use as in paragraph (c)(1), entry (i); 
entry (ii), item 3 of this section.
    (3) To 061133: 90 grams per pound arsanilic acid and 4.6 grams per 
pound erythromycin equivalents as erythromycin thiocyanate for use as in 
paragraph (c)(1), entry (iii); 90 grams per pound arsanilic acid and 
9.25 grams per pound erythromycin equivalents as erythromycin 
thiocyanate for use as in paragraph (c)(1), entry (v).
    (b) Related tolerances. See Sec.  556.60 of this chapter.
    (c) Conditions of use. (1) It is used as follows:

----------------------------------------------------------------------------------------------------------------
 Arsanilic acid in grams per    Combination in grams
             ton                      per ton            Indications for use         Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 45 to 90................  .......................  1. Growing chickens:    Withdraw 5 days before     015565
                                                        For growth promotion    slaughter; as sole
                                                        and feed efficiency;    source of organic
                                                        improving               arsenic.
                                                        pigmentation.
                              .......................  2. Growing turkeys:     .......do.............     015565
                                                        For growth promotion
                                                        and feed efficiency;
                                                        improving
                                                        pigmentation.
                              .......................  3. Growing swine: For   .......do.............     015565
                                                        increased rate of
                                                        weight gain and
                                                        improved feed
                                                        efficiency.
(ii) 90.....................  .......................  Swine: As an aid in     .......do.............     015565
                                                        control of swine
                                                        dysentery
                                                        (hemorrhagic
                                                        enteritis, bloody
                                                        dysentery).
(iii).......................  Erythromycin 4.6.......  Chickens; growth        As erythromycin            012487
                                                        promotion and feed      thiocyanate; withdraw
                                                        efficiency; improving   5 days before
                                                        pigmentation..          slaughter; as sole
                                                                                source of organic
                                                                                arsenic..
(iv)........................  Erythromycin 4.6 to      Chickens; growth        As erythromycin             15565
                               18.5.                    promotion and feed      thiocyanate; withdraw
                                                        efficiency; improving   5 days before
                                                        pigmentation.           slaughter; as sole
                                                                                source of organic
                                                                                arsenic.
(v).........................  Erythromycin 9.25......  Chickens; growth        As erythromycin            012487
                                                        promotion and feed      thiocyanate; withdraw
                                                        efficiency; improving   5 days before
                                                        pigmentation..          slaughter; as sole
                                                                                source of organic
                                                                                arsenic..
(vi)........................  Erythromycin 92.5......  1. Chickens; as an aid  As erythromycin            015565
                                                        in the prevention of    thiocyanate; feed for
                                                        chronic respiratory     2 days before stress
                                                        disease during          and 3 to 6 days after
                                                        periods of stress;      stress; withdraw 5
                                                        growth promotion and    days before
                                                        feed efficiency;        slaughter; as sole
                                                        improving               source of organic
                                                        pigmentation.           arsenic.
                                                       2. Chickens; as an aid  As erythromycin            015565
                                                        in the prevention of    thiocyanate; feed for
                                                        infectious coryza;      7 to 14 days;
                                                        growth promotion and    withdraw 5 days
                                                        feed efficiency;        before slaughter; as
                                                        improving               sole source of
                                                        pigmentation.           organic arsenic.
(vii).......................  Erythromycin 185.......  Chickens; as an aid in  As erythromycin             15565
                                                        the prevention and      thiocyanate; feed for
                                                        reduction of lesions    5 to 8 days; do not
                                                        and in lowering         use in birds
                                                        severity of chronic     producing eggs for
                                                        respiratory disease;    food purposes;
                                                        growth promotion and    withdraw 5 days
                                                        feed efficiency;        before slaughter; as
                                                        improving               sole source of
                                                        pigmentation.           organic arsenic.
----------------------------------------------------------------------------------------------------------------


[[Page 384]]

    (2) Arsanilic acid may be used in accordance with the provisions of 
this section in the combinations provided as follows:
    (i) Amprolium in accordance with Sec.  558.55.
    (ii) Amprolium and ethopabate in accordance with Sec.  558.58.
    (iii) Bacitracin zinc in accordance with Sec.  558.78.
    (iv) Bacitracin and zoalene in accordance with Sec.  558.680.
    (v) Zoalene in accordance with Sec.  558.680.

[41 FR 10992, Mar. 15, 1976, as amended at 42 FR 18617, Apr. 8, 1977; 51 
FR 7395, Mar. 3, 1986; 51 FR 33897, Sept. 24, 1986; 54 FR 18281, Apr. 
28, 1989; 56 FR 19268, Apr. 26, 1991; 60 FR 39847, Aug. 4, 1995; 66 FR 
14074, Mar. 9, 2001; 66 FR 57873, Nov. 19, 2001]