[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: 21CFR558.195]

[Page 395-398]
 
                        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. 558.195  Decoquinate.

    (a) Approvals. Type A medicated articles: 6 percent to 046573 in 
Sec. 510.600(c) of this chapter.
    (b) Related tolerances in edible products. See Sec. 556.170 of this 
chapter.
    (c) Special considerations. (1) Bentonite should not be used in 
decoquinate feeds.
    (2) Type A medicated articles containing 6 percent decoquinate may 
be used to make dry or liquid Type B cattle (including veal calf), 
sheep, and goat feeds as in paragraph (d) of this section.
    (3) Type A medicated articles containing 6 percent decoquinate may 
be used to manufacture dry or liquid Type B cattle feeds as indicated in 
paragraph (d) of this section.
    (d) Conditions of use. It is used as follows:

----------------------------------------------------------------------------------------------------------------
                                Combination in grams
Decoquinate in grams per ton          per ton            Indications for use         Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
13.6 (0.00149 pct)..........  .......................  Young goats; for the    Feed at a rate to          046573
                                                        prevention of           provide 22.7 mg per
                                                        coccidiosis caused by   100 lbs of body
                                                        Eimeria christenseni    weight per day (0.5
                                                        and E.                  mg per kilogram); do
                                                        ninakohlyakimovae.      not feed to goats
                                                                                producing milk for
                                                                                food; feed for at
                                                                                lest 28 days during
                                                                                periods of exposure
                                                                                to coccidiosis or
                                                                                when it is likely to
                                                                                be a hazard.
13.6 (0.0015 pct)...........  .......................  Young sheep; for the    Feed Type C feed at a      046573
                                                        prevention of           rate to provide 22.7
                                                        coccidiosis caused by   mg per 100 lb of body
                                                        Eimeria ovinoidalis,    weight (0.5 mg per
                                                        E. crandallis, E.       kg) per day. Feed at
                                                        parva, E. bakuensis.    least 28 days during
                                                                                periods of exposure
                                                                                to coccidiosis or
                                                                                when it is likely to
                                                                                be a hazard. Do not
                                                                                feed to sheep
                                                                                producing milk for
                                                                                food.

[[Page 396]]


13.6 to 27.2 (0.0015 to       .......................  Cattle; for the         Feed Type C feed at a
 0.003 pct).                                            prevention of           rate to provide 22.7
                                                        coccidiosis in          mg per 100 lb of body
                                                        ruminating and          weight (0.5 mg per
                                                        nonruminating calves    kg) per day. May be
                                                        and cattle caused by    prepared from dry or
                                                        Eimeria bovis and E.    liquid Type B feed
                                                        zumii.                  containing 0.0125 to
                                                                                0.5 pct decoquinate.
                                                                                Liquid Type B feed
                                                                                must have a pH range
                                                                                of 5.0 to 6.5 and
                                                                                contain a suspending
                                                                                agent to maintain a
                                                                                viscosity of not less
                                                                                tha 500 centipoises.
                                                                                Feed at least 28 days
                                                                                during periods of
                                                                                exposure to
                                                                                coccidiosis or when
                                                                                it is likely to be a
                                                                                hazard. Do not feed
                                                                                to cows producing
                                                                                milk for food..
                              Monensin 5 to 30.......  Cattle fed in           Feed only to cattle        046573
                                                        confinement for         fed in confinement
                                                        slaughter; for          for slaughter. Feed
                                                        prevention of           continuously as the
                                                        coccidiosis caused by   sole ration to
                                                        Eimeria bovis and E.    provide 22.7 mg of
                                                        zuernii, and improved   decoquinate per 100
                                                        feed efficiency..       lb body weight per
                                                                                day and 50 to 360 mg
                                                                                of monensin per head
                                                                                per day. Feed at
                                                                                least 28 days during
                                                                                period of exposure to
                                                                                coccidiosis or when
                                                                                it is likely to be a
                                                                                hazard. Do not feed
                                                                                to animals producing
                                                                                milk for food. Also
                                                                                see (c)(1) of this
                                                                                paragraph and Sec.
                                                                                558.355(d)(8).
                                                                                Monensin as monensin
                                                                                sodium provided by
                                                                                000986 in Sec.
                                                                                510.600(c) of this
                                                                                chapter..
                              Monensin 5 to 30; plus   Cattle fed in           Feed only to cattle        046573
                               tylosin 8 to 10.         confinement for         fed in confinement
                                                        slaughter; for          for slaughter. Feed
                                                        prevention of           continuously as the
                                                        coccidiosis caused by   sole ration to
                                                        Eimeria bovis and E.    provide 22.7 mg of
                                                        zuernii, improved       decoquinate per 100
                                                        feed efficiency, and    lb body weight per
                                                        reduction of            day, 50 to 360 mg of
                                                        incidence of liver      monensin per head per
                                                        abscesses caused by     day, and 60 to 90 mg
                                                        Fusobacterium           of tylosin per head
                                                        necrophorum and         per day. Feed at
                                                        Actinomyces pyogenes..  least 28 days during
                                                                                period of exposure to
                                                                                coccidiosis or when
                                                                                it is likely to be a
                                                                                hazard. Do not feed
                                                                                to animals producing
                                                                                milk for food. Also
                                                                                see (c)(1) of this
                                                                                paragraph and Sec.
                                                                                558.355(d)(8).
                                                                                Monensin as monensin
                                                                                sodium and tylosin as
                                                                                tylosin phosphate
                                                                                provided by 000986 in
                                                                                Sec.  510.600(c) of
                                                                                this chapter..

[[Page 397]]


                              Chlortetracycline        Calves, beef and        Feed Type C feed to        046573
                               approximately 400,       nonlactating dairy      provide 22.7 mg
                               varying with body        cattle: prevention of   decoquinate and 1 g
                               weight and feed          coccidiosis caused by   chlortetracycline/100
                               consumption to provide   Eimeria bovis and E.    lb body weight (0.5
                               10 mg/lb of body         zuernii, for            mg/kg)/day for not
                               weight per day..         treatment of            more than 5 days.
                                                        bacterial enteritis     Type C feed may be
                                                        caused by Escherichia   prepared from Type B
                                                        coli, and for           feed containing 535.8
                                                        treatment of            to 5,440 g/ton
                                                        bacterial pneumonia     decoquinate and 6,700
                                                        caused by Pasteurella   to 80,000 g/ton
                                                        multocida organisms     chlortetracycline.
                                                        susceptible to          When consumed, feed
                                                        chlortetracycline..     22.7 mg decoquinate/
                                                                                100 lb body weight/
                                                                                day for a total of 28
                                                                                days to prevent
                                                                                coccidiosis. Withdraw
                                                                                24 hours prior to
                                                                                slaughter. Do not
                                                                                feed to calves to be
                                                                                processed for veal.
                                                                                Do not feed to
                                                                                animals producing
                                                                                milk for food..
13.6 to 535.7 (0.0015 to      .......................  Cattle: prevention of   Feed Type C feed           046573
 0.059 pct).                                            coccidiosis in          (including dry milk
                                                        ruminating and          replacer) to provide
                                                        nonruminating calves    22.7 mg per 100 lb
                                                        (including veal         body weight (0.5 mg
                                                        calves) and cattle      per kg) per day. May
                                                        caused by Eimeria       be prepared from dry
                                                        bovis and E. zurnii..   Type B feed
                                                                                containing 0.06 to
                                                                                0.6 pct decoquinate
                                                                                or liquid Type B feed
                                                                                containing 0.0125 to
                                                                                0.05 pct decoquinate.
                                                                                The liquid Type B
                                                                                feed must have pH 5.0
                                                                                to 6.5 and contain a
                                                                                suspending agent to
                                                                                maintain a viscosity
                                                                                of not less than 500
                                                                                centipoises. Feed at
                                                                                least 28 days during
                                                                                period of exposure to
                                                                                coccidiosis or when
                                                                                it is likely to be a
                                                                                hazard. Do not feed
                                                                                to animals producing
                                                                                milk for food.
                                .....................  Young sheep:            ......do..............   ......do
                                                        prevention of
                                                        coccidiosis caused by
                                                        Eimeria ovinoidalis,
                                                        E. parva, E.
                                                        bakuensis, E.
                                                        crandallis..
                                .....................  Young goats:            ......do..............   ......do
                                                        prevention of
                                                        coccidiosis caused by
                                                        Eimeria christenseni,
                                                        E. ninakohlyakimovae..
27.2 (0.003 pct)............  .......................  Broiler chickens; for   Do not feed to laying      046573
                                                        the prevention of       chickens.
                                                        coccidiosis caused by
                                                        Eimeria tenella, E.
                                                        necatrix, E. mivati,
                                                        E. acervulina, E.
                                                        maxima and E.
                                                        brunetti.
                              Bacitracin 4 to 50.....  Broiler chickens; for   Do not feed to laying      046573
                                                        the prevention of       chickens; feed
                                                        coccidiosis caused by   continuously as sole
                                                        Eimeria tenella, E.     ration; bacitracin
                                                        necatrix, E. mivati,    methylene
                                                        E. acervulina, E.       disalicylate as
                                                        maxima, and E.          provided by 046573 in
                                                        brunetti, and for       Sec.  510.600(c) of
                                                        increased rate of       this chapter..
                                                        weight gain and
                                                        improved feed
                                                        efficiency..
                              Bacitracin 10 to 50....  Broiler chickens; for   Do not feed to laying      046573
                                                        the prevention of       chickens; feed as
                                                        coccidiosis caused by   sole ration; as zinc
                                                        Eimeria tenella, E.     bacitracin provided
                                                        necatrix, E. mivati,    by Nos. 046573 and
                                                        E. acervulina, E.       011716 in sec.
                                                        maxima, and E.          510.600(c) of this
                                                        brunetti; for           chapter.
                                                        increased rate of
                                                        weight gain and
                                                        improved feed
                                                        efficiency.

[[Page 398]]


                              Bacitracin methylene     Broiler chickens; for   Feed continuously as       046573
                               disalicylate 50 and      prevention of           sole ration. Withdraw
                               roxarsone 22.7-45.4.     coccidiosis caused by   5 days before
                                                        Eimeria tenella, E.     slaughter. Do not
                                                        necatrix, E. mivati,    feed to laying
                                                        E. acervulina, E.       chickens. Not for use
                                                        maxima, E. brunetti;    in breeder chickens.
                                                        as an aid in the        Use as sole source of
                                                        prevention of           organic arsenic.
                                                        necrotic enteritis      Poultry should have
                                                        caused or complicated   access to drinking
                                                        by Clostridium spp.     water at all times.
                                                        or other organisms      Drug overdosage or
                                                        susceptible to          lack of drinking
                                                        bacitracin; for         water may result in
                                                        increased rate of       leg weakness or
                                                        weight gain, improved   paralysis.
                                                        feed efficiency, and    Decoquinate,
                                                        improved pigmentation.  bacitracin methylene
                                                                                disalicylate, and
                                                                                roxarsone, as
                                                                                provided by No.
                                                                                046573 in Sec.
                                                                                510.600(c) of this
                                                                                chapter.
                              Chlortetracycline 100    Chickens; for the       Do not feed to             046573
                               to 200.                  prevention of           chickens producing
                                                        coccidiosis caused by   eggs for human
                                                        Eimeria tenella, E.     consumption; in low
                                                        necatrix, E. mivati,    calcium feed
                                                        E. acervulina, E.       containing 0.8 pct.
                                                        maxima, and E.          of calcium; feed
                                                        brunetti; control of    continuously 7 to 14
                                                        infectious synovitis    days.
                                                        caused by Mycoplasma
                                                        synoviae susceptible
                                                        to chlortetracycline.
                              Chlortetracycline 200    Chickens; for the       ......do..............     046573
                               to 400.                  prevention of
                                                        coccidiosis caused by
                                                        E. tenella, E.
                                                        necatrix, E. mivati ,
                                                        E. acervulina, E.
                                                        maxima, and E.
                                                        brunetti; control of
                                                        chronic respiratory
                                                        disease (CRD) and air
                                                        sac infection caused
                                                        by M. gallisepticum
                                                        and E. coli
                                                        susceptible to
                                                        chlortetracycline.
                              Roxarsone 45.4 (0.005    Broiler chickens; for   Do not feed to laying      046573
                               pct.).                   the prevention of       chickens; withdraw 5
                                                        coccidiosis caused by   days before
                                                        Eimeria tenella, E.     slaughter; as sole
                                                        necatrix, E. mivati,    source of organic
                                                        E. acervulina, E.       arsenic.
                                                        maxima, and E.
                                                        brunetti; growth
                                                        promotion and feed
                                                        efficiency; improving
                                                        pigmentation.
                              Lincomycin 2...........  Broiler chickens; for   Do not feed to laying     000009,
                                                        the prevention of       chickens; feed as         046573
                                                        coccidiosis caused by   sole ration; as
                                                        Eimeria tenella, E.     lincomycin
                                                        necatrix, E.            hydrochloride
                                                        acervulina, E.          monohydrate provided
                                                        maxima, E. mivati,      by No. 000009 in sec.
                                                        and E. brunetti; for    510.600(c) of this
                                                        increased rate of       chapter.
                                                        weight gain and
                                                        improved feed
                                                        efficiency.
                              Roxarsone 11 to 45       Broiler chickens; for   Do not feed to laying      046573
                               (0.0012-0.005 pct.)      the prevention of       chickens; withdraw 5
                               plus Bacitracin 12 to    coccidiosis caused by   days before
                               50.                      Eimeria tenella, E.     slaughter; as sole
                                                        necatrix, E.            source of organic
                                                        acervulina, E.          arsenic; as zinc
                                                        mivati, E. maxima,      bacitracin provided
                                                        and E. brunetti; for    by Nos. 011716,
                                                        increased rate of       046573, and 063238 in
                                                        weight gain and         sec. 510.600(c) of
                                                        improved feed           this chapter; as
                                                        efficiency.             roxarsone provided by
                                                                                No. 046573 in sec.
                                                                                510.600(c) of this
                                                                                chapter.
----------------------------------------------------------------------------------------------------------------


[40 FR 13959, Mar. 27, 1975]

    Editorial Note: For Federal Register citations affecting 
Sec. 558.195, see the List of CFR Sections Affected, which appears in 
the Finding Aids section of the printed volume and on GPO Access.