Section

[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: 21CFR558.58]

[Page 377-382]

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. 558.58 Amprolium and ethopabate.

(a) Approvals. Type A medicated articles: (1) 25 percent amprolium
and 0.8 percent ethopabate; 25 percent amprolium and 8 percent
ethopabate; 5 percent amprolium and 0.16 percent ethopabate; 5 percent
amprolium and 1.6 percent ethopabate; to 000006.
(2) 0.15 percent amprolium and 0.004 percent ethopabate and 0.05
gram per pound bacitracin (as bacitracin methylene disalicylate) to
047019 in Sec. 510.600(c) of this chapter.
(b) Special considerations. Do not use in Type B or Type C medicated
feeds containing bentonite.
(c) Related tolerances. See Sec. Sec. 556.50 and 556.260 of this
chapter.
(d) Conditions of use. (1) It is used for chickens as follows:

----------------------------------------------------------------------------------------------------------------
Amprolium and ethopabate in Combination in grams
grams per ton per ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) Amprolium 113.5 (0.0125 ....................... Broiler chickens as an Not for laying hens; .........
pct) and ethopabate 3.6 aid in the prevention as sole source of
(0.0004 pct). of coccidiosis. amprolium.

[[Page 378]]

(ii) Amprolium 113.5 Bambermycins 2 to 3 Broiler chickens; as Feed continuously as .........
(0.0125%) and ethopabate plus roxarsone 22.8 to an aid in the the sole ration; as
3.6 (0.0004%). 34.1 (0.0025% to prevention of sole source of
0.00375%). coccidiosis; for amprolium and organic
increased rate of arsenic; amprolium
weight gain, improved and ethopabate as
feed efficiency, and provided by No.
pigmentation. 050604 in Sec.
510.600(c) of this
chapter, roxarsone by
No. 046573,
bambermycins by No.
057926; withdraw 5 d
before slaughter.
Lincomycin 2 to 4...... Broiler chickens; for Not for laying .........
increase in rate of chickens; as
weight gain; improved lincomycin
feed efficiency; as hydrochloride
an aid in the monohydrate; as sole
prevention of source of amprolium.
coccidiosis.
Lincomycin 2 to 4 plus Broiler chickens; for Not for laying .........
roxarsone 45.4 increase in rate of chickens; as
(0.005%). weight gain; improved lincomycin
feed efficiency and hydrochloride
pigmentation; as an monohydrate; withdraw
aid in the prevention 5 d before slaughter;
of coccidiosis. as sole source of
amprolium and organic
arsenic.
Roxarsone 45.4 (0.005 Broiler chickens; to Do not feed to laying .........
pct). aid in prevention of chickens; withdraw 5
coccidiosis where d before slaughter;
severe exposure to as sole source of
coccidiosis from amprolium; do not use
Eimeria acervulina, as a treatment for
E. maxima, and E. outbreaks of
brunetti is likely to coccidiosis; feed as
occur; for increased sole ration from time
rate of weight gain chickens are placed
in broiler chickens on litter until the
raised in floor pens. past the time when
coccidiosis is
ordinarily a hazard;
roxarsone as provided
by No. 046573 in Sec.
510.600(c) of this
chapter; combinations
as provided by No.
050604.
(iii) Amprolium 113.5 ....................... Broiler chickens and Not for chickens over .........
(0.0125%) and ethopabate replacement chickens 16 weeks of age.
36.3 (0.004%). where immunity to
coccidiosis is not
desired; as an aid in
the prevention of
coccidiosis where
severe exposure to
coccidiosis from
Eimeria acervulina,
E. maxima, and E.
brunetti is likely to
occur.
Arsanilic acid 90 (0.01 Broiler chickens and Not for laying hens; 061133
pct) plus erythromycin replacement chickens withdraw 5 d before
4.6 to 18.5. where immunity to slaughter; as sole
coccidiosis is not source of organic
desired; prevention arsenic; as
of coccidiosis; erythromycin
growth promotion and thiocyanate.
feed efficiency;
improve pigmentation.
Bacitracin 4 to 50..... 1. Broiler chickens Not for chickens over .........
and replacement 16 weeks of age; do
chickens where not feed to laying
immunity to chickens; as sole
coccidiosis is not source of amprolium;
desired; to aid in not for use as a
prevention of treatment for
coccidiosis where outbreaks of
severe exposure to coccidiosis; as
coccidiosis from bacitracin methylene
Eimeria acervulina, disalicylate as
E. maxima, and E. provided by No.
brunetti is likely to 046573 or bacitracin
occur; for increased zinc as provided by
rate of weight gain No. 046573 in Sec.
in broiler chickens 510.600(c) of this
raised in floor pens. chapter; feed as the
sole ration from the
time chickens are
placed on litter
until past the time
when coccidiosis is
ordinarily a hazard;
combination as
provided by No.
050604 in Sec.
510.600(c) of this
chapter.

[[Page 379]]

....................... 2. Broiler chickens; Not for chickens over 046573
as an aid in 16 weeks of age; do
prevention of not feed to laying
coccidiosis where chickens; as sole
severe exposure to source of amprolium;
coccidiosis from not for use as a
Eimeria acervulina, treatment for
E. maxima, and E. coccidiosis;
brunetti is likely to bacitracin zinc as
occur; improved feed provided by No.
efficiency. 046573 in Sec.
510.600(c) of this
chapter; feed as the
sole ration from the
time chickens are
placed on litter
until market weight;
combination as
provided by No.
046573..
Bacitracin 5 to 35 plus Broiler chickens; for Do not feed to laying .........
roxarsone 34 increased rate of chickens; withdraw 5
(0.00375%). weight gain and as an d before slaughter;
aid in the prevention as sole source of
of coccidiosis where amprolium and organic
severe exposure to arsenic; do not use
coccidiosis from as a treatment for
Eimeria acervulina, outbreaks of
E. maxima, and E. coccidiosis; feed as
brunetti is likely to the sole ration from
occur in broiler time chickens are
chickens raised in placed on litter
floor pens. until past the time
when coccidiosis is
ordinarily a hazard;
amprolium and
ethopabate as
provided by No.
050604 in Sec.
510.600(c) of this
chapter; bacitracin
methylene
disalicylate as
provided by No.
046573 or bacitracin
zinc as provided by
No. 046573 in Sec.
510.600(c) of this
chapter; roxarsone as
provided by No.
046573 in Sec.
510.600(c) of this
chapter; combination
as provided by No.
050604 in Sec.
510.600(c) of this
chapter.
Bacitracin 20 to 35 Broiler chickens; for Do not feed to laying .........
plus roxarsone 34 increased rate of chickens; withdraw 5
(0.00375%). weight gain, improved d before slaughter;
feed efficiency, and as sole source of
as an aid in the amprolium and organic
prevention of arsenic; do not use
coccidiosis where as a treatment for
severe exposure to outbreaks of
coccidiosis from coccidiosis; feed as
Eimeria acervulina, the sole ration from
E. maxima, and E. time chickens are
brunetti is likely to placed on litter
occur in broiler until past the time
chickens raised in when coccidiosis is
floor pens. ordinarily a hazard;
amprolium and
ethopabate as
provided by No.
050604 in Sec.
510.600(c) of this
chapter; bacitracin
methylene
disalicylate as
provided by No.
046573 in Sec.
510.600(c) of this
chapter; roxarsone as
provided by No.
046573 in Sec.
510.600(c) of this
chapter; combination
as provided by No.
050604 in Sec.
510.600(c) of this
chapter.

[[Page 380]]

Bacitracin 10 to 50 Broiler chickens; as Do not feed to laying 046573
plus roxarsone 15.4 to an aid in prevention chickens; withdraw 5
45.4 (0.0017% to of coccidiosis where d before slaughter;
0.005%). severe exposure to as sole source of
coccidiosis from amprolium and organic
Eimeria acervulina, arsenic; do not use
E. maxima, and E. as a treatment for
brunetti is likely to outbreaks of
occur; improved feed coccidiosis; feed as
efficiency. the sole ration from
time chicks are
placed on litter
until past the time
when coccidiosis is
ordinarily a hazard;
amprolium and
ethopabate as
provided by No.
050604 in Sec.
510.600(c) of this
chapter; bacitracin
zinc as provided by
No. 046573 roxarsone
as provided by No.
046573 combination as
provided by No.
046573.
Bacitracin 10 plus Broiler chickens; as ......do.............. 063238
roxarsone 30 to 45.4 an aid in prevention
(0.0033% to 0.005%). of coccidiosis where
severe exposure to
coccidiosis from E.
acervulina, E.
maxima, and E.
brunetti is likely to
occur; improved feed
efficiency and
improved pigmentation.
Bambermycins 1 to 3.... Broiler chickens; as Feed continuously as .........
an aid in the the sole ration; as
prevention of sole source of
coccidiosis where amprolium; amprolium,
severe exposure to ethopabate as
coccidiosis from provided by No.
Eimeria acervulina, 050604 in Sec.
E. maxima, and E. 510.600(c) of this
brunetti is likely to chapter, bambermycins
occur; for increased as provided by No.
rate of weight gain, 057926 in Sec.
and improved feed 510.600(c) of this
efficiency. chapter.
Bambermycins 1 to 3 Broiler chickens; as Feed continuously as .........
plus roxarsone 22.8 to an aid in the the sole ration; as
34.1 (0.0025% to prevention of sole source of
0.00375%). coccidiosis where amprolium and organic
severe exposure to arsenic; amprolium
coccidiosis from and ethopabate as
Eimeria acervulina, provided by No.
E. maxima, and E. 050604 in Sec.
brunetti is likely to 510.600(c) of this
occur; for increased chapter, roxarsone by
rate of weight gain; No. 046573
improved feed bambermycins by No.
efficiency, and 057926. Withdraw 5
improved pigmentation. days before slaughter.
Erythromycin 4.6 to Broiler chickens and Not for laying hens; .........
18.5. replacement chickens withdraw 24 hours
where immunity to before slaughter;
coccidiosis is not erythromycin
desired; prevention thiocyanate.
of coccidiosis;
growth promotion and
feed efficiency.
Virginiamycin, 15...... Broiler chickens, as Feed continuously as 000069
an aid in the sole ration, do not
prevention of feed to laying hens,
coccidiosis where not for chickens over
severe exposure to 16 weeks of age, as
Eimeria acervulina, sole source of
E. brunetti, and E. amprolium, amprolium
maxima is likely to and ethopabate as
occur, for increased provided by 050604 in
rate of weight gain Sec. 510.600(c),
and improved feed virginiamycin as
efficiency. provided by 066104.
Virginiamycin, 5 to 15. Broiler chickens, as ......do.............. .........
an aid in the
prevention of
coccidiosis where
severe exposure to
Eimeria acervulina,
E. brunetti, and E.
maxima is likely to
occur, for increased
rate of weight gain.
(iv) Amprolium 113.5 to 227 ....................... For broiler chickens Not for laying hens... .........
(0.0125% to 0.025%) and and replacement
ethopabate 3.6 (0.0004%). chickens where
immunity to
coccidiosis is not
desired; prevention
of coccidiosis.

[[Page 381]]

Arsanilic acid 90 Broiler chickens and As sole source of .........
(0.01%). replacement chickens organic arsenic;
where immunity to withdraw 5 d before
coccidiosis is not slaughter; not for
desired; prevention laying hens.
of coccidiosis;
growth promotion and
feed efficiency;
improving
pigmentation.
Arsanilic acid 90 1. For broiler Feed for 2 d before .........
(0.01%) plus chickens and stress and 3 to 6 d
erythromycin 92.5. replacement chickens after stress;
where immunity to withdraw 5 d before
coccidiosis is not slaughter; as sole
desired; prevention source of organic
of coccidiosis; as an arsenic; not for
aid in the prevention laying hens.
of chronic
respiratory disease
during periods of
stress; growth
promotion and feed
efficiency; improving
pigmentation.
2. For broiler Feed for 7 to 14 d; .........
chickens and withdraw 5 d before
replacement chickens slaughter; as sole
where immunity to source of organic
coccidiosis is not arsenic; not for
desired; prevention laying hens.
of coccidiosis; as an
aid in the prevention
of infectious coryza;
growth promotion and
feed efficiency;
improving
pigmentation.
Arsanilic acid 90 For broiler chickens Feed for 5 to 8 d; do .........
(0.01%) plus and replacement not use in birds
erythromycin 185. chickens where producing eggs for
immunity to food purposes;
coccidiosis is not withdraw 5 d before
desired; prevention slaughter; as sole
of coccidiosis; as an source of organic
aid in the prevention arsenic.
and reduction of
lesions and in
lowering severity of
chronic respiratory
disease; growth
promotion and feed
efficiency; improving
pigmentation.
Bacitracin 4 to 50..... For broiler chickens As bacitracin .........
and replacement methylene
chickens where disalicylate; not for
immunity to laying hens.
coccidiosis is not
desired; prevention
of coccidiosis;
growth promotion and
feed efficiency.
Bacitracin 100 to 200.. 1. Broiler chickens ......do.............. .........
and replacement
chickens where
immunity to
coccidiosis is not
desired; prevention
of coccidiosis;
treatment of chronic
respiratory disease
(air-sac infection)
and blue comb
(nonspecific
infectious enteritis).
2. For broiler As zinc bacitracin, .........
chickens and not for laying hens.
replacement chickens
where immunity to
coccidiosis is not
desired; prevention
of coccidiosis;
treatment of chronic
respiratory disease
(air-sac infection),
blue comb
(nonspecific
infectious enteritis).
Bacitracin 4 to 50 plus Broiler chickens and As bacitracin .........
roxarsone 22.7 to 45.4 replacement chickens methylene
(0.0025% to 0.005%). where immunity to disalicylate; not for
coccidiosis is not laying hens; as sole
desired; prevention source of organic
of coccidiosis; arsenic; withdraw 5 d
growth promotion and before slaughter.
feed efficiency;
improving
pigmentation.
Chlortetracycline 100 For chickens where Do not feed to .........
to 200. immunity to chickens producing
coccidiosis is not eggs for human
desired; prevention consumption. Feed for
of coccidiosis; 7 to 14 d.
control of infectious
synovitis caused by
Mycoplasma synoviae
susceptible to
chlortetracycline.

[[Page 382]]

Chlortetracycline 200 For chickens where In low calcium feed .........
to 400. immunity to containing 0.8%
coccidiosis is not dietary calcium and
desired; prevention 1.5% sodium sulfate;
of coccidiosis; feed continuously as
control of chronic sole ration for 7 to
respiratory disease 14 d; do not feed to
(CRD) and air sac chickens producing
infection caused by eggs for human
M. gallisepticum and consumption.
E. coli susceptible
to chlortetracycline.
Erythromycin 92.5...... 1. For broiler Feed for 2 d before .........
chickens and for stress and 3 to 6 d
replacement chickens after stress;
where immunity to withdraw 24 h before
coccidiosis is not slaughter; not for
desired; prevention laying hens.
of coccidiosis; as an
aid in the prevention
of chronic
respiratory disease
during periods of
stress.
2. For broiler Feed for 7 to 14 d; .........
chickens and withdraw 24 h before
replacement chickens slaughter; not for
where immunity to laying hens.
coccidiosis is not
desired; prevention
of coccidiosis; as an
aid in the prevention
of infectious coryza.
Erythromycin 185....... For broiler chickens Feed for 5 to 8 d; do .........
and replacement not use in birds
chickens where producing eggs for
immunity to food purposes;
coccidiosis is not withdraw 48 h before
desired; prevention slaughter.
of coccidiosis; as an
aid in the prevention
and reduction of
lesions and in
lowering severity of
chronic respiratory
disease.
Penicillin 2.4 to 50... For broiler chickens Not for laying hens; .........
and replacement as procaine
chickens where penicillin.
immunity to
coccidiosis is not
desired; prevention
of coccidiosis;
growth promotion and
feed efficiency;
improving
pigmentation.
Roxarsone 22.7 to 45.4 Broiler chickens and As sole source of .........
(0.0025% to 0.005%). replacement chickens organic arsenic;
where immunity to withdraw 5 d before
coccidiosis is not slaughter; not for
desired; prevention laying hens.
of coccidiosis;
growth promotion and
feed efficiency;
improving
pigmentation.
----------------------------------------------------------------------------------------------------------------

(2) [Reserved]

[41 FR 10990, Mar. 15, 1976]

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