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: 21CFR558.55]

[Page 371-377]

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. 558.55 Amprolium.

(a) Approvals. Type A medicated articles: 25 percent to 050604 in
Sec. 510.600(c) of this chapter for use as in paragraph (d) of this
section.
(b) Special considerations. Do not use in Type B or Type C medicated
feeds containing bentonite.
(c) Related tolerances. See Sec. 556.50 of this chapter.
(d) Conditions of use--(1) Calves. It is top-dressed on or
thoroughly mixed in the daily feed ration as follows:
(i) Amount. 227 milligrams per 100 pounds (5 milligrams per
kilogram) body weight per day.
(a) Indications for use. As an aid in the prevention of coccidiosis
caused by Eimeria bovis and E. zurnii.
(b) Limitations. Administer from a Type B feed containing from 0.05
to 1.25 percent amprolium with the usual amount of feed consumed in 1
day; feed for 21 days during periods of exposure or when experience
indicates that coccidiosis is likely to be a hazard; withdraw 24 hours
before slaughter; as sole source of amprolium.
(ii) Amount. 454 milligrams per 100 pounds (10 milligrams per
kilogram) body weight per day.
(a) Indications for use. As an aid in the treatment of coccidiosis
caused by Eimeria bovis and E. zurnii.
(b) Limitations. Administer from a Type B feed containing from 0.05
to 1.25 percent amprolium with the usual amount of feed consumed in 1
day; feed for 5 days; for a satisfactory diagnosis, a microscopic
examination of the feces should be done by a veterinarian or diagnostic
laboratory before treatment; when treating outbreaks, the drug should be
administered promptly after diagnosis is determined; withdraw 24 hours
before slaughter; as sole source of amprolium.
(2) Chickens and turkeys. It is used as follows:

----------------------------------------------------------------------------------------------------------------
Combination in grams per
Amprolium in grams per ton ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 36.3 to 113.5 (0.004% ........................... Replacement chickens; Feed as follows--
to 0.0125%). development of active
immunity to
coccidiosis.
----------------------------------------------------------------------------------------------------------------

[[Page 372]]

Up to 5 weeks of From 5 to 8 Over 8 weeks of
Growing conditions age weeks of age age
----------------------------------------------------------------------------------------------------------------
Amprolium Amprolium Amprolium
grams per ton grams per ton grams per ton

Severe exposure to 113.5 (0.0125%) 72.6-113.5 36.3-113.5
coccidiosis. (0.008%- (0.004%-
0.0125%) 0.0125%)
Moderate exposure to 72.6-113.5 54.5-113.5 36.3-113.5
coccidiosis. (0.008%- (0.006%- (0.004%-
0.0125%) 0.0125%) 0.0125%)
Slight exposure to 36.3-113.5 36.3-113.5 36.3-113.5
coccidiosis. (0.004%- (0.004%- (0.004%-
0.0125%) 0.0125%) 0.0125%)
-------------------------

----------------------------------------------------------------------------------------------------------------
Combination in grams
Amprolium in grams per ton per ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
Arsanilate sodium 90 Replacement chickens; Withdraw 5 d before
(0.01%). development of active slaughter; as sole
immunity to source of organic
coccidiosis; growth arsenic; feed
promotion and feed according to subtable
efficiency; improving in item (i).
pigmentation.

Arsanilic acid 90 Replacement chickens; Withdraw 5 d before
(0.01%). development of active slaughter; as sole
immunity to source of organic
coccidiosis; growth arsenic; feed
promotion and feed according to subtable
efficiency; improving in item (i).
pigmentation.

Arsanilic acid 90 Replacement chickens; Withdraw 5 d before
(0.01%) plus development of active slaughter; as sole
erythromycin 4.6 to immunity to source of organic
18.5. coccidiosis; growth arsenic. Feed
promotion and feed according to subtable
efficiency; improving in item (i).
pigmentation.
Arsanilic acid 90 1. Replacement Feed for 2 d before
(0.01%) plus chickens; development stress and 3 to 6 d
erythromycin 92.5. of active immunity to after stress;
coccidiosis; growth withdraw 5 d before
promotion and feed slaughter; as sole
efficiency; improving source of organic
pigmentation; as an arsenic. Feed
aid in the prevention according to subtable
of chronic in item (i).
respiratory disease
during periods of
stress.
2. Replacement Feed for 7 to 14 d;
chickens; development withdraw 5 d before
of active immunity to slaughter; as sole
coccidiosis; growth source of organic
promotion and feed arsenic. Feed
efficiency; improving according to subtable
pigmentation; as an in item (i).
aid in the prevention
of infectious coryza.
(i) 36.3 to 113.5 (0.004% to Arsanilic acid 90 Replacement chickens; Feed for 5 to 8 d; do .........
0.0125%). (0.01%) plus development of active not use in birds
erythromycin 185. immunity to producing eggs for
coccidiosis; growth food purposes;
promotion and feed withdraw 5 d before
efficiency; improving slaughter; as sole
pigmentation; as an source of organic
aid in the prevention arsenic. Feed
and reduction of according to subtable
lesions and in in item (i).
lowering severity of
chronic respiratory
disease.
Bacitracin 100 to 200.. Replacement chickens; As bacitracin .........
development of active methylene
immunity to disalicylate or
coccidiosis; bacitracin zinc. Feed
treatment of chronic according to subtable
respiratory disease in item (i).
(air-sac infection)
and blue comb
(nonspecific
infectious enteritis).
Bacitracin methylene Replacement chickens; Feed according to 046573
disalicylate 4 to 50.. development of active subtable in item (i);
immunity to bacitracin methylene
coccidiosis, disalicylate as
increased rate of provided by 046573 in
weight gain, and Sec. 510.600(c) of
improved feed this chapter..
efficiency..

[[Page 373]]

Bacitracin methylene Replacement chickens; Feed according to 046573
disalicylate 50 plus development of active subtable in entry
roxarsone 22.7 to immunity to (i); bacitracin
45.4.. coccidiosis; as an methylene
aid in the control of disalicylate and
necrotic enteritis roxarsone as provided
caused or complicated by 046573 in Sec.
by Clostridium spp. 510.600(c) of this
or other organisms chapter..
susceptible to
bacitracin; increased
rate of weight gain,
improved feed
efficiency, and
improved
pigmentation..
Chlortetracycline 100 Chickens; development Do not feed to .........
to 200. of active immunity to chickens producing
coccidiosis; control eggs for human
of infectious consumption. Feed for
synovitis caused by 7 to 14 d.
Mycoplasma synoviae
susceptible to
chlortetracycline.
Chlortetracycline 200 Chickens; development Do not feed to .........
to 400. of active immunity to chickens producing
coccidiosis; control eggs for human
of chronic consumption. Feed for
respiratory disease 7 to 14 d.
(CRD) and air sac
infection caused by
M. gallisepticum and
E. coli susceptible
to chlortetracycline.
Erythromycin 4.6 to Replacement chickens; As erythromycin .........
18.5. development of active thiocyanate. Feed
immunity to according to subtable
coccidiosis; growth in item (i).
promotion and feed
efficiency.
Erythromycin 92.5...... 1. Replacement Feed for 7 to 14 d; .........
chickens; development withdraw 24 h before
of active immunity to slaughter. Feed
coccidiosis; as an according to subtable
aid in the prevention in item (i).
of infectious coryza.
2. Replacement Feed for 2 d before .........
chickens; development stress and 3 to 6 d
of active immunity to after stress;
coccidiosis; as an withdraw 24 h before
aid in the prevention slaughter. Feed
of chronic according to subtable
respiratory disease in item (i).
during periods of
stress.
Erythromycin 185....... Replacement chickens; Feed for 5 to 8 d; do .........
development of active not use in birds
immunity to producing eggs for
coccidiosis; as an food purposes;
aid in the prevention withdraw 48 h before
and reduction of slaughter. Feed
lesions and in according to subtable
lowering severity of in item (i).
chronic respiratory
disease.
Hygromycin B 8 to 12... Replacement chickens; Feed according to .........
development of active subtable in item (i).
immunity to
coccidiosis; control
of infestation of
large round worms
(Ascaris galli),
cecal worms
(Heterakis gallinae),
and capillary worms
(Capillaria
obsignata).
Penicillin 2.4 to 50... Replacement chickens; As procaine .........
development of active penicillin. Feed
immunity to according to subtable
coccidiosis; growth in item (i).
promotion and feed
efficiency.
Roxarsone 22.7 to 45.4 Replacement chickens; Withdraw 5 d before .........
(0.0025% to 0.005%). development of active slaughter; as sole
immunity to source of organic
coccidiosis; growth arsenic. Feed
promotion, and feed according to subtable
efficiency; improving in item (i).
pigmentation.
(ii) 72.6 to 113.5 (0.008% ....................... Broiler chickens; Withdraw 5 d before .........
to 0.0125%). prevention of slaughter; as sole
coccidiosis caused by source of organic
Eimeria tenella only. arsenic. Feed
according to subtable
in item (i).
Arsanilate sodium 90 Broiler chickens; Withdraw 5 d before .........
(0.01%). prevention of slaughter; as sole
coccidiosis caused by source of organic
E. tenella only; arsenic.
growth promotion and
feed efficiency;
improving
pigmentation.

[[Page 374]]

Arsanilic acid 90 ......do.............. ......do.............. .........
(0.01%).
Bacitracin 100 to 200.. Broiler chickens; As bacitracin .........
prevention of methylene
coccidiosis caused by disalicylate, or zinc
E. tenella only; bacitracin.
treatment of chronic
respiratory disease
(air-sac infection)
and blue comb
(nonspecific
infectious enteritis).
Chlortetracycline 100 Chickens; prevention Do not feed to .........
to 200. of coccidiosis caused chickens producing
by E. tenella only; eggs for human
control of infectious consumption. Feed for
synovitis caused by 7 to 14 d.
M. synoviae
susceptible to
chlortetracycline.
Chlortetracycline 200 Chickens; prevention Do not feed to .........
to 400. of coccidiosis caused chickens producing
by E. tenella only; eggs for human
control of chronic consumption. Feed for
respiratory disease 7 to 14 d.
(CRD) and air sac
infection caused by
M. gallisepticum and
E. coli susceptible
to chlortetracycline.
Hygromycin B 8 to 12... Broiler chickens; Feed according to .........
prevention of subtable in item (i).
coccidiosis caused by
Eimeria tenella only;
control of
infestation of large
round worms
(Heterakis gallinae),
and capillary worms
(Capillaria
obsignata).
Penicillin 2.4 to 50... Broiler chickens; As procaine penicillin .........
prevention of
coccidiosis caused by
E. tenella only;
growth promotion and
feed efficiency.
Roxarsone 22.7 to 45.4 Broiler chickens; Withdraw 5 d before .........
(0.0025% to 0.005%). prevention of slaughter; as sole
coccidiosis caused by source of organic
E. tenella only; arsenic.
growth promotion and
feed efficiency;
improving
pigmentation.
(iii) 113.5 (0.0125%)....... ....................... 1. Laying chickens; ...................... .........
prevention of
coccidiosis.
2. Laying chickens; For moderate outbreaks .........
treatment of of coccidiosis;
coccidiosis. administer for 2
weeks.
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; for amprolium and organic
increased rate of arsenic; roxarsone as
weight gain, improved provided by No.
feed efficiency, and 053501 in Sec.
improved pigmentation. 510.600(c) of this
chapter, bambermycins
by No. 057926;
withdraw 5 d before
slaughter.
Bambermycins 1 to 4.... Growing turkeys; Feed continuously as 057926
prevention of the sole source of
coccidiosis; amprolium;
increased rate of bambermycins as
weight gain and provided by No.
improved feed 057926 in Sec.
efficiency. 510.600(c) of this
chapter.
(iv) 113.5 to 227 (0.0125% ....................... 1. Broiler chickens ...................... .........
to 0.025%). and replacement
chickens where
immunity to
coccidiosis is not
desired; prevention
of coccidiosis.
2. Turkeys; prevention ...................... .........
of coccidiosis.
Arsanilate sodium 90 1. Broiler chickens Withdraw 5 d before .........
(0.01%). and replacement slaughter; as sole
chickens where source of organic
immunity to arsenic.
coccidiosis is not
desired; prevention
of coccidiosis;
growth promotion and
feed efficiency;
improving
pigmentation.

[[Page 375]]

2. Turkeys; prevention ......do.............. .........
of coccidiosis;
growth promotion and
feed efficiency;
improving
pigmentation.
Arsanilic acid 90 1. Broiler chickens ......do.............. .........
(0.01%). and replacement
chickens where
immunity to
coccidiosis is not
desired; prevention
of coccidiosis;
growth promotion and
feed efficiency;
improving
pigmentation.
2. Turkeys; prevention ......do.............. .........
of coccidiosis;
growth promotion and
feed efficiency;
improving
pigmentation.
Arsanilic acid 90 1. Broiler chickens Feed for 2 d before .........
(0.01%) plus and replacement stress and 3 to 6 d
erythromycin 92.5. chickens where after stress;
immunity to withdraw 5 d before
coccidiosis is not slaughter; as sole
desired; prevention source of organic
of coccidiosis; arsenic.
growth promotion and
feed efficiency;
improving
pigmentation; as an
aid in the prevention
of chronic
respiratory disease
during periods of
stress.
2. Broiler chickens Feed for 7 to 14 d; .........
and replacement withdraw 5 d before
chickens where slaughter; as sole
immunity to source of organic
coccidiosis is not arsenic.
desired; prevention
of coccidiosis;
growth promotion and
feed efficiency;
improving
pigmentation; as an
aid in the prevention
of infectious coryza.
Arsanilic acid 90 Broiler chickens and Feed for 5 to 8 d; do .........
(0.01%) plus replacement chickens not use in birds
erythromycin 185. where immunity to producing eggs for
coccidiosis is not food purposes;
desired; prevention withdraw 5 d before
of coccidiosis; slaughter; as sole
growth promotion and source of organic
feed efficiency; arsenic.
improving
pigmentation; as an
aid in the prevention
and reduction of
lesions and in
lowering severity of
chronic respiratory
disease.
Arsanilic acid 90 Broiler chickens and Withdraw 5 d before .........
(0.01%) plus replacement chickens slaughter; as sole
erythromycin 4.6 to where immunity to source of organic
18.5. coccidiosis is not arsenic.
desired; prevention
of coccidiosis;
growth promotion and
feed efficiency;
improved pigmentation.
Bacitracin 4 to 50..... 1. Broiler chickens As bacitracin \1\
and replacement methylene 012769
chickens where disalicylate or
immunity to bacitracin zinc.
coccidiosis is not
desired; prevention
of coccidiosis;
growth promotion and
feed efficiency.
2. Turkeys; prevention ......do.............. .........
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),
blue comb
(nonspecific
infectious enteritis).

[[Page 376]]

2. Broiler chickens As bacitracin zinc.... .........
and replacement
chickens where
immunity to
coccidiosis is not
desired; prevention
of coccidiosis;
treatment of chronic
ry disease (air-sac
infection), blue comb
(nonspecific
infectious enteritis).
Bacitracin 100 to 500.. Turkeys; prevention of As bacitracin zinc.... .........
coccidiosis;
treatment of
infectious sinusitis,
blue comb (mud fever).
Bacitracin plus ......do.............. Feed contains 50% to .........
penicillin 100 to 500 75% of bacitracin but
(of combination). not more than 125 g
penicillin; as
procaine penicillin;
as bacitracin zinc.
Carbarsone 227 to 340.5 Turkeys; aid in Feed continuously 2 000006
prevention of weeks before
coccidiosis (Eimeria coccidiosis and
adenoeides, E. blackhead are
meleagrimitis, and E. expected and continue
gallopavonis) and as long as prevention
blackhead. is needed; withdraw 5
days before
slaughter; use as
sole source of
amprolium and organic
arsenic; do not use
as a treatment for
outbreaks of
coccidiosis;
carbarsone by 046573
in Sec. 510.600(c)
of this chapter.
Chlortetracycline 100 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
M. synoviae
susceptible to
chlortetracycline.
Chlortetracycline 200 Chickens where Do not feed to .........
to 400. immunity to chickens producing
coccidiosis is not eggs for human
desired; control of consumption. Feed for
chronic respiratory 7 to 14 d.
disease (CRD) and air
sac infection caused
by M. gallisepticum
and E. coli
susceptible to
chlortetracycline.
Erythromycin 4.6 to Broiler chickens and As erythromycin .........
18.5. replacement chickens thiocyanate.
where immunity to
coccidiosis is not
desired; prevention
of coccidiosis;
growth promotion and
feed efficiency.
Erythromycin 92.5...... 1. Broiler chickens Feed for 2 d before .........
and replacement stress and 3 to 6 d
chickens where after stress;
immunity to withdraw 24 h before
coccidiosis is not slaughter.
desired; prevention
of coccidiosis; as an
aid in the prevention
of chronic
respiratory disease
during periods of
stress.
2. Broiler chickens Feed for 7 to 14 d; .........
and replacement withdraw 24 h before
chickens where slaughter.
immunity to
coccidiosis is not
desired; prevention
of coccidiosis; as an
aid in the prevention
of infectious coryza.
Erythromycin 185....... Broiler chickens and Feed for 5 to 8 d, do .........
replacement chickens not use in birds
where immunity to producing eggs for
coccidiosis is not food purposes;
desired; prevention withdraw 48 h before
of coccidiosis; as an slaughter.
aid in the prevention
and reduction of
lesions and in
lowering severity of
chronic respiratory
disease.

[[Page 377]]

Hygromycin B 8 to 12... Broiler chickens and Feed according to .........
replacement chickens subtable in item (i).
where immunity to
coccidiosis is not
desired; prevention
of coccidiosis;
control of
infestation of large
round worms
(Heterakis gallinae)
and capillary worms
(Capillaria
obsignata).
Penicillin 2.4 to 50... 1. Broiler chickens As procaine penicillin .........
and replacement
chickens where
immunity to
coccidiosis is not
desired; prevention
of coccidiosis;
growth promotion and
feed efficiency.
2. Turkeys; prevention ......do.............. .........
of coccidiosis;
growth promotion and
feed efficiency.
Roxarsone 22.7 to 45.4 1. Broiler chickens Withdraw 5 d before .........
(0.0025% to 0.005%). and replacement slaughter; as sole
chickens where source of organic
immunity to arsenic.
coccidiosis is not
desired; prevention
of coccidiosis;
growth promotion and
feed efficiency;
improving
pigmentation.
2. Turkeys; prevention ......do.............. .........
of coccidiosis;
growth promotion and
feed efficiency;
improving
pigmentation.
(v) 227 (0.025%)............ ....................... Laying chickens; For severe outbreaks .........
treatment of of coccidiosis;
coccidiosis. administer for 2
weeks.
----------------------------------------------------------------------------------------------------------------

(3) Pheasants. It is used as follows:
(i) Amount. 0.0175 percent (159 grams per ton).
(ii) Indications for use. For the prevention of coccidiosis in
growing pheasants caused by Eimeria colchici, E. duodenalis, and E.
phasiani.
(iii) Limitations. Feed continuously as sole ration. Use as sole
source of amprolium. Fertility, hatchability, and other reproductive
data are not available on amprolium in breeding pheasants. Do not use in
feeds containing bentonite.

[41 FR 10985, Mar. 15, 1976]

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