CFR 2000 Title21 Vol6 Part558
CFR 2000 Title21 Vol6 Part558
CFR 2000 Title21 Vol6 Part558
558
558.415 Novobiocin.
558.430 Nystatin.
558.435 Oleandomycin.
558.450 Oxytetracycline.
558.460 Penicillin.
558.464 Poloxalene.
558.465 Poloxalene free-choice liquid Type C
feed.
558.485 Pyrantel tartrate.
558.500 Ractopamine.
558.515 Robenidine hydrochloride.
558.530 Roxarsone.
558.550 Salinomycin.
558.555 Semduramicin.
558.575 Sulfadimethoxine, ormetoprim.
558.579 Sulfaethoxypyridazine.
558.582 Sulfamerazine.
558.586 Sulfaquinoxoline.
558.600 Tiamulin.
558.615 Thiabendazole.
558.618 Tilmicosin.
558.625 Tylosin.
558.630 Tylosin and sulfamethazine.
558.635 Virginiamycin.
558.680 Zoalene.
AUTHORITY: 21 U.S.C. 360b, 371.
SOURCE: 40 FR 13959, Mar. 27, 1975, unless
otherwise noted.
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558.4
CATEGORY I
Assay limits
percent 1 type
A
Drug
Aklomide ..................................................
Amprolium with Ethopabate ....................
Bacitracin methylene disalicylate ............
90110
94114
85115
85120.
80120.
70130.
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558.4
Drug
84115
90110
90110
85115
95115
90105
100115
90110
94113
85115
85115
90110
95115
Lincomycin ...............................................
Melengestrol acetate ...............................
Monensin .................................................
90115
90110
90110
Narasin ....................................................
Nequinate ................................................
Niclosamide .............................................
Nystatin ....................................................
Oleandomycin ..........................................
90110
95112
85120
85125
85120
Oxytetracycline ........................................
Penicillin ..................................................
Poloxalene ...............................................
Ractopamine ...........................................
Salinomycin .............................................
Semduramicin ..........................................
Tiamulin ...................................................
90120
80120
90110
85105
95115
90110
113.4 g/lb,
100108
5 and 10 g/
1b, 90115
80120
85115
92104
70130.
80120/70130.
80120.
80115/70130.
80120.
80120.
90120/80130.
85115/70120.
80120.
<20g/ton 70115/150
50:>20g/ton 75125.
75125.
90115/85115.
Type B (cattle and
sheep): 80120; Type
C (all): 75125.
80130.
70120.
Chickens, turkeys, and
quail: 75125; Cattle:
510 g/ton 80120;
Cattle: 1030 g/ton 85
115; Goats: 20 g/ton
85115; Liq. feed: 80
120.
85115/75125.
80120.
80120.
75125.
<11.25 g/ton 70130;
>11.25 g/ton 75125.
75125/65135.
65135.
Liq. feed: 85115.
80110.
80120.
80110.
90115.
..................................................................
70130.
75125.
70130.
85115.
Tylosin .....................................................
Virginiamycin ...........................................
Zoalene ....................................................
CATEGORY II
Assay limits
percent 1
Type A
Drug
Amprolium ...............................................
Apramycin ................................................
Arsanilate sodium ....................................
Arsanilic acid ...........................................
Carbadox .................................................
Carbarsone ..............................................
Clopidol ....................................................
Famphur ..................................................
Fenbendazole ..........................................
Halofuginone hydrobromide ....................
Hygromycin B ..........................................
Ivermectin ................................................
Levamisole ..............................................
Maduramicin ammonium .........................
94114
88112
90110
90110
90110
93102
94106
100110
93113
90115
90110
95105
85120
90110
80120.
80120.
85115/75125.
85115/75125.
75125.
85115.
90115/80120.
90115/80120.
75125
75125.
75125.
80110.
85125.
80120.
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558.4
CATEGORY IIContinued
Assay limits
percent 1
Type A
Drug
90110
80120
80120
80120
90110
90110
98106
90110
90110
85115
90110
85115
90110
85115
90110
95115
85115
90110
90110
90110
90110
94106
85115
90110
90110
95115
95115
95115
95115
95105
85115
85115
85115
85115
85115
85115
85115
80120
85115
90110
85115
90110
90110
85115
90110
90110
98106
85115
85125
80120
94106
Tilmicosin .................................................
90110
85115.
70125.
65135.
70125.
85115/75125
85115/75125
85115/80120
85120.
80120.
75125.
85115.
75125.
85120.
80120.
75125.
80120.
80120.
85120.
85120.
85120.
85120.
80120.
70130.
85120.
75125.
85115/75125.
85115.
85115/75125.
85115.
85115.
85115.
80120.
85125/70130.
85125/70130.
80120.
85125/70130.
80120.
75125.
75125.
85120.
75125.
85120.
85120.
75125.
85120.
85120.
85115.
80120.
70130.
70130.
>7% 85115; <7% 90
110.
85115.
1 Percent
of labeled amount.
2 Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limit, the
first set is for a Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been
assigned in order to provide for the possibility of dilution of a Type B medicated feed with lower assay limits to make a Type C
medicated feed.
EDITORIAL NOTE: For FEDERAL REGISTER citations affecting 558.4, see the List of CFR
Sections Affected in the Finding Aids section of this volume.
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558.5
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558.15
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558.15
Drug sponsor
Type A article
Species
Use levels
Sec. 558.78.
......do ...................
......do ...................
Do.
Sec. 558.76.
Chickens, turkeys,
swine, pheasants, quail, and
cattle.
Chickens, turkeys,
pheasants, and
quail.
Chicken turkeys,
swine, and cattle.
Chickens and
swine.
Chickens, swine,
and beef cattle.
Chickens, turkeys,
and swine.
Chickens ..............
Chickens, turkeys,
and swine.
Chickens ..............
Swine ...................
Sec. 558.274.
Do ......................................
Tylosin .................
Erythromycin ........
Lincomycin ...........
Oleandomycin ......
Bambermycins .....
Tylosin and
sulfamethazine.
Chlortetracycline ..
Procaine Penicillin
Oxytetracycline ....
Chlortetracycline
and
sulfamethazine.
Erythromycin ........
Sulfadimethoxine
and ormetoprim.
Oxytetracycline
and neomycin.
Chlortetracycline,
sulfamethazine,
and penicillin.
Chlortetracycline,
sulfathiazole,
and penicillin.
Sec. 558.625.
Sec. 558.248.
Sec. 558.325.
Sec. 558.435.
Sec. 558.95.
Sec. 558.630.
Chickens, turkeys,
swine, and cattle.
Sec. 558.128.
Chickens, turkeys,
swine, pheasants, and quail.
Sec. 558.450 .......
Cattle ...................
Sec. 558.460.
Sec. 558.450.
Sec. 558.128.
Sec. 558.248.
37 mg per head
per day.
Sec. 558.575 .......
As provided in
paragraph (g)(2)
of this section.
......do ...................
As provided in paragraph
(g)(2) of this section.
......do ...................
......do ...................
Cattle ...................
Sec. 558.575.
Do.
Do.
Type A article
Species
Use levels
Chlortetracycline
and arsanilic
acid.
Chlortetracycline
and
sulfamethazine.
Swine ...................
10 to 50 g/ton and
0.005 to 0.01
percent.
Sec. 558.128 .......
Cattle ...................
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Type A article
558.15
Species
Use levels
Oxytetracycline
and neomycin
base.
Chickens ..............
50 g/ton and 35 to
140 g/ton.
Do ......................................
......do ...................
Chickens (first 2
weeks).
50 to 100 g/ton
and 35 to 140
g/ton.
Do ......................................
......do ...................
Chickens ..............
......do ...................
Do ......................................
......do ...................
......do ...................
Do ......................................
......do ...................
Turkeys ................
50 g/ton and 35 to
140 g/ton.
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558.15
Species
Do ......................................
Drug sponsor
......do ...................
......do ...................
50 to 100 g/ton
and 35 to 140
g/ton.
Use levels
Do ......................................
......do ...................
Turkeys (first 4
weeks).
......do ...................
Do ......................................
......do ...................
......do ...................
Do ......................................
......do ...................
Turkeys ................
......do ...................
Do ......................................
......do ...................
......do ...................
Do ......................................
......do ...................
......do ...................
Do ......................................
......do ...................
Swine ...................
50 g/ton and 35 to
140 g/ton.
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558.15
Type A article
Species
Do ......................................
......do ...................
......do ...................
50 to 150 g/ton
and 70 to 140
g/ton.
Do ......................................
......do ...................
Calves ..................
Do ......................................
......do ...................
......do ...................
Do ......................................
......do ...................
......do ...................
Do ......................................
......do ...................
......do ...................
Lincomycin,
amprolium, and
ethopabate.
Lincomycin and
zoalene.
Lincomycin,
amprolium,
ethopabate, and
roxarsone.
Lincomycin,
monensin, and
roxarsone.
Nicarbazin and
procaine penicillin.
Nicarbazin and
bacitracin methylene disalicylate.
Nicarbazin, bacitracin methylene
disalicylate, and
roxarsone.
Nicarbazin, procaine penicillin,
and roxarsone.
Chickens ..............
50 g/ton and 35 to
140 g/ton.
100 g/ton and 70
to 140 g/ton.
8 to 100 mg/gal
and 100 to 200
mg/gal reconstituted milk replacer.
40 to 200 mg/gal
and 200 to 400
mg/gal reconstituted milk replacer.
Secs. 558.58 and
558.325.
Amprolium and
bacitracin methylene disalicylate.
Amprolium,
ethopabate, and
bacitracin methylene disalicylate.
Amprolium,
ethopabate,
bacitracin methylene disalicylate, and
roxarsone.
Amprolium and
procaine penicillin.
Amprolium, procaine penicillin,
and roxarsone.
Do ......................................
Do ......................................
Do ......................................
Do ......................................
Do ......................................
Do ......................................
Do ......................................
Do ......................................
Do ......................................
Do ......................................
Do ......................................
Do ......................................
......do ...................
......do ...................
......do ...................
Chickens ..............
.....do ....................
.....do ....................
.....do ....................
Use levels
Secs. 558.325
and 558.680.
Secs. 558.58,
558.325, and
558.530.
Secs. 558.325,
558.355, and
558.530.
0.01 to 0.02 percent and 2.4 to
50 g/ton.
0.01 to 0.02 percent and 4 to 50
g/ton.
Do.
Do.
Chickens ..............
0.0125 to 0.025
percent, 0.0004
percent, and 4
to 50 g/ton.
.....do ....................
0.0125 to 0.025
percent, 0.0004
percent, 4 to 50
g/ton, and
0.0025 to 0.005
percent.
0.004 to 0.025
percent and 2.4
to 50 g/ton.
0.004 to 0.025
percent, 2.4 to
50 g/ton, and
0.0025 to 0.005
percent.
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558.15
Drug sponsor
Type A article
Species
Use levels
Amprolium,
ethopabate, procaine penicillin,
and erythromycin.
Amprolium and
erythromycin.
......do ...................
Do ......................................
Amprolium and
ethopabate.
......do ...................
Do ......................................
Amprolium,
arsanilic acid,
and erythromycin.
Amprolium,
arsanilic acid,
and ethopabate.
......do ...................
Amprolium,
ethopabate, and
bacitracin methylene disalicylate.
Amprolium,
ethopabate,
bacitracin methylene disalicylate, and
roxarsone.
Bacitracin zinc,
amprolium, and
ethopabate.
......do ...................
0.0125 to 0.025
percent, 0.0004
percent, 2.4 to
50 g/ton, and
4.6 to 18.5 g/ton.
0.0125 to 0.025
percent and 4.6
to 18.5 g/ton.
0.0125 to 0.025
percent and
0.0004 percent.
0.0125 to 0.025
percent, 0.01
percent, and 4.6
to 18.5 g/ton.
0.0125 to 0.025
percent, 0.01
percent, and
0.0004 percent.
0.0125 percent,
0.004 percent,
and 4 to 50 g/
ton.
Do ......................................
Bacitracin zinc,
amprolium,
ethopabate, and
roxarsone.
......do ...................
Do ......................................
Bacitracin zinc
and arsanilic
acid.
Amprolium,
ethopabate, procaine penicillin,
and roxarsone.
Swine ...................
Chickens ..............
Do ......................................
Zoalene,
roxarsone, and
bacitracin zinc.
......do ...................
Do ......................................
......do ...................
Do ......................................
Zoalene,
roxarsone, and
penicillin.
......do ...................
Do ......................................
Do ......................................
Do ......................................
Do ......................................
Do ......................................
Do ......................................
Do ......................................
......do ...................
......do ...................
......do ...................
0.0125 percent,
0.004 percent, 5
to 35 g/ton, and
0.00375 percent.
......do ...................
4 to 50 g/ton,
0.0125 to 0.025
percent, and
0.0004 percent.
4 to 50 g/ton,
0.0125 to 0.025
percent, 0.0004
percent, and
0.0025 to 0.005
percent.
10 to 50 g/ton and
0.005 to 0.01
percent.
0.125 to 0.025
percent, 0.0004
percent, 2.4 to
50 g/ton, and
0.0025 to 0.005
percent.
0.0125 percent
and 4 to 50 g/
ton.
0.0125 percent,
0.005 percent,
and 4 to 50 g/
ton.
Chickens ..............
......do ...................
......do ...................
0.0125 percent
and 4 to 50 g/
ton.
0.0125 percent,
0.0025 to 0.005
percent, and 4
to 50 g/ton.
0.0125 percent
and 2.4 to 50 g/
ton.
0.0125 percent,
0.0025 to 0.005
percent, and 2.4
to 50 g/ton.
Sec. 558.55.
Sec. 558.58.
Sec. 558.55.
Sec. 558.58.
Do.
Do.
Prevention of coccidiosis.
Growth promotion and feed
efficiency. Sec.558.78.
Prevention of coccidiosis.
Growth promotion and feed
efficiency. Improving pigmentation. Sec. 558.78.
Sec. 558.680.
Do.
Do.
Do.
Do.
Do.
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Do ......................................
Do ......................................
Do ......................................
558.35
Type A article
Species
Zoalene, arsanilic
acid, and bacitracin methylene
disalicylate or
bacitracin zinc.
Zoalene, arsanilic
acid, and penicillin.
......do ...................
0.0125 percent,
0.01 percent,
and 4 to 50 g/
ton.
Do.
......do ...................
Do.
......do ...................
0.0125 percent,
0.01 percent,
and 2.4 to 50 g/
ton.
0.004 to 0.0125
percent and 4 to
50 g/ton.
0.004 to 0.0125
percent, 0.0025
to 0.005 percent, and 4 to
50 g/ton.
Sec. 558.120 .......
Nitarsone and
bacitracin zinc.
......do ...................
Turkeys ................
Chickens ..............
Swine ...................
Turkeys ................
Use levels
8 to 12 g/ton and
4 to 50 g/ton.
12 g/ton and 10 to
100 g/ton.
0.01875 percent,
4 to 50 g/ton.
Do.
Do.
Sec. 558.120.
Sec. 558.274.
Do.
As an aid in the prevention of
blackhead. To increase rate
of weight gain and improve
feed efficiency.
[51 FR 8811, Mar. 14, 1986; 51 FR 11014, Apr. 1, 1986, as amended at 51 FR 28547, Aug. 8, 1986;
53 FR 20843, June 7, 1988; 54 FR 37098, Sept. 7, 1989; 54 FR 51386, Dec. 15, 1989; 55 FR 8460, 8462,
Mar. 8, 1990; 56 FR 41912, Aug. 23, 1991; 56 FR 64702, Dec. 12, 1991; 57 FR 6476, Feb. 25, 1992; 57
FR 8577, Mar. 11, 1992; 57 FR 14639, Apr. 22, 1992; 58 FR 17515, Apr. 5, 1993; 58 FR 30119, May
26, 1993; 61 FR 51589, Oct. 3, 1996; 64 FR 992, Jan. 7, 1999; 64 FR 37673, July 13, 1999]
Aklomide.
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558.55
558.55 Amprolium.
(a) Approvals. Type A medicated articles: 25 percent to 050604 in 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 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.
Amprolium in grams
per ton
Combination in grams
per ton
Limitations
Growing conditions
Severe exposure to
coccidiosis.
Up to 5 weeks of
age
Sponsor
Feed as follows
From 5 to 8
weeks of age
Over 8 weeks
of age
Amprolium
grams per ton
Amprolium
grams per ton
Amprolium
grams per ton
113.5 (0.0125%)
72.6113.5
(0.008%
0.0125%)
54.5113.5
(0.006%
0.0125%)
36.3113.5
(0.004%
0.0125%)
36.3113.5
(0.004%
0.0125%)
36.3113.5
(0.004%
0.0125%)
36.3113.5
(0.004%
0.0125%)
Moderate exposure to
coccidiosis.
Slight exposure to
coccidiosis.
72.6113.5
(0.008%
0.0125%)
36.3113.5
(0.004%
0.0125%)
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Combination in grams
per ton
Limitations
Arsanilate sodium 90
(0.01%).
Arsanilic acid 90
(0.01%).
Arsanilic acid 90
(0.01%) plus erythromycin 4.6 to 18.5.
Arsanilic acid 90
(0.01%) plus erythromycin 92.5.
558.55
Arsanilic acid 90
(0.01%) plus erythromycin 185.
Chlortetracycline 100
to 200.
Chlortetracycline 200
to 400.
Erythromycin 4.6 to
18.5.
Sponsor
Do not feed to chickens producing eggs for human consumption. Feed for 7 to 14 d.
Do not feed to chickens producing eggs for human consumption. Feed for 7 to 14 d.
As erythromycin thiocyanate.
Feed according to subtable
in item (i).
Feed for 7 to 14 d; withdraw 24
h before slaughter. Feed according to subtable in item (i).
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558.55
Amprolium in grams
per ton
Hygromycin B 8 to 12
Roxarsone 22.7 to
45.4 (0.0025% to
0.005%).
....................................
Arsanilate sodium 90
(0.01%).
Arsanilic acid 90
(0.01%).
Bacitracin 100 to 200
Chlortetracycline 100
to 200.
Chlortetracycline 200
to 400.
Hygromycin B 8 to 12
Limitations
Sponsor
......do ........................................
As bacitracin methylene disalicylate, or zinc bacitracin.
Do not feed to chickens producing eggs for human consumption. Feed for 7 to 14 d.
Do not feed to chickens producing eggs for human consumption. Feed for 7 to 14 d.
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Combination in grams
per ton
Roxarsone 22.7 to
45.4 (0.0025% to
0.005%).
....................................
558.55
Indications for use
Limitations
Bambermycins 1 to 3
plus roxarsone 22.8
to 34.1 (0.0025% to
0.00375%).
Bambermycins 1 to 4
....................................
1. Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis.
2. Turkeys; prevention of coccidiosis.
1. Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and
feed efficiency; improving
pigmentation.
2. Turkeys; prevention of coccidiosis; growth promotion
and feed efficiency; improving pigmentation.
1. Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and
feed efficiency; improving
pigmentation.
2. Turkeys; prevention of coccidiosis; growth promotion
and feed efficiency; improving pigmentation.
1. Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and
feed efficiency; improving
pigmentation; as an aid in
the prevention of chronic respiratory disease during periods of stress.
2. Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and
feed efficiency; improving
pigmentation; as an aid in
the prevention of infectious
coryza.
Arsanilate sodium 90
(0.01%).
Arsanilic acid 90
(0.01%).
Arsanilic acid 90
(0.01%) plus erythromycin 92.5.
Sponsor
...................................................
For moderate outbreaks of coccidiosis; administer for 2
weeks.
Feed continuously as the sole
ration; as sole source of
amprolium and organic arsenic; roxarsone as provided
by
No.
053501
in
510.600(c) of this chapter,
bambermycins
by
No.
012799; withdraw 5 d before
slaughter.
Feed continuously as the sole
source
of
amprolium;
bambermycins as provided
by
No.
012799
in
510.600(c) of this chapter.
...................................................
012799
...................................................
Withdraw 5 d before slaughter;
as sole source of organic arsenic.
......do ........................................
......do ........................................
......do ........................................
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558.55
Amprolium in grams
per ton
Arsanilic acid 90
(0.01%) plus erythromycin 4.6 to 18.5.
Bacitracin 4 to 50 .......
Limitations
Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and
feed efficiency; improving
pigmentation; as an aid in
the prevention and reduction
of lesions and in lowering severity of chronic respiratory
disease.
Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and
feed efficiency; improved pigmentation.
1. Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and
feed efficiency.
2. Turkeys; prevention of coccidiosis; growth promotion
and feed efficiency.
1. Broiler chickens 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).
2. Broiler chickens 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).
Turkeys; prevention of coccidiosis; treatment of infectious
sinusitis, blue comb (mud
fever).
......do ........................................
Carbarsone 227 to
340.5.
Chlortetracycline 100
to 200.
Sponsor
1 012769
......do ........................................
......do ........................................
000006
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Combination in grams
per ton
Chlortetracycline 200
to 400.
Erythromycin 4.6 to
18.5.
Hygromycin B 8 to 12
Roxarsone 22.7 to
45.4 (0.0025% to
0.005%).
....................................
558.55
Indications for use
Limitations
Do not feed to chickens producing eggs for human consumption. Feed for 7 to 14 d.
Sponsor
......do ........................................
......do ........................................
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558.58
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
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 556.50 and
556.260 of this chapter.
(d) Conditions of use. (1) It is used for
chickens as follows:
Combination in
grams per ton
Limitations
..................................
Bambermycins 2 to
3 plus roxarsone
22.8 to 34.1
(0.0025% to
0.00375%).
Lincomycin 2 to 4 ....
Lincomycin 2 to 4
plus roxarsone
45.4 (0.005%).
Roxarsone 45.4
(0.005 pct).
Sponsor
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558.58
Combination in
grams per ton
Limitations
..................................
Broiler chickens and replacement chickens 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.
Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and
feed efficiency; improve pigmentation.
1. Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; to aid in prevention of
coccidiosis where severe exposure to coccidiosis from
Eimeria acervulina, E. maxima, and E. brunetti is likely to
occur; for increased rate of
weight gain in broiler chickens
raised in floor pens.
Arsanilic acid 90
(0.01 pct) plus
erythromycin 4.6
to 18.5.
Bacitracin 4 to 50 ....
..................................
Bacitracin 5 to 35
plus roxarsone 34
(0.00375%).
Sponsor
046573
and
063238
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558.58
Amprolium and
ethopabate in grams
per ton
Limitations
Bacitracin 20 to 35
plus roxarsone 34
(0.00375%).
Bacitracin 10 to 50
plus roxarsone
15.4 to 45.4
(0.0017% to
0.005%).
Bacitracin 10 plus
roxarsone 30 to
45.4 (0.0033% to
0.005%).
Bambermycins 1 to
3.
Bambermycins 1 to
3 plus roxarsone
22.8 to 34.1
(0.0025% to
0.00375%).
Sponsor
046573,
063238
063238
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Combination in
grams per ton
Erythromycin 4.6 to
18.5.
Virginiamycin, 15 .....
Virginiamycin, 5 to
15.
..................................
Arsanilic acid 90
(0.01%).
Arsanilic acid 90
(0.01%) plus
erythromycin 92.5.
Arsanilic acid 90
(0.01%) plus
erythromycin 185.
Bacitracin 4 to 50 ....
558.58
Limitations
Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and
feed efficiency.
Broiler chickens, as 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 and improved
feed efficiency.
Sponsor
000069
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558.58
Amprolium and
ethopabate in grams
per ton
Bacitracin 4 to 50
plus roxarsone
22.7 to 45.4
(0.0025% to
0.005%).
Chlortetracycline 100
to 200.
Chlortetracycline 200
to 400.
Roxarsone 22.7 to
45.4 (0.0025% to
0.005%).
Limitations
1. Broiler chickens 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 chickens 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).
Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and
feed efficiency; improving pigmentation.
For chickens where immunity to
coccidiosis is not desired; prevention of coccidiosis; control
of infectious synovitis caused
by Mycoplasma synoviae susceptible to chlortetracycline.
For chickens where immunity to
coccidiosis is not desired; prevention of coccidiosis; control
of chronic respiratory disease
(CRD) and air sac infection
caused by M. gallisepticum
and E. coli susceptible to
chlortetracycline.
1. For broiler chickens and for
replacement chickens where
immunity to coccidiosis is not
desired; prevention of coccidiosis; as an aid in the prevention of chronic respiratory disease during periods of stress.
2. For broiler chickens and replacement chickens where immunity to coccidiosis is not
desired; prevention of coccidiosis; as an aid in the prevention of infectious coryza.
For broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; as an aid in the prevention and reduction of lesions
and in lowering severity of
chronic respiratory disease.
For broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and
feed efficiency; improving pigmentation.
Broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and
feed efficiency; improving pigmentation.
......do .........................................
Sponsor
Do not feed to chickens producing eggs for human consumption. Feed for 7 to 14 d.
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558.62
Combination in
grams per ton
Limitations
Bacitracin 10 ............
(2) [Reserved]
[41 FR 10990, Mar. 15, 1976]
EDITORIAL NOTE: For FEDERAL REGISTER citations affecting 558.58, see the List of CFR
Sections Affected in the Finding Aids section of this volume.
558.59
Apramycin.
558.60
Arsanilate sodium.
(a) Appprovals. Type A medicated articles: 20, 50, or 100 percent to 015565 in
510.600(c) of this chapter.
(b) Related tolerances. See 556.60 of
this chapter.
Arsanilic acid in grams
per ton
Sponsor
047019
Combination in
grams per ton
Limitations
(i) 45 to 90 (0.005%
to 0.01%).
..................................
015565
..................................
......do .........................................
015565
......do .........................................
015565
......do .........................................
015565
Sponsor
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558.76
Arsanilic acid in grams
per ton
Limitations
As erythromycin thiocyanate;
withdraw 5 days before
slaughter; as sole source of
organic arsenic.
As erythromycin thiocyanate;
feed for 2 days before stress
and 3 to 6 days after stress;
withdraw 5 days before
slaughter; as sole source of
organic arsenic.
As erythromycin thiocyanate;
feed for 7 to 14 days; withdraw 5 days before slaughter;
as sole source of organic arsenic.
As erythromycin thiocyanate;
feed for 5 to 8 days; do not
use in birds producing eggs
for food purposes; withdraw 5
days before slaughter; as sole
source of organic arsenic.
(iii) ..............................
Erythromycin 4.6 to
18.5.
(iv) ..............................
(v) ...............................
(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
558.55.
(ii) Amprolium and ethopabate in accordance with 558.58.
(iii) Bacitracin zinc in accordance
with 558.78.
(iv) Bacitracin and zoalene in accordance with 558.680.
(v) Zoalene in accordance with
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]
Sponsor
15565
015565
015565
15565
Bacitracin methylene
disalicylate in grams
per ton
Combination in
grams per ton
Limitations
(i) 4 to 50 ...................
..................................
.....................................................
046573
(ii) 5 to 20 ..................
..................................
.....................................................
046573
(iii) 10 to 25 ...............
..................................
046573
(iv) 10 to 30 ...............
..................................
000004
and
046573
Sponsor
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(v) [Reserved]
(vi) 50 ........................
Combination in
grams per ton
Limitations
000004
and
046573
..................................
046573
..................................
(vii)(viii) [Reserved]
(ix) 100 to 200 ...........
..................................
..................................
..................................
..................................
558.76
..................................
..................................
Sponsor
046573
046573
046573
046573
046573
046573
1 These conditions are NAS/NRC reviewed and found effective. Applications for these uses may not require effectiveness data
as specified by 514.111 of this chapter, but may require bioequivalency and safety information.
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558.78
558.78
Bacitracin zinc.
Bacitracin zinc in
grams per ton
Combinations in
grams per ton
Limitations
(i) 4 to 50 ...................
..................................
063238,
046573
(ii) 5 to 20 ..................
..................................
..................................
063238,
046573
(iii) 10 to 25 ...............
(iv) 10 to 50 ...............
..................................
046573
Sponsor
046573
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558.95
Bacitracin zinc in
grams per ton
Combinations in
grams per ton
Limitations
(v) 20 .........................
..................................
063238
(vi) 20 to 40 ...............
..................................
Growing-finishing
swine;
increased rate of weight gain.
Growing-finishing swine; improved feed efficiency.
......do .........................................
063238
(2) It is used in feed for growing cattle at 35 to 70 milligrams per head per
day as follows:
(i) To aid in stimulating growth and
improving feed efficiency.
(ii) For increased rate of weight gain
and improved feed efficiency; see sponsor 063238.
(3) Bacitracin zinc may be used as approved in combination as follows:
(i) Amprolium as in 558.55.
(ii) Amprolium and roxarsone as in
558.55.
(iii) Amprolium and ethopabate as in
558.58.
(iv) Amprolium and ethopabate with
roxarsone as in 558.58.
(v) Carbarsone as in 558.120.
(vi) Clopidol as in 558.175.
(vii) Clopidol and roxarsone as in
558.175.
(viii) Decoquinate as in 558.195.
(ix) Decoquinate and roxarsone as in
558.195.
(x) Hygromycin B as in 558.274.
(xi) Hygromycin B and penicillin as
in 558.274.
(xii) Lasalocid sodium alone or with
roxarsone as in 558.311.
(xiii) Monensin as in 558.355.
(xiv) Monensin and roxarsone as in
558.355.
(xv) Robenidine as in 558.515.
(xvi) Salinomycin as in 558.550.
(xvii) Salinomycin and roxarsone as
in 558.550.
(xviii) Zoalene as in 558.680.
(xix) Zoalene and arsanilic acid as in
558.680.
(xx) Zoalene and roxarsone as in
558.680.
(xxi) Nicarbazin as in 558.366.
[41 FR 10994, Mar. 15, 1976]
EDITORIAL NOTE: For FEDERAL REGISTER citations affecting 558.78, see the List of CFR
Sections Affected in the Finding Aids section of this volume.
558.95 Bambermycins.
(a) Approvals. To sponsors identified
by drug labeler codes in 510.600(c) of
Sponsor
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558.95
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558.95
(b) Limitations. Do not feed to chickens over 14 weeks of age; feed continuously as sole ration; feed as sole source
of organic arsenic; withdraw 5 days before slaughter; zoalene as provided by
No. 025700, roxarsone as provided by No.
046573 in 510.600(c) of this chapter.
(x) Amount per ton. Bambermycins, 1
gram plus lasalocid sodium, 68 to 113
grams (0.0075 to 0.0125 percent) plus
roxarsone, 45.4 grams (0.005 percent).
(a) Indications for use. For prevention
of coccidiosis caused by Eimeria tenella,
E. necatrix, E. acervulina, E. brunetti, E.
mivati, and E. maxima; as an aid in the
reduction of lesions due to E. tenella;
and for increased rate of weight gain.
(b) Limitations. For broiler chickens
only; feed continuously as sole ration;
withdraw 5 days before slaughter;
roxarsone as provided by Nos. 046573
and 011526 in 510.600(c) of this chapter,
and lasalocid sodium as provided by .
000004 in 510.600(c) of this chapter.
(xi) Amount per ton. Bambermycins 1
to 2 grams, plus roxarsone 45.4 grams,
and salinomycin 40 to 60 grams.
(a) Indications for use. For prevention
of coccidiosis caused by Eimeria
necatrix, E. acervulina, E. maxima, E.
brunetti, E. tenella, and E. mivati, including some field strains of E. tenella
that are more susceptible to roxarsone
combined
with
salinomycin
than
salinomycin alone; and for improved
feed efficiency.
(b) Limitations. For broiler chickens
only; do not feed to laying chickens;
feed continuously as sole ration; as
sole source or organic arsenic; withdraw 5 days before slaughter; not approved for use with pellet binders; may
be fatal if accidentally fed to adult turkeys or horses; as roxarsone provided
by No. 011526 or 046573 in 510.600(c) of
this chapter; as salinomycin sodium
biomass provided by Nos. 012799 and
063238 in 510.600(c) of this chapter.
(xii) Amount per ton. Bambermycins 1
to 3 grams, plus salinomycin 40 to 60
grams.
(a) Indications for use. For prevention
of coccidiosis caused by Eimeria tenella,
E. necatrix, E. acervulina, E. brunetti, E.
mivati, and E. maxima; and improved
feed efficiency.
(b) Limitations. For broiler chickens
only: Do not feed to laying chickens;
feed continuously as sole ration; not
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558.95
Ingredient
Percent
601080
604152
601069
528236
602756
.........
.........
705533
.........
602431
602758
.........
601720
606098
42.50
20.10
15.24
9.57
5.15
3.72
1.00
0.75
0.60
0.50
0.32
0.21
0.18
0.16
*Content of vitamin/trace mineral premix may be varied. However, they should be comparable to those used for other freechoice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920.
Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).
384
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558.120
558.105
[Reserved]
558.115 Carbadox.
(a) Approvals. Type A medicated articles: 2.2. percent (10 grams per pound)
to 000069 in 510.600(c) of this chapter.
(b) Related tolerances. See 556.100 of
this chapter.
(c) Special considerations. Do not use
in Type B or Type C medicated feeds
containing bentonite.
(d) Conditions of use. It is used for
swine as follows:
(1) Amount per ton. 1025 grams
(0.00110.00275 percent).
(i) Indications for use. For increase in
rate of weight gain and improvement of
feed efficiency.
(ii) Limitations. Not for use in pregnant swine or swine intended for breeding purposes. Do not feed to swine
within 42 days of slaughter.
(2) Amount per ton. 50 grams (0.0055
percent).
(i) Indications for use. For control of
swine dysentery (vibrionic dysentery,
bloody scours, or hemorrhagic dysentery); control of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis);
increased rate of weight gain and improved feed efficiency.
(ii) Limitations. Not for use in pregnant swine or swine intended for breeding purposes. Do not feed to swine
within 42 days of slaughter.
(3) Amount per ton. Carbadox 50 grams
(0.0055 percent) plus pyrantel tartrate,
96 grams (0.0106 percent).
558.120
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558.128
Chlortetracycline amount
Combination
(i) 10 to 50 g/t
558.128 Chlortetracycline.
(a) Approvals. Type A medicated articles containing the following concentrations of either chlortetracycline
calcium complex equivalent to chlortetracycline hydrochloride or, for products intended for use in milk replacer,
chlortetracycline hydrochloride:
(1) 50 to 100 grams per pound to 063238
in 510.600(c) of this chapter.
(2) 50 to 100 grams per pound to
000069.
(3) 50 to 100 grams per pound to
046573.
(4) 50 grams per pound to 017519.
(5) 50 to 100 grams per pound to
053389.
(b) Related tolerances. See 556.150 of
this chapter.
(c) [Reserved]
(d)(1) It is used in feeds as follows:
Limitations
Sponsor
063238.
(ii) 20 to 50 g/t
000069,
017519,
046573,
053389.
000069,
017519,
046573,
053389,
063238.
Do.
000069,
046573,
053389,
063238.
000069,
017519,
046573,
053389,
063238.
063238.
000069,
017519,
046573,
053389.
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Combination
558.128
Indications for use
Limitations
1. Turkeys; control of
hexamitiasis caused by
Hexamita meleagrides susceptible to chlortetracycline.
2. Turkey poults not over 4
weeks of age; reduction of
mortality due to paratyphoid
caused by Salmonella
typhimurium susceptible to
chlortetracycline.
3. Breeding swine; control of
leptospirosis (reducing the
incidence of abortion and
shedding of leptospirae)
caused by Leptospira pomona susceptible to chlortetracycline.
Chickens; reduction of mortality due to E. coli infections susceptible to chlortetracycline.
Sponsor
000069,
017519,
046573,
053389,
063238.
063238.
000069,
017519,
046573,
053389.
063238.
000069,
017519,
046573,
053389,
063238.
Do.
Do.
1. Feed for 5 d.
063238.
000069,
017519,
046573,
053389.
00004
063238,
000069,
017519,
046573,
053389
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558.128
Chlortetracycline amount
Combination
Limitations
(xiv) 25 to 70 mg/head/day
(xv) 70 mg/head/day
(xvi) 80 mg/head/day
Sponsor
Do.
Do.
063238,
000069,
017519,
046573,
053389
Do.
063238,
000069,
017519,
046573,
053389
Do.
063238,
000069,
046573,
053389
063238,
000069,
017519,
046573,
053389
388
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Combination
558.145
Indications for use
Limitations
Sponsor
......do
Do.
558.140 Chlortetracycline
sulfamethazine.
and
558.145 Chlortetracycline,
procaine
penicillin, and sulfamethazine.
(a) Approvals. Type A medicated articles: (1) 20 grams of chlortetracycline
per pound, 4.4 percent (20 grams) of
sulfamethazine, and procaine penicillin
equivalent in activity to 10 grams of
penicillin per pound to 046573 and 063238
in 510.600(c) of this chapter.
(2) 40 grams of chlortetracycline per
pound, 8.8 percent of sulfamethazine,
and penicillin procaine equivalent in
activity to 20 grams of penicillin per
pound to 063238 in 510.600(c) of this
chapter.
(b) Specifications. (1) The antibiotic
substance refers to the antibiotic or
feed-grade antibiotic.
389
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558.155
(2) The antibiotic activities are expressed in terms of the appropriate antibiotic standards.
(3) Type C medicated feed contains in
each ton, 100 grams of chlortetracycline, 50 grams of penicillin as procaine penicillin, and 100 grams of
sulfamethazine.
(c) Related tolerances. See 556.150,
556.510, and 556.670 of this chapter.
(d) Conditions of use. (1) It is administered to swine in a Type C feed for reduction of the incidence of cervical abscesses; treatment of bacterial swine
enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis
and vibrionic dysentery); prevention of
these diseases during times of stress;
maintenance of weight gains in the
presence of atrophic rhinitis; growth
promotion and increased feed efficiency in swine weighing up to 75
pounds.
(2) Withdraw 15 days prior to slaughter.
[40 FR 13959, Mar. 27, 1975, as amended at 43
FR 19385, May 5, 1978; 47 FR 39814, Sept. 10,
1982; 48 FR 30615, July 5, 1983; 51 FR 7396,
Mar. 3, 1986; 52 FR 2684, Jan. 26, 1987; 56 FR
14019, Apr. 5, 1991; 61 FR 18082, Apr. 24, 1996;
62 FR 14300, Mar. 26, 1997; 63 FR 27845, May 21,
1998]
558.155 Chlortetracycline,
thiazole, penicillin.
sulfa-
Type of feed
Minimum
desired
daily feed
intake in
pounds
20
50
80
112
2
150
558.175
Clopidol.
390
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558.175
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558.185
558.185
Coumaphos.
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558.195
558.195 Decoquinate.
(a) Approvals. Type A medicated articles: 6 percent to 046573 in 510.600(c) of
this chapter.
(b) Related tolerances in edible products. See 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:
Decoquinate in grams
per ton
Combination in
grams per ton
Limitations
..................................
..................................
Sponsor
046573
046573
393
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558.195
Decoquinate in grams
per ton
Limitations
..................................
Cattle; for the prevention of coccidiosis in ruminating and nonruminating calves and cattle
caused by Eimeria bovis and
E. zumii.
..................................
.............................
.............................
..................................
Bacitracin 4 to 50 ....
Bacitracin 10 to 50 ..
Sponsor
046573
......do
......do .........................................
......do
046573
046573
046573
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558.198
Combination in
grams per ton
Limitations
Bacitracin methylene
disalicylate 50 and
roxarsone 22.7
45.4.
046573
Chlortetracycline 100
to 200.
......do .........................................
046573
046573
000009,
046573
046573
Chlortetracycline 200
to 400.
Roxarsone 45.4
(0.005 pct.).
Lincomycin 2 ...........
Roxarsone 11 to 45
(0.00120.005
pct.) plus Bacitracin 12 to 50.
558.198 Diclazuril.
(a) Approvals. Type A medicated article: 0.2 percent of diclazuril to 000061 in
510.600(c) of this chapter.
Sponsor
046573
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558.205
558.205 Dichlorvos.
(a) Approvals. Type A medicated articles: 3.1 and 9.6 percent to 000010 in
510.600(c) of this chapter.
(b)
Special
considerations.
(1)
Dichlorvos is to be included in meal or
mash or mixed with feed in crumble
form only after the crumble feed has
been manufactured. Do not mix in
feeds to be pelleted nor with pelleted
feed. Do not soak the feed or administer as wet mash. Feed must be dry
when administered. Do not use in animals other than swine. Do not allow
fowl access to feed containing this
preparation or to feces from treated
animals.
(2) Dichlorvos is a cholinesterase inhibitor. Do not use this product in animals simultaneously or within a few
days before or after treatment with or
exposure to cholinesterase-inhibiting
drugs, pesticides, or chemicals. If
human or animal poisoning should
occur, immediately consult a physician
or a veterinarian. Atropine is antidotal.
(3) Labeling for Type A articles and
Type B feeds must include a statement
that containers or materials used in
packaging such Type A articles and
Type B feeds are not to be reused and
all such packaging materials must be
destroyed after the product has been
used.
(c) Related tolerances. See 556.180 of
this chapter.
(d) Conditions of use. It is used in feed
for swine as follows:
(1) Amount per ton. Dichlorvos, 348
grams (0.0384 percent).
(i) Indications for use. For the removal and control of mature, immature, and/or fourth-stage larvae of the
whipworm (Trichuris suis), nodular
worm (Oesophagostomum sp.), large
558.235
Efrotomycin.
(a) Approvals. Type A medicated article: 14.5 grams per pound to 050604 in
510.600(c) of this chapter.
396
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558.248
Erythromycin
thiocyanate in grams
per ton
Combination in
grams per ton
..................................
..................................
..................................
..................................
..................................
..................................
Limitations
.....................................................
For turkeys not over 12 weeks
of age.
Starter ration for animals up to
35 lb body weight.
Sponsor
,
050604
,
050604
050604
.....................................................
050604
050604
050604
050604
397
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558.254
558.254 Famphur.
(a) Approvals. Type A medicated articles: 13.2 and 33.3 percent to 000061 in
510.600(c) of this chapter.
(b) Special considerations. Famphur is
a cholinesterase inhibitor. Do not use
this product in animals simultaneously
or within a few days before or after
treatment with or exposure to cholinesterase-inhibiting drugs, pesticides, or
chemicals.
(c) Related tolerances. See 556.273 of
this chapter.
(d) Conditions of use. It is used in the
feed for cattle as follows:
(1) Amount. 1.1 milligrams per pound
body weight per day.
(i) Indications for use. For control of
grubs and as an aid in control of sucking lice.
(ii) Limitations. For beef cattle and
nonlactating dairy cows; feed for 30
days; withdraw from dry dairy cows
and heifers 21 days prior to freshening;
withdraw 4 days prior to slaughter.
(2) Amount. 2.3 milligrams per pound
body weight per day.
(i) Indications for use. For control of
grubs.
(ii) Limitations. For beef cattle and
nonlactating dairy cows; feed for 10
days; withdraw from dry dairy cows
and heifers 21 days prior to freshening;
withdraw 4 days prior to slaughter.
[41 FR 11000, Mar. 15, 1976, as amended at 51
FR 7397, Mar. 3, 1986; 57 FR 7652, Mar. 4, 1992;
62 FR 55161, Oct. 23, 1997; 62 FR 61626, Nov. 19,
1997]
558.258 Fenbendazole.
(a) Approvals. Type A medicated articles: 4 percent (18.1 grams per pound), 8
percent (36.2 grams per pound), and 20
percent
(90.7
grams
per
pound)
fenbendazole and all combinations provided for in this section to 012799 in
510.600(c) of this chapter.
(b) Related tolerances. See 556.275 of
this chapter.
(c) Conditions of use. (1) It is used in
swine feed as follows:
(i) Amount. Fenbendazole, 10 to 300
grams per ton (to provide 9 milligrams
per kilogram of body weight) given
over a 3- to 12-day period.
(A) Indications for use. For the removal of: adult stage lungworms
(Metastrongylus
apri
and
M.
pudendotectus); adult and larvae (L3, 4
398
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558.258
Ingredient
(A) Ingredient:.
Copper sulfate ..............................
Dried Cane Molasses ...................
Monosodium phosphate ...............
Salt (sodium chloride) ..................
Zinc sulfate ...................................
Fenbendazole Type A article (200
grams per kilogram) ..................
(B) Ingredient:.
Dicalcium phosphate ....................
Limestone .....................................
Magnesium oxide .........................
Zinc sulfate ...................................
Copper sulfate ..............................
Potassium iodide ..........................
Dried Cane Molasses ...................
Selenium ......................................
Salt ...............................................
Fenbendazole Type A article (200
grams per kilogram) ..................
Percent
International
feed No.
0.45
3.12
31.16
59.00
0.76
601720
404695
604288
604152
605556
5.51
32.31
17.13
9.79
1.47
0.29
0.0098
0.98
0.0002
35.93
600080
602632
602756
605556
601720
603759
404695
604152
2.09
399
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558.265
not necessary. Retreatment may be required in 6 weeks. Consult your veterinarian for assistance in the diagnosis,
treatment, and control of parasitism.
Do not use 14 days before or during the
hunting season.
[49 FR 3846, Jan. 31, 1984, as amended at 51
FR 7397, Mar. 3, 1986; 53 FR 14788, Apr. 26,
1988; 54 FR 36963, Sept. 6, 1989; 55 FR 48231,
Nov. 20, 1990; 57 FR 34516, Aug. 5, 1992; 58 FR
47973, Sept. 13, 1993; 59 FR 35252, July 11, 1994;
61 FR 29478, June 11, 1996; 64 FR 26844, May
18, 1999]
558.265
Halofuginone hydrobromide.
(a) Approvals. Type A medicated articles: 6 grams per kilogram (2.72 grams
per pound) to 012799 in 510.600(c) of
this chapter.
(b) Related tolerances. See 556.308 of
this chapter.
(c) Conditions of use. (1) It is used in
feed for broiler chickens as follows:
(i) Amount. 2.72 grams per ton.
(A) Indications for use. For the prevention of coccidiosis caused by Eimeria
tenella, E. necatrix, E. acervulina, E.
brunetti, E. mivati, and E. maxima.
(B) Limitations. Feed continuously as
sole ration; withdraw 4 days before
slaughter; do not feed to layers; avoid
contact with skin, eyes, or clothing;
keep out of lakes, ponds, or streams.
(ii) Amount per ton. Halofuginone 2.72
grams
(0.0003
percent)
plus
bambermycins 1 to 2 grams.
(A) Indications for use. For the prevention of coccidiosis caused by Eimeria
tenella, E. necatrix, E. acervulina, E.
brunetti, E. mivati, and E. maxima; for
increased rate of weight gain and improved feed efficiency.
(B) Limitations. Feed continuously as
sole ration; withdraw 5 days before
slaughter; do not feed to layers.
(iii) Amount per ton. Halofuginone 2.72
grams
(0.0003
percent)
plus
virginiamycin 5 grams.
(A) Indications for use. For the prevention of coccidiosis caused by Eimeria
tenella, E. necatrix, E. acervulina, E.
brunetti, E. mivati, and E. maxima; for
increased rate of weight gain and improved feed efficiency.
(B) Limitations. Feed continuously as
sole ration; withdraw 6 days before
slaughter; do not feed to layers.
400
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558.274
(A) Indications for use. For the prevention of coccidiosis in growing turkeys caused by Eimeria adenoeides, E.
meleagrimitis, and E. gallopavonis.
(B) Limitations. Feed continuously as
sole ration; withdraw 7 days before
slaughter; do not feed to layers or
water fowl; avoid contact with skin,
eyes, or clothing; keep out of lakes,
ponds, or streams.
(ii) Amount per ton. Halofuginone
hydrobromide 1.36 to 2.72 grams plus
bacitracin methylene disalicylate 10 to
50 grams.
(A) Indications for use. For prevention
of coccidiosis caused by Eimeria
adenoeides, E. meleagrimitis., and E.
gallopavonis, and for increased rate of
weight gain in growing turkeys.
(B) Limitations. Feed continuously as
sole ration. Withdraw 7 days before
slaughter. Do not feed to laying chickens or water fowl. Keep out of lakes,
ponds, and streams. Halofuginone is
toxic to fish and aquatic life.
Halofuginone is an irritant to eyes and
skin. Avoid contact with skin, eyes, or
clothing.
(iii) Amount per ton. 1.36 to 2.72 grams
of halofuginone hydrobromide plus 2
grams of bambermycins.
(A) Indications for use. For the prevention of coccidiosis caused by Eimeria
adenoides, E. meleagrimitis, and E.
gallopavonis, and for increased rate of
weight gain in growing turkeys.
(B) Limitations. Feed continuously as
sole ration. Withdraw 7 days before
slaughter. Do not feed to laying chickens
or
waterfowl.
Halofuginone
hydrobromide is toxic to fish and other
aquatic life. Keep out of lakes, ponds,
and
streams.
Halofuginone
hydrobromide is an eye and skin irritant. Avoid contact with skin, eyes,
and clothing.
(3) It is used in feed for replacement
cage laying chickens and replacement
broiler breeder chickens as follows:
(i) Amount per ton. 2.72 grams.
(A) Indications for use. For the prevention of coccidiosis caused by Eimeria
tenella, E. necatrix, E. acervulina, E.
maxima, E. mivati/E. mitis, and E.
brunetti.
(B) Limitations. Feed continuously as
sole ration to replacement cage laying
chickens until 20 weeks of age. Feed
continuously as sole ration to replace-
558.274 Hygromycin B.
(a) Approvals. (1) Type A medicated
articles: 2.4 and 8 grams per pound to
000986 in 510.600(c) of this chapter for
use as in paragraph (c) of this section.
(2) 2.4 grams per pound to 016968 and
043733 in 510.600(c) of this chapter for
use in swine feed as in paragraph
(c)(1)(ii) of this section.
(3) 1.2 grams per pound to 016968 in
510.600(c) of this chapter for use in
swine as in paragraph (c)(1)(ii) of this
section.
(4) 0.6 gram per pound to 016968,
017790, 043733, and 050639 in 510.600(c) of
this chapter for use in chickens as in
paragraph (c)(1)(i) of this section and
in swine as in paragraph (c)(1)(ii) of
this section.
(5) 0.48 and 2.4 grams per pound to
026186 in 510.600(c) of this chapter for
use in chickens as in paragraph (c)(1)(i)
of this section and in swine as in paragraph (c)(1)(ii) of this section.
(6) [Reserved]
(7) 2.4 grams per pound to 011790 and
017519 in 510.600(c) of this chapter for
use in chickens as in paragraph (c)(1)(i)
and in swine as in paragraph (c)(1)(ii) of
this section.
(8) 0.6 and 1.6 grams per pound granted to 046573 in 510.600(c) of this chapter for use in chickens as in paragraph
(c)(1)(i) and in swine as in paragraph
(c)(1)(ii) of this section.
(b) Related tolerances. See 556.330 of
this chapter.
(c) Conditions of use. (1) It may be
used as follows:
401
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558.274
Hygromycin B in
grams per ton
Combination in
grams per ton
Limitations
(i) 8 to 12 ...................
..................................
Chlortetracycline 100
to 200.
Chlortetracycline 200
to 400.
Sponsor
000986,
016968,
017519,
017790,
026186,
043733,
046573,
050639
Do not feed to chickens producing eggs for human consumption; feed for 7 to 14
days; withdraw 3 days before
slaughter.
......do .........................................
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Combination in
grams per ton
Limitations
Tylosin 4 to 50 .........
(ii) 12 .........................
..................................
Chlortetracycline
400..
1 Amount
558.295
Sponsor
000986
Withdraw
15
slaughter.
000986,
016968,
017519,
017790,
026186,
043733,
046573,
050639
days
before
000986
of Tylosin (g/t).
403
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558.300
558.300
Ivermectin.
404
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558.300
405
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558.305
558.311
Lasalocid.
406
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558.311
407
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558.311
Combination in
grams per ton
Limitations
..................................
Sponsor
000004
000004
000004
000004
000004
046573
000004
408
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Combination in
grams per ton
Lincomycin 2
(0.00022 pct).
Bacitracin 10 to 50 ..
Virginiamycin 20 ......
..................................
558.311
Limitations
000004
000004
000004
Oxytetracycline 7.5 ..
Cattle: for improved feed efficiency and reduction of incidence and severity of liver abscesses.
..................................
Oxytetracycline 7.5 ..
..................................
(ix) ..............................
..................................
Sponsor
063238
000004
000004
000004
000004
000004
409
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558.311
Combination in
grams per ton
Limitations
Bacitracin 4 to 50 ....
(xi) ..............................
..................................
(xii) .............................
..................................
..................................
.............................
...............................
Bacitracin 4 to 50 ....
...............................
Virginiamycin 10 to
20.
(xv) .............................
..................................
..................................
Sponsor
000004
000004,
021930
000004
000004
000004
063238
063238
000004
000004
Ingredient
Percent
International
feed No.
35.9
20.0
18.0
10.0
601080
604152
601069
501621
410
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558.315
Ingredient
Percent
International
feed No.
3.0
603755
3.0
2.5
1.7
1.4
1.2
1.2
1.04
1.06
................
404695
602758
................
602756
606098
................
................
Ingredient
Percent
55.167
24.0
12.0
1.0
3.0
0.05
4.0
0.5
0.2
0.083
1 Content of vitamin and trace mineral premixes may be varied. However, they should be comparable to those used for other
free-choice liquid feeds. Formulation modifications require FDA approval prior to marketing. The amount of selenium and ethylenediamine dihydroiodide (EDDI) must comply with published regulations (for selenium see 21 CFR 573.920; for EDDI see 51
FR 11483, April 3, 1986).
2 To provide 150 gm lasalocid per ton, use 1.652 lb (0.083%) of Bovatec Liquid 20 (90.8 gm/lb). If dry Bovatec-68 (68 gm/lb) is
used, use 2.206 lbs per ton (0.111%), replacing molasses.
558.315 Levamisole
hydrochloride
(equivalent).
(a) Approvals. Type A medicated articles: 227 grams per pound to 043781 in
510.600(c) of this chapter.
(b) Related tolerances. See 556.350 of
this chapter.
(c) Conditions of use. It is used in
Type C medicated feed as follows:
(1) Cattle(i) Amount per pound. 0.36
3.6 grams (0.080.8 percent).
(ii) Indications for use. Treatment of
the following gastrointestinal worms
and lung worm infections; stomach
worms (Haemonchus, Trichostrongylus,
Ostertagia),
intestinal
worms
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558.325
558.325
Lincomycin.
412
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558.342
413
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558.342
414
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558.342
415
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558.348
558.348 Mibolerone.
(a) Approvals. To No. 000009 in
510.600(c) of this chapter for a canned
558.355 Monensin.
(a) Specifications. Monensin, as the
base or the sodium salt, contains a
minimum of 90 percent monensin activity derived from monensin A and a
minimum of 95 percent derived from
monensin A plus B. Using thin layer
chromatography, the Rf value must be
comparable to a reference standard
(the Rf value is the distance the spots
travel from the starting line divided by
the distance the solvent front travels
from the starting line), or, using High
Performance Liquid Chromatography,
the factor distribution of monensin
Factor A or B is calculated as the percentage of total biopotency of all
peaks. The loss on drying is not more
than 10 percent when dried in vacuum
at 60 C for 2 hours.
(b) Approvals. Approvals for Type A
medicated articles containing the specified levels of monensin activity granted to firms identified by sponsor numbers in 510.600(c) of this chapter for
the conditions of use indicated in paragraph (f) of this section are as follows:
(1) To 000986: 36.3 (for export only), 44,
45, or 60 grams per pound, paragraphs
(f) (1)(i) and (4) of this section.
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(2) To 000986: 110 grams per lb., paragraphs (f)(1) (i), (iii), (iv), (v), (ix), and
(x).
(3) To 000986: 44 grams per lb. with 18
grams per lb. of roxarsone, 110 grams
per lb. with 45 grams per lb. of
roxarsone, paragraph (f)(1)(ii).
(4) To 000986: 45 and 60 grams per
pound, as monensin sodium, paragraph
(f)(2) of this section.
(5) To 000069: 45 and 60 grams per
pound, as monensin sodium provided by
No. 000986, paragraphs (f)(1)(xiii), (xx),
and (xxi) of this section.
(6) To 000986: 45 and 60 grams per
pound, as monensin sodium, paragraph
(f)(5) of this section.
(7) To 000986: 20, 30, 45, 60, 80, and 90.7
grams per pound, as monensin sodium,
paragraph (f)(3) of this section.
(8) To 063238: 45 and 60 grams per
pound, as monensin sodium provided by
No. 000986, paragraph (f)(1)(xiv) of this
section.
(9) To 063238: 45 and 60 grams per
pound, as monensin sodium provided by
No. 000986, paragraphs (f)(1)(xv) and
(xvi) of this section.
(10) To 012799: 45 and 60 grams per
pound, as monensin sodium, paragraph
(f)(1)(xvii) of this section.
(11) To 046573: 45 and 60 grams per
pound, as monensin sodium provided by
No.
000986,
paragraphs
(f)(1)(xiv),
(xviii), (xix), (xxiii), (xxiv), (xxv),
(xxvi), and (xxvii) of this section.
(12) To 000069: 45 and 60 grams per
pound, as monensin sodium provided by
No. 000986, paragraph (f)(1)(xxii) of this
section.
(13) To 021930: 60 and 80 grams per
pound, paragraph (f)(3)(v) of this section.
(14) To 000986: 60, 80, and 90.7 grams
per pound, as monensin sodium, paragraph (f)(6) of this section.
(c) [Reserved]
(d) Special considerations. (1) Type C
chicken feed containing monensin as
the mycelial cake shall bear an expiration date of 90 days after its date of
manufacture.
(2) Type C cattle feeds containing 30
grams or less monensin sodium per ton
shall bear an expiration date of 30 days
after its date of manufacture.
(3) Type C goat feeds shall bear an expiration date of 30 days after date of
manufacture.
(4) [Reserved]
(5) Liquid Type B feeds shall bear an
expiration date of 8 weeks after its
date of manufacture.
(6) The labeling of all formulations
containing monensin shall bear the following caution statememt: Do not
allow horses or other equines access to
formulations containing monensin. Ingestion of monensin by equines has
been fatal.
(7) The labeling of all Type A articles
and Type B feeds (liquid and dry) containing monensin intended for use in
cattle shall bear, in addition to the
caution statement in paragraph (d)(6)
of this section, the following caution
statements:
(i) Monensin medicated cattle feed is
safe for use in cattle only. Consumption by unapproved species may result
in toxic reactions;
(ii) Feeding undiluted or mixing errors resulting in high concentrations of
monensin has been fatal to cattle.
(iii) Must be thoroughly mixed in
feeds before use;
(iv) Do not feed undiluted;
(v) Do not exceed the levels of
monensin recommended in the feeding
directions, as reduced average daily
gains may result.
(vi) Do not feed to lactating dairy
cows.
(8) The labeling of complete feeds
containing monensin intended for use
in cattle shall bear the caution statements specified in paragraphs (d) (6)
and (7) (i) and (v) of this section.
(9) The labeling of Type A articles
containing monensin intended for use
in chickens shall bear the caution
statements specified in paragraphs (d)
(6) and (7) (iii) and (iv) of this section.
(10) The labeling of all Type A articles and Type B feeds (liquid and dry)
containing monensin intended for use
in goats shall bear, in addition to the
caution statement in paragraph (d)(6)
of this section, the following caution
statements:
(i) Monensin medicated goat feed is
safe for use in goats only. Consumption
by unapproved species may result in
toxic reactions.
(ii) Feeding undiluted or mixing errors resulting in high concentrations of
monensin could be fatal to goats.
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558.355
continuously
as
sole
ration;
as
monensin sodium.
(ix) Amount per ton. Monensin, 90110
grams plus lincomycin, 2 grams.
(a) Indications for use. For increase in
rate of weight gain and improved feed
efficiency; as an aid in the prevention
of coccidiosis caused by E. necatrix, E.
tenella, E. acervulina, E. brunetti, E.
mivati, and E. maxima.
(b) Limitations. Do not feed to laying
chickens; to be fed as a sole ration; in
the absence of coccidiosis, the use of
monensin with no withdrawal period
may limit feed intake resulting in reduced weight gain; as monensin sodium.
(x) Amount per ton. Monensin, 90110
grams plus lincomycin, 2 grams and
roxarsone, 1545 grams.
(a) Indications for use. For increase in
rate of weight gain; as an aid in the
prevention of coccidiosis caused by E.
necatrix, E. tenella, E. acervulina, E.
brunetti, E. mivati, and E. maxima.
(b) Limitations. Do not feed to laying
chickens; feed continuously as the sole
ration; withdraw 5 days before slaughter; as sole source of organic arsenic;
as roxarsone provided by No. 046573,
510.600(c) of this chapter; as monensin
sodium
provided
by
No.
000986,
510.600(c) of this chapter; as lincomycin
provided
by
No.
000009,
510.600(c) of this chapter; as a combination provided by No. 000009,
510.600(c) of this chapter.
(xi) Amount per ton. Monensin, 90 to
110 grams, plus lincomycin, 2 grams
and roxarsone, 15 to 30 grams.
(a) Indications for use. For increase in
rate of weight gain, improved feed efficiency, improved pigmentation, and as
an aid in the prevention of coccidiosis
caused by E. necatrix, E. tenella, E.
acervulina, E. brunetti, E. mivati and E.
maxima.
(b) Limitations. Do not feed to laying
chickens; feed continuously as the sole
ration; withdraw 5 days before slaughter; as sole source of organic arsenic;
as roxarsone provided by No. 046573 in
510.600(c) of this chapter; as monensin
sodium provided by No. 000986 in
510.600(c) of this chapter; as lincomycin provided by No. 000009 in
510.600(c) of this chapter; as a combination provided by No. 000009 in
510.600(c) of this chapter.
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558.355
first clinical signs of disease. The dosage range permitted provides for different levels based on the severity of
infection. Use continuously for 5 to 7
days or as long as clinical signs persist,
then reduce dosage to prevention level.
Animals should have access to drinking
water at all times. Drug overdosage or
lack of water may result in leg weakness. As roxarsone and bacitracin
methylene disalicylate provided by No.
046573 in 510.600(c) of this chapter.
(2) Turkeys(i) Amount per ton.
Monensin, 54 to 90 grams.
(a) Indications for use. For the prevention of coccidiosis in turkeys caused by
E. adenoeides, E. meleagrimitis, and E.
gallopavonis.
(b) Limitations. For growing turkeys
only; as monensin sodium; feed continuously as sole ration. Do not allow
horses, other equines, mature turkeys,
or guinea fowl access to feed containing
monensin.
Ingestion
of
monensin by horses and guinea fowl
has been fatal. Some strains of turkey
coccidia may be monensin tolerant or
resistant. Monensin may interfere with
development of immunity to turkey
coccidiosis.
(ii) Amount per ton. Monensin, 54 to 90
grams, and bacitracin methylene disalicylate, 4 to 50 grams.
(a) Indications for use. For prevention
of coccidiosis caused by Eimeria
adenoeides, E. meleagrimitis, and E.
gallopavonis, for increased rate of
weight gain, and for improved feed efficiency.
(b) Limitations. For growing turkeys
only; as monensin sodium; feed continuously as sole ration. Do not allow
horses, other equines, mature turkeys
or guinea fowl access to feed containing
monensin.
Ingestion
of
monensin by horses and guinea fowl
has been fatal. Some strains of turkey
coccidia may be monensin tolerant or
resistant. Monensin may interfere with
development of immunity to turkey
coccidiosis. Bacitracin methylene disalicylate as provided by No. 046573 in
510.600(c) of this chapter.
(iii) Amount per ton. Monensin, 54 to
90 grams, and bacitracin methylene disalicylate, 200 grams.
(a) Indications for use. For the prevention of coccidiosis caused by Eimeria
adenoides, E. meleagrimitis, and E.
gallopavonis, and as an aid in the control of transmissible enteritis complicated by organisms susceptible to
bacitracin methylene disalicylate.
(b) Limitations. For growing turkeys
only; as monensin sodium; feed continuously as sole ration. Do not allow
horses, other equines, mature turkeys
or guinea fowl access to feed containing
monensin.
Ingestion
of
monensin by horses and guinea fowl
has been fatal. Some strains of turkey
coccidia may be monensin tolerant or
resistant. Monensin may interfere with
development of immunity to turkey
coccidiosis. Bacitracin methylene disalicylate as provided by No. 046573 in
510.600(c) of this chapter.
(iv) Amount per ton. Monensin, 54 to
90 grams, with virginiamycin, 10 to 20
grams.
(a) Indications for use. For the prevention of coccidiosis caused by Eimeria
adenoeides, E. meleagrimitis, and E.
gallopavonis, and for increased rate of
weight gain and improved feed efficiency in growing turkeys.
(b) Limitations. For growing turkeys
only. Feed continuously as sole ration.
Do not allow horses, other equines, mature turkeys, or guinea fowl access to
feed containing monensin. Ingestion of
monensin by horses, mature turkeys,
and guinea fowl has been fatal. Some
strains of turkey coccidia may be
monensin
tolerant
or
resistant.
Monensin may interfere with development of immunity to turkey coccidiosis. Virginiamycin as provided by No.
000069 in 510.600(c) of this chapter.
(3)
Cattle(i)
Amount
per
ton.
Monensin, 530 grams.
(a) Indications for use. Improved feed
efficiency.
(b) Limitations. (1) Feed only to cattle
being fed in confinement for slaughter.
Feed continuously in complete feed at
a rate of 50 to 360 milligrams of
monensin per head per day; as
monensin sodium. Complete feeds may
be manufactured from monensin liquid
Type B feeds. The liquid Type B feeds
have a pH of 4.3 to 7.1 and their labels
must bear appropriate mixing directions. Mixing directions for liquid Type
B feeds stored in recirculating tank
systems are: Recirculate immediately
prior to use for no less than 10 minutes,
moving not less than 1 percent of the
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tank contents per minute from the bottom of the tank to the top. Recirculate
daily, as directed in this paragraph,
even when Type B feed is not used.
Mixing directions for liquid Type B
feeds stored in mechanical, air, or
other agitation-type tank systems are:
Agitate immediately prior to use for
not less than 10 minutes, creating a
turbulence at the bottom of the tank
that is visible at the top. Agitate daily,
as directed in this paragraph, even
when Type B feed is not used. The liquid Type B feed must bear directions to
mix thoroughly with grain and/or
roughage prior to feeding and must
bear caution statements as follows: Inadequate mixing, (recirculation or agitation), of liquid Type B feeds has resulted in increased monensin concentration which has been fatal to cattle.
(2) An approved positionally stable
monensin liquid Type B feed will not be
subject to the requirements for mixing
directions and cautionary labeling prescribed in paragraph (f)(3)(i)(b)(1) of
this section. A manufacturer may secure approval of a positionally stable
liquid Type B feed by (i) either filing
an NADA for the product or by establishing a master file containing data to
support the stability of its product; (ii)
authorizing the agency to reference
and rely upon the data in the master
file to support approval of a supplemental NADA to establish positional
stability; and (iii) requesting No. 000986
in 510.600(c) of this chapter to file a
supplemental NADA to provide for the
use of its monensin Type A article in
the manufacture of the liquid Type B
feed specified in the appropriate master file. If the data demonstrate the
stability of the liquid Type B feed described in the master file, the agency
will approve the supplemental NADA.
Approval of the Type B feed need not
be published in the FEDERAL REGISTER
because approval will not affect or
alter the content of the regulation. The
approval will, however, provide a basis
for the individual liquid feed manufacturer to submit, and for the agency to
approve, a medicated feed application
under section 512(m) of the act for the
liquid Type B feed. A manufacturer
who seeks to market a positionally unstable monensin liquid Type B feed
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For prevention and control of coccidiosis, feed at a rate of 0.14 to 0.42 milligram per pound of body weight per day,
depending upon severity of challenge,
up to a maximum of 200 milligrams per
head per day. During first 5 days of
feeding, cattle should receive no more
than 100 milligrams per head per day.
(vii) Amount per ton. Monensin, 10 to
30 grams.
(a) Indications for use. For improved
feed efficiency; for prevention and control of coccidiosis due to E. bovis and E.
zuernii.
(b) Limitations. For feedlot cattle,
feed continuously to provide 50 to 360
milligrams monensin per head per day.
For prevention and control of coccidiosis, feed at a rate of 0.14 to 0.42 milligram per pound of body weight per day,
depending upon the severity of challenge, up to maximum of 360 milligrams per head per day.
(viii)
Additional
combinations.
Monensin may be used for heifers being
fed in confinement for slaughter with
melengestrol acetate with or without
tylosin as in 558.342.
(ix) Amount. To 000986: To make liquid Type B medicated feed containing
400 grams per ton monensin sodium
with 150 grams per ton tylosin phosphate used to make a dry Type C medicated feed containing 21.4 to 26.8 grams
per ton monensin plus 8 to 10 grams per
ton tylosin.
(a) Indications for use. Improved feed
efficiency; for reduction of incidence of
liver abscesses caused by Fusobacterium
necrophorum
and
Actinomyces
(Corynebacterium) pyogenes.
(b) Limitations. Feed only to cattle
being fed in confinement for slaughter.
Feed continuously at the rate of 8.2 to
10.2 kilograms (18 to 22.5 pounds) of
Type C medicated feed per head per day
to supply 240 milligrams of monensin
and 90 milligrams of tylosin per head
per day; as monensin sodium; as
tylosin phosphate. Do not allow horses
or other equines access to feeds containing
monensin.
Ingestion
of
monensin by equines has been fatal.
Safe use in unapproved species and
breeding cattle has not been established. The liquid Type B medicated
feed must bear an expiration date of 14
days after date of manufacture. The
mixing directions for this liquid Type
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558.355
B medicated feed stored in recirculation or agitation tank systems are: Recirculate or agitate immediately prior
to use for not less than 10 minutes,
moving at least 1 percent of the tanks
contents per minute from the bottom
of the tank to the top. Recirculate or
agitate as directed daily, even when
the Type B medicated feed is not used.
Inadequate mixing (recirculation or
agitation) of liquid Type B medicated
feeds may result in increased monensin
concentrations which have been fatal
Ingredient
Percent
29.49
24.25
20.0
13.75
3.0
5.0
2.5
1.01
1.0
1Content of the vitamin/trace mineral premix may be varied. However, they should be comparable to those used for other freechoice feeds. Formulation modifications require FDA approval prior to marketing. The amount of selenium and ethylenediamine
dihydroiodide (EDDI) must comply with the published requirements. (For selenium see 21 CFR 573.920; for EDDI see 51 FR
11483 (April 3, 1986).)
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558.360
(6)
Goats(i)
Amount
per
ton.
Monensin, 20 grams.
(a) Indications for use. For the prevention of coccidiosis caused by Eimeria
crandallis, E. christenseni, and E.
ninakohlyakimovae.
(b) Limitations. (1) Feed only to goats
being fed in confinement. Do not feed
to lactating goats. Feed continuously
in Type C feed as monensin sodium.
Type C feeds may be manufactured
from monensin liquid Type B feeds.
The liquid Type B feeds have a pH of 4.3
to 7.1 and their labels must bear appropriate mixing directions. Mixing directions for liquid Type B feeds stored in
recirculating tank systems are: Recirculate immediately prior to use for no
less than 10 minutes, moving not less
than 1 percent of the tank contents per
minute from the bottom of the tank to
the top. Recirculate daily, as directed
in this paragraph, even when Type B
feed is not used. Mixing directions for
liquid Type B feeds stored in mechanical, air, or other agitation-type tank
systems are: Agitate immediately prior
to use for not less than 10 minutes, creating a turbulence at the bottom of the
tank that is visible at the top. Agitate
daily, as directed in this paragraph,
even when Type B feed is not used. The
liquid Type B feed must bear directions
to mix thoroughly with grain and/or
roughage prior to feeding and must
bear caution statement as follows: Inadequate mixing (recirculation or agitation), of liquid Type B feeds has resulted in increased monensin concentration which could be fatal to
goats.
(2) An approved positionally stable
monensin liquid Type B feed will not be
subject to the requirements for mixing
directions and cautionary labeling prescribed in paragraph (f)(6)(i)(b)(1) of
this section. A manufacturer may secure approval of a positionally stable
liquid Type B feed by (i) either filing
an NADA for the product or by establishing a master file containing data to
support the stability of its product; (ii)
authorizing the agency to reference
and rely upon the data in the master
file to support approval of a supplemental NADA to establish positional
stability; and (iii) requesting No. 000986
in 510.600(c) of this chapter to file a
supplemental NADA to provide for the
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558.363
contortus,
Ostertagia
(Teladorsagia)
circumcincta, and Trichostrongylus axei.
(3) Limitations. Feed as a single therapeutic treatment at 0.44 gram of
morantel tartrate per 100 pounds of
body weight. Fresh water should be
available at all times. When medicated
feed is consumed, resume normal feeding. Conditions of constant worm exposure may require retreatment in 2 to 4
weeks. Do not treat cattle within 14
days of slaughter; do not treat goats
within 30 days of slaughter.
[46 FR 50950, Oct. 16, 1981, as amended at 47
FR 53352, Nov. 26, 1982; 51 FR 7399, Mar. 3,
1986; 51 FR 9005, Mar. 17, 1986; 52 FR 11642,
Apr. 10, 1987; 59 FR 17922, Apr. 15, 1994]
558.363 Narasin.
(a) Approvals. Type A medicated articles containing specified levels of
narasin approved for sponsors identified in 510.600(c) of this chapter for use
as in paragraph (d) of this section are
as follows:
(1) To 000986: 36, 45, 54, 72, and 90
grams per pound, paragraph (d)(1)(i) of
this section.
(2) To 000986: 36, 45, 54, 72, and 90
grams per pound, with 10, 20, 50, and 80
percent roxarsone, paragraph (d)(1)(ii)
of this section.
(3) To 000986: 36 grams per pound,
with 36 grams per pound nicarbazin,
paragraph (d)(1)(iii) of this section.
(4) To 012799: 36, 45, 54, 72, and 90
grams per pound, with 2 and 10 grams
per pound bambermycins, paragraph
(d)(1)(iv) of this section.
(5) To 012799: 45 grams per pound,
with 4 and 10 grams per pound
bambermycins, and 45.4, 90, and 227
grams per pound roxarsone, paragraph
(d)(1)(vii) of this section.
(6) To 046573: 45 grams per pound with
10, 25, 30, 40, 50, 60, or 75 grams per
pound bacitracin methylene disalicylate and 45.4, 90, or 227 grams per pound
roxarsone, paragraphs (d)(1)(viii) and
(d)(1)(ix) of this section.
(b) Tolerances. See 556.428 of this
chapter.
(c) [Reserved]
(d) Conditions of use. It is used as follows:
(1) Broiler chickens(i) Amount per
ton. Narasin, 54 to 72 grams.
(A) Indications for use. For prevention
of coccidiosis caused by Eimeria
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558.364
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558.364
Neomycin Sulfate
Combination
Limitations
Sponsor
000009
430
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Neomycin Sulfate
Combination
558.365
Limitations
To provide 10 mg of
neomycin sulfate per
pound of body weight
per day for a maximum of 14 days.
Amount consumed
will vary depending
on animals consumption and weight.
If symptoms persist
after using for 2 or 3
days, consult a veterinarian. Treatment
should continue 24 to
48 hours beyond remission of disease
symptoms. Discontinue treatment
prior to slaughter as
follows: Cattle 1 day,
swine 3 days, sheep
2 days, and goats 3
days. A withdrawal
period has not been
established for use in
preruminating calves.
Do not use in calves
to be processed for
veal. A milk discard
time has not been
established for use in
lactating dairy cattle
or lactating dairy
goats. Do not use in
female dairy cattle 20
months of age or
older or female dairy
goats 12 months of
age or older. For use
in milk replacers
only.
Sponsor
000009
558.365
Nequinate.
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558.366
558.366
Nicarbazin.
Nicarbazin in grams
per ton
Combination in
grams per ton
Limitations
27 to 45 .....................
Narasin 27 to 45 ......
000986
000986
Narasin 27 to 45 and
bacitracin methylene disalicylate 4
to 50.
Narasin 27 to 45,
bacitracin methylene disalicylate
50, and roxarsone
22.7 to 45.4. .
Narasin 27 to 45 and
Lincomycin 2 to 4.
Sponsor
046573
000986
432
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558.366
Combination in
grams per ton
Limitations
Narasin 27 to 45 and
roxarsone 22.7 to
45.4..
.............................
Bacitracin methylene
disalicylate 30.
Feed continuously as sole ration. Use as sole source of organic arsenic. Withdraw 5
days before slaughter. Do not
allow turkeys, horses or other
equines access to formulations containing narasin. Ingestion of narasin by these
species has been fatal. Do not
feed to laying hens. Use as
sole source of organic arsenic.
Narasin and nicarbazin as
provided
by
000986,
roxarsone by 046573..
Feed continuously as sole ration
from time chicks are placed
on litter until past the time
when coccidiosis is ordinarily
a hazard; do not use as a
treatment for coccidiosis; do
not use in flushing mashes; do
not feed to laying hens; withdraw 4 days before slaughter.
......do .........................................
Bacitracin zinc 4 to
50..
Bambermycins 1 to
2.
Lincomycin 2
(0.00044 pct).
Sponsor
000986
000986
060728
063271
060728
063271
063271
012799
060728
063271
433
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558.369
Nicarbazin in grams
per ton
Combination in
grams per ton
Limitations
Roxarsone 22.7
(0.0025)..
......do .........................................
Roxarsone 22.7
(0.0025) plus lincomycin 2
(0.0004)..
......do .........................................
Sponsor
060728
063271
060728
063271
[42 FR 56729, Oct. 28, 1977; 43 FR 1942, Jan. 13, 1978, as amended at 44 FR 40887, July 13, 1979;
50 FR 13562, Apr. 5, 1985; 51 FR 7399, Mar. 3, 1986; 54 FR 1928, Jan. 18, 1989; 60 FR 29483, June
5, 1995; 61 FR 1832, Jan. 24, 1996; 61 FR 14021, Mar. 29, 1996; 61 FR 14483, Apr. 2, 1996; 62 FR 29011,
May 29, 1997; 63 FR 13124, Mar. 18, 1998; 63 FR 57248, Oct. 27, 1998; 64 FR 4966, Feb. 2, 1999; 64
FR 18574, Apr. 15, 1999; 64 FR 20164, Apr. 26, 1999; 64 FR 49384, Sept. 13, 1999; 65 FR 11889, Mar.
7, 2000]
558.369
Nitarsone.
558.376
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558.415
558.415 Novobiocin.
(a) Approvals. Type A medicated articles: 25 grams of activity per pound to
000009 in 510.600(c) of this chapter.
Type B medicated feeds: 17.5 grams per
pound to 000009 in 510.600(c) of this
chapter.
(b) Related tolerances. See 556.460 of
this chapter.
(c) Conditions of use. It is used in animal feeds as follows:
(1) Chickens(i) Amount. Novobiocin,
67 mgs. per lb. body weight per day.
(a) Indications for use. Aid in the
treatment of breast blisters associated
with staphylococcal infections susceptible to novobiocin.
(b) Limitations. Administer, as sole ration, feed which contains not less than
200 grams of novobiocin activity per
ton of feed; not for laying chickens;
feed 5 to 7 days; withdraw 4 days before
slaughter.
(ii) Amount. Novobiocin, 1014 mgs.
per lb. body weight per day.
(a) Indications for use. Treatment of
staphylococcal synovitis and generalized staphylococcal infections susceptible to novobiocin.
(b) Limitations. Administer, as sole ration, feed which contains not less than
350 grams of novobiocin activity per
ton of feed; not for laying chickens;
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558.430
558.430
Nystatin.
558.450 Oxytetracycline.
(a) Approvals. Type A medicated articles:
(1) 10, 20, 30, 50, 100, and 200 grams per
pound to 000069 in 510.600(c) of this
chapter.
(2) 50 and 100 grams per pound to
053389 in 510.600(c) of this chapter.
(b) Special considerations. (1) In accordance with 558.5 labeling shall bear
the statement: FOR USE IN DRY
ANIMAL FEED ONLY. NOT FOR USE
IN LIQUID FEED SUPPLEMENTS.
(2) The articles in paragraph (a)(1) of
this section contain an amount of
mono-alkyl
(C8C18)
trimethylammonium oxytetracycline
expressed in terms of an equivalent
amount of oxytetracycline hydrochloride or an amount of oxytetracycline dihydrate base expressed in
terms of an equivalent amount of oxytetracycline hydrochloride.
(3) The articles in paragraph (a)(2) of
this section contain an amount of
mono-alkyl
(C8C18)
trimethylammonium oxytetracycline
expressed in terms of an equivalent
amount of oxytetracycline hydrochloride.
(c) Related tolerances. See 556.500 of
this chapter.
(d)(1) Conditions of use. It is used in
feed as follows:
558.435
Oleandomycin.
TABLE 1
Oxytetracycline amount
Combination
Limitations
Sponsor
.......................................
000069,
053389
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558.450
TABLE 1Continued
Oxytetracycline amount
Combination
(ii) 10 to 50 g/ton
1. Chickens; increased
rate of weight gain and
improved feed efficiency.
2. Growing turkeys; increased rate of weight
and improved feed efficiency.
3. Swine; increased rate
of weight and improved
feed efficiency.
Turkeys; control of
hexamitiasis caused by
Hexamita meleagridis
susceptible to oxytetracycline.
Chickens; control of infectious synovitis caused
by Mycoplasma
synoviae; control of fowl
cholera caused by
Pasteurella multocida
susceptible to oxytetracycline.
Chickens; control of infectious synovitis caused
by M. synoviae; control
of fowl cholera caused
by P. multocida susceptible to oxytetracycline;
as an aid in the control
of coccidiosis caused
by Eimeria tenella, E.
necatrix, E. acervulina,
E. maxima, E. brunetti,
and E. mivati.
Turkeys; control of infectious synovitis caused
by M. synoviae susceptible to oxytetracycline.
Chickens; control of
chronic respiratory disease (CRD) and air sac
infection caused by M.
gallisepticum and Escherichia coli susceptible
to oxytetracycline.
Chickens; control of CRD
and air sac infection
caused by M.
gallisepticum and E. coli
susceptible to oxytetracycline; and as an aid
in the prevention of coccidiosis caused by E.
necatrix, E. tenella, E.
acervulina, E. brunetti,
E. mivati, and E. maxima.
Limitations
Sponsor
Do.
Do.
.......................................
Do.
Do.
......do ...............................
000069
000069,
053389
Do.
Do.
000069
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558.450
Oxytetracycline amount
Combination
Nequinate 18.16 g/ton
(0.002%)
Salinomycin 40 to 60 g/
ton
Limitations
......do ...............................
Do.
000069,
053389
......do ...............................
000069,
012799
000069,
053389
Chickens; reduction of
mortality due to air
sacculitis (air-sac-infection) caused by E. coli
susceptible to oxytetracycline; as an aid in the
prevention of coccidiosis caused by E.
necatrix, E. tenella, E.
acervulina, E. brunetti,
E. mivati, and E. maxima.
Chickens; reduction of
mortality due to air
sacculitis (air-sac-infection) caused by E. coli
susceptible to oxytetracycline; prevention of
coccidiosis caused by
E. necatrix, E. tenella,
E. acervulina, E.
brunetti, E. mivati, and
E. maxima.
Calves (up to 250 lb); for
increased rate of weight
gain and improved feed
efficiency.
1.Calves and beef and
nonlactating dairy cattle;
treatment of bacterial
enteritis caused by E.
coli and bacterial pneumonia (shipping fever
complex) caused by P.
multocida susceptible to
oxytetracycline.
2. Calves (up to 250 lb);
treatment of bacterial
enteritis caused by E.
coli susceptible to oxytetracycline.
3. Sheep; treatment of
bacterial enteritis
caused by E. coli and
bacterial pneumonia
caused by P. multocida
susceptible to oxytetracycline.
Sponsor
000069
Do.
Do.
Do.
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558.450
TABLE 1Continued
Oxytetracycline amount
Combination
(xi) 25 mg/head/day
(xii) 75 mg/head/day
Limitations
4. Swine; treatment of
bacterial enteritis
caused by E. coli and
Salmonella choleraesuis
susceptible to oxytetracycline and treatment of
bacterial pneumonia
caused by P. multocida
susceptible to oxytetracycline.
5. Breeding swine; control
and treatment of leptospirosis (reducing the
incidence of abortion
and shedding of
leptospirae) caused by
Leptospira pomona susceptible to oxytetracycline.
Turkeys; control of complicating bacterial organisms associated with
bluecomb (transmissible
enteritis; coronaviral enteritis) susceptible to
oxytetracycline.
Calves (250 to 400 lb); increased rate of weight
gain and improved feed
efficiency.
Growing cattle (over 400
lb); increased rate of
weight gain; improved
feed efficiency, and reduction of liver condemnation due to liver
abscesses.
Cattle; prevention and
treatment of the early
stages of shipping fever
complex.
Honey bees; control of
American foulbrood
caused by Bacillus larvae and European
foulbrood caused by
Streptococcus pluton
susceptible to oxytetracycline.
Sponsor
Do.
Do.
Do.
.......................................
Do.
.......................................
Do.
Do.
Do.
Combination
Limitations
Sponsor
000069
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558.460
Oxytetracycline amount
Combination
Limitations
1. Salmonids; control of
ulcer disease caused by
Hemophilus piscium, furunculosis caused by
Aeromonas
salmonicida, bacterial
hemorrhagic septicemia
caused by A.
liquefaciens, and
pseudomonas disease.
Administer as mono-alkyl
(C8C18) trimethyl ammonium oxytetracycline
in mixed ration for 10 d;
do not liberate fish or
slaughter fish for food
for 21 d following the
last administration of
medicated feed; do not
administer when water
temperature is below 9
cC (48.2 cF).
Administer as mono-alkyl
(C8C18) trimethyl ammonium oxytetracycline
in mixed ration for 10 d;
do not liberate fish or
slaughter fish for food
for 21 d following the
last administration of
medicated feed; do not
administer when water
temperature is below
16.7 cC (62 cF)
Administer as sole ration
for 5 consecutive days
in feed containing
monoalkyl (C8C18)
trimethyl ammonium oxytetracycline; withdraw
medicated feed 30 d
before harvesting lobsters.
Lobsters; control of
gaffkemia caused by
Aerococcus viridans.
Combination in
grams per ton
.............................
(ii) 5 to 20 ..................
.............................
(iii) 10 to 50 ...............
.............................
000069
000069
000069
558.460 Penicillin.
(a) Specifications. As penicillin procaine G or feed grade penicillin procaine.
(b) Sponsors. Type A medicated articles: To 000069, 100 grams per pound. To
046573, 100 and 227 grams per pound.
(c) Related tolerances. See 556.510 of
this chapter.
(d) Conditions of use. (1) It is used as
follows:
Limitations
(2) Penicillin may be used in accordance with the provisions of this section
Sponsor
Sponsor
000069,
046573.
Do.
.....................................................
Do.
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558.485
558.464
Poloxalene.
558.485
Pyrantel tartrate.
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558.485
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558.485
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558.500
558.500 Ractopamine.
(a) Approvals. Type A medicated articles: 9 grams of ractopamine hydrochloride per pound to 000986 in
510.600(c) of this chapter.
(b) [Reserved]
(c) Related tolerances. See 556.570 of
this chapter.
(d) Conditions of use. (1) Swine(i)
Amount. 4.5 grams of ractopamine hydrochloride per ton of Type C feed for
increased rate of weight gain, improved
feed efficiency, and increased carcass
leanness; 4.5 to 18 grams per ton for improved feed efficiency and increased
carcass leanness; fed in a complete ration containing at least 16 percent
crude protein to finishing swine from
150 to 240 pounds body weight.
(ii) Limitations. Feed continuously as
sole ration. Not for use in breeding
swine.
(2) [Reserved]
[65 FR 4112, Jan. 26, 2000]
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558.515
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558.530
558.530 Roxarsone.
(a) Approvals. Type A medicated articles: (1) 10, 20, and 50 percent to 046573
in 510.600(c) of this chapter for use as
in paragraph (d)(1) of this section.
(2) 10, 20, 50, and 80 percent to 046573
in 510.600(c) of this chapter for use as
in paragraphs (d)(1), (d)(2), (d)(3), and
(d)(4) of this section.
(b) Related tolerances. See 556.60 of
this chapter.
(c) [Reserved]
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558.530
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558.550
558.550 Salinomycin.
(a) Approvals. Type A medicated articles containing 30 or 60 grams of
salinomycin activity per pound (as
salinomycin sodium biomass) as follows:
(1) To 063238 in 510.600(c) of this
chapter for use as in paragraph (d) of
this section.
(2) To 012799 for use as in paragraphs
(d)(1)(i), (d)(1)(iii) through (d)(1)(xvi),
and (d)(3)(i) through (d)(3)(iii) of this
section.
(3) To 046573 for use as in paragraphs
(d)(1)(xv) and (d)(1)(xvi) of this section.
(b)(c) [Reserved]
(d) Conditions of use. (1) Broilers: It is
used as follows:
(i)(a) Amount per ton. Salinomycin 40
to 60 grams.
(b) Indications for use. For the prevention of coccidiosis caused by Eimeria
tenella, E. necatrix, E. acervulina, E.
maxima, E. brunetti, and E. mivati.
(c) Limitations. Feed continuously as
sole ration. Do not feed to layers. Not
approved for use with pellet binders.
May be fatal if accidentally fed to
adult turkeys or horses.
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558.550
than to salinomycin alone; for increased rate of weight gain and improved feed efficiency.
(c)
Limitations.
See
paragraph
(b)(1)(iv)(c) of this section.
(ix)(a) Amount per ton. Salinomycin
40 to 60 grams with roxarsone 34.1
grams and bacitracin zinc 10 to 50
grams.
(b) Indications for use. For the prevention of coccidiosis caused by Eimeria
tenella, E. necatrix, E. acervulina, E.
maxima, E. brunetti, and E. mivati, and
for increased rate of weight gain and
improved feed efficiency.
(c) Limitations. Feed continuously as
sole ration. Use as sole source of organic arsenic. Do not feed to layers.
May be fatal if accidentally fed to
adult turkeys or horses. Withdraw 5
days before slaughter. Roxarsone as
provided by No. 046573 and bacitracin
as provided by No. 063238 in 510.600(c)
of this chapter.
(x)(a) Amount per ton. Salinomycin 40
to 60 grams and virginiamycin 5 grams.
(b) Indications for use. For the prevention of coccidiosis caused by Eimeria
tenella, E. necatrix, E. acervulina, E.
maxima, E. brunetti, and E. mivati, and
for increased rate of weight gain and
improved feed efficiency.
(c) Limitations. Feed continuously as
sole ration. Not approved for use with
pellet binders. Do not feed to layers or
to chickens over 16 weeks of age. May
be fatal if accidentally fed to adult turkeys or horses. Virginiamycin as provided by No. 053571 in 510.600(c) of this
chapter.
(xi)(a) Amount per ton. Salinomycin
40 to 60 grams and virginiamycin 5 to
15 grams.
(b) Indications for use. For the prevention of coccidiosis caused by Eimeria
tenella, E. necatrix, E. acervulina, E.
maxima, E. brunetti, and E. mivati, and
for increased rate of weight gain.
(c)
Limitations.
See
paragraph
(b)(1)(x)(c) of this section.
(xii) (a) Amount per ton. Salinomycin
40 to 60 grams, virginiamycin 5 grams,
and roxarsone 45.4 grams.
(b) Indications for use. For prevention
of coccidiosis caused by Eimeria tenella,
E. necatrix, E. acervulina, E. maxima, E.
brunetti, and E. mivati, including some
field strains of E. tenella which are
more susceptible to roxarsone com-
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558.555
amended by removing No. 000004 and adding in its place Nos. 000004 and 046573.
Since 558.550(b) does not exist, these amendments could not be incorporated.
558.555 Semduramicin.
(a) Approvals. Type A medicated article
containing
5.13
percent
semduramicin sodium (equivalent to 50
grams semduramicin per kilogram or
22.7 grams per pound) to 000069 in
510.600(c) of this chapter.
(b) Related tolerances. See 556.597 of
this chapter.
(c) [Reserved]
(d) Conditions of use in broiler chickens. (1)(i) Amount. Semduramicin: 25
parts per million.
(ii) Indications for use. For the prevention of coccidiosis caused by Eimeria
tenella, E. acervulina, E. maxima, E.
brunetti, E. necatrix, and E. mivati/E.
mitis.
(iii) Limitations. Do not feed to laying
hens.
(2) Amount. Semduramicin 22.7 grams
with bacitracin methylene disalicylate
10 to 50 grams and roxarsone 45.4 grams
per ton.
(i) Indications for use. For the prevention of coccidiosis caused by Eimeria
acervulina, E. brunetti, E. maxima, E.
mivati/E. mitis, E. necatrix, and E.
tenella, including some field strains of
E. tenella that are more susceptible to
semduramicin
combined
with
roxarsone than semduramicin alone,
and for improved feed efficiency.
(ii) Limitations. Feed continuously as
sole ration. Use feed within 2 weeks of
production. Withdraw 5 days before
slaughter. Do not feed to laying hens.
Use as sole source of organic arsenic.
Poultry should have access to drinking
water at all times. Drug overdosage or
lack of water intake may result in leg
weakness or paralysis. Semduramicin
as provided by 000069 in 510.600(c) of
this chapter, bacitracin methylene disalicylate and roxarsone as provided by
046573.
(3) Amount. Semduramicin 22.7 grams
with bacitracin methylene disalicylate
10 to 50 grams per ton.
(i) Indications for use. For the prevention of coccidiosis caused by Eimeria
acervulina, E. brunetti, E. maxima, E.
mivati/E. mitis, E. necatrix, and E.
tenella, and for improved feed efficiency
in broiler chickens.
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558.575
558.575 Sulfadimethoxine,
ormetoprim.
(a) Approvals. Type A medicated articles to sponsors as identified in
510.600(c) of this chapter for uses as in
paragraph (d) of this section as follows:
(1) 25 percent sufadimethoxine and 15
percent ormetoprim to 000004 for use
for poultry as in paragraphs (d)(1),
(d)(2), (d)(3), (d)(4), and (d)(7) of this
section.
(2) 25 percent sulfadimethoxine and 5
percent ormetoprim to 000004 for use
for fish as in paragraphs (d)(5) and
(d)(6) of this section.
(b) Related tolerances. See 556.490
and 556.640 of this chapter.
(c) [Reserved]
(d) Conditions of use. It is used in
feeds for animals as follows:
(1) Broiler chickens(i) Amount per
ton. Sulfadimethoxine, 113.5 grams
(0.0125 percent) plus ormetoprim, 68.1
grams (0.0075 percent).
(a) Indications for use. As an aid in
the prevention of coccidiosis caused by
all Eimeria species known to be pathogenic to chickens, namely, E. tenella, E.
necatrix, E. acervulina, E. brunetti, E.
mivati, and E. maxima, and bacterial infections due to H. gallinarum (infectious coryza), E. coli (colibacillosis) and
P. multocida (fowl cholera).
(b) Limitations. Feed as sole ration;
withdraw 5 days before slaughter.
(ii)
Amount
per
ton.
Sulfadimethoxine, 113.5 grams (0.0125
percent) plus ormetoprim, 68.1 grams
(0.0075 percent) plus roxarsone, 22.7
grams (0.0025 percent).
(a) Indications for use. As an aid in
the prevention of coccidiosis caused by
all Eimeria species known to be pathogenic to chickens, namely E. tenella, E.
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558.579
(ii)
Amount
per
ton.
Sulfadimethoxine, 454 grams (0.05 percent) plus ormetoprim, 272.4 grams (0.03
percent).
(a) Indications for use. As an aid in
the control of bacterial infections due
to E. coli, Riemerella anatipestifer, and
severe challenge of P. multocida (fowl
cholera) in ducks.
(b) Limitations. Feed as a sole ration
for 7 days; withdraw 5 days before
slaughter; medication should be started at the first signs of infection; not
for breeding ducks; do not feed to
ducks producing eggs for food.
(5) Salmonids(i) Amount. 50 milligrams of active ingredients per kilogram of body weight per day.
(ii) Indications of use. For the control
of furunculosis in salmonids (trout and
salmon)
caused
by
Aeromonas
salmonicida strains susceptible to
sulfadimethoxine and ormetoprim combination.
(iii) Limitations. Administer for 5 consecutive days; withdraw 42 days before
release as stocker fish or slaughter.
(6) Catfish(i) Amount. 50 milligrams
of active ingredients per kilogram of
body weight per day.
(ii) Indications for use. For control of
enteric septicemia of catfish caused by
Edwardsiella ictaluri strains susceptible
to sulfadimethoxine and ormetoprim
combination.
(iii) Limitations. Administer for 5 consecutive days; withdraw 3 days before
slaughter or release as stocker fish.
(7) Chukar partridges(i) Amount per
ton. Sulfadimethoxine 113.5 grams
(0.0125 percent) plus ormetoprim 68.1
grams (0.0075 percent).
(ii) Indications for use. For prevention
of coccidiosis caused by Eimeria kofoidi
and E. legionensis.
(iii) Limitations. Feed continuously to
young birds up to 8 weeks of age as sole
ration.
[40 FR 13959, Mar. 27, 1975, as amended at 42
FR 13550, Mar. 11, 1977; 49 FR 33442, Aug. 23,
1984; 49 FR 46371, Nov. 26, 1984; 51 FR 7400,
Mar. 3, 1986; 51 FR 18884, May 23, 1986; 52 FR
2686, Jan. 26, 1987; 54 FR 1686, Jan. 17, 1989; 63
FR 27846, May 21, 1998; 64 FR 26672, May 17,
1999; 64 FR 43910, Aug. 12, 1999]
558.579 Sulfaethoxypyridazine.
(a) Approvals. Type A medicated articles: 5.5 percent for swine, and 5.5 and
558.582 Sulfamerazine.
(a) Approvals. Type A medicated articles: 99 percent to 063238 in 510.600(c)
of this chapter.
(b) Related tolerances. See 556.660 of
this chapter.
(c) Conditions of use. It is used in fish
feed for rainbow trout, brook trout,
and brown trout as follows:
(1) Amount. 10 grams of sulfamerazine
per 100 pounds of fish per day.
(2) Indications for use. Control of furunculosis.
(3) Limitations. Treat for not more
than 14 days; do not treat within 3
weeks of marketing or stocking in
stream open to fishing.
[41 FR 11005, Mar. 15, 1976, as amended at 51
FR 7400, Mar. 3, 1986; 61 FR 18082, Apr. 24,
1996; 63 FR 27846, May 21, 1998]
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558.586
558.586 Sulfaquinoxoline.
(a) Approvals. Type A medicated articles: 40 percent to 050749 in 510.600(c)
of this chapter.
(b)(c) [Reserved]
(d) NAS/NRC status. The conditions of
use specified in this section have been
reviewed by NAS/NRC and are found effective. Applications for these uses
need not include effectiveness data as
specified by 514.111 of this chapter,
but may require bioequivalency information. Applications must be accompanied by a written commitment to undertake the human safety studies required by FDA.
(e) Special considerations. (1) For control of outbreaks of disease, medication should be initiated as soon as the
diagnosis is determined. Medicated
chickens, turkeys, and rabbits must actually consume enough medicated feed
which provides a recommended dose of
approximately 3.5 to 60 milligrams per
pound per day in chickens, 2.5 to 100
milligrams per pound per day in turkeys, and 2.8 to 68 milligrams per
pound per day in rabbits depending
upon age and class of animal, ambient
temperature, and other factors. Consult a veterinarian or poultry pathologist for diagnosis.
(2) [Reserved]
(f) Conditions of use. It is used as follows:
(1) Chickens(i) Amount. 0.015 percent.
(a) Indications for use. As an aid in
preventing outbreaks of coccidiosis
caused by Eimeria tenella, E. necatrix, E.
acervulina, E. maxima, and E. brunetti
under average conditions of exposure.
(b) Limitations. Feed continuously
from the time birds are placed on litter
and continue past the age when coccidiosis is ordinarily a hazard. If death
losses exceed 0.5 percent in a 2-day period, obtain a laboratory diagnosis. If
coccidiosis is the cause, use the
sulfaquinoxaline levels recommended
for control of outbreaks, returning to
the original dosage schedule after the
outbreak has subsided. Losses may result from intercurrent disease, other
conditions affecting drug intake, or
variant strains of coccidia species
which can contribute to the virulence
of coccidiosis under field conditions.
Do not treat chickens within 10 days of
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558.600
days of slaughter. Do not medicate turkeys producing eggs for human consumption.
(ii) Amount. 0.05 percent.
(a) Indications for use. As an aid in
controlling outbreaks of coccidiosis
caused by Eimeria meleagrimitis, and E.
adenoeides.
(b) Limitations. Feed 0.05 percent for 2
days. Follow with 3 days on regular
feed and 2 more days on 0.05 percent
sulfaquinoxaline feed. Again follow
with 3 days on regular feed and 2 more
days on 0.05 percent sulfaquinoxaline
feed. Continue this schedule if necessary till all signs of the outbreaks
have subsided. Do not treat turkeys
within 10 days of slaughter. Do not
medicate turkeys producing eggs for
human consumption.
(3) Chickens and turkeys(i) Amount.
0.05 or 0.1 percent.
(a) Indications for use. As an aid in
the control of acute fowl cholera
caused by Pasteurella multocida susceptible to sulfaquinoxaline and fowl typhoid caused by Salmonella gallinarum
susceptible to sulfaquinoxaline.
(b) Limitations. Feed 0.1 percent for 48
to 72 hours. Mortality should be
brought under control. After medication, move birds to clean ground or to
a clean house. If disease recurs, use 0.05
percent in feed again for 2 days. Do not
treat chickens or turkeys within 10
days of slaughter for food. Do not
medicate chickens or turkeys producing eggs for human consumption.
(ii) [Reserved]
(4) Rabbits(i) Amount. 0.025 percent.
(a) Indications for use. As an aid in
preventing
coccidiosis
caused
by
Eimeria stiedae.
(b) Limitations. Treatment to be started after weaning. Feed continuously
for 30 days or feed medicated feed for 2
days out of every week until marketing. Do not treat within 10 days of
slaughter.
(ii) Amount. 0.1 percent.
(a) Indications for use. As an aid in
controlling outbreaks of coccidiosis
caused by Eimeria stiedae.
(b) Limitations. Feed for 2 weeks. Do
not treat within 10 days of slaughter.
[48 FR 3965, Jan. 28, 1983, as amended at 51
FR 7400, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987;
55 FR 29843, July 23, 1990; 59 FR 33197, June
28, 1994]
558.600
Tiamulin.
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558.615
558.615 Thiabendazole.
(a) Approvals. Dry Type A medicated
articles: 22, 44.1, 66.1, and 88.2 percent
to 050604 in 510.600(c) of this chapter.
The 66.1 percent Type A is solely for
the manufacture of cane molasses liquid Type B feed which is mixed in dry
feeds. The 88.2 percent Type A is used
solely for the manufacture of an aqueous slurry for adding to a Type C dry
cattle feed.
(b) Special considerations. Do not use
in Type B or Type C medicated feed
containing bentonite.
(c) Related tolerances. See 556.730 of
this chapter.
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558.618
558.618
Tilmicosin.
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558.625
558.625
Tylosin.
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558.625
(74)(76) [Reserved]
(77) To 050639: 5, 10, 20, and 40 grams
per pound, paragraphs (f)(1) (i) through
(vi) of this section.
(78) To 050972: 0.36, 0.4, 0.72, and 0.8
gram per pound, paragraph (f)(1)(vi)(a)
of this section; 1 gram per pound, paragraphs (f)(1)(vi) (a), (b), and (d) of this
section.
(79) To 012286: 5, 10, 20, and 40 grams
per pound, paragraphs (f)(1) (i) through
(vi) of this section.
(80) To 049685: 5, 10, 20, and 40 grams
per pound, paragraphs (f)(1) (i) through
(vi) of this section.
(81)(82) [Reserved]
(83) To 046573: 5-, 10-, 20-, and 40grams per pound, paragraphs (f)(1) (i)
through (vi) of this section.
(84) [Reserved]
(85) To 047126: 10, 40, and 100 grams
per pound, paragraphs (f)(1) (i) through
(vi) of this section.
(86)(88) [Reserved]
(89) To 053389: 5, 10, 20, and 40 grams
per pound, paragraph (f)(1) (i) through
(vi) of this section.
(c)(d) [Reserved]
(e) Related tolerances. See 556.740 of
this chapter.
(f) Conditions of use. (1) It is used in
animal feeds as follows:
(i) For beef cattle(a) Amount per ton.
810 grams.
(b) Indications for use. For reduction
of incidence of liver abscesses caused
by Fusobacterium necrophorum and
Actinomyces (Corynebacterium) pyogenes.
(c) Limitations. As tylosin phosphate;
each animal must receive not more
than 90 milligrams per day and not less
than 60 milligrams per day; feed continuously as sole ration.
(ii) Broiler chickens(a) Amount per
ton. Tylosin, 8001000 grams.
(b) Indications for use. To aid in the
control of chronic respiratory disease
caused by Mycoplasma gallisepticum.
(c) Limitations. As tylosin phosphate;
withdraw 5 days before slaughter; administer in feed to chickens 0 to 5 days
of age, follow with second administration in feed for 2448 hours at 3 to 5
weeks of age.
(iii) Chickens(a) Amount per ton.
Tylosin, 450 grams.
(1) Indications for use. For increased
rate of weight gain and improved feed
efficiency.
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558.630
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558.635
558.635
Virginiamycin.
(a) Approvals. Type A medicated articles. (1) 1.1 percent activity (5 grams
per pound), 2.2 percent activity (10
grams per pound), 4.4 percent activity
(20 grams per pound), 11 percent activity (50 grams per pound), and 50 percent
activity (227 grams per pound) used as
in paragraph (d) of this section; and 30
percent activity (136.2 grams per
pound) for the manufacture of Type C
medicated feed for cattle used as in
paragraph (d)(3); to 000069 in 510.600(c)
of this chapter.
(2) 2.2 percent activity (10 grams per
pound) to 046573, 016968, and 017790 in
510.600(c) of this chapter for use as in
paragraphs (d)(1)(iv) and (d)(1)(v) of
this section.
(b) Related tolerances. See 556.750 of
this chapter.
(c) Special considerations. (1) Not for
use in breeding swine over 120 pounds.
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558.680
(iii) 11.0 to 16.0 grams per ton to provide 70 to 240 milligrams per head per
day for improved feed efficiency.
(iv) Feed continuously as sole ration
to cattle fed in confinement for slaughter. Not for use in animals intended for
breeding.
(4) Virginiamycin may be used in accordance with the provisions of this
section in the combinations provided,
as follows:
(i) Monensin sodium in accordance
with 558.355.
(ii) Lasalocid sodium in accordance
with 558.311.
(iii) Monensin and roxarsone as in
558.355.
(iv) Amprolium and ethopabate as in
558.58.
Zoalene in grams/ton
Combination in grams/ton
558.680 Zoalene.
(a) Approvals. Type A medicated articles: 25 percent to 046573 in 510.600(c)
of this chapter.
(b) Related tolerances. See 556.770 of
this chapter.
(c) Conditions of use(1) Chickens and
turkeys:
Indications for use
Limitations
Growing conditions
Severe exposure
Light to moderate exposure
Zoalene in grams/ton
Combination in grams/ton
Starter ration
Grams per ton
Grower ration
Grams per ton
113.5 (0.0125%)
75.4113.5 (0.0083%
0.0125%)
36.375.4 (0.004%
0.0083%)
75.4113.5 (0.0083%
0.0125%)
Limitations
Arsanilate sodium 90
(0.01%).
1. Replacement chickens; as an
aid in the prevention of chronic
respiratory disease during periods of stress; development of
active immunity to coccidiosis;
growth promotion and feed efficiency; improving pigmentation.
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558.680
Zoalene in grams/ton
Limitations
2. Replacement chickens; as an
aid in the prevention of infectious coryza; development of
active immunity to coccidiosis;
growth promotion and
feedefficiency; improving pigmentation.
Replacement chickens; as an aid
in the prevention and reduction
of lesions and in lowering severity of chronic respiratory
disease; growth promotion and
feed efficiency; improving pigmentation and development of
active immunity to coccidiosis.
Replacement chickens; growth
promotion and feed efficiency;development of active
immunity to coccidiosis; improving pigmentation.
Feed for 7 to 14 d; as erythromycin thiocyanate; grower ration not to be fed to birds over
14 weeks of age; withdraw 5 d
before slaughter; as sole
source of organic arsenic; feed
as in subtable in item (i).
Feed for 5 to 8 d; do not use in
birds producing eggs for food
purposes; withdraw 5 d before
slaughter; as erythromycin
thiocyanate; as sole source of
organic arsenic; feed as in
subtable in item (i).
Chlortetracycline 100 to
200.
Chlortetracycline 200 to
400.
Erythromycin 92.5.
2. Replacement chickens; as an
aid in the prevention of infectious coryza; development of
active immunity to coccidiosis.
Erythromycin 185.
Hygromycin B 8 to 12.
Do not feed to chickens producing eggs for human consumption; grower ration not to
be fed to birds over 14 weeks
of age; feed as in subtable in
item (i).
Do not feed to chickens producing eggs for human consumption; grower ration not to
be fed to birds over 14 weeks
of age; feed as in subtable in
item (i).
As erythromycin thiocyanate;
grower ration not to be fed to
birds over 14 weeks of age;
feed as in subtable in item (i).
Feed for 2 d before stress and 3
to 6 after stress; withdraw 24
hours (h) before slaughter; as
erythromycin thiocyanate;
grower ration not to be fed to
birds over 14 weeks of age;
feed as in subtable in item (i).
Feed for 7 to 14 d; withdraw 24 h
before slaughter; as erythromycin thiocyanate; grower ration not to be fed to birds over
14 weeks of age; feed as in
subtable in item (i).
Feed for 5 to 8 d; do not use in
birds producing eggs for food
purposes; withdraw 48 h before slaughter; grower ration
not to be fed to birds over 14
weeks of age; feed as in
subtable in item (i).
Grower ration not to be fed to
birds over 14 weeks of age;
feed as in subtable in item (i).
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558.680
Combination in grams/ton
Penicillin 2.4 to 50.
Bacitracin 4 to 50.
Bacitracin 4 to 50 plus
roxarsone 22.7 to 45.4
(0.0025 to 0.005%).
Limitations
As erythromycin thiocyanate;
withdraw 5 d before slaughter;
as sole source of organic arsenic.
Do.
Do.
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558.680
Zoalene in grams/ton
Combination in grams/ton
Limitations
As zinc bacitrain.
Chlortetracycline 100 to
200
Do not feed to chickens producing eggs for human consumption; feed continuously for
7 to 14 d.
Chlortetracycline 200 to
400
Erythromycin 92.5.
Erythromycin 185.
Hygromycin B 8 to 12.
Lincomycin 2.
Do not feed to chickens producing eggs for human consumption; feed continuously for
7 to 14 d.
As erythromycin thiocyanate.
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570.3
Combination in grams/ton
Limitations
For turkeys grown for meat purposes only, not to be fed to
laying birds, feed continuously
as sole ration until 14 to 16
weeks of age.
For turkeys grown for meat purposes only; feed continuously
beginning 2 weeks before
blackhead and coccidiosis are
expected and continue as long
as prevention of blackhead
and prevention and control of
coccidiosis is needed; withdraw 5 d before slaughter; as
sole source of organic arsenic.
Withdraw 5 d before slaughter;
as sole source of organic arsenic.
Definitions.
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