[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR558.355]
[Page 428-440]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS--Table of Contents
Subpart B--Specific New Animal Drugs for Use in Animal Feeds
Sec. 558.355 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 [deg]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 Sec. 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.
(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 066104: 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 046573: 45 and 60 grams per pound, as monensin sodium
provided by No. 000986, paragraph (f)(1)(xiv) of this section.
(9) To 046573: 45 and 60 grams per pound, as monensin sodium
provided by No. 000986, paragraphs (f)(1)(xv) and (xvi) of this section.
(10) To 057926: 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 066104: 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 statement: Do not allow horses or other equines
access to feed containing monensin. Ingestion of monensin by horses 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;
[[Page 429]]
(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.
(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.
(11) The labeling of complete feeds containing monensin intended for
use in goats shall bear the caution statements specified in paragraphs
(d)(6) and (d)(10) (i) and (v) of this section.
(e) Related tolerances. See Sec. 556.420 of this chapter.
(f) Conditions of use. It is used as follows:
(1) Broiler chickens--(i) Amount per ton. Monensin, 90-110 grams.
(a) Indications for use. 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; in the absence of coccidiosis, the use of monensin
with no withdrawal period may limit feed intake resulting in reduced
weight gain; as monensin or monensin sodium.
(ii) Amount per ton. Monensin, 90-110 grams, plus roxarsone 45.4
grams (0.005 percent).
(a) Indications for use. Growth promotion and feed efficiency,
improving pigmentation; 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 monensin or monensin sodium.
(iii) Amount per ton. Monensin, 90-110 grams plus bacitracin, 5-25
grams.
(a) Indications for use. For increased 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; feed continuously
as 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 bacitracin methylene disalicylate provided by No. 046573 in
Sec. 510.600(c) of this chapter; as monensin sodium.
(iv) Amount per ton. Monensin, 90-110 grams plus bacitracin, 10
grams.
(a) Indications for use. For increased 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; feed continuously
as 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 zinc bacitracin provided by No. 046573 in Sec. 510.600(c) of
this chapter; as monensin sodium.
(v) Amount per ton. Monensin, 90-110 grams plus bacitracin, 10-30
grams.
[[Page 430]]
(a) Indications for use. For 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; feed continuously
as 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 zinc bacitracin provided by No. 046573 in Sec. 510.600(c) of
this chapter; as monensin sodium.
(vi) Amount per ton. Monensin, 90 to 110 grams plus bambermycins, 1
to 2 grams. See Sec. 558.95(b)(1)(vi).
(vii) Amount per ton. Monensin, 90 to 110 grams plus bambermycins, 1
gram plus roxarsone, 22.7 to 45.4 grams (.0025 to .005 percent). See
Sec. 558.95(b)(1)(vii).
(viii) Amount per ton. Monensin, 90 to 110 grams plus
oxytetracycline, 200 grams.
(a) Indications for use. As an aid in the prevention of coccidiosis
caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E.
mivati, and E. maxima; and for the control of complicated chronic
respiratory disease (CRD or air-sac infection) caused by Mycoplasma
gallisepticum and Escherichia coli.
(b) Limitations. In the absence of coccidiosis, the use of monensin
with no withdrawal period may limit feed intake resulting in reduced
weight gain; do not feed to laying chickens; feed continuously as sole
ration; as monensin sodium.
(ix) Amount per ton. Monensin, 90-110 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, 90-110 grams plus lincomycin, 2 grams
and roxarsone, 15-45 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, Sec. 510.600(c)
of this chapter; as monensin sodium provided by No. 000986, Sec.
510.600(c) of this chapter; as lincomycin provided by No. 000009, Sec.
510.600(c) of this chapter; as a combination provided by No. 000009,
Sec. 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 Sec. 510.600(c)
of this chapter; as monensin sodium provided by No. 000986 in Sec.
510.600(c) of this chapter; as lincomycin provided by No. 000009 in
Sec. 510.600(c) of this chapter; as a combination provided by No.
000009 in Sec. 510.600(c) of this chapter.
(xii) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin
methylene disalicylate, 10 to 25 grams, and roxarsone, 11.3 to 45.4
grams.
(a) Indications for use. As an aid in the prevention of coccidiosis
caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E.
maxima, and E. mivati; for increased rate of weight gain and for
improved feed efficiency.
(b) Limitations. Do not feed to laying chickens; feed continuously
as sole ration; withdraw 5 days before slaughter; as sole source of
organic arsenic; as monensin sodium provided by No. 000986 in Sec.
510.600 of this chapter; as bacitracin methylene disalicylate provided
by No. 046573 in Sec. 510.600 of this chapter; as roxarsone provided by
No.
[[Page 431]]
011526 or 046573 in Sec. 510.600 of this chapter.
(xiii) Amount per ton. Monensin, 90 to 110 grams, plus 5 grams
virginiamycin.
(a) Indications for use. As an aid in the prevention of coccidiosis
caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E.
maxima, and E. mivati; for increased rate of weight gain and improved
feed efficiency.
(b) Limitations. Do not feed to laying chickens; feed continuously
as sole ration; as monensin sodium provided by No. 000986 in Sec.
510.600 of this chapter; virginiamycin provided by No. 066104 in Sec.
510.600 of this chapter.
(xiv) Amount per ton. Monensin, 90 to 110 grams, plus 500 grams
chlortetracycline.
(a) Indications for use. As an aid in the reduction of mortality due
to Escherichia coli infections susceptible to such treatment. As an aid
in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella,
E. acervulina, E. brunetti, E. mivati, and E. maxima.
(b) Limitations. Do not feed to laying chickens; feed for 5 days as
the sole ration; withdraw 24 hours before slaughter; in the absence of
coccidiosis, the use of monensin with no withdrawal period may limit
feed intake resulting in reduced weight gain; not to be fed continuously
for more than 5 days; as monensin sodium; as chlortetracycline
hydrochloride provided by No. 046573 in Sec. 510.600(c) of this
chapter.
(xv) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin
zinc, 10 grams, and roxarsone, 15 grams (0.0017 percent).
(a) Indications for use. For increase in rate of weight gain; for
the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E.
acervulina, E. maxima, E. brunetti, and E. mivati.
(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; feed must be used within 4 weeks of manufacture; as
monensin sodium; as bacitracin zinc provided by No. 046573 in Sec.
510.600(c) of this chapter; as roxarsone provided by No. 046573 in Sec.
510.600(c) of this chapter.
(xvi) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin
zinc, 4 to 50 grams, and roxarsone, 15 to 45.4 grams (0.0017 percent to
0.005 percent).
(a) Indications for use. For improved feed efficiency; for improved
pigmentation by enhancing carotenoid and xanthophyll utilization; for
the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E.
acervulina, E. maxima, E. brunetti, and E. mivati.
(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; feed must be used within 4 weeks of manufacture; as
monensin sodium; as bacitracin zinc provided by No. 046573 in Sec.
510.600(c) of this chapter; as roxarsone provided by No. 046573 in Sec.
510.600(c) of this chapter.
(xvii) Amount per ton. Monensin, 90 to 110 grams plus bambermycins,
1 to 2 grams plus roxarsone, 22.7 to 45.4 grams (0.0025 to 0.005
percent). See Sec. 558.95(b)(1)(xiii) of this chapter.
(xviii) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin
methylene disalicylate, 50 grams, and roxarsone, 22.7 to 34.0 grams
(0.0025 percent to .00375 percent).
(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 Eimeria necatrix, E. tenella, E. acervulina, E. maxima, E.
brunetti, and E. mivati; as an aid in the prevention of necrotic
enteritis caused or complicated by Clostridium spp or other organisms
susceptible to bacitracin methylene disalicylate.
(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 monensin sodium provided by No. 000986 in Sec.
510.600(c) of this chapter; as bacitracin methylene disalicylate
provided by No. 046573 in Sec. 510.600(c) of this chapter; as roxarsone
provided by No. 046573 in Sec. 510.600(c) of this chapter.
(xix) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin
methylene disalicylate, 50 grams, and roxarsone, 22.7 to 45.4 grams
(0.0025 percent to .005 percent).
(a) Indications for use. For increased rate of weight gain; as an
aid in the prevention of necrotic enteritis caused or complicated by
Clostridium spp or
[[Page 432]]
other organisms susceptible to bacitracin methylene disalicylate; as an
aid in the prevention of coccidiosis caused by Eimeria necatrix, E.
tenella, E. acervulina, E. maxima, E. brunetti, and E. mivati.
(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 monensin sodium provided by No. 000986 in Sec.
510.600(c) of this chapter; as bacitracin methylene disalicylate
provided by No. 046573 in Sec. 510.600(c) of this chapter; as roxarsone
provided by No. 046573 in Sec. 510.600(c) of this chapter.
(xx) Amount per ton. Monensin, 90 to 110 grams, plus virginiamycin,
5 to 15 grams, and roxarsone, 22.7 grams (0.0025 percent).
(a) Indications for use. For incease in rate of weight gain; as an
aid in the prevention of coccidiosis caused by Eimeria necatrix, E.
tenella, E. acervulina, E. maxima, E. brunetti, and E. mivati.
(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 monensin sodium provided by No. 000986 in Sec.
510.600(c) of this chapter; as virginiamycin provided by No. 066104 in
Sec. 510.600(c) of this chapter; roxarsone provided by Nos. 046753 and
011526 in Sec. 510.600(c) of this chapter.
(xxi) Amount per ton. Monensin, 90 to 110 grams, plus virginiamycin,
5 to 15 grams.
(a) Indications for use. For increase in rate of weight gain; as an
aid in the prevention of coccidiosis caused by Eimeria necatrix, E.
tenella, E. acervulina, E. maxima, E. brunetti, and E. mivati.
(b) Limitations. Do not feed to laying chickens; feed continuously
as sole ration; as monensin sodium provided by No. 000986 in Sec.
510.600 of this chapter; virginiamycin provided by No. 066104 in Sec.
510.600 of this chapter.
(xxii) Amount per ton. Monensin, 90 to 110 grams plus
oxytetracycline, 500 grams.
(a) Indications for use. As an aid in the prevention of coccidiosis
caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E.
Mivati, and E. maxima; as an aid in the reduction of mortality due to
air-sacculities (air-sac infection) caused by Escherichia coli sensitive
to oxytetracycline.
(b) Limitations. Feed for 5 days as sole ration. Do not feed to
laying chickens. Withdraw 24 hours before slaughter. As monensin sodium
provided by No. 000986 in Sec. 510.600(c) of this chapter. As mono-
alkyl (C8-C18) trimethylammonium oxytetracycline
provided by No. 066104 in Sec. 510.600(c) of this chapter.
(xxiii) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin
zinc, 4 to 50 grams, and roxarsone, 22.7 to 45.4 grams (0.0025 percent
to 0.005 percent).
(a) Indications for use. For improved feed efficiency; as an aid in
the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E.
acervulina, E. maxima, E. brunetti, and E. mivati.
(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 monensin sodium provided by No. 000986 in Sec.
510.600(c) of this chapter; as bacitracin zinc provided by No. 046573 in
Sec. 510.600(c) of this chapter; as roxarsone provided by No. 046573 in
Sec. 510.600(c) of this chapter.
(xxiv) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin
methylene disalicylate, 4 to 50 grams.
(xxv) Amount per ton. Monensin, 90 to 110 grams plus bacitracin, 4
to 50 grams.
(a) Indications for use. For increased rate of weight gain and
improved feed efficiency; as an aid in the prevention of coccidiosis
caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E.
mivati, and E. maxima.
(b) Limitations. Do not feed to laying chickens; feed continuously
as 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 bacitracin zinc provided by No. 046573 in Sec. 510.600(c) of
this chapter, as monensin sodium.
(xxvi) Amount per ton. Monensin 90 to 110 grams plus bacitracin 100
to 200 grams and roxarsone 22.7 to 34.0 grams.
(a) Indications for use. As an aid in the control of necrotic
enteritis caused or complicated by Clostridium spp. or
[[Page 433]]
other organisms susceptible to bacitracin methylene disalicylate; as an
aid in the prevention of coccidiosis caused by Eimeria tenella, E.
necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; for
increased rate of weight gain and improved feed efficiency.
(b) Limitations. For broiler chickens only. Feed continuously as
sole ration. Use as sole source of organic arsenic. Withdraw 5 days
before slaughter. Do not feed to laying hens. To control necrotic
enteritis, start medication at 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 Sec. 510.600(c) of
this chapter.
(xxvii) Amount per ton. Monensin 90 to 110 grams plus bacitracin 100
to 200 grams and roxarsone 22.7 to 45.4 grams.
(a) Indications for use. As an aid in the control of necrotic
enteritis caused or complicated by Clostridium spp. or other organisms
susceptible to bacitracin methylene disalicylate; as an aid in the
prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E.
acervulina, E. maxima, E. brunetti, and E. mivati; for increased rate of
weight gain.
(b) Limitations. For broiler chickens only. Feed continuously as
sole ration. Use as sole source of organic arsenic. Withdraw 5 days
before slaughter. Do not feed to laying hens. To control necrotic
enteritis, start medication at 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 Sec. 510.600(c) of
this chapter.
(xxviii) Amount per ton. Monensin, 90 to 110 grams, plus tylosin
phosphate, 4 to 50 grams.
(a) Indications for use. As an aid in the prevention of coccidiosis
caused by Eimeria necatrix, E. tenella, 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. In the absence of
coccidiosis, the use of monensin with no withdrawal period may limit
feed intake resulting in reduced weight gain. Do not feed to laying
chickens. As monensin sodium and tylosin phosphate provided by No.
000986 in Sec. 510.600(c) of this chapter.
(xxix) Amount per ton. Monensin, 90 to 110 grams; plus bacitracin
methylene disalicylate, 50 grams.
(a) Indications for use. As an aid in the prevention of coccidiosis
caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E.
mivati, and E. maxima; and as an aid in the prevention of necrotic
enteritis caused or complicated by Clostridium spp. or other organisms
susceptible to bacitracin.
(b) Limitations. Feed continuously as sole ration. Do not feed to
chickens over 16 weeks of age. Do not feed to laying chickens. As
monensin sodium provided by 000986; bacitracin methylene disalicylate as
provided by 046573 in Sec. 510.600(c) of this chapter.
(xxx) Amount per ton. Monensin, 90 to 110 grams; plus bacitracin
methylene disalicylate, 100 to 200 grams.
(a) Indications for use. As an aid in the prevention of coccidiosis
caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E.
mivati, and E. maxima; and as an aid in the control of necrotic
enteritis caused or complicated by Clostridium spp. or other organisms
susceptible to bacitracin.
(b) Limitations. Feed continuously as sole ration. Do not feed to
chickens over 16 weeks of age. Do not feed to laying chickens. To
control necrotic enteritis, start medication at first clinical signs of
disease; vary dosage based on the severity of infection; administer
continuously for 5 to 7 days or as long as clinical signs persist, then
reduce bacitracin to prevention level (50 grams per ton). As monensin
sodium provided by 000986; bacitracin methylene disalicylate as provided
by 046573 in Sec. 510.600(c) of this chapter.
[[Page 434]]
(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 Sec. 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 Sec. 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. 066104 in Sec. 510.600(c) of this
chapter.
(v) Amount per ton. Monensin, 54 to 90 grams, plus bambermycins, 1
to 2 grams.
(a) Indications for use. For the prevention of coccidiosis in
turkeys caused by E. adenoeides, E. meleagrimitis, and E. gallopavonis,
and for improved feed efficiency in growing turkeys.
(b) Limitations. For growing turkeys only. Feed continuously as sole
ration. Some strains of turkey coccidia may be monensin tolerant or
resistant. Monensin may interfere with development of immunity to turkey
coccidiosis. Bambermycins as provided by No. 057926 in Sec. 510.600(c)
of this chapter.
(vi) Amount per ton. Monensin, 54 to 90 grams, plus bambermycins, 2
grams.
(a) Indications for use. For the prevention of coccidiosis in
turkeys caused by E. 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. Some strains of turkey coccidia may be monensin tolerant or
resistant.
[[Page 435]]
Monensin may interfere with development of immunity to turkey
coccidiosis. Bambermycins as provided by No. 057926 in Sec. 510.600(c)
of this chapter.
(3) Cattle--(i) Amount per ton. Monensin, 5-30 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 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 Sec.
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 with mixing directions different from the standard
established in paragraph (f)(3)(i)(b)(1) of this section may also follow
this procedure.
(ii) Amount per ton. Monensin, 5 to 30 grams, plus tylosin, 8 to 10
grams.
(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 as sole ration at the rate of 50 to 360
milligrams of monensin and 60 to 90 milligrams of tylosin per head per
day; as monensin sodium; as tylosin phosphate. Combination drug liquid
Type B medicated feeds may be used to manufacture dry Type C medicated
feeds and shall conform to mixing instructions as in Sec. 558.625 (c).
(iii) Amount per ton. Monensin, 25 to 400 grams.
(a) Indications for use. For increased rate of weight gain; for
prevention and control of coccidiosis due to Eimeria bovis and E.
zuernii.
(b) Limitations. Feed to pasture cattle (slaughter, stocker, feeder,
and dairy and beef replacement heifers). For increased rate of weight
gain, feed at a rate of 50 to 200 milligrams monensin per head per day
in not less than 1 pound of feed or, after the 5th day, feed
[[Page 436]]
at a rate of 400 milligrams per head per day every other day in not less
than 2 pounds of feed. 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 on severity of challenge, up to 200 milligrams per head per
day. During first 5 days of feeding, cattle should receive no more than
100 milligrams per day in not less than 1 pound of feed.
(iv) [Reserved]
(v) Amount. 150 milligrams per pound (0.033 percent).
(a) Indications for use. For increased rate of weight gain and for
prevention and control of coccidiosis caused by Eimeria bovis and E.
zuernii.
(b) Limitations. As protein-mineral blocks to be fed free choice to
cattle (slaughter, stocker, feeder, and dairy and beef replacement
heifers) on pasture which may require supplemental feed. Provide 50 to
200 milligrams of monensin (0.34 to 1.33 pounds) per head per day, at
least 1 block per 10 to 12 head of cattle. Roughage must be available at
all times. Do not allow animals access to other protein blocks, salt or
mineral, while being fed this product. Do not allow horses or other
equines access to formulations containing monensin (ingestion of
monensin by equines has been fatal). Block's effectiveness in cull cows
and bulls has not been established. Approval must comply with Sec.
510.455 of this chapter.
(vi) Amount per ton. Monensin, 25 to 400 grams.
(a) Indications for use. For improved feed efficiency; for
prevention and control of coccidiosis due to E. bovis and E. zuernii.
(b) Limitations. Feed to mature reproducing beef cows. Feed as
supplemental feed, either hand-fed in a minimum of 1 pound of feed or
mixed in a total ration. For improved feed efficiency, feed continuously
at a rate of 50 to 200 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 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 Sec. 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 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
[[Page 437]]
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 to cattle. Both an
approved NADA and an approved medicated feed application are required to
make this liquid Type B medicated feed.
(x) Amount per ton. Monensin, 1,620 grams as monensin sodium (810
milligrams per pound).
(a) Indications for use. For increased rate of weight gain; and for
prevention and control of coccidiosis caused by Eimeria bovis and E.
zuernii in pasture cattle (slaughter, stocker, feeder, and dairy and
beef replacement heifers).
(b) Specifications. Use as free-choice Type C medicated feed
formulated as mineral granules as follows:
----------------------------------------------------------------------------------------------------------------
Ingredient Percent International feed no.
----------------------------------------------------------------------------------------------------------------
Monocalcium phosphate (21% phosphorus, 15% calcium) 29.49 6-01-082
Sodium chloride (salt) 24.25 6-04-152
Dried cane molasses 20.0 4-04-695
Ground limestone (33% calcium) or calcium carbonate (38% 13.75 6-02-632
calcium)
Cane molasses 3.0 4-04-696
Processed grain by-products (as approved by AAFCO) 5.0
Vitamin/trace mineral premix\1\ 2.5
Monensin Type A article, 80 grams per pound 1.01
Antidusting oil 1.0
----------------------------------------------------------------------------------------------------------------
\1\Content of the vitamin/trace mineral premix may be varied. However, they should be comparable to those used
for other free-choice 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).)
(c) Limitations. For free-choice feeding to pasture cattle
(slaughter, stocker, feeder, and dairy and beef replacement heifers) at
a rate of 50 to 200 milligrams per head per day. During the first 5 days
of feeding, cattle should receive no more than 100 milligrams per day.
Do not feed additional salt or minerals. Do not mix with grain or other
feeds. Monensin is toxic to cattle when consumed at higher than approved
levels. Stressed and/or feed- and/or water-deprived cattle should be
adapted to the pasture and to unmedicated mineral supplement before
using the monensin mineral supplement. Do not feed to lactating dairy
cattle. The product's effectiveness in cull cows and bulls has not been
established. Consumption by unapproved species may result in toxic
reactions. A feed manufacturing facility must possess a medicated feed
mill license issued under Sec. 515.20 of this chapter in order to
manufacture this free-choice Type C feed.
(xi) Amount per ton. Monensin, 10 to 200 grams.
(a) Indications for use. For prevention and control of coccidiosis
due to E. bovis and E. zuernii.
(b) Limitations. For calves excluding veal calves. Feed at a rate of
0.14 to 1.0 milligram monensin per pound of body weight per day,
depending upon the severity of challenge, up to maximum of 200
milligrams per head per day.
(xii) Amount per ton. Monensin, 10 to 30 grams; plus tylosin, 8 to
10 grams.
(a) Indications for use. For improved feed efficiency, prevention
and control of coccidiosis due to Eimeria bovis and E. zuernii, and
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 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 monensin per pound of body weight per
day, depending upon the severity of challenge, up to maximum of 360
milligrams per head per day; and 60 to 90 milligram of tylosin per head
per day.
(4) Replacement chickens intended for use as cage layers--(i) Amount
per ton. Monensin, 90 to 110 grams.
(i)(a) Indications for use. As an aid in the prevention of
coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E.
brunetti, E. mivati, and E. maxima.
[[Page 438]]
(ii) Amount per ton. Monensin, 90 to 110 grams; plus bacitracin
methylene disalicylate, 4 to 50 grams.
(a) Indications for use. As an aid in the prevention of coccidiosis
caused by E. necatrix, E. tenella, 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. Do not feed to
chickens over 16 weeks of age. Do not feed to laying chickens. As
monensin sodium provided by 000986; bacitracin methylene disalicylate as
provided by 046573 in Sec. 510.600(c) of this chapter.
(iii) Amount per ton. Monensin, 90 to 110 grams; plus bacitracin
methylene disalicylate, 50 grams.
(a) Indications for use. As an aid in the prevention of coccidiosis
caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E.
mivati, and E. maxima; and as an aid in the prevention of necrotic
enteritis caused or complicated by Clostridium spp. or other organisms
susceptible to bacitracin.
(b) Limitations. Feed continuously as sole ration. Do not feed to
chickens over 16 weeks of age. Do not feed to laying chickens. As
monensin sodium provided by 000986; bacitracin methylene disalicylate as
provided by 046573 in Sec. 510.600(c) of this chapter.
(iv) Limitations. Do not feed to laying chickens; feed continuously
as sole ration; as monensin sodium; do not feed to chickens over 16
weeks of age.
(v) Amount per ton. Monensin, 90 to 110 grams; plus bacitracin
methylene disalicylate, 100 to 200 grams.
(a) Indications for use. As an aid in the prevention of coccidiosis
caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E.
mivati, and E. maxima; and as an aid in the control of necrotic
enteritis caused or complicated by Clostridium spp. or other organisms
susceptible to bacitracin.
(b) Limitations. Feed continuously as sole ration. Do not feed to
chickens over 16 weeks of age. Do not feed to laying chickens. To
control necrotic enteritis, start medication at first clinical signs of
disease; vary dosage based on the severity of infection; administer
continuously for 5 to 7 days or as long as clinical signs persist, then
reduce bacitracin to prevention level (50 grams per ton). As monensin
sodium provided by 000986; bacitracin methylene disalicylate as provided
by 046573 in Sec. 510.600(c) of this chapter.
(vi) Amount per ton. Monensin, 90 to 110 grams; bacitracin methylene
disalicylate, 50 grams; plus roxarsone, 22.7 to 45.4 grams.
(a) Indications for use. As an aid in the prevention of coccidiosis
caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E.
mivati, and E. maxima; as an aid in the prevention of necrotic enteritis
caused or complicated by Clostridium spp. or other organisms susceptible
to bacitracin; and for increased rate of weight gain, improved feed
efficiency, and improved pigmentation.
(b) Limitations. Feed continuously as sole ration. Do not feed to
laying chickens. Use as sole source of organic arsenic. Do not feed to
chickens over 16 weeks of age. Poultry should have access to drinking
water at all times. Drug overdosage or lack of water may result in leg
weakness or paralysis. Withdraw 5 days before slaughter. As monensin
sodium provided by 000986; bacitracin methylene disalicylate and
roxarsone as provided by 046573 in Sec. 510.600(c) of this chapter.
(vii) Amount per ton. Monensin, 90 to 110 grams; bacitracin
methylene disalicylate, 100 to 200 grams; plus roxarsone, 22.7 to 45.4
grams.
(a) Indications for use. As an aid in the prevention of coccidiosis
caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E.
mivati, and E. maxima; as an aid in the control of necrotic enteritis
caused or complicated by Clostridium spp. or other organisms susceptible
to bacitracin; and for increased rate of weight gain, improved feed
efficiency, and improved pigmentation.
(b) Limitations. Feed continuously as sole ration. To control
necrotic enteritis, start medication at first clinical signs of disease;
vary bacitracin dosage based on the severity of infection; administer
continuously for 5 to 7 days or as long as clinical signs persist, then
reduce bacitracin to prevention level (50 grams/ton). Do not feed to
laying chickens. Use as sole source of organic arsenic. Do not feed to
chickens over 16 weeks of age. Poultry should have access to drinking
water at all times. Drug overdosage or lack of water may
[[Page 439]]
result in leg weakness or paralysis. Withdraw 5 days before slaughter.
As monensin sodium provided by 000986; bacitracin methylene disalicylate
and roxarsone as provided by 046573 in Sec. 510.600(c) of this chapter.
(iv) Amount per ton. Monensin, 90 to 110 grams, plus roxarsone, 22.7
to 45.4 grams.
(a) Indications for use. As an aid in the prevention of coccidiosis
caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E.
mivati, and E. maxima, and for increased rate of weight gain, improved
feed efficiency, and improved pigmentation.
(b) Limitations. Feed continuously as sole ration. Use as sole
source of organic arsenic. Withdraw 5 days before slaughter. Do not feed
to laying chickens. Do not feed to chickens over 16 weeks of age.
Poultry should have access to drinking water at all times. Drug
overdosage or lack of water may result in leg weakness or paralysis. As
monensin sodium provided by 000986; roxarsone as provided by 046573 in
Sec. 510.600(c) of this chapter.
(5) Bobwhite quail--(i) Amount per ton. Monensin, 73 grams.
(ii) Indications for use. For the prevention of coccidiosis in
growing bobwhite quail caused by Eimeria dispersa and E. Lettyae.
(iii) Limitations. Feed continuously as the sole ration; do not
allow horses, other equines, mature turkeys, or guinea fowl access to
feed containing monensin.
(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 Sec.
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 with mixing directions different from
[[Page 440]]
the standard established in paragraph (f)(6)(i)(b)(1) of this section
may also follow this procedure.
(ii) [Reserved]
(7) Monensin may also be used in combination with:
(i) Decoquinate alone or with tylosin as in Sec. 558.195.
(ii) Melengestrol acetate alone or with tylosin as in Sec. 558.342.
[40 FR 13959, Mar. 27, 1975]
Editorial Note: For Federal Register citations affecting Sec.
558.355, see the List of CFR Sections Affected, which appears in the
Finding Aids section of the printed volume and on GPO Access.