[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR558.311]
[Page 411-416]
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. 558.311 Lasalocid.
(a) Specifications. A minimum of 90 percent of lasalocid activity is
derived from lasalocid A.
(b) Approvals. Type A medicated articles approved for sponsors
identified in Sec. 510.600(c) of this chapter for use as in paragraph
(e) of this section as follows:
(1) 3.0, 3.3, 3.8, 4.0, 4.3, 4.4, 5.0, 5.1, 5.5, 5.7, 6.0, 6.3, 6.7,
7.2, 7.5, 8.0, 8.3, 10.0, 12.5, 15, 20, and 50 percent activity to No.
000004 for use as in paragraphs (e)(1) (i), (ii), (iii), (iv), and (x)
of this section.
(2) 15 percent activity to No. 000069 as provided by No. 063238 for
use as in paragraph (e)(1)(v) of this section.
(3) 15, 20, 33.1, and 50 percent activity to No. 063238 for use in
cattle feeds as in paragraphs (e)(1)(vi), (vii), (ix), (xi), (xii), and
(xv) of this section, and for use in sheep as in paragraph (e)(1)(viii)
of this section.
(4) 15 percent activity to No. 063238 for use in Type C rabbit feeds
as in paragraph (e)(1)(xvi) of this section and for use in ruminant
free-choice Type C feeds as in paragraphs (e)(2) and (e)(3) of this
section.
[[Page 412]]
(5) 15 percent activity to 021930 (Type A article provided by
063238) for use in free-choice vitamin-mineral Type C cattle feeds as in
paragraph (e)(1)(xi).
(6) 20 percent activity as a liquid Type A article to No. 063238 for
use in cattle feeds as in paragraphs (e)(1)(vi), (e)(1)(vii),
(e)(1)(ix), (e)(1)(xi), (e)(1)(xii), and (e)(3) of this section, and for
use in sheep feeds as in paragraph (e)(1)(viii) of this section.
(7) 20 percent activity to No. 063238 for use as follows:
(i) Chukar partridges as in paragraph (e)(1)(xiii).
(ii) Turkeys as in paragraph (e)(1)(xiv).
(iii) Rabbits as in paragraph (e)(1)(xvi).
(c) Related tolerance. See Sec. 556.347 of this chapter.
(d) Special considerations. (1) Type C cattle and sheep feeds may be
manufactured from lasalocid liquid Type B feeds which have a pH of 4.0
to 8.0 and bear appropriate mixing directions as follows:
(i) For liquid Type B feeds stored in recirculating tank systems:
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 described even when not
used.
(ii) For liquid Type B feeds stored in mechanical, air, or other
agitation-type tank systems: 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 described even when not
used.
(2) A positionally stable lasalocid liquid Type B feed will not be
subject to the requirements for mixing directions prescribed in
paragraph (d)(1) of this section provided it has a pH of 4.0 to 8.0 and
contains a suspending agent(s) sufficient to maintain a viscosity of not
less than 300 centipoises per second for 3 months. Form FDA 1900 must
indicate the pH and centipoises per second for such lasalocid liquid
Type B feed.
(3) If a manufacturer is unable to meet the requirements of
paragraph (d)(1) or (2) of this section, the manufacturer may secure
approval of a positionally stable liquid Type B feed by (i) either
filing a new animal drug application for the product or 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 new animal drug
application to establish positional stability; and (iii) requesting the
sponsor of an approved new animal drug application to file a supplement
to provide for use of its lasalocid 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 supplement new animal drug application will be
approved. Approval of the supplement will not be published in the
Federal Register because such approval will not affect or alter
conditions or use of the product in the new animal drug application or
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 liquid Type B feed. A manufacturer who seeks to market a
positionally unstable lasalocid liquid Type B feed with mixing
directions different from the standard directions established in
paragraph (d)(1) of this section may also follow this procedure.
(4) If adequate information is submitted to show that a particular
liquid Type B feed containing lasalocid is stable outside the pH of 4.0
to 8.0, the pH restriction described in paragraphs (d)(1) and (2) of
this section may be waived.
(5) Required label statements:
(i) For liquid Type B feed (cattle and sheep): Mix thoroughly with
grain and/or roughage prior to feeding. Feeding undiluted, mixing
errors, or inadequate mixing (recirculation or agitation) may result in
an excess lasalocid concentration which could be fatal to cattle and
sheep. Do not allow horses or other equines access to Type A articles or
Type B feeds containing lasalocid as ingestion may be fatal. Safety of
lasalocid for use in unapproved species has not been established.
[[Page 413]]
(ii) For Type A articles or Type B feeds (cattle and sheep): Feeding
undiluted or mixing errors may result in an excess lasalocid
concentration which could be fatal to cattle and sheep. Do not allow
horses or other equines access to Type A articles or Type B feeds
containing lasalocid as ingestion may be fatal. Safety of lasalocid for
use in unapproved species has not been established.
(6) Lasalocid Type A medicated articles containing lasalocid dried
fermentation residue are for use in cattle and sheep feed only.
(e)(1) Conditions of use. It is used as follows:
----------------------------------------------------------------------------------------------------------------
Lasalocid sodium activity in Combination in grams
grams per ton per ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 68 (0.0075 pct) to 113 ....................... For the prevention of For broiler or fryer 000004
(0.0125 pct). coccidiosis caused by chickens only; feed
Eimeria tenella, E. continuously as the
necatrix, E. sole ration.
acervulina, E.
brunetti, E. mivati,
and E. maxima.
(ii) 68 (0.0075 pct) to 113 Roxarsone 45.4 (0.005 Broiler or fryer For broiler or fryer 000004
(0.0125 pct). pct). chickens; for the chickens only; feed
prevention of continuously as the
coccidiosis caused by sole ration; as sole
Eimeria tenella, E. source of organic
necatrix, E. arsenic; withdraw 5 d
acervulina, E. before slaughter;
brunetti, E. mivati, roxarsone provided by
and E. maxima and as Nos. 046573 and
an aid in the 011526 in Sec.
reduction of lesions 510.600(c) of this
due to E. tenella. chapter.
Roxarsone 45.4 plus For prevention of For broiler chickens 000004
bambermycins 1 coccidiosis caused by only; feed
(0.00011 pct). Eimeria tenella, E. continuously as sole
necatrix, E. ration; withdraw 5
acervulina, E. days before
brunetti, E. mivati, slaughter; roxarsone
and E. maxima; as an provided by Nos.
aid in the reduction 046573 and 011526 in
of lesions due to E. Sec. 510.600(c) of
tenella; and for this chapter,
increased rate of bambermycins provided
weight gain. by No. 012799.
Roxarsone 45.4 plus For prevention of For broiler chickens 000004
lincomycin 2.0. coccidiosis caused by only; feed
Eimeria tenella, E. continuously as sole
necatrix, E. ration; withdraw 5
acervulina, E. days before
brunetti, E. mivati, slaughter; roxarsone
and E. maxima; as an provided by Nos.
aid in the reduction 046573 and 011526 in
of lesions due to E. Sec. 510.600(c) of
tenella; and for this chapter,
increased rate of lincomycin provided
weight gain and by No. 000009.
improved feed
efficiency.
Roxarsone 45.4 plus For prevention of For broiler or fryer 000004
bacitracin 10 to 25. coccidiosis caused by chickens only; feed
Eimeria tenella, E. continuously as the
necatrix, E. sole ration; withdraw
acervulina, E. 5 days before
brunetti, E. mivati, slaughter; roxarsone
and E. maxima; as an provided by Nos.
aid in the reduction 046573 and 011526 in
of lesions due to E. Sec. 510.600(c) of
tenella; and for this chapter,
increased rate of bacitracin methylene
weight gain. disalicylate provided
by No. 046573 in Sec.
510.600(c) of this
chapter.
Roxarsone 45.4 plus For prevention of For broiler chickens 000004
bacitracin 10 or 30. coccidiosis caused by only; feed
E. tenella, E. continuously as sole
necatrix, E. ration; withdraw 5
acervulina, E. days before
brunetti, E. mivati slaughter; roxarsone
and E. maxima; as an provided by Nos.
aid in the reduction 046573 and 011526 in
of lesions due to E. Sec. 510.600(c) of
tenella; and for this chapter,
increased rate of bacitracin zinc
weight gain (10 grams provided by No.
per ton) or improved 000004.
feed efficiency (30
grams per ton).
Roxarsone 45.5 plus Prevention of Feed continuously as 046573
bacitracin methylene coccidiosis caused by sole ration; as sole
disalicylate 50. Eimeria necatrix, E. source of organic
tenella, E. arsenic; withdraw 5
acervulina, E. days before slaughter.
brunetti; E. mivati,
and E. maxima;
reduction of lesions
due to E. tenella;
prevention of
necrotic enteritis
caused or complicated
by Clostridium spp.
or other susceptible
organisms.
[[Page 414]]
(iii) 68 (0.0075 pct)....... Lincomycin 2 (0.00022 Broiler or fryer For broiler and fryer 000004
pct). chickens; for the chickens only; feed
prevention of continuously as sole
coccidiosis caused by ration; withdraw 5 d
Eimeria mivati, E. before slaughter;
brunetti, E. tenella, Type C feed must be
E. acervulina, E. used within 4 weeks
maxima, and E. of manufacture; as
necatrix; for lincomycin
increased rate of hydrochloride
weight gain and monohydrate.
improved feed
efficiency.
(iv) 68 (0.0075 percent).... Bacitracin 10 to 50.... For prevention of For broiler or fryer 000004
coccidiosis caused by chickens only; feed
Eimeria tenella, E. continuously as the
necatrix, E. sole ration; withdraw
acervulina, E. 3 days before
brunetti, E. mivati, slaughter bacitracin
and E. maxima, and methylene
for increased rate of disalicylate provided
weight gain and by No. 046573 in Sec.
improved feed 510.600(c) of this
efficiency. chapter.
(v) 68 (0.0075 pct) to 113 Virginiamycin 20....... For prevention of For broiler and fryer 063238
(0.0125 pct). coccidiosis caused by chickens only; feed
Eimeria tenella E. continuously as sole
necatrix, E. ration; do not feed
acervulina, E. to laying chickens;
brunetti, E. mivati, lasalocid sodium
and E. maxima, and provided by No.
for increased rate of 063238 in Sec.
weight gain and 510.600(c) of this
improved feed chapter.
efficiency.
(vi) 10 (0.0011 pct) to 30 ....................... Cattle; for improved In Type C feeds; for 000004
(0.0033 pct). feed efficiency. cattle fed in
confinement for
slaughter only; feed
continuously in
complete feed to
provide not less than
100 mg nor more than
360 mg of lasalocid
sodium activity per
head per day.
Oxytetracycline 7.5.... Cattle: for improved In Type C feeds, for 000004
feed efficiency and beef cattle fed in
reduction of confinement for
incidence and slaughter; feed
severity of liver continuously at 100
abscesses. to 360 mg/head/day
lasalocid and 75 mg/
head/day
oxytetracycline. As
monoalkyl (C8-C18)
trimethyl ammonium
oxytetracycline.
(vii) 25 (0.0027 pct) to 30 ....................... Cattle; for improved In Type C feeds; for 000004
(0.0033 pct). feed efficiency and cattle fed in
increased rate of confinement for
weight gain. slaughter only; feed
continuously in
complete feed to
provide not less than
250 mg nor more than
360 mg of lasalocid
sodium activity per
head per day.
Oxytetracycline 7.5.... Cattle: for improved In Type C feeds, for 000004
feed efficiency, beef cattle fed in
increased rate of confinement for
weight gain, and slaughter; feed
reduction of continuously at 250
incidence and to 360 mg/head/day
severity of liver lasalocid and 75 mg/
abscesses. head/day
oxytetracycline. As
monoalkyl (C8-C18)
trimethyl ammonium
oxytetracycline.
(viii) 20 (0.0022 pct) to 30 ....................... Sheep; for the In Type C feeds; for 000004
(0.0033 pct). prevention of sheep maintained in
coccidiosis caused by confinement; feed
Eimeria ovina, E. continuously in
crandallis, E. complete feed to
ovinoidalis (E. provide not less than
ninakohlyakimovae), 15 mg nor more than
E. parva, and E. 70 mg of lasalocid
intricata. sodium activity per
head per day
depending on body
weight.
(ix)........................ ....................... Cattle; for increased For pasture cattle 000004
rate of weight gain. (slaughter, stocker,
feeder cattle, and
dairy and beef
replacement heifers)
only; feed
continuously at a
rate of not less than
60 mg nor more than
200 mg of lasalocid
per head per day when
on pasture; the drug
must be contained in
at least 1 pound of
feed.
[[Page 415]]
(x) 68 (0.0075 pct) to 113 Bacitracin 4 to 50..... Broiler chickens; for For broiler chickens 000004
(0.0125 pct). prevention of only; feed
coccidiosis caused by continuously as the
Eimeria tenella, E. sole ration; withdraw
necatrix, E. 3 days before
acervulina, E. slaughter; bacitracin
brunetti, E. mivati, methylene
and E. maxima; and disalicylate provided
for improved feed by No. 046573 in Sec.
efficiency. 510.600(c) of this
chapter.
(xi)........................ ....................... Cattle; for increased For pasture cattle 000004,
rate of weight gain. (slaughter, stocker, 021930
feeder cattle, and
dairy and beef
replacement heifers)
only; feed
continuously on a
free-choice basis at
a rate of not less
than 60 mg nor more
than 200 mg of
lasalocid per head
per day. Each use in
a free-choice Type C
feed must be the
subject of an
approved NADA or
supplemental NADA as
provided in Sec.
510.455 of this
chapter.
(xii)....................... ....................... Cattle; for control of For cattle; hand feed 000004
coccidiosis caused by at a rate of 1 mg of
Eimeria bovis and lasalocid per 2.2
Eimeria zuernii. pounds body weight
per day to cattle
weighing up to 800
pounds with a maximum
of 360 mg of
lasalocid per head
per day.
(xiii) 113 (0.0125 pct)..... ....................... Chukar partridges; for Feed continuously as 000004
prevention of sole ration up to 8
coccidiosis caused by weeks of age.
Eimeria legionensis.
(xiv) 68 (0.0075 pct) to 113 ..................... Growing turkeys; for Feed continuously as 000004
(0.0125 pct). prevention of sole ration.
coccidiosis caused by
E. meleagrimitis, E.
gallopavonis, and E.
adenoeides..
.......................... Bacitracin 4 to 50..... Growing turkeys; for Feed continuously as 063238
prevention of sole ration.
coccidiosis caused by
E. meleagrimitis, E.
gallopavonis, and E.
adenoeides; for
increased rate of
weight gain and
improved feed
efficiency..
.......................... Virginiamycin 10 to 20. Growing turkeys; for Feed continuously as 063238
prevention of sole ration. As
coccidiosis caused by lasalocid sodium
E. meleagrimitis, E. provided by 063238
gallopavonis, and E. and virginiamycin
adenoeides, and for provided by 000069..
increased rate of
weight gain and
improved feed
efficiency..
(xv)........................ ....................... Replacement calves; In milk replacer 000004
for control of powder; hand feed at
coccidiosis caused by a rate of 1 mg of
E. bovis and E. lasalocid per 2.2 lb
zuernii.. body weight per day;
include on labeling
warning: ``A
withdrawal period has
not been established
for lasalocid in pre-
ruminating calves. Do
not use in calves to
be processed for
veal''.
(xvi) 113 (0.0125 pct)...... ....................... Rabbits; for Feed continuously as 000004
prevention of sole ration up to 6 1/
coccidiosis caused by 2 weeks of age.
Eimeria stiedae.
----------------------------------------------------------------------------------------------------------------
(2) It is used as a free-choice mineral Type C feed as follows:
(i) Specifications.
------------------------------------------------------------------------
International
Ingredient Percent feed No.
------------------------------------------------------------------------
Defluorinated Phosphate (20.5 percent Calcium, 35.9 6-01-080
18.5 percent Phosphorus).......................
Sodium Chloride (Salt).......................... 20.0 6-04-152
Calcium Carbonate (38 percent Calcium).......... 18.0 6-01-069
Cottonseed Meal................................. 10.0 5-01-621
[[Page 416]]
Potassium Chloride.............................. 3.0 6-03-755
Selenium Premix (0.02 percent Selenium) \1\..... 3.0 .............
Dried Cane Molasses............................. 2.5 4-04-695
Magnesium Sulfate............................... 1.7 6-02-758
Vitamin Premix \1\.............................. 1.4 .............
Magnesium Oxide................................. 1.2 6-02-756
Potassium Sulfate............................... 1.2 6-06-098
Trace Mineral Premix \1\........................ 1.04 .............
Bovatec Premix (68 grams per pound)............. 1.06 .............
------------------------------------------------------------------------
\1\ Content of the vitamin and trace mineral premixes may be varied;
however, they should be comparable to those used by the firm for other
free-choice feeds. Formulation modifications require FDA approval
prior to marketing. The amount of selenium and ethylenediamine
dihydroiodide (EDDI) must comply with published regulations. For
selenium (21 CFR 573.920): up to 120 parts per million in a mixture
for free-choice feeding at a rate not to exceed an intake of 3
milligrams per head per day.
(ii) Amount. 1,440 grams per ton (0.16 percent).
(iii) Indications for use. Cattle, for increased rate of weight
gain.
(iv) Limitations. For pasture cattle (slaughter, stocker, feeder
cattle, and dairy and beef replacement heifers); feed continuously on a
free-choice basis at a rate of 60 to 200 milligrams lasalocid per head
per day; each use of this Type C free-choice feed must be the subject of
an approved FD-1900 as provided in Sec. 510.455 of this chapter.
(v) Sponsor. See No. 063238 in Sec. 510.600(c) of this chapter.
(3) It is used as a ruminant free-choice liquid Type C feed as
follows:
(i) Specifications.
------------------------------------------------------------------------
Ingredient Percent International feed No.
------------------------------------------------------------------------
Cane Molasses.................... 55.167 4-13-241
Condensed Molasses Fermentation 24.0 N/A
Solubles.
50% Urea Solution (23% N)........ 12.0 N/A
Ammonium Polyphosphate Solution.. 1.0 6-08-42
Phosphoric Acid (54%)............ 3.0 6-03-707
Xanthan Gum...................... 0.05 8-15-818
Water............................ 4.0 N/A
Trace Mineral Mix 1.............. 0.5 N/A
Vitamin Premix 1................. 0.2 N/A
Bovatec Liquid 20 (90.8 gm/lb) 2. 0.083 N/A
------------------------------------------------------------------------
\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.
(ii) Amount. 150 grams per ton (.017 percent).
(iii) Indications for use. Cattle: for increased rate of weight
gain.
(iv) Limitations. For pasture cattle (slaughter, stocker, feeder
cattle, and dairy and beef replacement heifers). Feed continuously on a
free-choice basis at a rate of 60 to 200 milligrams lasalocid per head
per day. Each use of this free-choice liquid Type C feed must be the
subject of an approved FD-1900 as in Sec. 510.455 of this chapter.
(v) Sponsor. See No. 063238 in Sec. 510.600(c) of this chapter.
(4) Additional combinations. Lasalocid may be used in accordance
with the provisions of this section in combination as follows:
(i) Melengestrol acetate alone or in combination with tylosin in
accordance with Sec. 558.342.
(ii) Bambermycins as in Sec. 558.95 of this chapter.
[41 FR 44382, Oct. 8, 1976]
Editorial Note: For Federal Register citations affecting
Sec. 558.311, see the List of CFR Sections Affected, which appears in
the Finding Aids section of the printed volume and on GPO Access.