(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. 054771 for use as in paragraphs (e)(1) (i), (ii), (iii), (iv), and (x) of this section.
(2) 15 percent activity to No. 066104 as provided by No. 054771 for use as in paragraph (e)(1)(v) of this section.
(3) 15, 20, 33.1, and 50 percent activity to No. 054771 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. 054771 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), (e)(3), and (e)(4) of this section.
(5) 15 and 20 percent activity to Nos. 012286 and 017800 for use in free-choice mineral feeds for cattle as in paragraph (e)(1)(xviii) of this section.
(6) 20 percent activity as a liquid Type A article to No. 054771 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. 054771 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).
(8) [Reserved]
(9) 15 percent activity to No. 068287 for use in free-choice protein blocks for cattle as in paragraphs (e)(1)(xix) of this section.
(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:
(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 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 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 physically stable lasalocid liquid 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.
(3) If a manufacturer is unable to meet the requirements of paragraph (d)(1) or (d)(2) of this section, the manufacturer may secure approval of a positionally stable liquid 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 physical 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 feed specified in the appropriate master file. If the data demonstrate the stability of the liquid feed described in the master file, the supplemental new animal drug application will be approved. The approval will provide a basis for the individual liquid feed manufacturer to manufacture under a medicated feed license the liquid mediated feed described in the master file. A manufacturer who seeks to market a physically unstable lasalocid liquid 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 feed containing lasalocid is stable outside the pH of 4.0 to 8.0, the pH restriction described in paragraphs (d)(1) and (d)(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.
(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.
(iii) For Type A articles, Type B or Type C feeds (cattle): A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.
(6) Lasalocid Type A medicated articles containing lasalocid dried fermentation residue are for use in cattle and sheep feed only.
(7) Each use in a free-choice Type C cattle feed as in paragraphs (e)(1)(xii) and (e)(1)(xviii) of this section must be the subject of an approved NADA or supplemental NADA as provided in Sec. 510.455 of this chapter.
(e)(1) Conditions of use. It is used as follows: ----------------------------------------------------------------------------------------------------------------
(1) Conditions of use. It is used as follows: ----------------------------------------------------------------------------------------------------------------
Lasalocid sodium activity in Combination in grams
(i) 68 (0.0075 pct) to 113 .................... For the prevention of For broiler or 054771
(0.0125 pct). coccidiosis caused by fryer chickens
Eimeria tenella, E. only; feed
necatrix, E. continuously as
acervulina, E. the sole ration.
brunetti, E. mivati,
and E. maxima.
Bambermycins 1 to 2. Broiler chickens: For Feed continuously 016592
prevention of as sole ration.
coccidiosis caused by Bambermycins
Eimeria tenella, E. provided by No.
necatrix, E. 016592 in Sec.
acervulina, E. 510.600(c) of this
brunetti, E. mivati, chapter..
and E. maxima; and for
increased rate of
weight gain and
improved feed
efficiency..
(iii) 68 (0.0075 pct)............ Lincomycin 2 Broiler or fryer For broiler and 054771
(0.00022 pct). chickens; for the fryer chickens
prevention of only; feed
coccidiosis caused by continuously as
Eimeria mivati, E. sole ration;
brunetti, E. tenella, withdraw 5 d
E. acervulina, E. before slaughter;
maxima, and E. Type C feed must
necatrix; for be used within 4
increased rate of weeks of
weight gain and manufacture; as
improved feed lincomycin
efficiency. hydrochloride
monohydrate.(iv) 68 (0.0075 percent)......... Bacitracin 10 to 50. For prevention of For broiler or 054771
coccidiosis caused by fryer chickens
Eimeria tenella, E. only; feed
necatrix, E. continuously as
acervulina, E. the sole ration;
brunetti, E. mivati, bacitracin
and E. maxima, and for methylene
increased rate of disalicylate
weight gain and provided by No.
improved feed 054771 in Sec.
efficiency. 510.600(c) of this
chapter.(v) 68 (0.0075 pct) to 113 Virginiamycin 20.... For prevention of For broiler and 054771
(0.0125 pct). coccidiosis caused by fryer chickens
Eimeria tenella E. only; feed
necatrix, E. continuously as
acervulina, E. sole ration; do
brunetti, E. mivati, not feed to laying
and E. maxima, and for chickens;
increased rate of lasalocid sodium
weight gain and provided by No.
improved feed 054771 in Sec.
efficiency. 510.600(c) of this
chapter.(vi) 10 (0.0011 pct) to 30 .................... Cattle; for improved In Type C feeds; 054771
(0.0033 pct). feed efficiency. for 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, 054771
feed efficiency and for beef cattle
reduction of incidence fed in confinement
and severity of liver for slaughter;
abscesses. feed continuously
at 100 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; 054771
(0.0033 pct). feed efficiency and for 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, 054771
feed efficiency, for beef cattle
increased rate of fed in confinement
weight gain, and for slaughter;
reduction of incidence feed continuously
and severity of liver at 250 to 360 mg/
abscesses. head/day lasalocid
and 75 mg/head/day
oxytetracycline.
As monoalkyl (C8-
C18) trimethyl
ammonium
oxytetracycline.(viii) 20 (0.0022 pct) to 30 .................... Sheep; for the In Type C feeds; 054771
(0.0033 pct). prevention of for sheep
coccidiosis caused by maintained in
Eimeria ovina, E. confinement; feed
crandallis, E. continuously in
ovinoidalis (E. complete feed to
ninakohlyakimovae), E. provide not less
parva, and E. than 15 mg nor
intricata. more than 70 mg of
lasalocid sodium
activity per head
per day depending
on body weight.(ix)............................. .................... Pasture cattle Feed continuously 054771
(slaughter, stocker, at a rate of not
feeder cattle, and less than 60 mg or
dairy and beef more than 300 mg
replacement heifers): of lasalocid per
for increased rate of head per day when
weight gain. Intakes on pasture; the
of lasalocid in excess drug must be
of 200 mg/head/day contained in at
have not been shown to least 1 pound of
be more effective than feed..
200 mg/head/day..
(x) 68 (0.0075 pct) to 113 Bacitracin 4 to 50.. Broiler chickens; for For broiler 054771
(0.0125 pct). prevention of chickens only;
coccidiosis caused by feed continuously
Eimeria tenella, E. as the sole
necatrix, E. ration; bacitracin
acervulina, E. methylene
brunetti, E. mivati, disalicylate
and E. maxima; and for provided by No.
improved feed 054771 in Sec.
efficiency. 510.600(c) of this
chapter.(xi) 68 (0.0075 pct) to 113 Bacitracin zinc 4 to Broiler chickens. For Feed continuously 054771
(0.0125 pct). 50. prevention of as sole ration.
coccidiosis caused by Bacitracin zinc
Eimeria tenella, E. and lasalocid
necatrix, E. sodium as provided
acervulina, E. by No. 054771 in
brunetti, E. mivati, Sec. 510.600(c)
and E. maxima, and for of this chapter..
increased rate of
weight gain and
improved feed
efficiency..(xii)............................ .................... Pasture cattle Feed continuously 054771
(slaughter, stocker, on a free-choice
feeder cattle, and basis at a rate of
dairy and beef not less than 60
replacement heifers): mg or more than
For increased rate of 300 mg of
weight gain. Intakes lasalocid per head
of lasalocid in excess per day..
of 200 mg/head/day
have not been shown to
be more effective than
200 mg/head/day..(xiii)........................... .................... Cattle; for control of For cattle; hand 054771
coccidiosis caused by feed at a rate of
Eimeria bovis and 1 mg of lasalocid
Eimeria zuernii. per 2.2 pounds
body weight per
day to cattle
weighing up to 800
pounds with a
maximum of 360 mg
of lasalocid per
head per day.(xiv) 113 (0.0125 pct)........... .................... Chukar partridges; for Feed continuously 054771
prevention of as sole ration up
coccidiosis caused by to 8 weeks of age.
Eimeria legionensis.(xv) 68 (0.0075 pct) to 113 .................... Growing turkeys; for Feed continuously 054771
(0.0125 pct). prevention of as sole ration.
coccidiosis caused by
E. meleagrimitis, E.
gallopavonis, and E.
adenoeides..
Bacitracin 4 to 50.. Growing turkeys; for Feed continuously 054771
prevention of as sole ration.
coccidiosis caused by
E. meleagrimitis, E.
gallopavonis, and E.
adenoeides; for
increased rate of
weight gain and
improved feed
efficiency..
Bacitracin methylene Growing turkeys; for Feed continuously 054771
disalicylate 4 to prevention of as sole ration.
50. coccidiosis caused by Bacitracin
E. meleagrimitis, E. methylene
gallopavonis, and E. disalicylate as
adenoeides; for provided by No.
increased rate of 054771 in Sec.
weight gain and 510.600(c) of this
improved feed chapter..
efficiency..
Virginiamycin 10 to Growing turkeys; for Feed continuously 054771
20. prevention of as sole ration. As
coccidiosis caused by lasalocid sodium
E. meleagrimitis, E. provided by 063238
gallopavonis, and E. and virginiamycin
adenoeides, and for provided by
increased rate of 066104..
weight gain and
improved feed
efficiency..(xvi)............................ .................... Replacement calves; for In milk replacer 054771
control of coccidiosis powder; hand feed
caused by E. bovis and at a rate of 1 mg
E. zuernii.. of lasalocid per
2.2 lb 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''.(xvii) 113 (0.0125 pct).......... .................... Rabbits; for prevention Feed continuously 054771
of coccidiosis caused as sole ration up
by Eimeria stiedae. to 6\1/2\ weeks of
age.(xviii) 1440..................... .................... Pasture cattle Feed continuously 021930
(slaughter, stocker, on a free-choice 017800
feeder cattle, and basis at a rate of
dairy and beef not less than 60
replacement heifers): mg nor more than
For increased rate of 200 mg of
weight gain.. lasalocid per head
per day..
(xix) 300........................ .................... Pasture cattle Feed continuously 068287
(slaughter, stocker, on a free-choice
feeder cattle, and basis at a rate of
dairy and beef not less than 60
replacement heifers): mg nor more than
for increased rate of 200 mg of
weight gain.. lasalocid per head
per day..(xx) 10 to 30.................... Chlortetracycline 25 1. Cattle fed in Feed continuously 054771
to 100. confinement for in complete feed
slaughter: For at a rate of 350
improved feed mg
efficiency; and for chlortetracycline
control of bacterial and not less than
pneumonia associated 100 mg nor more
with shipping fever than 360 mg of
complex caused by lasalocid sodium
Pasteurella spp. activity per head
susceptible to per day..
chlortetracycline..
.................... 2. Cattle under 700 Feed continuously 054771
pounds fed in in complete feed
confinement for at a rate of 350
slaughter: For mg
improved feed chlortetracycline
efficiency; and for and not less than
control of active 100 mg nor more
infection of than 360 mg of
anaplasmosis caused by lasalocid sodium
Anaplasma marginale activity per head
susceptible to per day..
chlortetracycline..(xxi) 10 to 30................... Chlortetracycline Cattle fed in Feed continuously 054771
500 to 2000. confinement for in complete feed
slaughter: For for not more than
improved feed 5 days to provide
efficiency; and for 10 mg
treatment of bacterial chlortetracycline
enteritis caused by E. per lb body weight
coli and bacterial per day and not
pneumonia caused by P. less than 100 mg
multocida organisms nor more than 360
susceptible to mg of lasalocid
chlortetracycline.. sodium activity
per head per day..(xxii) 25 to 30.................. Chlortetracycline 25 1. Cattle fed in Feed continuously 054771
to 42.2. confinement for in complete feed
slaughter: For at a rate of 350
increased rate of mg
weight gain and chlortetracycline
improved feed and not less than
efficiency; and for 250 mg nor more
control of bacterial than 360 mg of
pneumonia associated lasalocid sodium
with shipping fever activity per head
complex caused by per day..
Pasteurella spp.
susceptible to
chlortetracycline..
.................... 2. Cattle under 700 Feed continuously 054771
pounds fed in in complete feed
confinement for at a rate of 350
slaughter: For mg
increased rate of chlortetracycline
weight gain and and not less than
improved feed 250 mg nor more
efficiency; and for than 360 mg of
control of active lasalocid sodium
infection of activity per head
anaplasmosis caused by per day..
Anaplasma marginale
susceptible to
chlortetracycline..(xxiii) 25 to 30................. Chlortetracycline Cattle fed in Feed continuously 054771
500 to 1200. confinement for in complete feed
slaughter: For for not more than
increased rate of 5 days to provide
weight gain and 10 mg
improved feed chlortetracycline
efficiency; and for per lb body weight
treatment of bacterial per day and not
enteritis caused by E. less than 250 mg
coli and bacterial nor more than 360
pneumonia caused by P. mg of lasalocid
multocida organisms sodium activity
susceptible to per head per day..
chlortetracycline..(xxiv) 30 to 181.8............... Chlortetracycline 25 1. Beef cattle under Hand feed 054771
to 2800. 700 pounds: For continuously at a
control of coccidiosis rate of 350 mg
caused by Eimeria chlortetracycline
bovis and E. zuernii; per head per day
and for control of and 1 mg lasalocid
active infection of per 2.2 lb body
anaplasmosis caused by weight per day
Anaplasma marginale with a maximum of
susceptible to 360 mg lasalocid
chlortetracycline.. per head per day..
.................... 2. Beef cattle up to Hand feed 054771
800 pounds: For continuously at a
control of coccidiosis rate of 350 mg
caused by Eimeria chlortetracycline
bovis and E. zuernii; per head per day
and for control of and 1 mg lasalocid
bacterial pneumonia per 2.2 lb body
associated with weight per day
shipping fever complex with a maximum of
caused by Pasteurella 360 mg lasalocid
spp. susceptible to per head per day..
chlortetracycline..
(xxv) 30 to 181.8................ Chlortetracycline Cattle up to 800 Hand feed 054771
500 to 4000. pounds: For control of continuously for
coccidiosis caused by not more than 5
Eimeria bovis and E. days to provide 10
zuernii; and for mg
treatment of bacterial chlortetracycline
enteritis caused by E. per lb body weight
coli and bacterial per day and 1 mg
pneumonia caused by P. lasalocid per 2.2
multocida organisms lb body weight per
susceptible to day with a maximum
chlortetracycline.. of 360 mg
lasalocid per head
per day..(xxvi) 30 to 600................. Chlortetracycline 25 1. Pasture cattle Hand feed 054771
to 700. (slaughter, stocker, continuously at a
feeder cattle, and rate of 350 mg
beef replacement chlortetracycline
heifers): for and not less than
increased rate of 60 mg or more than
weight gain; and for 300 mg lasalocid
control of bacterial per head daily in
pneumonia associated at least 1 lb of
with shipping fever feed. Intakes of
complex caused by lasalocid in
Pasteurella spp. excess of 200 mg/
susceptible to head/day have not
chlortetracycline.. been shown to be
more effective
than 200 mg/head/
day..
.................... 2. Pasture cattle under Hand feed 054771
700 pounds (slaughter, continuously at a
stocker, feeder rate of 350 mg
cattle, and beef chlortetracycline
replacement heifers): and not less than
for increased rate of 60 mg or more than
weight gain; and for 300 mg lasalocid
control of active per head daily in
infection of at least 1 lb of
anaplasmosis caused by feed. Intakes of
Anaplasma marginale lasalocid in
susceptible to excess of 200 mg/
chlortetracycline.. head/day have not
been shown to be
more effective
than 200 mg/head/
day..(xxvii) 30 to 600................ Chlortetracycline 25 Pasture cattle over 700 Hand feed 054771
to 1100. pounds (slaughter, continuously at a
stocker, feeder rate of 0.5 mg
cattle, and beef chlortetracycline
replacement heifers): per lb body weight
For increased rate of per day and not
weight gain; and for less than 60 mg or
control of active more than 300 mg
infection of lasalocid per head
anaplasmosis caused by daily in at least
Anaplasma marginale 1 lb of feed.
susceptible to Intakes of
chlortetracycline.. lasalocid in
excess of 200 mg/
head/day have not
been shown to be
more effective
than 200 mg/head/
day..(xxviii) 30 to 600............... Chlortetracycline Pasture cattle Hand feed 054771
500 to 4000.. (slaughter, stocker, continuously for
feeder cattle, and not more than 5
dairy and beef days to provide 10
replacement heifers): mg
For increased rate of chlortetracycline
weight gain; and for per lb body weight
treatment of bacterial per day and not
enteritis caused by E. less than 60 mg or
coli and bacterial more than 300 mg
pneumonia caused by P. lasalocid per head
multocida organisms daily in at least
susceptible to 1 lb of feed.
chlortetracycline.. Intakes of
lasalocid in
excess of 200 mg/
head/day have not
been shown to be
more effective
than 200 mg/head/
day..----------------------------------------------------------------------------------------------------------------
(2) It is used as a free-choice mineral Type C feed as follows:
(i) Specifications. ------------------------------------------------------------------------
Ingredient Percent International feed No.------------------------------------------------------------------------Defluorinated phosphate (20.5% Ca, 35.9 6-01-080
18.5% P).Sodium chloride (salt)............ 20.0 6-04-152Calcium carbonate (38% Ca)........ 18.0 6-01-069Cottonseed meal................... 10.0 5-01-621Potassium chloride................ 3.0 6-03-755Selenium premix (0.02 percent 3.0 ..........................
Se)\1\.Dried cane molasses (46% sugars).. 2.5 4-04-695Magnesium sulfate................. 1.7 6-02-758Vitamin premix\1\................. 1.4 ..........................Magnesium oxide (58% Mg).......... 1.2 6-02-756Potassium sulfate................. 1.2 6-06-098Trace mineral premix\1\........... 1.04 ..........................
Lasalocid Type A medicated article 1.06 ..........................
(68 g/lb)\2\.------------------------------------------------------------------------\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. Selenium must comply with 21 CFR 573.920.
Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance
Policy Guides Sec. 651.100 (CPG 7125.18).\2\ To provide 1,440 g lasalocid per ton, use 21.2 lbs (1.06%) of a
lasalocid Type A medicated article containing 68 g/lb. If using a
lasalocid Type A medicated article containing 90.7 g/lb, use 15.88 lbs
per ton (0.794%), adding molasses.
(ii) Amount. 1,440 grams per ton.
(iii) Indications for use. Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): for increased rate of weight gain. Intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day.
(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 300 milligrams lasalocid per head per day.
(v) Sponsor. See No. 054771 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 4-13-241Condensed molasses fermentation 24.0 .........................
solubles.50% Urea Solution (23% N)........ 12.0 .........................Ammonium polyphosphate solution.. 1.0 6-08-42Phosphoric acid (54%)............ 3.0 6-03-707Xanthan gum...................... 0.05 8-15-818Water............................ 4.0 .........................Trace mineral premix\1\.......... 0.5 .........................Vitamin premix\1\................ 0.2 .........................Lasalocid Type A medicated 0.083 .........................
article (90.7 g/lb)\2\.------------------------------------------------------------------------\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. Selenium must comply with 21 CFR 573.920.
Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance
Policy Guides Sec. 651.100 (CPG 7125.18).\2\ To provide 150 gm lasalocid per ton, use 1.652 lb (0.083%) of a
lasalocid liquid Type A medicated article containing 90.7 g/lb. If
using a dry lasalocid Type A medicated article containing 68 g/lb,
use, use 2.206 lbs per ton (0.111%), replacing molasses. If using a
dry lasalocid Type A medicated article containing 90.7 g/lb, use 1.652
lbs per ton (0.083%), adding molasses.
(ii) Amount. 150 grams per ton.
(iii) Indications for use. Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): for increased rate of weight gain. Intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day.
(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 300 milligrams lasalocid per head per day.
(v) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(4) It is used as a free-choice, loose mineral Type C feed as follows:
(i) Specifications. ------------------------------------------------------------------------
Ingredient Percent International feed No.------------------------------------------------------------------------Monocalcium phosphate (21% P)..... 57.70 6-01-082Salt.............................. 17.55 6-04-152Distillers dried grains w/ 5.40 5-28-236
solubles.Dried cane molasses (46% Sugars).. 5.20 4-04-695Potassium chloride................ 4.90 6-03-755Trace mineral/vitamin premix\1\... 3.35 ..........................Calcium carbonate (38% Ca)........ 2.95 6-01-069Mineral oil....................... 1.05 8-03-123Magnesium oxide (58% Mg).......... 1.00 6-02-756Iron oxide (52% Fe)............... 0.10 6-02-431
Lasalocid Type A medicated article 0.80 ..........................
(68 g/lb)\2\.------------------------------------------------------------------------\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. Selenium must comply with 21 CFR 573.920.
Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance
Policy Guides Sec. 651.100 (CPG 7125.18).\2\ To provide 1,088 g lasalocid per ton, use 16 lbs (0.80%) of a
lasalocid Type A medicated article containing 68 g/lb. If using a
lasalocid Type A medicated article containing 90.7 g/lb, use 12 lbs
per ton (0.6%), adding molasses.
(ii) Amount. 1,088 grams per ton.
(iii) Indications for use. Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): For increased rate of weight gain. Intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day.
(iv) Limitations. Feed continuously on a free-choice basis at a rate of 60 to 300 mg lasalocid per head per day.
(v) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(5) Lasalocid may also be used in combination with:
(i) Melengestrol acetate alone or in combination with tylosin as in Sec. 558.342.
(ii) [Reserved] [41 FR 44382, Oct. 8, 1976]
Editorial Notes: 1. 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 at www.fdsys.gov.
2. At 79 FR 13545, Mar. 11, 2014, Sec. 558.311 was amended; however, the amendment could not be incorporated because of the inaccurate amendatory instruction.