Section

[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR558.76]

[Page 384-386]

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. 558.76 Bacitracin methylene disalicylate.

(a) Approvals. Type A medicated articles: 10, 25, 30, 40, 50, 60, or
75 grams per pound to 046573 in Sec. 510.600(c) of this chapter.
(b) Special considerations. The quantities of antibiotics are
expressed in terms of the equivalent amount of antibiotic standard.
(c) Related tolerances. See Sec. 556.70 of this chapter.
(d) Conditions of use. (1) It is used as follows:

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Bacitracin methylene
disalicylate in grams per Combination in grams Indications for use Limitations Sponsor
ton per ton
----------------------------------------------------------------------------------------------------------------
(i) 4 to 50................. ....................... Chickens, turkeys, and ...................... 046573
pheasants; increased
rate of weight gain
and improved feed
efficiency \1\.
(ii) 5 to 20................ ....................... Quail not over 5 weeks ...................... 046573
of age; increased
rate of weight gain
and improved feed
efficiency \1\.
(iii) 10 to 25.............. ....................... Chickens; for For first 7 months of 046573
increased egg production.
production and
improved feed
efficiency for egg
production.
(iv) 10 to 30............... ....................... Swine: for increased For growing and 046573
rate of weight gain finishing swine.
and improved feed
efficiency.
Chlortetracycline Swine; for increased Feed for not more than 046573
approximately 400, rate of weight gain 14 days to provide 10
varying with body and improved feed milligrams of
weight and food efficiency; for chlortetracycline per
consumption to provide treatment of pound of body weight
10 milligrams per bacterial enteritis per day; as
pound of body weight caused by Escherichia chlortetracycline
per day. coli and Salmonella provided by No.
choleraesuis and 046573 in Sec.
bacterial pneumonia 510.600(c) of this
caused by Pasteurella chapter. Type C feed
multocida susceptible may be prepared from
to chlortetracycline. Type B feed
containing 1 to 3
grams per pound BMD
with 400 grams per
pound CTC, to 046573
in Sec. 510.600(c).
....................... Swine; for control of Feed for not more than 046573
porcine proliferative 14 days;
enteropathies chlortetracycline and
(ileitis) caused by BMD[reg] as provided
Lawsonia by 046573 in Sec.
intracellularis 510.600(c) of this
susceptible to chapter.
chlortetracycline..
(v) [Reserved]
(vi) 50..................... ....................... Broiler chickens; as ...................... 046573
an aid in the
prevention of
necrotic enteritis
caused or complicated
by Clostridium spp.
or other organisms
susceptible to
bacitracin.
....................... Replacement chickens; Feed continuously as 046573
as an aid in the sole ration.
prevention of
necrotic enteritis
caused or complicated
by Clostridium spp.
or other organisms
susceptible to
bacitracin

[[Page 385]]

(vii)-(viii) [Reserved]
(ix) 100 to 200............. ....................... Broiler chickens; as ...................... 046573
an aid in the control
of necrotic enteritis
caused or complicated
by Clostridium spp.
or other organisms
susceptible to
bacitracin.
....................... Replacement chickens; Feed continuously as 046573
as an aid in the sole ration. Start at
control of necrotic first clinical signs
enteritis caused or of disease, vary
complicated by dosage based on
Clostridium spp. or severity of
other organisms infection, administer
susceptible to continuously for 5 to
bacitracin 7 days or as long as
clinical signs
persist, then reduce
medication to
prevention level (50
g/t).
(x) 200..................... ....................... Turkeys; as an aid in ...................... 046573
the control of
transmissible
enteritis in growing
turkeys complicated
by organisms
susceptible to
bacitracin methylene
disalicylate.
....................... Quail; for the From Type A medicated 046573
prevention of articles containing
ulcerative enteritis 25, 40, or 50 grams
in growing quail due of bacitracin
to Clostridium methylene
colinum susceptible disalicylate. Feed
to bacitracin continuously as the
methylene sole ration.
disalicylate
(xi) 250.................... ....................... 1. Growing/Finishing As the sole ration. 046573
Swine: For control of Not for use in swine
swine dysentery weighing more than
associated with 250 pounds. Diagnosis
Treponema should be confirmed
hyodysenteriae on by a veterinarian
premises with a when results are not
history of swine satisfactory.
dysentery but where
signs of the disease
have not yet
occurred; or
following an approved
treatment of the
disease condition.
....................... 2. Pregnant sows: For As the sole ration.
control of Feed to sows from 14
clostridial enteritis days before through
caused by C. 21 days after
perfringens in farrowing on premises
suckling piglets.. with a history of
clostridial scours.
Diagnosis should be
confirmed by a
veterinarian when
results are not
satisfactory.
----------------------------------------------------------------------------------------------------------------
\1\ These conditions are NAS/NRC reviewed and found effective. Applications for these uses may not require
effectiveness data as specified by Sec. 514.111 of this chapter, but may require bioequivalency and safety
information.

(2) It is used as bacitracin methylene disalicylate in feed for
animals as follows:
(i) Amount. 70 milligrams per head per day.
(a) Indications for use. Feedlot beef cattle; reduction in the
number of liver condemnations due to abscesses.
(b) Limitations. Administer continuously throughout the feeding
period.
(ii) Amount. 250 milligrams per head per day.
(a) Indications for use. Feedlot beef cattle; reduction in the
number of liver condemnations due to abscesses.
(b) Limitations. Administer continuously for 5 days then discontinue
for subsequent 25 days, repeat the pattern during the feeding period.
(3) Bacitracin methylene disalicylate may also be used with:
(i) Amprolium as in Sec. 558.55.
(ii) Amprolium and ethopabate as in Sec. 558.58.
(iii) Carbarsone (not USP) as in Sec. 558.120.
(iv) Decoquinate alone and with roxarsone as in Sec. 558.195.
(v) Diclazuril alone and with roxarsone as in Sec. 558.198.
(vi) Fenbendazole as in Sec. 558.258.
(vii) Halofuginone hydrobromide alone and with roxarsone as in Sec.
558.265.
(viii) Hygromycin B as in Sec. 588.274.
(ix) Ivermectin as in Sec. 558.300.

[[Page 386]]

(x) Lasalocid sodium alone and with roxarsone as in Sec. 558.311.
(xi) Monensin alone and with roxarsone as in Sec. 588.355.
(xii) Narasin alone and with roxarsone as in Sec. 558.363.
(xiii) Nicarbazin alone and with narasin or narasin and roxarsone as
in Sec. 558.366.
(xiv) Nitarsone as in Sec. 558.369.
(xv) Robenidine alone and with roxarsone as in Sec. 558.515.
(xvi) Salinomycin alone and with roxarsone as in Sec. 558.550.
(xvii) Semduramicin alone and with roxarsone as in Sec. 558.555.
(xviii) Zoalene alone and with arsanilic acid as in Sec. 558.680.

[41 FR 10993, Mar. 15, 1976]

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