Section

[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: 21CFR558.128]

[Page 388-391]

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. 558.128 Chlortetracycline.

(a) Approvals. Type A medicated articles containing the following
concentrations of either chlortetracycline calcium complex equivalent to
chlortetracycline hydrochloride or, for products intended for use in
milk replacer, chlortetracycline hydrochloride:
(1) 50 to 100 grams per pound to 063238 in Sec. 510.600(c) of this
chapter.
(2) 50 to 100 grams per pound to 000069.
(3) 50 to 100 grams per pound to 046573.
(4) 50 grams per pound to 017519.
(5) 50 to 100 grams per pound to 053389.
(b) Related tolerances. See Sec. 556.150 of this chapter.
(c) [Reserved]
(d)(1) It is used in feeds as follows:

----------------------------------------------------------------------------------------------------------------
Chlortetracycline amount Combination Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10 to 50 g/t 1. Chickens; increased ...................... 063238.
rate of weight gain
and improved feed
efficiency.
Do not feed to 000069,
chickens producing 017519,
eggs for human 046573,
consumption. 053389.
2. Growing turkeys; Do not feed to turkeys 000069,
increased rate of producing eggs for 017519,
weight gain and human consumption. 046573,
improved feed 053389,
efficiency. 063238.
3. Growing swine; Do.
increased rate of
weight gain and
improved feed
efficiency.
(ii) 20 to 50 g/t Growing sheep; 000069,
increased rate of 046573,
weight gain and 053389,
improved feed 063238.
efficiency.
(iii) 50 to 100 g/t Swine; reducing the 000069,
incidence of cervical 017519,
lymphadenitis (jowl 046573,
abscesses) caused by 053389,
Group E. Streptococci 063238.
susceptible to
chlortetracycline.
(iv) 100 to 200 g/t Chickens; control of 1. Feed continuously 063238.
infectious synovitis for 7 to 14 d.
caused by Mycoplasma
synoviae susceptible
to chlortetracycline.

[[Page 389]]

2. Feed continuously 000069,
for 7 to 14 d; do not 017519,
feed to chickens 046573,
producing eggs for 053389.
human consumption.
(v) 200 g/t Turkeys; control of Feed continuously for 000069,
infectious synovitis 7 to 14 d; do not 017519,
caused by M. synoviae feed to turkeys 046573,
susceptible to producing eggs for 053389,
chlortetracycline. human consumption. 063238.
(vi) 200 to 400 g/t 1. Chickens; control of 1. Feed continuously 063238.
chronic respiratory for 7 to 14 d.
disease (CRD) and air
sac infection caused
by M. gallisepticum
and E. coli
susceptible to
chlortetracycline.
2. Feed continuously 000069,
for 7 to 14 d; do not 017519,
feed to chickens 046573,
producing eggs for 053389.
human consumption.
2. Ducks; control and Feed in complete 063238.
treatment of fowl ration to provide
cholera caused by from 8 to 28
Pasteurella multocida milligrams per pound
susceptible to of body weight per
chlortetracycline. day depending upon
age and severity of
disease, for not more
than 21 d. Do not
feed to ducks
producing eggs for
human consumption.
(vii) 400 g/t 1. Turkeys; control of Feed continuously for 000069,
hexamitiasis caused by 7 to 14 d; do not 017519,
Hexamita meleagrides feed to turkeys 046573,
susceptible to producing eggs for 053389,
chlortetracycline. human consumption. 063238.
2. Turkey poults not Do.
over 4 weeks of age;
reduction of mortality
due to paratyphoid
caused by Salmonella
typhimurium
susceptible to
chlortetracycline.
3. Breeding swine; Feed continuously for Do.
control of not more than 14 d.
leptospirosis
(reducing the
incidence of abortion
and shedding of
leptospirae) caused by
Leptospira pomona
susceptible to
chlortetracycline.
(viii) 500 g/t Chickens; reduction of 1. Feed for 5 d. 063238.
mortality due to E.
coli infections
susceptible to
chlortetracycline.
2. Feed for 5 d; do 000069,
not feed to chickens 017519,
producing eggs for 046573,
human consumption. 053389.
(ix)10 mg/g of finished Psittacine birds Feed continuously for 00004
feed daily. (cockatoos, macaws, 45 d; each bird
and parrots) suspected should consume daily
or known to be an amount of
infected with medicated feed equal
psittacosis caused by to one fifth of its
Chlamydia psittaci body weight. Warning:
sensitive to ``Psittacosis, avian
chlortetracycline. chlamydiosis, or
ornithosis is a
reportable
communicable disease,
transmissible between
wild and domestic
birds, other animals,
and man. Contact
appropriate public
health and regulatory
officials.''

[[Page 390]]

(x) 0.1 mg/lb of body Calves (up to 250 lb); In milk replacers or 063238,
weight daily. for increased rate of starter feed; include 000069,
weight gain and on labeling the 017519,
improved feed warning: ``A 046573,
efficiency. withdrawal period has 053389
not been established
for this product in
pre-ruminating
calves. Do not use in
calves to be
processed for veal.''
(xi) 0.5 mg/lb of body Beef cattle (over 700 Withdraw 48 h prior to Do.
weight daily. lb); control of active slaughter. For
infection of sponsor 000004 zero
anaplasmosis caused by withdrawal time. For
Anaplasma marginale sponsor 053389 1 d
susceptible to withdrawal time.
chlortetracycline.
(xii) 10 mg/lb of body 1. Calves, beef and Feed approximately 400 Do.
weight nonlactating dairy g/t, varying with
cattle; treatment of body weight and feed
bacterial enteritis consumption to
caused by E. coli and provide 10 mg/lb per
bacterial pneumonia day. Treat for not
caused by P. multocida more than 5 d; in
organisms susceptible feed including milk
to chlortetracycline. replacers; withdraw
For sponsor 053389 1 d 10 d prior to
withdrawal time. slaughter except for
24 h for sponsor
046573; zero
withdrawal for
sponsor 000004;
include on labeling
the warning: ``A
withdrawal period has
not been established
for this product in
pre-ruminating
calves. Do not use in
calves to be
processed for veal.''
2. Calves (up to 250 In milk replacers or
lb); treatment of starter feed; include
bacterial enteritis on labeling the
caused by E. coli warning: ``A
susceptible to withdrawal period has
chlortetracycline. not been established
for this product in
pre-ruminating
calves. Do not use in
calves to be
processed for veal.''
3. Swine; treatment of Feed approximately 400 063238,
bacterial enteritis g/t, varying with 000069,
caused by E. coli and body weight and feed 017519,
S. choleraesuis and consumption to 046573,
bacterial pneumonia provide 10 mg/lb per 053389
caused by P. multocida day. Feed for not
susceptible to more than 14 d;
chlortetracycline. withdraw 5 d prior to
slaughter for sponsor
012286.
4. Swine; for control Feed for not more than 046573
of porcine 14 d.
proliferative
enteropathies
(ileitis) caused by
Lawsonia
intracellularis
susceptible to
chlortetracycline.
(xiii) 25 mg/lb of body Turkeys; control of Feed continuously for Do.
weight complicating bacterial 7 to 14 d; do not
organisms associated feed to turkeys
with bluecomb producing eggs for
(transmissible human consumption.
enteritis; coronaviral
enteritis) susceptible
to chlortetracycline.
(xiv) 25 to 70 mg/head/day Calves (250 to 400 lb); Include on labeling 063238,
increased rate of the warning: ``A 000069,
weight gain and withdrawal period has 017519,
improved feed not been established 046573,
efficiency. for this product in 053389
pre-ruminating
calves. Do not use in
calves to be
processed for veal.''
(xv) 70 mg/head/day Growing cattle (over ......do Do.
400 lb) increased rate
of weight gain,
improved feed
efficiency, and
reduction of liver
condemnation due to
liver abscesses.

[[Page 391]]

(xvi) 80 mg/head/day Breeding sheep; 063238,
reducing the incidence 000069,
of (vibrionic) 046573,
abortion caused by 053389
Campylobacter fetus
infection susceptible
to chlortetracycline.
(xvii) 350 mg/head/day 1. Beef cattle; control Withdraw 48 h prior to 063238,
of bacterial pneumonia slaughter. For 000069,
associated with sponsor 000004 zero 017519,
shipping fever complex withdrawal time. For 046573,
caused by Pasteurella sponsor 053389 1 d 053389
spp. susceptible to withdrawal time.
chlortetracycline.
2. Beef cattle (under ......do Do.
700 lb); control of
active infection of
anaplasmosis caused by
A. marginale
susceptible to
chlortetracycline.
----------------------------------------------------------------------------------------------------------------

(2) For sponsor 000004: it is used in free-choice cattle feeds such
as feed blocks or salt-mineral mixes manufactured from approve Type A
articles; such feeds are given to beef cattle and nonlactating dairy
cattle to provide a daily intake of 0.5 to 2.0 milligrams of
chlortetracycline per pound of body weight to aid in the control of
active infection of anaplsmosis caused by Anaplasma marginale
susceptible to chlortetracycline; the use of these Type A articles to
make specific free-choice feed formulations must be approved under
section 512(b) of the act and be based on a demonstration of drug
stability and consumption which is consistent with the effective dose;
the specific free-choice feed formulations approved in this paragraph
can be manufactured under section 512(m) of the act.
(3) Chlortetracycline may be used in accordance with the provisions
of this section in the combinations provided as follows:
(i) Amprolium in accordance with Sec. 558.55.
(ii) Amprolium plus ethopabate in accordance with Sec. 558.58.
(iii) Bacitracin methylene disalicylate in accordance with
Sec. 558.76.
(iv) Clopidol in accordance with Sec. 558.175.
(v) Decoquinate in accordance with Sec. 558.195.
(vi) Hygromycin B in accordance with Sec. 558.274.
(vii) Monensin in accordance with Sec. 558.355.
(viii) Roxarsone and salinomycin in accordance with Sec. 558.550.
(ix) Robenidine hydrochloride in accordance with Sec. 558.515.
(x) Roxarsone in accordance with Sec. 558.530.
(xi) Salinomycin in accordance with Sec. 558.550.
(xii) Zoalene in accordance with Sec. 558.680.
(xiii) Tiamulin in accordance with Sec. 558.600.

[41 FR 10995, Mar. 15, 1976]

Editorial Note: For Federal Register citations affecting
Sec. 558.128, see the List of Sections Affected, which appears in the
Finding Aids section of the printed volume and on GPO Access.