New Animal Drugs; Change of Sponsor, 10965-10974 [2014-01958]
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Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Rules and Regulations
(c) Limitations. Milk taken from
animals during treatment and for 60
hours (5 milkings) after the latest
treatment must not be used for food. Do
not administer within 5 days of
slaughter. A withdrawal period has not
been established for this product in
preruminating calves. Do not use in
calves to be processed for veal.
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PART 526—INTRAMAMMARY DOSAGE
FORM NEW ANIMAL DRUGS
8. The authority citation for 21 CFR
part 526 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 526.1696c
[Amended]
§ 529.1940
inserts.
Progesterone intravaginal
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(e) * * *
(1) * * *
(ii) * * *
(D) For induction of estrous cycles in
anestrous lactating dairy cows.
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12. The authority citation for 21 CFR
part 558 continues to read as follows:
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PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
10. The authority citation for 21 CFR
part 529 continues to read as follows:
11. In § 529.1940, in paragraphs (b)
and (e)(1)(iii), remove ‘‘000009’’ and in
its place add ‘‘054771’’; in paragraph (c),
remove ‘‘§ 556.540(a)’’ and in its place
add ‘‘§ 556.540’’; and add paragraph
(e)(1)(ii)(D) to read as follows:
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
9. In paragraph (b) of § 526.1696c,
remove ‘‘033392’’ and in its place add
‘‘042791’’.
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Authority: 21 U.S.C. 360b.
■
through (d)(5)(xi); and add new
paragraph (d)(5)(iii) to read as follows:
§ 558.95
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(d) * * *
(5) * * *
(iii) Clopidol as in § 558.175.
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14. In § 558.175:
a. Redesignate paragraph (d)(9) as
paragraph (d)(11).
■ b. Redesignate paragraphs (d)(5)
through (d)(8) as paragraphs (d)(6)
through (d)(9).
■ c. Add new paragraphs (d)(5) and
(d)(10).
The additions read as follows:
■
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§ 558.175
Authority: 21 U.S.C. 360b, 371.
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13. In paragraph (d)(5) of § 558.95,
redesignate paragraphs (d)(5)(iii)
through (d)(5)(x) as paragraphs (d)(5)(iv)
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Bambermycins.
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Clopidol.
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(d) * * *
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Clopidol in
grams per
ton
Combination in
grams per ton
Indications for use
Limitations
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(5) 113.5 ......
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Bambermycins 1 to 2
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Broiler chickens: As an aid in prevention of
coccidiosis caused by Eimeria tenella,
E. necatrix, E. acervulina, E. maxima, E.
brunetti, and E. mivati; and for increased
rate of weight gain and improved feed
efficiency
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Feed continuously as the sole ration. Do
not feed to chickens over 16 weeks of
age
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(10) 227 .......
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Bambermycins 1 to 2
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Broiler chickens: As an aid in prevention of
coccidiosis caused by Eimeria tenella,
E. necatrix, E. acervulina, E. maxima, E.
brunetti, and E. mivati; and for increased
rate of weight gain and improved feed
efficiency
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Feed continuously as sole ration until 5
days before slaughter. Withdraw 5 days
before slaughter or feed 113.5 g/ton
clopidol and 1 to 2 g/ton bambermycins
during those 5 days before slaughter.
Do not feed to chickens over 16 weeks
of age
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Dated: January 27, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014–01959 Filed 2–26–14; 8:45 am]
BILLING CODE 4160–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 524, 526, and 529
[Docket No. FDA–2014–N–0002]
TKELLEY on DSK3SPTVN1PROD with RULES
New Animal Drugs; Change of Sponsor
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendments.
ACTION:
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016592
016592
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animal drug regulations to reflect a
change of sponsor for 54 approved new
animal drug applications (NADAs) and
1 approved abbreviated new animal
drug application (ANADA) for topical,
intramammary, and certain other dosage
form new animal drug products from
Pfizer, Inc., including its several
subsidiaries and divisions, to Zoetis,
Inc.
This rule is effective February
27, 2014.
DATES:
FOR FURTHER INFORMATION CONTACT:
The Food and Drug
Administration (FDA) is amending the
SUMMARY:
Sponsor
Steven D. Vaughn, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7520 Standish Pl.,
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Rockville, MD 20855; 240–276–8300,
steven.vaughn@fda.hhs.gov.
subsidiaries Alpharma, LLC; Fort Dodge
Animal Health, Division of Wyeth; Fort
Dodge Animal Health, Division of
Wyeth Holdings Corp.; and its division,
Pharmacia & Upjohn Co., have informed
FDA that they have transferred
Pfizer,
Inc., 235 E. 42d St., New York, NY
10017, and its wholly owned
SUPPLEMENTARY INFORMATION:
ownership of, and all rights and interest
in, the 54 approved NADAs and 1
approved ANADA in table 1 to Zoetis,
Inc., 333 Portage St., Kalamazoo, MI
49007.
TABLE 1—NADAS AND ANADA TRANSFERRED FROM PFIZER, INC., TO ZOETIS, INC.
File No.
Product name
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030–025
032–168
032–319
034–872
037–586
038–801
042–661
042–883
043–784
045–512
047–334
047–925
047–997
049–725
049–726
055–072
055–095
055–098
065–114
065–119
065–122
065–149
091–534
093–514
096–676
100–808
102–511
120–299
127–892
130–435
140–839
140–844
140–879
141–003
141–036
141–082
141–095
141–152
141–200
141–238
141–239
141–302
200–102
TKELLEY on DSK3SPTVN1PROD with RULES
008–763
009–035
009–782
009–809
010–434
010–524
011–703
012–258
012–991
013–293
014–170
015–433
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TERRAMYCIN (oxytetracycline hydrochloride) Ophthalmic Ointment with Polymyxin.
OPHTHAINE (proparacaine hydrochloride) Solution.
NOLVASAN (chlorhexidine acetate) Antiseptic Ointment.
NOLVASAN CAP–TABS (chlorhexidine acetate) Tablets.
NOLVASAN (chlorhexidine acetate) Suspension.
NEO–CORTEF with Tetracaine (neomycin sulfate, hydrocortisone acetate, tetracaine hydrochloride) Ointment.
NEO–DELTA CORTEF with Tetracaine (neomycin sulfate, prednisolone acetate, tetracaine hydrochloride) Ointment.
PANOLOG (triamcinolone acetonide, nystatin, thiostrepton, neomycin sulfate) Ointment.
KOPERTOX (copper naphthenate) Topical.
TERRA–CORTRIL (oxytetracycline hydrochloride and hydrocortisone) Topical Spray.
FLUOTHANE (halothane, USP).
NEO–PREDEF with Tetracaine (neomycin sulfate, isoflupredone acetate, tetracaine hydrochloride, and myristylgammapicolinium chloride) Ointment.
NEO–PREDEF with Tetracaine (neomycin sulfate, isoflupredone acetate, tetracaine hydrochloride) Topical Ointment.
DOMOSO (dimethyl sulfoxide) Solution.
TOPAZONE (furazolidone) Aerosol Powder.
NEO PREDEF (neomycin sulfate and isoflupredone acetate) Ointment.
ERYTHROMAST 36 (erythromycin) Intramammary Infusion.
ANAPRIME (flumethasone, polymyxin B sulfate, and neomycin sulfate) Ophthalmic Solution.
KANTRIM (kanamycin sulfate) Ophthalmic Ointment.
KANTRIM (kanamycin sulfate) Ophthalmic Solution.
KANFOSONE (kanamycin sulfate, calcium amphomycin, and hydrocortisone acetate) Ointment.
SYNOTIC(fluocinolone acetonide and dimethyl sulfoxide) Otic Solution.
SYNSAC (fluocinolone acetonide and dimethyl sulfoxide) Topical Solution.
DOMOSO (dimethyl sulfoxide) Gel.
AMPHODERM (kanamycin sulfate, calcium amphomycin, and hydrocortisone acetate) Ointment.
ANAPRIME Opthakote (flumethasone, polymyxin B sulfate, and neomycin sulfate) Ophthalmic.
OPTIPRIME OPTHAKOTE (neomycin sulfate and polymixin B sulfate) Ophthalmic Solution.
ALBACILLIN (procaine penicillin G/novobiocin) Suspension for Intramammary Infusion.
TICILLIN (ticarcillin disodium) Powder for Intrauterine Infusion.
ALBADRY Plus (procaine penicillin G and novobiocin sodium) Suspension for Intramammary Infusion.
MYCITRACIN (bacitracin zinc, neomycin sulfate, and polymyxin B sulfate) Ophthalmic Ointment.
FORTE (neomycin sulfate, penicillin, polymyxin B, hydrocortisone) Topical Ointment.
TETRACYN (tetracycline hydrochloride) Ointment.
CHLOROMYCETIN (chloramphenicol) Ophthalmic Ointment.
NEO–DELTA CORTEF (prednisolone acetate and neomycin sulfate) Solution.
NEO–CORTEF (neomycin sulfate and hydrocortisone acetate) Ointment.
PANOLOG (triamcinolone acetonide, nystatin, thiostrepton, neomycin sulfate) Cream.
ALBAMAST (novobiocin sodium) Suspension for Intramammary Infusion.
BIODRY (novobiocin sodium) Suspension for Intramammary Infusion.
MITABAN (amitraz) Liquid Concentrate.
AMIGLYDE–V (amikacin sulfate) Intrauterine Infusion.
OXYMARINE (oxytetracycline hydrochloride) Fish Marker.
BACTODERM (mupirocin) Ointment.
TRAMISOL (levamisole) Pour-On Topical Solution.
DERMA 4 (nystatin, neomycin sulfate, thiostrepton, and triamcinolone acetonide) Ointment.
DERM–OTIC (nystatin, neomycin, thiostrepton, and triamcinolone acetonide) Ointment.
PIRSUE (pirlimycin hydrochloride) Intramammary Infusion.
DOXIROBE (doxycycline hyclate) Gel.
DECTOMAX (doramectin) Pour-on Solution.
REVOLUTION (selamectin) Topical Solution.
EAZI-Breed CIDR (progesterone) Cattle Insert.
SPECTRAMAST LC (ceftiofur hydrochloride) Sterile Suspension for Intramammary Infusion.
SPECTRAMAST DC (ceftiofur hydrochloride) Sterile Suspension for Intramammary Infusion.
EAZI–BREED CIDR (progesterone) Sheep Insert.
GENTAGLYDE (gentamicin sulfate) Solution.
Accordingly, the Agency is amending
the regulations in 21 CFR parts 524, 526,
and 529 to reflect these transfers of
ownership. In addition, the regulations
are being amended to make minor
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corrections and to reflect a current
format. This is being done to increase
the accuracy and readability of the
regulations.
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In addition, FDA has noticed that
certain sections of part 526 contain
entries describing conditions of use for
new animal drug products for which no
NADA is approved. These errors were
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introduced by the Agency during the
1992 recodification of the regulations
for certifiable antibiotics (57 FR 37318,
August 18, 1992). That rule did not
identify whether particular regulations
were the subject of an approved NADA
and consequently resulted in
codification of certain conditions of use
for which there is no approved NADA.
At this time, the Agency is amending
the regulations to remove these entries.
This action is being taken to improve
the accuracy of the regulations.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
List of Subjects in 21 CFR Parts 524,
526, and 529
Animal drugs.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR parts 524, 526, and 529 are
amended as follows:
(1) No. 054771 for use of product
described in paragraph (a)(1) as in
paragraph (c) of this section.
(2) Nos. 000061 and 043264 for use of
product described in paragraph (a)(2) as
in paragraph (c) of this section.
(c) Conditions of use in dogs and
cats.* * *
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■ 4. In § 524.155, revise the section
heading, redesignate paragraphs (a) and
(b) as paragraphs (b) and (c); add new
paragraph (a); and revise paragraph (b),
and the introductory text in paragraph
(c) to read as follows:
§ 524.155 Bacitracin, neomycin, polymyxin
B, and hydrocortisone ophthalmic ointment.
(a) Specifications. Each gram of
ointment contains 400 units of
bacitracin zinc, 5 milligrams (mg) of
neomycin sulfate (equivalent to 3.5 mg
of neomycin sulfate), 10,000 units of
polymyxin B sulfate, and10 mg of
hydrocortisone.
(b) Sponsors. See Nos. 000061 and
043264 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs and
cats.* * *
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PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
§ 524.390
1. The authority citation for 21 CFR
part 524 continues to read as follows:
§ 524.390 Chloramphenicol ophthalmic
ointment.
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Authority: 21 U.S.C. 360b.
2. In § 524.86, revise the section
heading, and paragraphs (b) and (c)(3) to
read as follows:
■
§ 524.86
Amitraz.
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(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
(c) * * *
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 3. In § 524.154, revise the section
heading, redesignate paragraphs (a) and
(b) as paragraphs (b) and (c); add new
paragraph (a); and revise paragraph (b),
and the introductory text in paragraph
(c) to read as follows:
TKELLEY on DSK3SPTVN1PROD with RULES
§ 524.154 Bacitracin, neomycin, and
polymyxin B ophthalmic ointment.
(a) Specifications. Each gram of
ointment contains:
(1) 500 units of bacitracin, 3.5
milligrams of neomycin, and 10,000
units of polymyxin B sulfate; or
(2) 400 units of bacitracin zinc, 3.5
milligrams of neomycin, and 10,000
units of polymyxin B sulfate.
(b) Sponsors. See sponsor numbers in
§ 510.600(c) of this chapter as follows:
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[Amended]
5. In § 524.390, revise paragraphs (b)
and (c)(3) to read as follows:
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(b) Sponsors. See Nos. 043264 and
054771 in § 510.600(c) of this chapter.
(c) * * *
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian. Federal law
prohibits the use of this drug in foodproducing animals.
§ 524.402
[Amended]
6. In paragraph (b) of § 524.402,
remove ‘‘000856’’ and in its place add
‘‘054771’’.
■ 7. In § 524.450, revise the section
heading, and paragraphs (b) and (c)(3) to
read as follows:
■
§ 524.450
Clotrimazole.
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(b) Sponsors. See No. 000859 in
§ 510.600(c) of this chapter.
(c) * * *
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
§ 524.463
[Amended]
8. In paragraph (b) of § 524.463,
remove ‘‘000856, 017135, and 058829’’
and in its place add ‘‘017135, 054771,
and 058829’’.
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9. In § 524.575, revise paragraphs
(c)(1) and (c)(3) to read as follows:
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§ 524.575 Cyclosporine ophthalmic
ointment.
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(c) * * *
(1) Amount. Apply a 1⁄4-inch strip of
ointment directly on the cornea or into
the conjunctival sac of the affected
eye(s) every 12 hours.
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(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 10. Revise § 524.660 to read as
follows:
§ 524.660
Dimethyl sulfoxide.
(a) Specifications—(1) Each milliliter
(mL) of solution contains 90 percent
dimethyl sulfoxide and 10 percent
water.
(2) Each milliliter (mL) of gel product
contains 90 percent dimethyl sulfoxide.
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
(c) Conditions of use in horses and
dogs—(1) Amount—(i) Horses. Apply
topically two to three times daily in an
amount not to exceed 100 mL per day.
Total duration of therapy should not
exceed 30 days.
(ii) Dogs. Apply topically three to four
times daily in an amount not to exceed
20 mL per day. Total duration of
therapy should not exceed 14 days.
(2) Indications for use. To reduce
acute swelling due to trauma.
(3) Limitations. Do not use in horses
intended for human consumption.
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
§§ 524.660a and 524.660b
[Removed]
11. Remove §§ 524.660a and 524.660b.
■ 12. In § 524.770, in paragraph (b),
remove ‘‘000069’’ and in its place add
‘‘054771’’; and revise paragraph (e)(3) to
read as follows:
■
§ 524.770
Doramectin.
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(e) * * *
(3) Limitations. Do not slaughter cattle
within 45 days of latest treatment. This
product is not approved for use in
female dairy cattle 20 months of age or
older, including dry dairy cows. Use in
these cattle may cause drug residues in
milk and/or in calves born to these
cows. A withdrawal period has not been
established for this product in
preruminating calves. Do not use in
calves to be processed for veal.
■ 13. In § 524.802, revise the section
heading and paragraph (c)(3) to read as
follows:
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§ 524.802 Enrofloxacin and silver
sulfadiazine otic emulsion.
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(c) * * *
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian. Federal law
prohibits the extralabel use of this drug
in food-producing animals.
■ 14. In § 524.900, remove paragraph
(a); redesignate paragraphs (b) through
(f) as paragraphs (a) through (e); and
revise newly redesignated (e) to read as
follows:
§ 524.900
Famphur.
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(e) Conditions of use—(1) Amount.
Apply 1 ounce per 200 pounds body
weight, not to exceed a total dosage of
4 ounces, from the shoulder to the tail
head as a single treatment. Apply as
soon as possible after heel fly activity
ceases.
(2) Indications for use in beef and
nonlactating dairy cattle. For control of
cattle grubs and to reduce cattle lice
infestations.
(3) Limitations. Do not slaughter
within 35 days after treatment. Do not
use on lactating dairy cows or dry dairy
cows within 21 days of freshening,
calves less than 3 months old, animals
stressed from castration, overexcitement
or dehorning, sick or convalescent
animals. Animals may become
dehydrated and under stress following
shipment. Do not treat until they are in
good condition. Brahman and Brahman
crossbreeds are less tolerant of
cholinesterase-inhibiting insecticides
than other breeds. Do not treat Brahman
bulls. Swine should be eliminated from
area where runoff occurs.
■ 15. Revise § 524.920, to read as
follows:
TKELLEY on DSK3SPTVN1PROD with RULES
§ 524.920
Fenthion.
(a) Specifications. (1) The drug is a
liquid containing:
(i) 3 percent of fenthion; or
(ii) 20 percent fenthion.
(2) The drug is a solution containing
either 5.6 or 13.8 percent fenthion. Each
concentration is available in 2 volumes
which are contained in single-dose
applicators.
(b) Sponsor. See sponsors in
§ 510.600(c) of this chapter:
(1) No. 000859 for use of product
described in paragraph (a)(1)(i) as in
paragraph (d)(1) of this section.
(2) No. 000859 for use of product
described in paragraph (a)(1)(ii) as in
paragraph (d)(2) of this section.
(3) No. 000859 for use of products
described in paragraph (a)(2) as in
paragraph (d)(3) of this section.
(c) Related tolerances. See 40 CFR
180.214.
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(d) Conditions of use—(1) Beef cattle
and nonlactating dairy cattle—(i)
Amount. It is used at the rate of one-half
fluid ounce per 100 pounds of body
weight applied topically on the backline
of the animal. Only one application per
season should be made for grub control
and this will also provide initial control
of lice. A second application for lice
control may be made if animals become
reinfested, but no sooner than 35 days
after the first treatment. Proper timing of
treatment is important for grub control;
cattle should be treated as soon as
possible after heel-fly activity ceases.
(ii) Indications for use. For the control
of grubs and lice in beef and
nonlactating cattle.
(iii) Limitations. Do not use on
animals simultaneously or within a few
days before or after treatment with or
exposure to cholinesterase-inhibiting
drugs, pesticides, or chemicals. Cattle
should not be slaughtered within 35
days following a single treatment. If a
second application is made for lice
control, cattle should not be slaughtered
within 45 days of the second treatment.
The drug must not be used within 28
days of freshening of dairy cattle. If
freshening should occur within 28 days
after treatment, do not use milk as
human food for the balance of the 28day interval. Do not treat lactating dairy
cattle; calves less than 3 months old; or
sick, convalescent, or stressed livestock.
Do not treat cattle for 10 days before or
after shipping, weaning, or dehorning or
after exposure to contagious infectious
diseases.
(2) Beef cattle and dairy cattle not of
breeding age—(i) Amount. It is
administered as a single, topical
application placed on the backline of
animals as follows: For animals
weighing 150 to 300 pounds, apply 4
milliliters (mL); for animals weighing
301 to 600 pounds, apply 8 mL; for
animals weighing 601 to 900 pounds,
apply 12 mL; for animals weighing 901
to 1,200 pounds, apply 16 mL; and for
animal weighing over 1,200 pounds,
apply 20 mL. For most effective results,
cattle should be treated as soon as
possible after heel-fly activity ceases. A
second application is required for
animals heavily infested with lice or for
those which become reinfested. A
second application should be made no
sooner than 35 days after the first
treatment.
(ii) Indications for use. For control of
cattle grubs and as an aid in controlling
lice on beef cattle and on dairy cattle
not of breeding age.
(iii) Limitations. Do not use on
animals simultaneously or within a few
days before or after treatment with or
exposure to cholinesterase-inhibiting
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drugs, pesticides, or chemicals. Hostparasite reactions such as bloat,
salivation, staggering and paralysis may
sometimes occur when cattle are treated
while the common cattle grub
(Hypoderma lineatum) is in the gullet,
or while the northern cattle grub (H.
bovis) is in the area of the spinal cord.
Cattle should be treated before these
stages of grub development. Consult
your veterinarian, extension livestock
specialist, or extension entomologist
regarding the timing of treatment. If it is
impossible to determine the area from
which the cattle came and/or exact stage
of the grubs, it is recommended that the
cattle receive only a maintenance ration
of low-energy feed during the treatment
period. This lessens the likelihood of
severe bloat which may occur in cattle
on full feed when the common grub is
killed while in the gullet. Do not treat
dairy cattle of breeding age; calves less
than 3 months old; sick, convalescent,
or severely stressed livestock. Do not
treat cattle for 10 days before or after
shipping, weaning, dehorning, or after
exposure to contagious or infectious
diseases. Do not slaughter within 45
days of treatment.
(3) Dogs—(i) Amount. Four to 8
milligrams per kilogram of body weight.
Apply the contents of the proper size,
single-dose tube directly to one spot on
the dog’s skin.
(ii) Indications for use. For flea
control on dogs only.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 16. In § 524.960, in paragraph (b),
remove ‘‘000856’’ and in its place add
‘‘054771’’; and revise the section
heading and paragraph (c)(3) to read as
follows:
§ 524.960 Flumethasone, neomycin, and
polymyxin B ophthalmic solution.
*
*
*
*
*
(c) * * *
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
§ 524.981
[Removed and Reserved]
17. Remove and reserve § 524.981.
■ 18. In § 524.981a, revise the section
heading, the introductory text in
paragraph (c), and paragraphs (c)(1) and
(c)(2) to read as follows:
■
§ 524.981a
Fluocinolone cream.
*
*
*
*
*
(c) Conditions of use in dogs—(1)
Amount—A small amount is applied to
the affected area two or three times
daily.
(2) Indications for use. For the relief
of pruritis and inflammation associated
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with certain superficial acute and
chronic dermatoses. It is used in the
treatment of allergic and acute moist
dermatitis and for the relief of
superficial inflammation caused by
chemical burns and physical abrasions.
*
*
*
*
*
■ 19. In § 524.981b, revise the section
heading, paragraph (a), the introductory
text in paragraph (c), and paragraphs
(c)(1) and (c)(2) to read as follows:
§ 524.981b
Fluocinolone solution.
(a) Specifications. The drug contains
0.01 percent fluocinolone acetonide.
*
*
*
*
*
(c) Conditions of use in dogs—(1)
Amount—A small amount of solution is
applied to the affected area two or three
times daily.
(2) Indications for use—(i) Dogs. For
the relief of pruritis and inflammation
associated with otitis externa and
certain superficial acute and chronic
dermatoses.
(ii) Cats. For the relief of pruritis and
inflammation associated with acute
otitis externa and certain superficial
acute and chronic dermatoses.
*
*
*
*
*
■ 20. In § 524.981c, revise the section
heading, the introductory text in
paragraph (c), and paragraphs (c)(1) and
(c)(2) to read as follows:
§ 524.981c
cream.
Fluocinolone and neomycin
*
*
*
*
*
(c) Conditions of use in dogs—(1)
Amount—A small amount is applied to
the affected area two or three times
daily.
(2) Indications for use—(i) Dogs. For
the relief of pruritis and inflammation
associated with superficial acute and
chronic dermatoses. It is used in the
treatment of allergic and acute moist
dermatitis and nonspecific dermatoses.
(ii) Dogs and cats. Used in the
treatment of wound infections.
*
*
*
*
*
■ 21. Revise § 524.981d to read as
follows:
apparently normal anal sacs, for the
reversal of inflammatory changes
associated with abnormal anal sacs, and
to counteract the offensive odor of anal
sac secretions.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 22. Revise § 524.981e to read as
follows:
§ 524.981e Fluocinolone and dimethyl
sulfoxide otic solution.
(a) Specifications. Each milliliter of
solution contains 0.01 percent
fluocinolone acetonide and 60 percent
dimethyl sulfoxide.
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount—Instill 4 to 6 drops (0.2
milliliter) twice daily into the ear canal
for a maximum period of 14 days. The
total dosage used should not exceed 17
milliliters.
(2) Indications for use. For the relief
of pruritis and inflammation associated
with acute and chronic otitis.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 23. In § 524.1005, in paragraph (b)(1),
remove ‘‘053501’’ and in its place add
‘‘054771’’; in paragraph (c)(3), remove
the last sentence and in its place add
‘‘Do not use in horses intended for
human consumption.’’; and revise the
section heading to read as follows:
§ 524.1005
Furazolidone powder.
*
*
*
*
*
24. In § 524.1044, revise the section
heading to read as follows:
■
§ 524.1044 Gentamicin ophthalmic and
topical dosage forms.
25. In § 524.1044b, revise the section
heading to read as follows:
■
10969
(ii) Infected superficial lesions. Apply
to cover the treatment area twice daily
for 7 to 14 days.
(2) Indications for use. For the
treatment of acute and chronic otitis
externa and infected superficial lesions
caused by bacteria sensitive to
gentamicin.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 28. In § 524.1044e, revise the section
heading and paragraph (c) to read as
follows:
§ 524.1044e
Gentamicin spray.
*
*
*
*
*
(c) Conditions of use in cattle—(1)
Amount. Hold the sprayer upright 3 to
6 inches from the affected eye, with the
opening directed towards the eye, and
pump once. Treat once daily for up to
3 days.
(2) Indications for use. For the
treatment of pinkeye in cattle (infectious
bovine keratoconjunctivitis) caused by
Moraxella bovis.
(3) Limitations. Conditions other than
bacterial infections of the bovine eye
and infectious keratoconjunctivitis
caused by Moraxella bovis may produce
similar signs. If conditions persists or
increases, discontinue use and consult a
veterinarian.
■ 29. In § 524.1044g, remove the second
occurrence of paragraph (b)(3); and
revise the section heading to read as
follows:
§ 524.1044g Gentamicin, betamethasone,
and clotrimazole ointment.
*
*
*
*
*
30. In § 524.1044h, revise the section
heading and add paragraph (c)(3) to read
as follows:
■
§ 524.1044h Gentamicin, mometasone, and
clotrimazole otic suspension.
§ 524.981d Fluocinolone and dimethyl
sulfoxide solution.
TKELLEY on DSK3SPTVN1PROD with RULES
*
*
*
*
26. In § 524.1044c, revise the section
heading to read as follows:
*
*
*
*
(c) * * *
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 31. In § 524.1132, revise the section
heading to read as follows:
§ 524.1044c
ointment.
§ 524.1132 Hydrocortisone, miconazole,
and gentamicin otic suspension.
(a) Specifications. Each milliliter of
solution contains 0.01 percent
fluocinolone acetonide and 20 percent
dimethyl sulfoxide.
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount—Instill 1 to 2 milliliters into
each anal sac following expression of
anal sac contents.
(2) Indications for use. For the relief
of impaction commonly present in
*
*
■
■
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§ 524.1044b Gentamicin and
betamethasone otic solution.
*
■
Gentamicin ophthalmic
*
*
*
*
27. In § 524.1044d, revise the section
heading and paragraph (c) to read as
follows:
§ 524.1044d Gentamicin and
betamethasone ointment.
*
*
*
*
*
(c) Conditions of use in dogs—(1)
Amount—(i) Otitis externa. Instill 3 to 8
drops into the ear canal twice daily for
7 days.
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*
*
*
*
*
32. Revise § 524.1200a to read as
follows:
§ 524.1200a
ointment.
Kanamycin ophthalmic
(a) Specifications. Each gram of
ointment contains 3.5 milligrams
kanamycin activity as kanamycin
sulfate.
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
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(c) Conditions of use in dogs—(1)
Amount. Apply a thin film to the
affected eye three or four times daily or
more frequently if deemed advisable.
Treatment should be continued for at
least 48 hours after the eye appears
normal.
(2) Indications for use. For the
treatment of various eye infections
(conjunctivitis, blepharitis,
dacryocystitis, keratitis, and corneal
ulcerations) due to bacteria sensitive to
kanamycin. For prophylaxis in
traumatic conditions, removal of foreign
bodies, and intraocular surgery.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 33. Revise § 524.1200b to read as
follows:
§ 524.1200b
solution.
Kanamycin ophthalmic
(a) Specifications. Each milliliter of
solution contains 10 milligrams
kanamycin activity as kanamycin
sulfate.
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Instill a few drops into the
affected eye every 3 hours or more
frequently if deemed advisable.
Administer as frequently as possible for
the first 48 hours, after which the
frequency of applications may be
decreased. Treatment should be
continued for at least 48 hours after the
eye appears normal.
(2) Indications for use. For the
treatment of various eye infections
(conjunctivitis, blepharitis,
dacryocystitis, keratitis, and corneal
ulcerations) due to bacteria sensitive to
kanamycin. For prophylaxis in
traumatic conditions, removal of foreign
bodies, and intraocular surgery.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 34. Revise § 524.1204 to read as
follows:
TKELLEY on DSK3SPTVN1PROD with RULES
§ 524.1204 Kanamycin, amphomycin, and
hydrocortisone ointment.
(a) Specifications. Each gram of
ointment contains 5 milligrams
kanamycin activity as kanamycin
sulfate, 5 milligrams of amphomycin
activity as the calcium salt, and 10
milligrams of hydrocortisone acetate.
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Apply to the affected areas of
the skin at least twice daily. In severe
or widespread lesions it may be
desirable to apply the ointment more
than twice daily. After some
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improvement is observed, treatment can
usually be reduced to once daily.
(2) Indications for use. For the
treatment of acute otitis externa,
furunculosis, folliculitis, pruritus, anal
gland infections, erythema, decubital
ulcers, superficial wounds, and
superficial abscesses associated with
bacterial infections caused by organisms
susceptible to one or both antibiotics.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 35. In § 524.1240, revise paragraph (b)
to read as follows:
§ 524.1240
Levamisole.
*
*
*
*
*
(b) Sponsors. See Nos. 000061 and
054771 in § 510.600(c) of this chapter.
*
*
*
*
*
■ 36. In § 524.1446, revise the section
heading to read as follows:
§ 524.1446
Milbemycin otic solution.
*
*
*
§ 524.1465
*
*
[Amended]
37. In paragraph (b) of § 524.1465,
remove ‘‘000069, 025463, 026637, and
051672’’ and in its place add ‘‘025463,
026637, 051672, and 054771’’.
■ 38. In § 524.1484, revise the section
heading to read as follows:
■
§ 524.1484 Neomycin ophthalmic and
topical dosage forms.
*
*
*
*
*
39. In § 524.1484b, revise the section
heading and paragraphs (b) and (c) to
read as follows:
■
§ 524.1484b Neomycin, isoflupredone,
tetracaine, and myristyl-gamma-picolinium
powder.
*
*
*
*
*
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
(c) Conditions of use in horses, dogs,
and cats—(1) Amount. Apply to affected
areas as a dusting powder.
(2) Indications for use. For the
treatment or as adjunctive therapy of
certain ear and skin conditions caused
by or associated with neomycinsusceptible organisms and/or allergy; as
a superficial dressing applied to minor
cuts, wounds, lacerations, abrasions,
and for postsurgical application where
reduction of pain and inflammatory
response is deemed desirable; as a
dusting powder following amputation of
tails, claws, and dewclaws and
following ear trimming, castrating, and
such surgical procedures as
ovariohysterectomies. For the treatment
of acute otitis externa, acute moist
dermatitis, and interdigital dermatitis in
dogs.
PO 00000
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Fmt 4700
Sfmt 4700
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
40. In § 524.1484c, revise the section
heading and paragraphs (b) and (c) to
read as follows:
■
§ 524.1484c Neomycin, isoflupredone, and
tetracaine ointment.
*
*
*
*
*
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. In treatment of otitis externa
and other inflammatory conditions of
the external ear canal, a quantity of
ointment sufficient to fill the external
ear canal; may be applied one to three
times daily. When used on the skin or
mucous membranes, the affected area
should be cleansed, and a small amount
of the ointment applied and spread or
rubbed in gently. The involved area may
be treated one to three times a day and
these daily applications continued in
accordance with the clinical response.
(2) Indications for use. For the
treatment of acute otitis externa in dogs
and to a lesser degree, chronic otitis
externa in dogs. It also is effective in
treating anal gland infections and moist
dermatitis in the dog and is a useful
dressing for minor cuts, lacerations,
abrasions, and post-surgical therapy in
the horse, cat, and dog. It may also be
used following amputation of dewclaws,
tails and claws, following ear trimming
and castrating operations.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
41. In § 524.1484d, revise the section
heading and paragraphs (b) and (c) to
read as follows:
■
§ 524.1484d Neomycin, hydrocortisone,
and tetracaine otic ointment.
*
*
*
*
*
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs and
cats—(1) Amount. Instill a quantity of
ointment sufficient to fill the external
ear canal; may be applied one to three
times daily.
(2) Indications for use. For the
treatment of ear canker and other
inflammatory conditions of the external
ear canal, acute otitis externa and, to a
lesser degree, chronic otitis externa.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
42. In § 524.1484e, revise the section
heading and paragraphs (b) and (c) to
read as follows:
■
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§ 524.1484e Neomycin and polymyxin B
ophthalmic solution.
*
*
*
*
*
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Instill 1 to 2 drops per eye
every 6 hours.
(2) Indications for use. For the
treatment of bacterial infections
associated with topical
ophthalmological conditions such as
corneal injuries, superficial keratitis,
conjunctivitis, keratoconjunctivitis, and
blepharitis.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 43. In § 524.1484f, revise the section
heading and paragraphs (b) and (c) to
read as follows:
§ 524.1484f Neomycin, prednisolone, and
tetracaine otic suspension.
*
*
*
*
*
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs and
cats—(1) Amount. Instill 2 to 6 drops in
the external ear canal 2 or 3 times daily.
(2) Indications for use. For the
treatment of acute otitis externa and, to
a lesser degree, chronic otitis externa; as
treatment or adjunctive therapy of
certain ear conditions caused by or
associated with neomycin-susceptible
organisms and/or allergy.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 44. In § 524.1484g, revise the section
heading and paragraph (c) to read as
follows:
§ 524.1484g Neomycin, thiabendazole, and
dexamethasone solution.
TKELLEY on DSK3SPTVN1PROD with RULES
*
*
*
*
*
(c) Conditions of use in dogs and
cats—(1) Amount. In treating
dermatoses affecting areas other than
the ear, the surface of the lesions should
be well moistened (2 to 4 drops per
square inch) twice daily. In treating
otitis externa, instill 5 to 15 drops in the
ear twice daily. Treat for up to 7 days.
(2) Indications for use. As an aid in
the treatment of bacterial, mycotic, and
inflammatory dermatoses and otitis
externa.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 45. In § 524.1484h, revise the section
heading and paragraphs (b) and (c) to
read as follows:
§ 524.1484h Neomycin, penicillin,
polymyxin B, and hydrocortisone
suspension.
*
*
*
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*
*
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(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Rub a small amount into the
affected area 1 to 3 times a day. After
definite improvement, apply once daily
or every other day.
(2) Indications for use. For the
treatment of summer eczema, atopic
dermatitis, interdigital eczema, and
otitis externa caused by bacteria
susceptible to neomycin, penicillin, and
polymyxin B.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 46. In § 524.1484i, revise the section
heading and paragraphs (b) and (c) to
read as follows:
§ 524.1484i
ointment.
Neomycin and hydrocortisone
*
*
*
*
*
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs and
cats—(1) Amount. Apply 3 or 4 times
daily into the conjunctival sac. With
improvement, frequency may be
reduced to 2 or 3 times daily. For
treatment of ear canker and other
inflammatory conditions of the external
ear canal, fill external ear canal 1 to 3
times daily.
(2) Indications for use. For the
treatment of infections, allergic and
traumatic keratitis, conjunctivitis, acute
otitis externa and, to a lesser degree,
chronic otitis externa.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 47. Add § 524.1484j to read as follows:
§ 524.1484j Neomycin and prednisolone
ophthalmic ointment.
(a) Specifications. Each gram of
ointment contains prednisolone sodium
phosphate equivalent to 2.5 milligrams
prednisolone 21-phosphate and 5
milligrams neomycin sulfate equivalent
to 3.5 milligrams neomycin base.
(b) Sponsor. See No. 050604 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs and
cats—(1) Amount. A small quantity of
the ointment should be expressed into
the conjunctival sac 4 times a day (at
intervals of 1 to 8 hours) for a few days
until there is a favorable response, then
the frequency of application may be
reduced to twice daily as long as the
condition remains under control.
Treatment may require from a few days
to several weeks.
(2) Indications for use. For use in
superficial ocular inflammations or
infections limited to the conjunctiva or
the anterior segment of the eye, such as
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10971
those associated with allergic reactions
or gross irritants.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 48. Add § 524.1484k to read as
follows:
§ 524.1484k Prednisolone and neomycin
suspension.
(a) Specifications. Each milliliter of
suspension contains 2.5 milligrams of
prednisolone acetate and 5 milligrams
of neomycin sulfate equivalent to 3.5
milligrams of neomycin base.
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs and
cats—(1) Amount. For beginning
treatment of acute ocular inflammations
place 1 or 2 drops in the conjunctival
sac 3 to 6 times during a 24 hour period.
When improvement occurs, reduce the
dosage to 1 drop 2 to 4 times daily. For
otitis externa, place 2 to 6 drops in the
external ear canal 2 or 3 times daily.
(2) Indications for use. For the
treatment of treating infectious, allergic
and traumatic keratitis and
conjunctivitis, acute otitis externa, and
chronic otitis externa.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 49. In § 524.1580, revise the section
heading to read as follows:
§ 524.1580
forms.
Nitrofurazone topical dosage
*
*
*
§ 524.1580a
■
*
*
[Removed]
50. Remove § 524.1580a.
§ 524.1580b
[Amended]
51. Redesignate § 524.1580b as
§ 524.1580a; and in newly designated
paragraph (b)(1), remove ‘‘000069,’’.
■
§ 524.1580c
[Amended]
52. Redesignate § 524.1580c as
§ 524.1580b; in paragraph (b), remove
‘‘Nos. 000069 and 054628’’ and in its
place add ‘‘No. 054628’’; and in
paragraphs (c)(2) and (c)(3), remove
footnote 1.
■
§ 524.1580d
■
[Removed]
53. Remove § 524.1580d.
§ 524.1580e
[Amended]
54. Redesignate § 524.1580e as
§ 524.1580c; in paragraph (c)(1) and
(c)(2), remove footnote 1; and revise the
section heading to read as follows:
■
§ 524.1580c
ointment.
*
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Nitrofurazone and butacaine
*
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*
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55. In § 524.1600a, revise the section
heading, paragraphs (b) and (c)(3) to
read as follows:
■
§ 524.1600a Nystatin, neomycin,
thiostrepton, and triamcinolone ointment.
*
*
*
*
*
(b) Sponsors. For petrolatum base
ointments see Nos. 000856, 025463,
054771, and 054925 in § 510.600(c) of
this chapter. For vanishing cream base
ointments see Nos. 025463, 054771, and
054925.
(c) * * *
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 56. In § 524.1600b, revise the section
heading, and paragraph (c) to read as
follows:
§ 524.1600a Nystatin, neomycin,
thiostrepton, and triamcinolone ophthalmic
ointment.
*
*
*
*
(c) Conditions of use—(1) Dogs and
cats—(i) Amount. Apply 1 drop of
ointment to the affected eye(s) 2 or 3
times daily. Treatment may be
continued for up to 2 weeks if
necessary.
(ii) Indications for use. For use as an
anti-inflammatory, antipruritic,
antifungal (Candida albicans), and
antibacterial ointment for local therapy
in keratitis and conjunctivitis.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
(2) Cattle—(i) Amount. Apply small
line of ointment to the affected eye(s)
once daily. Treatment may be continued
for up to 2 weeks if necessary.
(ii) Indications for use. For infectious
kerato-conjunctivitis (pinkeye).
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 57. In § 524.1662, revise the section
heading to read as follows:
TKELLEY on DSK3SPTVN1PROD with RULES
*
Only sufficient spray to coat the skin
thinly is necessary. The application of
small amounts at frequent intervals will
give best results. Before treating animals
with long or matted hair, it may be
necessary to clip the affected area or
spread the hairs to allow the medication
to contact the skin surface. Relief may
be noted following the first or second
treatment; however, treatment should
not be discontinued too soon after the
initial favorable response has been
obtained.
(2) Indications for use. For the relief
of discomfort and continued treatment
of many allergic, infectious, and
traumatic skin conditions; for the
prevention of bacterial infections in
superficial wounds, cuts, and abrasions,
treatment of allergic dermatoses,
including urticaria, eczemas, insect
bites, and cutaneous drug reactions,
infections associated with minor burns
and wounds, and nonspecific pruritus.
(3) Limitations. Keep away from eyes
or other mucous membranes; avoid
inhaling; use with adequate ventilation;
in case of deep or puncture wounds or
serious burns, consult a veterinarian.
■ 59. In § 524.1662b, in paragraph (b),
remove ‘‘000069’’ and in its place add
‘‘054771’’; and revise the section
heading and paragraph (c) to read as
follows:
§ 524.1662b Oxytetracycline and
polymyxin B ophthalmic ointment.
*
*
*
*
(c) Conditions of use in dogs and
cats—(1) Amount. Administer topically
to the eye two to four times daily.
(2) Indications for use. For the
prophylaxis and local treatment of
superficial ocular infections due to
oxytetracycline- and polymyxinsensitive organisms including ocular
infections due to streptococci,
rickettsiae, E. coli, and A. aerogenes
(such as conjunctivitis, keratitis,
pinkeye, corneal ulcer, and blepharitis
in dogs, cats, cattle, sheep, and horses);
§ 524.1662 Oxytetracycline ophthalmic and ocular infections due to secondary
topical dosage forms.
bacterial complications associated with
*
*
*
*
*
distemper in dogs; and ocular infections
due to bacterial inflammatory
■ 58. In § 524.1662a, in paragraph (b),
conditions which may occur secondary
remove ‘‘000069’’ and in its place add
to other infectious diseases in dogs, cats,
‘‘054771’’; and revise the section
cattle, sheep, and horses.
heading and paragraph (c) to read as
(3) Limitations. Allergic reactions may
follows:
occasionally occur. Treatment should be
§ 524.1662a Oxytetracycline and
discontinued if reactions are severe. If
hydrocortisone spray.
new infections due to nonsensitive
*
*
*
*
*
bacteria or fungi appear during therapy,
(c) Conditions of use in dogs and
appropriate measures should be taken.
cats—(1) Amount. A small quantity
§§ 524.1881, 524.1881a, and 524.1881b
should be sprayed on the affected
[Removed]
surface by holding the container about
6 inches from the area to be treated and
■ 60. Remove §§ 524.1881, 524.1881a,
pressing the nozzle for 1 or 2 seconds.
and 524.1881b.
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§ 524.1883
[Removed]
61. Remove § 524.1883.
■ 62. In § 524.1982, in paragraph (b),
remove ‘‘053501’’ and in its place add
‘‘054771’’; and revise the section
heading and paragraph (c) to read as
follows:
■
§ 524.1982
solution.
Proparacaine ophthalmic
*
*
*
*
*
(c) Conditions of use in dogs and
cats—(1) Amount. It is administered as
follows:
(i) For removal of sutures: Instill one
to two drops 2 or 3 minutes before
removal of stitches.
(ii) For removal of foreign bodies from
eye, ear, and nose: For ophthalmic use,
instill three to five drops in the eye
prior to examination; for otic use, instill
five to ten drops in the ear; for nasal use,
instill five to ten drops in each nostril
every 3 minutes for three doses.
(iii) For tonometry: Instill one to two
drops immediately before measurement.
(iv) As an aid in treatment of otitis:
Instill two drops into the ear every 5
minutes for three doses.
(v) For minor surgery: Instill one or
more drops as required.
(vi) For catheterization: Instill two to
three drops with a blunt 20-gauge
needle immediately before inserting
catheter.
(2) Indications for use. For use as a
topical ophthalmic anesthetic. It is used
as an anesthetic in cauterization of
corneal ulcers, removal of foreign bodies
and sutures from the cornea, and
measurement of intraocular pressure
(tonometry) when glaucoma is
suspected; as an aid in the removal of
foreign bodies from the nose and ear
canal; as an accessory in the
examination and treatment of painful
otitis, in minor surgery, and prior to
catheterization.
(3) Limitations. Keep away from eyes
or other mucous membranes; avoid
inhaling; use with adequate ventilation;
in case of deep or puncture wounds or
serious burns, consult a veterinarian.
§ 524.2098
[Amended]
63. In paragraph (b) of § 524.2098,
remove ‘‘000069’’ and in its place add
‘‘No. 054771’’.
■ 64. Revise § 524.2350 to read as
follows:
■
§ 524.2350
Tolnaftate cream.
(a) Specifications. The drug contains
1 percent tolnaftate in an anhydrous
cream base.
(b) Sponsor. See No. 000061 in
§ 510.600(c) of this chapter.
(c) Conditions of use—(1) Amount.
Apply a small amount of the cream to
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the affected areas once or twice a day for
2 to 4 weeks.
(2) Indications for use. For the
treatment of ringworm lesions due to
Microsporum canis and Microsporum
gypseum.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 65. Revise § 524.2620 to read as
follows:
§ 524.2620 Liquid crystalline trypsin, Peru
balsam, castor oil.
(a) Specifications—(1) Each gram of
liquid or aerosol contains 0.12
milligram of crystalline trypsin, 87.0
milligrams of Peru balsam, and 788.0
milligrams of castor oil.
(2) Each gram of liquid or aerosol
contains 0.1 milligram of crystalline
trypsin, 72.5 milligrams of Peru balsam,
and 800 milligrams of castor oil.
(b) Sponsors. See sponsor numbers in
§ 510.600(c) of this chapter for use as in
paragraph (c) in this section:
(1) No. 051079 for use of product
described in paragraph (a)(1).
(2) No. 017135 for use of product
described in paragraph (a)(2).
(c) Conditions of use—(1) Amount.
Apply directly to the wound site.
(2) Indications for use. As an aid in
the treatment of external wounds and
assists healing by facilitating the
removal of necrotic tissue, exudate, and
organic debris.
PART 526—INTRAMAMMARY DOSAGE
FORM NEW ANIMAL DRUGS
[Amended]
67. In paragraph (b) of § 526.313,
remove ‘‘000009’’ and in its place add
‘‘054771’’.
■
68. In § 526.464a, remove paragraph
(d).
■
■
[Removed]
69. Remove § 526.464d.
§ 526.820
[Amended]
70. In paragraph (b) of § 526.820,
remove ‘‘No. 061623’’ and in its place
add ‘‘Nos. 054771 and 061623’’.
■ 71. In § 526.1130, revise the section
heading to read as set forth below:
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■
§ 529.1130
Hetacillin infusion.
*
*
*
*
*
■ 72. In § 526.1590, in paragraphs (a)(2)
and (b)(2), remove ‘‘000009’’ and in its
place add ‘‘054771’’; and revise the
section heading to read as follows:
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§ 526.1696d
*
*
[Amended]
73. In paragraph (b) of § 526.1696d,
remove ‘‘000009’’ and in its place add
‘‘054771’’.
■
81. In § 529.1044a, revise the section
heading and paragraph (b) to read as
follows:
■
§ 529.1044a
infusion.
Gentamicin solution for
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
*
*
*
*
(b) Sponsors. See Nos. 000061,
000859, 054628, 054771, 057561,
058005, and 061623 in § 510.600(c) of
this chapter.
*
*
*
*
*
■ 82. In § 529.1044b, revise the section
heading and paragraph (c) to read as
follows:
75. The authority citation for 21 CFR
part 529 continues to read as follows:
§ 529.1044b Gentamicin solution for
dipping eggs.
§ 526.1810
[Amended]
74. In paragraph (b) of § 526.1810,
remove ‘‘000009’’ and in its place add
‘‘054771’’.
■
■
Authority: 21 U.S.C. 360b.
76. In § 529.40, remove paragraph (c);
redesignate paragraph (d) as paragraph
(c); and revise newly redesignated
paragraph (c)(3) to read as follows:
■
§ 529.40
Albuterol.
*
*
*
*
*
(c) * * *
(3) Not for use in horses intended for
food. Federal law restricts this drug to
use by or on the order of a licensed
veterinarian.
§ 529.56
[Amended]
77. In paragraph (b) of § 529.56,
remove ‘‘000856 and 000859’’ and in its
place add ‘‘000859 and 054771’’.
■
§ 529.400
§ 529.778
[Amended]
§ 526.464d
*
*
[Amended]
78. In § 529.400, revise the section
heading; in paragraph (b), remove
‘‘000856’’ and in its place add
‘‘054771’’; and in paragraphs (c)(1),
(c)(2), and (c)(3), remove the footnote.
■ 79. Add § 529.778 to read as follows:
Authority: 21 U.S.C. 360b.
§ 526.464a
Novobiocin infusion.
*
■
66. The authority citation for 21 CFR
part 526 continues to read as follows:
■
§ 526.313
§ 526.1590
10973
Doxycycline.
(a) Specifications. Doxycycline
hyclate solution contains 8.5 percent
doxycycline activity. A syringe of Nmethyl-2-pyrrolidone and poly (DLlactide) mixed with a syringe of
doxycycline produces 0.5 milliliter of
solution.
(b) Sponsor. See 054771 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Apply subgingivally to
periodontal pocket(s) of affected teeth.
(2) Indications for use. For treatment
and control of periodontal disease.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
§ 529.1044
80. In § 529.1044, remove the word
‘‘sulfate’’ in the section heading.
Frm 00023
Fmt 4700
*
*
*
*
*
(c) Conditions of use in turkeys—(1)
Amount. The drug is added to clean
water to provide a dip solution with a
gentamicin concentration of 250 to
1,000 parts per million. A concentration
of 500 parts per million is
recommended. Clean eggs should be
held submerged in the gentamicin
solution under a vacuum of about 27.5
to 38 centimeters of mercury for 5
minutes followed by additional soaking
in gentamicin solution for
approximately 10 minutes at
atmospheric pressure. Eggs can also be
treated by warming them for 3 to 6
hours at approximately 100 °F then
immediately submerging them in
gentamicin solution maintained at about
40 °F, keeping the eggs submerged for
10 to 15 minutes.
(2) Indications for use. As an aid in
the reduction or elimination of the
following microorganisms from turkeyhatching eggs: Arizona hinshawii
(paracolon), Salmonella Saintpaul, and
Mycoplasma meleagridis.
(3) Limitations. For use in the dipping
treatment of turkey-hatching eggs only.
Eggs which have been dipped in the
drug shall not be used for food.
■ 83. In § 529.1115, remove the footnote
in paragraphs (c)(1), (c)(2), and (c)(3);
and revise paragraphs (b) and (c)(3) to
read as follows:
§ 529.1115
Halothane.
*
*
*
*
*
(b) Sponsor. See Nos. 012164 and
054771 in § 510.600(c) of this chapter.
(c) * * *
(3) Limitations. Not for use in animals
intended for food. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
§ 529.1660
[Amended]
84. In § 529.1660, in paragraph (b)(1),
remove ‘‘046573’’ and in its place add
‘‘054771’’; and in paragraph (b)(2),
remove ‘‘000069, 048164, and 059130’’
■
[Amended]
■
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Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Rules and Regulations
and in its place add ‘‘048164, 054771,
and 061623’’.
§ 529.1940
[Amended]
85. In paragraph (b) of § 529.1940,
remove ‘‘000009’’ and in its place add
‘‘054771’’.
■ 86. Revise § 529.2464 to read as
follows:
■
§ 529.2464
Ticarcillin.
(a) Specifications. Each vial contains
ticarcillin disodium powder equivalent
to 6 grams of ticarcillin for
reconstitution with 25 milliliters of
sterile water for injection or sterile
physiological saline.
(b) Sponsor. See No. 054771 in
§ 510.600(c) of this chapter.
(c) Conditions of use in horses—(1)
Amount. Administer 6 grams daily by
intrauterine infusion for 3 consecutive
days during estrus.
(2) Indications for use. For the
treatment of endometritis caused by
beta-hemolytic streptococci.
(3) Limitations. Do not use in horses
intended for human consumption.
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
■ 87. Revise § 529.2503 to read as
follows:
§ 529.2503
Tricaine methanesulfonate.
(a) Specifications. The drug is ethylm-amino-benzoate methanesulfonate.
(b) Sponsor. See Nos. 050378 and
051212 in § 510.600(c) of this chapter.
(c) Conditions of use—(1) Amount. It
is used as follows:
(i) Fish. The drug is added to ambient
water at a concentration of from 15 to
330 milligrams per liter depending upon
the degree of anesthetization or sedation
desired, the species and size of the fish,
and the temperature and softness of the
water. Preliminary tests of solutions
must be made with small numbers of
fish to determine the desired rates of
sedation or anesthesia and the
appropriate exposure times for the
specific lots of fish under prevailing
conditions.
(ii) Amphibians and other aquatic
coldblooded animals. The drug is added
to ambient water in concentrations of
from 1:1000 to 1:20,000 depending upon
species and stage of development.
(2) Indications for use. For the
temporary immobilization of fish,
amphibians, and other aquatic
coldblooded animals (poikilotherms) as
an aid in handling during manual
spawning (fish stripping), weighing,
measuring, marking, surgical operations,
transport, photography, and research.
(3) Limitations. Do not use within 21
days of harvesting fish for food. Use in
fish intended for food should be
restricted to Ictaluridae, Salmonidae,
Esocidae, and Percidae, and water
temperature exceeding 10 °C (50 °F). In
other fish and in coldblooded animals,
the drug should be limited to hatchery
or laboratory use.
Dated: January 27, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014–01958 Filed 2–26–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 556 and 558
[Docket No. FDA–2014–N–0002]
Zoetis Inc., et al.; Withdrawal of
Approval of New Animal Drug
Applications for Combination Drug
Medicated Feeds Containing an
Arsenical Drug
AGENCY:
Food and Drug Administration,
HHS.
Notification of withdrawal of
approval.
ACTION:
The Food and Drug
Administration (FDA) is amending the
SUMMARY:
TKELLEY on DSK3SPTVN1PROD with RULES
NADA/ANADA
040–435
041–178
041–984
091–326
092–522
095–546
102–485
105–758
112–661
112–687
116–082
116–088
123–154
126–052
131–894
132–447
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
VerDate Mar<15>2010
animal drug regulations to reflect the
withdrawal approval of 69 new animal
drug applications (NADAs) and 22
abbreviated new animal drug
applications (ANADAs) for use of
arsanilic acid, carbarsone, or roxarsone
Type A medicated articles to
manufacture combination drug Type B
and Type C medicated feeds. This
action is being taken at the sponsor’s
request because the products are no
longer manufactured or marketed.
Withdrawal of approval is
effective March 10, 2014.
DATES:
John
Bartkowiak, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9079,
john.bartkowiak@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Recently,
the Agency provided notice of the
withdrawal of approval of NADAs for
Type A medicated articles containing
arsanilic acid, carbarsone, and
roxarsone and revoked applicable
regulations for their conditions of use to
manufacture single-ingredient
medicated feeds in 21 CFR part 558 New
Animal Drugs For Use in Animal Feeds
(78 FR 70062, November 22, 2013; 78
FR 69992, November 22, 2013; 78 FR
70566, November 26, 2013; 78 FR
70496, November 26, 2013).
Subsequently, the following six
sponsors of NADAs and ANADAs
permitting use of arsanilic acid,
carbarsone, or roxarsone Type A
medicated articles to manufacture
combination drug Type B and Type C
medicated feeds requested that FDA
withdraw approval of their applications
because these combination medicated
feeds are no longer manufactured or
marketed.
• Zoetis Inc., 333 Portage St.,
Kalamazoo, MI 49007 has requested that
FDA withdraw approval of the
following 39 NADAs and 11 ANADAs:
SUPPLEMENTARY INFORMATION:
Ingredient new animal drugs
3–NITRO (roxarsone)/DECCOX (decoquinate).
Roxarsone/AMPROL Plus (amprolium and ethopabate)/LINCOMIX (lincomycin).
Roxarsone/ROFENAID (sulfadimethoxine/ormetoprim).
3–NITRO (roxarsone)/DECCOX (decoquinate)/ALBAC (bacitracin zinc).
Roxarsone/COBAN (monensin)/LINCOMIX (lincomycin).
Roxarsone/ROBENZ (robenidine).
3–NITRO (roxarsone)/AVATEC (lasalocid).
3–NITRO (roxarsone)/AMPROL HI–E (amprolium and ethopabate)/BACIFERM (bacitracin zinc).
3–NITRO (roxarsone)/AVATEC (lasalocid)/LINCOMIX (lincomycin).
3–NITRO (roxarsone)/AVATEC (lasalocid)/FLAVOMYCIN (bambermycins).
3–NITRO (roxarsone)/AVATEC (lasalocid)/BMD (bacitracin MD).
3–NITRO (roxarsone)/COBAN (monensin)/BMD (bacitracin MD).
3–NITRO (roxarsone)/BACIFERM (bacitracin zinc)/COBAN (monensin).
3–NITRO (roxarsone)/AVATEC (lasalocid)/BACIFERM (bacitracin zinc).
3–NITRO (roxarsone)/AVATEC (lasalocid)/bacitracin MD.
Roxarsone/BIO–COX (salinomycin).
16:18 Feb 26, 2014
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]]>Agencies
[Federal Register Volume 79, Number 39 (Thursday, February 27, 2014)]
[Rules and Regulations]
[Pages 10965-10974]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01958]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 524, 526, and 529
[Docket No. FDA-2014-N-0002]
New Animal Drugs; Change of Sponsor
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor for 54 approved new
animal drug applications (NADAs) and 1 approved abbreviated new animal
drug application (ANADA) for topical, intramammary, and certain other
dosage form new animal drug products from Pfizer, Inc., including its
several subsidiaries and divisions, to Zoetis, Inc.
DATES: This rule is effective February 27, 2014.
FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520
Standish Pl.,
[[Page 10966]]
Rockville, MD 20855; 240-276-8300, steven.vaughn@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 E. 42d St., New York, NY
10017, and its wholly owned subsidiaries Alpharma, LLC; Fort Dodge
Animal Health, Division of Wyeth; Fort Dodge Animal Health, Division of
Wyeth Holdings Corp.; and its division, Pharmacia & Upjohn Co., have
informed FDA that they have transferred ownership of, and all rights
and interest in, the 54 approved NADAs and 1 approved ANADA in table 1
to Zoetis, Inc., 333 Portage St., Kalamazoo, MI 49007.
Table 1--NADAs and ANADA Transferred From Pfizer, Inc., to Zoetis, Inc.
------------------------------------------------------------------------
File No. Product name
------------------------------------------------------------------------
008-763.................. TERRAMYCIN (oxytetracycline hydrochloride)
Ophthalmic Ointment with Polymyxin.
009-035.................. OPHTHAINE (proparacaine hydrochloride)
Solution.
009-782.................. NOLVASAN (chlorhexidine acetate) Antiseptic
Ointment.
009-809.................. NOLVASAN CAP-TABS (chlorhexidine acetate)
Tablets.
010-434.................. NOLVASAN (chlorhexidine acetate) Suspension.
010-524.................. NEO-CORTEF with Tetracaine (neomycin sulfate,
hydrocortisone acetate, tetracaine
hydrochloride) Ointment.
011-703.................. NEO-DELTA CORTEF with Tetracaine (neomycin
sulfate, prednisolone acetate, tetracaine
hydrochloride) Ointment.
012-258.................. PANOLOG (triamcinolone acetonide, nystatin,
thiostrepton, neomycin sulfate) Ointment.
012-991.................. KOPERTOX (copper naphthenate) Topical.
013-293.................. TERRA-CORTRIL (oxytetracycline hydrochloride
and hydrocortisone) Topical Spray.
014-170.................. FLUOTHANE (halothane, USP).
015-433.................. NEO-PREDEF with Tetracaine (neomycin sulfate,
isoflupredone acetate, tetracaine
hydrochloride, and myristyl-gammapicolinium
chloride) Ointment.
030-025.................. NEO-PREDEF with Tetracaine (neomycin sulfate,
isoflupredone acetate, tetracaine
hydrochloride) Topical Ointment.
032-168.................. DOMOSO (dimethyl sulfoxide) Solution.
032-319.................. TOPAZONE (furazolidone) Aerosol Powder.
034-872.................. NEO PREDEF (neomycin sulfate and
isoflupredone acetate) Ointment.
037-586.................. ERYTHROMAST 36 (erythromycin) Intramammary
Infusion.
038-801.................. ANAPRIME (flumethasone, polymyxin B sulfate,
and neomycin sulfate) Ophthalmic Solution.
042-661.................. KANTRIM (kanamycin sulfate) Ophthalmic
Ointment.
042-883.................. KANTRIM (kanamycin sulfate) Ophthalmic
Solution.
043-784.................. KANFOSONE (kanamycin sulfate, calcium
amphomycin, and hydrocortisone acetate)
Ointment.
045-512.................. SYNOTIC(fluocinolone acetonide and dimethyl
sulfoxide) Otic Solution.
047-334.................. SYNSAC (fluocinolone acetonide and dimethyl
sulfoxide) Topical Solution.
047-925.................. DOMOSO (dimethyl sulfoxide) Gel.
047-997.................. AMPHODERM (kanamycin sulfate, calcium
amphomycin, and hydrocortisone acetate)
Ointment.
049-725.................. ANAPRIME Opthakote (flumethasone, polymyxin B
sulfate, and neomycin sulfate) Ophthalmic.
049-726.................. OPTIPRIME OPTHAKOTE (neomycin sulfate and
polymixin B sulfate) Ophthalmic Solution.
055-072.................. ALBACILLIN (procaine penicillin G/novobiocin)
Suspension for Intramammary Infusion.
055-095.................. TICILLIN (ticarcillin disodium) Powder for
Intrauterine Infusion.
055-098.................. ALBADRY Plus (procaine penicillin G and
novobiocin sodium) Suspension for
Intramammary Infusion.
065-114.................. MYCITRACIN (bacitracin zinc, neomycin
sulfate, and polymyxin B sulfate) Ophthalmic
Ointment.
065-119.................. FORTE (neomycin sulfate, penicillin,
polymyxin B, hydrocortisone) Topical
Ointment.
065-122.................. TETRACYN (tetracycline hydrochloride)
Ointment.
065-149.................. CHLOROMYCETIN (chloramphenicol) Ophthalmic
Ointment.
091-534.................. NEO-DELTA CORTEF (prednisolone acetate and
neomycin sulfate) Solution.
093-514.................. NEO-CORTEF (neomycin sulfate and
hydrocortisone acetate) Ointment.
096-676.................. PANOLOG (triamcinolone acetonide, nystatin,
thiostrepton, neomycin sulfate) Cream.
100-808.................. ALBAMAST (novobiocin sodium) Suspension for
Intramammary Infusion.
102-511.................. BIODRY (novobiocin sodium) Suspension for
Intramammary Infusion.
120-299.................. MITABAN (amitraz) Liquid Concentrate.
127-892.................. AMIGLYDE-V (amikacin sulfate) Intrauterine
Infusion.
130-435.................. OXYMARINE (oxytetracycline hydrochloride)
Fish Marker.
140-839.................. BACTODERM (mupirocin) Ointment.
140-844.................. TRAMISOL (levamisole) Pour-On Topical
Solution.
140-879.................. DERMA 4 (nystatin, neomycin sulfate,
thiostrepton, and triamcinolone acetonide)
Ointment.
141-003.................. DERM-OTIC (nystatin, neomycin, thiostrepton,
and triamcinolone acetonide) Ointment.
141-036.................. PIRSUE (pirlimycin hydrochloride)
Intramammary Infusion.
141-082.................. DOXIROBE (doxycycline hyclate) Gel.
141-095.................. DECTOMAX (doramectin) Pour-on Solution.
141-152.................. REVOLUTION (selamectin) Topical Solution.
141-200.................. EAZI-Breed CIDR (progesterone) Cattle Insert.
141-238.................. SPECTRAMAST LC (ceftiofur hydrochloride)
Sterile Suspension for Intramammary
Infusion.
141-239.................. SPECTRAMAST DC (ceftiofur hydrochloride)
Sterile Suspension for Intramammary
Infusion.
141-302.................. EAZI-BREED CIDR (progesterone) Sheep Insert.
200-102.................. GENTAGLYDE (gentamicin sulfate) Solution.
------------------------------------------------------------------------
Accordingly, the Agency is amending the regulations in 21 CFR parts
524, 526, and 529 to reflect these transfers of ownership. In addition,
the regulations are being amended to make minor corrections and to
reflect a current format. This is being done to increase the accuracy
and readability of the regulations.
In addition, FDA has noticed that certain sections of part 526
contain entries describing conditions of use for new animal drug
products for which no NADA is approved. These errors were
[[Page 10967]]
introduced by the Agency during the 1992 recodification of the
regulations for certifiable antibiotics (57 FR 37318, August 18, 1992).
That rule did not identify whether particular regulations were the
subject of an approved NADA and consequently resulted in codification
of certain conditions of use for which there is no approved NADA. At
this time, the Agency is amending the regulations to remove these
entries. This action is being taken to improve the accuracy of the
regulations.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects in 21 CFR Parts 524, 526, and 529
Animal drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 524,
526, and 529 are amended as follows:
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. In Sec. 524.86, revise the section heading, and paragraphs (b) and
(c)(3) to read as follows:
Sec. 524.86 Amitraz.
* * * * *
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) * * *
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
3. In Sec. 524.154, revise the section heading, redesignate paragraphs
(a) and (b) as paragraphs (b) and (c); add new paragraph (a); and
revise paragraph (b), and the introductory text in paragraph (c) to
read as follows:
Sec. 524.154 Bacitracin, neomycin, and polymyxin B ophthalmic
ointment.
(a) Specifications. Each gram of ointment contains:
(1) 500 units of bacitracin, 3.5 milligrams of neomycin, and 10,000
units of polymyxin B sulfate; or
(2) 400 units of bacitracin zinc, 3.5 milligrams of neomycin, and
10,000 units of polymyxin B sulfate.
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this
chapter as follows:
(1) No. 054771 for use of product described in paragraph (a)(1) as
in paragraph (c) of this section.
(2) Nos. 000061 and 043264 for use of product described in
paragraph (a)(2) as in paragraph (c) of this section.
(c) Conditions of use in dogs and cats.* * *
* * * * *
0
4. In Sec. 524.155, revise the section heading, redesignate paragraphs
(a) and (b) as paragraphs (b) and (c); add new paragraph (a); and
revise paragraph (b), and the introductory text in paragraph (c) to
read as follows:
Sec. 524.155 Bacitracin, neomycin, polymyxin B, and hydrocortisone
ophthalmic ointment.
(a) Specifications. Each gram of ointment contains 400 units of
bacitracin zinc, 5 milligrams (mg) of neomycin sulfate (equivalent to
3.5 mg of neomycin sulfate), 10,000 units of polymyxin B sulfate, and10
mg of hydrocortisone.
(b) Sponsors. See Nos. 000061 and 043264 in Sec. 510.600(c) of
this chapter.
(c) Conditions of use in dogs and cats.* * *
* * * * *
Sec. 524.390 [Amended]
0
5. In Sec. 524.390, revise paragraphs (b) and (c)(3) to read as
follows:
Sec. 524.390 Chloramphenicol ophthalmic ointment.
* * * * *
(b) Sponsors. See Nos. 043264 and 054771 in Sec. 510.600(c) of
this chapter.
(c) * * *
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian. Federal law prohibits the use of
this drug in food-producing animals.
Sec. 524.402 [Amended]
0
6. In paragraph (b) of Sec. 524.402, remove ``000856'' and in its
place add ``054771''.
0
7. In Sec. 524.450, revise the section heading, and paragraphs (b) and
(c)(3) to read as follows:
Sec. 524.450 Clotrimazole.
* * * * *
(b) Sponsors. See No. 000859 in Sec. 510.600(c) of this chapter.
(c) * * *
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 524.463 [Amended]
0
8. In paragraph (b) of Sec. 524.463, remove ``000856, 017135, and
058829'' and in its place add ``017135, 054771, and 058829''.
0
9. In Sec. 524.575, revise paragraphs (c)(1) and (c)(3) to read as
follows:
Sec. 524.575 Cyclosporine ophthalmic ointment.
* * * * *
(c) * * *
(1) Amount. Apply a \1/4\-inch strip of ointment directly on the
cornea or into the conjunctival sac of the affected eye(s) every 12
hours.
* * * * *
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
10. Revise Sec. 524.660 to read as follows:
Sec. 524.660 Dimethyl sulfoxide.
(a) Specifications--(1) Each milliliter (mL) of solution contains
90 percent dimethyl sulfoxide and 10 percent water.
(2) Each milliliter (mL) of gel product contains 90 percent
dimethyl sulfoxide.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in horses and dogs--(1) Amount--(i) Horses.
Apply topically two to three times daily in an amount not to exceed 100
mL per day. Total duration of therapy should not exceed 30 days.
(ii) Dogs. Apply topically three to four times daily in an amount
not to exceed 20 mL per day. Total duration of therapy should not
exceed 14 days.
(2) Indications for use. To reduce acute swelling due to trauma.
(3) Limitations. Do not use in horses intended for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
Sec. Sec. 524.660a and 524.660b [Removed]
0
11. Remove Sec. Sec. 524.660a and 524.660b.
0
12. In Sec. 524.770, in paragraph (b), remove ``000069'' and in its
place add ``054771''; and revise paragraph (e)(3) to read as follows:
Sec. 524.770 Doramectin.
* * * * *
(e) * * *
(3) Limitations. Do not slaughter cattle within 45 days of latest
treatment. This product is not approved for use in female dairy cattle
20 months of age or older, including dry dairy cows. Use in these
cattle may cause drug residues in milk and/or in calves born to these
cows. A withdrawal period has not been established for this product in
preruminating calves. Do not use in calves to be processed for veal.
0
13. In Sec. 524.802, revise the section heading and paragraph (c)(3)
to read as follows:
[[Page 10968]]
Sec. 524.802 Enrofloxacin and silver sulfadiazine otic emulsion.
* * * * *
(c) * * *
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian. Federal law prohibits the
extralabel use of this drug in food-producing animals.
0
14. In Sec. 524.900, remove paragraph (a); redesignate paragraphs (b)
through (f) as paragraphs (a) through (e); and revise newly
redesignated (e) to read as follows:
Sec. 524.900 Famphur.
* * * * *
(e) Conditions of use--(1) Amount. Apply 1 ounce per 200 pounds
body weight, not to exceed a total dosage of 4 ounces, from the
shoulder to the tail head as a single treatment. Apply as soon as
possible after heel fly activity ceases.
(2) Indications for use in beef and nonlactating dairy cattle. For
control of cattle grubs and to reduce cattle lice infestations.
(3) Limitations. Do not slaughter within 35 days after treatment.
Do not use on lactating dairy cows or dry dairy cows within 21 days of
freshening, calves less than 3 months old, animals stressed from
castration, overexcitement or dehorning, sick or convalescent animals.
Animals may become dehydrated and under stress following shipment. Do
not treat until they are in good condition. Brahman and Brahman
crossbreeds are less tolerant of cholinesterase-inhibiting insecticides
than other breeds. Do not treat Brahman bulls. Swine should be
eliminated from area where runoff occurs.
0
15. Revise Sec. 524.920, to read as follows:
Sec. 524.920 Fenthion.
(a) Specifications. (1) The drug is a liquid containing:
(i) 3 percent of fenthion; or
(ii) 20 percent fenthion.
(2) The drug is a solution containing either 5.6 or 13.8 percent
fenthion. Each concentration is available in 2 volumes which are
contained in single-dose applicators.
(b) Sponsor. See sponsors in Sec. 510.600(c) of this chapter:
(1) No. 000859 for use of product described in paragraph (a)(1)(i)
as in paragraph (d)(1) of this section.
(2) No. 000859 for use of product described in paragraph (a)(1)(ii)
as in paragraph (d)(2) of this section.
(3) No. 000859 for use of products described in paragraph (a)(2) as
in paragraph (d)(3) of this section.
(c) Related tolerances. See 40 CFR 180.214.
(d) Conditions of use--(1) Beef cattle and nonlactating dairy
cattle--(i) Amount. It is used at the rate of one-half fluid ounce per
100 pounds of body weight applied topically on the backline of the
animal. Only one application per season should be made for grub control
and this will also provide initial control of lice. A second
application for lice control may be made if animals become reinfested,
but no sooner than 35 days after the first treatment. Proper timing of
treatment is important for grub control; cattle should be treated as
soon as possible after heel-fly activity ceases.
(ii) Indications for use. For the control of grubs and lice in beef
and nonlactating cattle.
(iii) Limitations. Do not use on animals simultaneously or within a
few days before or after treatment with or exposure to cholinesterase-
inhibiting drugs, pesticides, or chemicals. Cattle should not be
slaughtered within 35 days following a single treatment. If a second
application is made for lice control, cattle should not be slaughtered
within 45 days of the second treatment. The drug must not be used
within 28 days of freshening of dairy cattle. If freshening should
occur within 28 days after treatment, do not use milk as human food for
the balance of the 28-day interval. Do not treat lactating dairy
cattle; calves less than 3 months old; or sick, convalescent, or
stressed livestock. Do not treat cattle for 10 days before or after
shipping, weaning, or dehorning or after exposure to contagious
infectious diseases.
(2) Beef cattle and dairy cattle not of breeding age--(i) Amount.
It is administered as a single, topical application placed on the
backline of animals as follows: For animals weighing 150 to 300 pounds,
apply 4 milliliters (mL); for animals weighing 301 to 600 pounds, apply
8 mL; for animals weighing 601 to 900 pounds, apply 12 mL; for animals
weighing 901 to 1,200 pounds, apply 16 mL; and for animal weighing over
1,200 pounds, apply 20 mL. For most effective results, cattle should be
treated as soon as possible after heel-fly activity ceases. A second
application is required for animals heavily infested with lice or for
those which become reinfested. A second application should be made no
sooner than 35 days after the first treatment.
(ii) Indications for use. For control of cattle grubs and as an aid
in controlling lice on beef cattle and on dairy cattle not of breeding
age.
(iii) Limitations. Do not use on animals simultaneously or within a
few days before or after treatment with or exposure to cholinesterase-
inhibiting drugs, pesticides, or chemicals. Host-parasite reactions
such as bloat, salivation, staggering and paralysis may sometimes occur
when cattle are treated while the common cattle grub (Hypoderma
lineatum) is in the gullet, or while the northern cattle grub (H.
bovis) is in the area of the spinal cord. Cattle should be treated
before these stages of grub development. Consult your veterinarian,
extension livestock specialist, or extension entomologist regarding the
timing of treatment. If it is impossible to determine the area from
which the cattle came and/or exact stage of the grubs, it is
recommended that the cattle receive only a maintenance ration of low-
energy feed during the treatment period. This lessens the likelihood of
severe bloat which may occur in cattle on full feed when the common
grub is killed while in the gullet. Do not treat dairy cattle of
breeding age; calves less than 3 months old; sick, convalescent, or
severely stressed livestock. Do not treat cattle for 10 days before or
after shipping, weaning, dehorning, or after exposure to contagious or
infectious diseases. Do not slaughter within 45 days of treatment.
(3) Dogs--(i) Amount. Four to 8 milligrams per kilogram of body
weight. Apply the contents of the proper size, single-dose tube
directly to one spot on the dog's skin.
(ii) Indications for use. For flea control on dogs only.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
16. In Sec. 524.960, in paragraph (b), remove ``000856'' and in its
place add ``054771''; and revise the section heading and paragraph
(c)(3) to read as follows:
Sec. 524.960 Flumethasone, neomycin, and polymyxin B ophthalmic
solution.
* * * * *
(c) * * *
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 524.981 [Removed and Reserved]
0
17. Remove and reserve Sec. 524.981.
0
18. In Sec. 524.981a, revise the section heading, the introductory
text in paragraph (c), and paragraphs (c)(1) and (c)(2) to read as
follows:
Sec. 524.981a Fluocinolone cream.
* * * * *
(c) Conditions of use in dogs--(1) Amount--A small amount is
applied to the affected area two or three times daily.
(2) Indications for use. For the relief of pruritis and
inflammation associated
[[Page 10969]]
with certain superficial acute and chronic dermatoses. It is used in
the treatment of allergic and acute moist dermatitis and for the relief
of superficial inflammation caused by chemical burns and physical
abrasions.
* * * * *
0
19. In Sec. 524.981b, revise the section heading, paragraph (a), the
introductory text in paragraph (c), and paragraphs (c)(1) and (c)(2) to
read as follows:
Sec. 524.981b Fluocinolone solution.
(a) Specifications. The drug contains 0.01 percent fluocinolone
acetonide.
* * * * *
(c) Conditions of use in dogs--(1) Amount--A small amount of
solution is applied to the affected area two or three times daily.
(2) Indications for use--(i) Dogs. For the relief of pruritis and
inflammation associated with otitis externa and certain superficial
acute and chronic dermatoses.
(ii) Cats. For the relief of pruritis and inflammation associated
with acute otitis externa and certain superficial acute and chronic
dermatoses.
* * * * *
0
20. In Sec. 524.981c, revise the section heading, the introductory
text in paragraph (c), and paragraphs (c)(1) and (c)(2) to read as
follows:
Sec. 524.981c Fluocinolone and neomycin cream.
* * * * *
(c) Conditions of use in dogs--(1) Amount--A small amount is
applied to the affected area two or three times daily.
(2) Indications for use--(i) Dogs. For the relief of pruritis and
inflammation associated with superficial acute and chronic dermatoses.
It is used in the treatment of allergic and acute moist dermatitis and
nonspecific dermatoses.
(ii) Dogs and cats. Used in the treatment of wound infections.
* * * * *
0
21. Revise Sec. 524.981d to read as follows:
Sec. 524.981d Fluocinolone and dimethyl sulfoxide solution.
(a) Specifications. Each milliliter of solution contains 0.01
percent fluocinolone acetonide and 20 percent dimethyl sulfoxide.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount--Instill 1 to 2
milliliters into each anal sac following expression of anal sac
contents.
(2) Indications for use. For the relief of impaction commonly
present in apparently normal anal sacs, for the reversal of
inflammatory changes associated with abnormal anal sacs, and to
counteract the offensive odor of anal sac secretions.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
22. Revise Sec. 524.981e to read as follows:
Sec. 524.981e Fluocinolone and dimethyl sulfoxide otic solution.
(a) Specifications. Each milliliter of solution contains 0.01
percent fluocinolone acetonide and 60 percent dimethyl sulfoxide.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount--Instill 4 to 6 drops
(0.2 milliliter) twice daily into the ear canal for a maximum period of
14 days. The total dosage used should not exceed 17 milliliters.
(2) Indications for use. For the relief of pruritis and
inflammation associated with acute and chronic otitis.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
23. In Sec. 524.1005, in paragraph (b)(1), remove ``053501'' and in
its place add ``054771''; in paragraph (c)(3), remove the last sentence
and in its place add ``Do not use in horses intended for human
consumption.''; and revise the section heading to read as follows:
Sec. 524.1005 Furazolidone powder.
* * * * *
0
24. In Sec. 524.1044, revise the section heading to read as follows:
Sec. 524.1044 Gentamicin ophthalmic and topical dosage forms.
0
25. In Sec. 524.1044b, revise the section heading to read as follows:
Sec. 524.1044b Gentamicin and betamethasone otic solution.
* * * * *
0
26. In Sec. 524.1044c, revise the section heading to read as follows:
Sec. 524.1044c Gentamicin ophthalmic ointment.
* * * * *
0
27. In Sec. 524.1044d, revise the section heading and paragraph (c) to
read as follows:
Sec. 524.1044d Gentamicin and betamethasone ointment.
* * * * *
(c) Conditions of use in dogs--(1) Amount--(i) Otitis externa.
Instill 3 to 8 drops into the ear canal twice daily for 7 days.
(ii) Infected superficial lesions. Apply to cover the treatment
area twice daily for 7 to 14 days.
(2) Indications for use. For the treatment of acute and chronic
otitis externa and infected superficial lesions caused by bacteria
sensitive to gentamicin.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
28. In Sec. 524.1044e, revise the section heading and paragraph (c) to
read as follows:
Sec. 524.1044e Gentamicin spray.
* * * * *
(c) Conditions of use in cattle--(1) Amount. Hold the sprayer
upright 3 to 6 inches from the affected eye, with the opening directed
towards the eye, and pump once. Treat once daily for up to 3 days.
(2) Indications for use. For the treatment of pinkeye in cattle
(infectious bovine keratoconjunctivitis) caused by Moraxella bovis.
(3) Limitations. Conditions other than bacterial infections of the
bovine eye and infectious keratoconjunctivitis caused by Moraxella
bovis may produce similar signs. If conditions persists or increases,
discontinue use and consult a veterinarian.
0
29. In Sec. 524.1044g, remove the second occurrence of paragraph
(b)(3); and revise the section heading to read as follows:
Sec. 524.1044g Gentamicin, betamethasone, and clotrimazole ointment.
* * * * *
0
30. In Sec. 524.1044h, revise the section heading and add paragraph
(c)(3) to read as follows:
Sec. 524.1044h Gentamicin, mometasone, and clotrimazole otic
suspension.
* * * * *
(c) * * *
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
31. In Sec. 524.1132, revise the section heading to read as follows:
Sec. 524.1132 Hydrocortisone, miconazole, and gentamicin otic
suspension.
* * * * *
0
32. Revise Sec. 524.1200a to read as follows:
Sec. 524.1200a Kanamycin ophthalmic ointment.
(a) Specifications. Each gram of ointment contains 3.5 milligrams
kanamycin activity as kanamycin sulfate.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
[[Page 10970]]
(c) Conditions of use in dogs--(1) Amount. Apply a thin film to the
affected eye three or four times daily or more frequently if deemed
advisable. Treatment should be continued for at least 48 hours after
the eye appears normal.
(2) Indications for use. For the treatment of various eye
infections (conjunctivitis, blepharitis, dacryocystitis, keratitis, and
corneal ulcerations) due to bacteria sensitive to kanamycin. For
prophylaxis in traumatic conditions, removal of foreign bodies, and
intraocular surgery.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
33. Revise Sec. 524.1200b to read as follows:
Sec. 524.1200b Kanamycin ophthalmic solution.
(a) Specifications. Each milliliter of solution contains 10
milligrams kanamycin activity as kanamycin sulfate.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Instill a few drops into
the affected eye every 3 hours or more frequently if deemed advisable.
Administer as frequently as possible for the first 48 hours, after
which the frequency of applications may be decreased. Treatment should
be continued for at least 48 hours after the eye appears normal.
(2) Indications for use. For the treatment of various eye
infections (conjunctivitis, blepharitis, dacryocystitis, keratitis, and
corneal ulcerations) due to bacteria sensitive to kanamycin. For
prophylaxis in traumatic conditions, removal of foreign bodies, and
intraocular surgery.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
34. Revise Sec. 524.1204 to read as follows:
Sec. 524.1204 Kanamycin, amphomycin, and hydrocortisone ointment.
(a) Specifications. Each gram of ointment contains 5 milligrams
kanamycin activity as kanamycin sulfate, 5 milligrams of amphomycin
activity as the calcium salt, and 10 milligrams of hydrocortisone
acetate.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Apply to the affected
areas of the skin at least twice daily. In severe or widespread lesions
it may be desirable to apply the ointment more than twice daily. After
some improvement is observed, treatment can usually be reduced to once
daily.
(2) Indications for use. For the treatment of acute otitis externa,
furunculosis, folliculitis, pruritus, anal gland infections, erythema,
decubital ulcers, superficial wounds, and superficial abscesses
associated with bacterial infections caused by organisms susceptible to
one or both antibiotics.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
35. In Sec. 524.1240, revise paragraph (b) to read as follows:
Sec. 524.1240 Levamisole.
* * * * *
(b) Sponsors. See Nos. 000061 and 054771 in Sec. 510.600(c) of
this chapter.
* * * * *
0
36. In Sec. 524.1446, revise the section heading to read as follows:
Sec. 524.1446 Milbemycin otic solution.
* * * * *
Sec. 524.1465 [Amended]
0
37. In paragraph (b) of Sec. 524.1465, remove ``000069, 025463,
026637, and 051672'' and in its place add ``025463, 026637, 051672, and
054771''.
0
38. In Sec. 524.1484, revise the section heading to read as follows:
Sec. 524.1484 Neomycin ophthalmic and topical dosage forms.
* * * * *
0
39. In Sec. 524.1484b, revise the section heading and paragraphs (b)
and (c) to read as follows:
Sec. 524.1484b Neomycin, isoflupredone, tetracaine, and myristyl-
gamma-picolinium powder.
* * * * *
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in horses, dogs, and cats--(1) Amount. Apply
to affected areas as a dusting powder.
(2) Indications for use. For the treatment or as adjunctive therapy
of certain ear and skin conditions caused by or associated with
neomycin-susceptible organisms and/or allergy; as a superficial
dressing applied to minor cuts, wounds, lacerations, abrasions, and for
postsurgical application where reduction of pain and inflammatory
response is deemed desirable; as a dusting powder following amputation
of tails, claws, and dewclaws and following ear trimming, castrating,
and such surgical procedures as ovariohysterectomies. For the treatment
of acute otitis externa, acute moist dermatitis, and interdigital
dermatitis in dogs.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
40. In Sec. 524.1484c, revise the section heading and paragraphs (b)
and (c) to read as follows:
Sec. 524.1484c Neomycin, isoflupredone, and tetracaine ointment.
* * * * *
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. In treatment of otitis
externa and other inflammatory conditions of the external ear canal, a
quantity of ointment sufficient to fill the external ear canal; may be
applied one to three times daily. When used on the skin or mucous
membranes, the affected area should be cleansed, and a small amount of
the ointment applied and spread or rubbed in gently. The involved area
may be treated one to three times a day and these daily applications
continued in accordance with the clinical response.
(2) Indications for use. For the treatment of acute otitis externa
in dogs and to a lesser degree, chronic otitis externa in dogs. It also
is effective in treating anal gland infections and moist dermatitis in
the dog and is a useful dressing for minor cuts, lacerations,
abrasions, and post-surgical therapy in the horse, cat, and dog. It may
also be used following amputation of dewclaws, tails and claws,
following ear trimming and castrating operations.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
41. In Sec. 524.1484d, revise the section heading and paragraphs (b)
and (c) to read as follows:
Sec. 524.1484d Neomycin, hydrocortisone, and tetracaine otic
ointment.
* * * * *
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats--(1) Amount. Instill a
quantity of ointment sufficient to fill the external ear canal; may be
applied one to three times daily.
(2) Indications for use. For the treatment of ear canker and other
inflammatory conditions of the external ear canal, acute otitis externa
and, to a lesser degree, chronic otitis externa.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
42. In Sec. 524.1484e, revise the section heading and paragraphs (b)
and (c) to read as follows:
[[Page 10971]]
Sec. 524.1484e Neomycin and polymyxin B ophthalmic solution.
* * * * *
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Instill 1 to 2 drops per
eye every 6 hours.
(2) Indications for use. For the treatment of bacterial infections
associated with topical ophthalmological conditions such as corneal
injuries, superficial keratitis, conjunctivitis, keratoconjunctivitis,
and blepharitis.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
43. In Sec. 524.1484f, revise the section heading and paragraphs (b)
and (c) to read as follows:
Sec. 524.1484f Neomycin, prednisolone, and tetracaine otic
suspension.
* * * * *
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats--(1) Amount. Instill 2 to 6
drops in the external ear canal 2 or 3 times daily.
(2) Indications for use. For the treatment of acute otitis externa
and, to a lesser degree, chronic otitis externa; as treatment or
adjunctive therapy of certain ear conditions caused by or associated
with neomycin-susceptible organisms and/or allergy.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
44. In Sec. 524.1484g, revise the section heading and paragraph (c) to
read as follows:
Sec. 524.1484g Neomycin, thiabendazole, and dexamethasone solution.
* * * * *
(c) Conditions of use in dogs and cats--(1) Amount. In treating
dermatoses affecting areas other than the ear, the surface of the
lesions should be well moistened (2 to 4 drops per square inch) twice
daily. In treating otitis externa, instill 5 to 15 drops in the ear
twice daily. Treat for up to 7 days.
(2) Indications for use. As an aid in the treatment of bacterial,
mycotic, and inflammatory dermatoses and otitis externa.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
45. In Sec. 524.1484h, revise the section heading and paragraphs (b)
and (c) to read as follows:
Sec. 524.1484h Neomycin, penicillin, polymyxin B, and hydrocortisone
suspension.
* * * * *
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Rub a small amount into
the affected area 1 to 3 times a day. After definite improvement, apply
once daily or every other day.
(2) Indications for use. For the treatment of summer eczema, atopic
dermatitis, interdigital eczema, and otitis externa caused by bacteria
susceptible to neomycin, penicillin, and polymyxin B.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
46. In Sec. 524.1484i, revise the section heading and paragraphs (b)
and (c) to read as follows:
Sec. 524.1484i Neomycin and hydrocortisone ointment.
* * * * *
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats--(1) Amount. Apply 3 or 4
times daily into the conjunctival sac. With improvement, frequency may
be reduced to 2 or 3 times daily. For treatment of ear canker and other
inflammatory conditions of the external ear canal, fill external ear
canal 1 to 3 times daily.
(2) Indications for use. For the treatment of infections, allergic
and traumatic keratitis, conjunctivitis, acute otitis externa and, to a
lesser degree, chronic otitis externa.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
47. Add Sec. 524.1484j to read as follows:
Sec. 524.1484j Neomycin and prednisolone ophthalmic ointment.
(a) Specifications. Each gram of ointment contains prednisolone
sodium phosphate equivalent to 2.5 milligrams prednisolone 21-phosphate
and 5 milligrams neomycin sulfate equivalent to 3.5 milligrams neomycin
base.
(b) Sponsor. See No. 050604 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats--(1) Amount. A small
quantity of the ointment should be expressed into the conjunctival sac
4 times a day (at intervals of 1 to 8 hours) for a few days until there
is a favorable response, then the frequency of application may be
reduced to twice daily as long as the condition remains under control.
Treatment may require from a few days to several weeks.
(2) Indications for use. For use in superficial ocular
inflammations or infections limited to the conjunctiva or the anterior
segment of the eye, such as those associated with allergic reactions or
gross irritants.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
48. Add Sec. 524.1484k to read as follows:
Sec. 524.1484k Prednisolone and neomycin suspension.
(a) Specifications. Each milliliter of suspension contains 2.5
milligrams of prednisolone acetate and 5 milligrams of neomycin sulfate
equivalent to 3.5 milligrams of neomycin base.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats--(1) Amount. For beginning
treatment of acute ocular inflammations place 1 or 2 drops in the
conjunctival sac 3 to 6 times during a 24 hour period. When improvement
occurs, reduce the dosage to 1 drop 2 to 4 times daily. For otitis
externa, place 2 to 6 drops in the external ear canal 2 or 3 times
daily.
(2) Indications for use. For the treatment of treating infectious,
allergic and traumatic keratitis and conjunctivitis, acute otitis
externa, and chronic otitis externa.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
49. In Sec. 524.1580, revise the section heading to read as follows:
Sec. 524.1580 Nitrofurazone topical dosage forms.
* * * * *
Sec. 524.1580a [Removed]
0
50. Remove Sec. 524.1580a.
Sec. 524.1580b [Amended]
0
51. Redesignate Sec. 524.1580b as Sec. 524.1580a; and in newly
designated paragraph (b)(1), remove ``000069,''.
Sec. 524.1580c [Amended]
0
52. Redesignate Sec. 524.1580c as Sec. 524.1580b; in paragraph (b),
remove ``Nos. 000069 and 054628'' and in its place add ``No. 054628'';
and in paragraphs (c)(2) and (c)(3), remove footnote 1.
Sec. 524.1580d [Removed]
0
53. Remove Sec. 524.1580d.
Sec. 524.1580e [Amended]
0
54. Redesignate Sec. 524.1580e as Sec. 524.1580c; in paragraph (c)(1)
and (c)(2), remove footnote 1; and revise the section heading to read
as follows:
Sec. 524.1580c Nitrofurazone and butacaine ointment.
* * * * *
[[Page 10972]]
0
55. In Sec. 524.1600a, revise the section heading, paragraphs (b) and
(c)(3) to read as follows:
Sec. 524.1600a Nystatin, neomycin, thiostrepton, and triamcinolone
ointment.
* * * * *
(b) Sponsors. For petrolatum base ointments see Nos. 000856,
025463, 054771, and 054925 in Sec. 510.600(c) of this chapter. For
vanishing cream base ointments see Nos. 025463, 054771, and 054925.
(c) * * *
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
56. In Sec. 524.1600b, revise the section heading, and paragraph (c)
to read as follows:
Sec. 524.1600a Nystatin, neomycin, thiostrepton, and triamcinolone
ophthalmic ointment.
* * * * *
(c) Conditions of use--(1) Dogs and cats--(i) Amount. Apply 1 drop
of ointment to the affected eye(s) 2 or 3 times daily. Treatment may be
continued for up to 2 weeks if necessary.
(ii) Indications for use. For use as an anti-inflammatory,
antipruritic, antifungal (Candida albicans), and antibacterial ointment
for local therapy in keratitis and conjunctivitis.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) Cattle--(i) Amount. Apply small line of ointment to the
affected eye(s) once daily. Treatment may be continued for up to 2
weeks if necessary.
(ii) Indications for use. For infectious kerato-conjunctivitis
(pinkeye).
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
57. In Sec. 524.1662, revise the section heading to read as follows:
Sec. 524.1662 Oxytetracycline ophthalmic and topical dosage forms.
* * * * *
0
58. In Sec. 524.1662a, in paragraph (b), remove ``000069'' and in its
place add ``054771''; and revise the section heading and paragraph (c)
to read as follows:
Sec. 524.1662a Oxytetracycline and hydrocortisone spray.
* * * * *
(c) Conditions of use in dogs and cats--(1) Amount. A small
quantity should be sprayed on the affected surface by holding the
container about 6 inches from the area to be treated and pressing the
nozzle for 1 or 2 seconds. Only sufficient spray to coat the skin
thinly is necessary. The application of small amounts at frequent
intervals will give best results. Before treating animals with long or
matted hair, it may be necessary to clip the affected area or spread
the hairs to allow the medication to contact the skin surface. Relief
may be noted following the first or second treatment; however,
treatment should not be discontinued too soon after the initial
favorable response has been obtained.
(2) Indications for use. For the relief of discomfort and continued
treatment of many allergic, infectious, and traumatic skin conditions;
for the prevention of bacterial infections in superficial wounds, cuts,
and abrasions, treatment of allergic dermatoses, including urticaria,
eczemas, insect bites, and cutaneous drug reactions, infections
associated with minor burns and wounds, and nonspecific pruritus.
(3) Limitations. Keep away from eyes or other mucous membranes;
avoid inhaling; use with adequate ventilation; in case of deep or
puncture wounds or serious burns, consult a veterinarian.
0
59. In Sec. 524.1662b, in paragraph (b), remove ``000069'' and in its
place add ``054771''; and revise the section heading and paragraph (c)
to read as follows:
Sec. 524.1662b Oxytetracycline and polymyxin B ophthalmic ointment.
* * * * *
(c) Conditions of use in dogs and cats--(1) Amount. Administer
topically to the eye two to four times daily.
(2) Indications for use. For the prophylaxis and local treatment of
superficial ocular infections due to oxytetracycline- and polymyxin-
sensitive organisms including ocular infections due to streptococci,
rickettsiae, E. coli, and A. aerogenes (such as conjunctivitis,
keratitis, pinkeye, corneal ulcer, and blepharitis in dogs, cats,
cattle, sheep, and horses); ocular infections due to secondary
bacterial complications associated with distemper in dogs; and ocular
infections due to bacterial inflammatory conditions which may occur
secondary to other infectious diseases in dogs, cats, cattle, sheep,
and horses.
(3) Limitations. Allergic reactions may occasionally occur.
Treatment should be discontinued if reactions are severe. If new
infections due to nonsensitive bacteria or fungi appear during therapy,
appropriate measures should be taken.
Sec. Sec. 524.1881, 524.1881a, and 524.1881b [Removed]
0
60. Remove Sec. Sec. 524.1881, 524.1881a, and 524.1881b.
Sec. 524.1883 [Removed]
0
61. Remove Sec. 524.1883.
0
62. In Sec. 524.1982, in paragraph (b), remove ``053501'' and in its
place add ``054771''; and revise the section heading and paragraph (c)
to read as follows:
Sec. 524.1982 Proparacaine ophthalmic solution.
* * * * *
(c) Conditions of use in dogs and cats--(1) Amount. It is
administered as follows:
(i) For removal of sutures: Instill one to two drops 2 or 3 minutes
before removal of stitches.
(ii) For removal of foreign bodies from eye, ear, and nose: For
ophthalmic use, instill three to five drops in the eye prior to
examination; for otic use, instill five to ten drops in the ear; for
nasal use, instill five to ten drops in each nostril every 3 minutes
for three doses.
(iii) For tonometry: Instill one to two drops immediately before
measurement.
(iv) As an aid in treatment of otitis: Instill two drops into the
ear every 5 minutes for three doses.
(v) For minor surgery: Instill one or more drops as required.
(vi) For catheterization: Instill two to three drops with a blunt
20-gauge needle immediately before inserting catheter.
(2) Indications for use. For use as a topical ophthalmic
anesthetic. It is used as an anesthetic in cauterization of corneal
ulcers, removal of foreign bodies and sutures from the cornea, and
measurement of intraocular pressure (tonometry) when glaucoma is
suspected; as an aid in the removal of foreign bodies from the nose and
ear canal; as an accessory in the examination and treatment of painful
otitis, in minor surgery, and prior to catheterization.
(3) Limitations. Keep away from eyes or other mucous membranes;
avoid inhaling; use with adequate ventilation; in case of deep or
puncture wounds or serious burns, consult a veterinarian.
Sec. 524.2098 [Amended]
0
63. In paragraph (b) of Sec. 524.2098, remove ``000069'' and in its
place add ``No. 054771''.
0
64. Revise Sec. 524.2350 to read as follows:
Sec. 524.2350 Tolnaftate cream.
(a) Specifications. The drug contains 1 percent tolnaftate in an
anhydrous cream base.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Apply a small amount of the
cream to
[[Page 10973]]
the affected areas once or twice a day for 2 to 4 weeks.
(2) Indications for use. For the treatment of ringworm lesions due
to Microsporum canis and Microsporum gypseum.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
65. Revise Sec. 524.2620 to read as follows:
Sec. 524.2620 Liquid crystalline trypsin, Peru balsam, castor oil.
(a) Specifications--(1) Each gram of liquid or aerosol contains
0.12 milligram of crystalline trypsin, 87.0 milligrams of Peru balsam,
and 788.0 milligrams of castor oil.
(2) Each gram of liquid or aerosol contains 0.1 milligram of
crystalline trypsin, 72.5 milligrams of Peru balsam, and 800 milligrams
of castor oil.
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this
chapter for use as in paragraph (c) in this section:
(1) No. 051079 for use of product described in paragraph (a)(1).
(2) No. 017135 for use of product described in paragraph (a)(2).
(c) Conditions of use--(1) Amount. Apply directly to the wound
site.
(2) Indications for use. As an aid in the treatment of external
wounds and assists healing by facilitating the removal of necrotic
tissue, exudate, and organic debris.
PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS
0
66. The authority citation for 21 CFR part 526 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 526.313 [Amended]
0
67. In paragraph (b) of Sec. 526.313, remove ``000009'' and in its
place add ``054771''.
Sec. 526.464a [Amended]
0
68. In Sec. 526.464a, remove paragraph (d).
Sec. 526.464d [Removed]
0
69. Remove Sec. 526.464d.
Sec. 526.820 [Amended]
0
70. In paragraph (b) of Sec. 526.820, remove ``No. 061623'' and in its
place add ``Nos. 054771 and 061623''.
0
71. In Sec. 526.1130, revise the section heading to read as set forth
below:
Sec. 529.1130 Hetacillin infusion.
* * * * *
0
72. In Sec. 526.1590, in paragraphs (a)(2) and (b)(2), remove
``000009'' and in its place add ``054771''; and revise the section
heading to read as follows:
Sec. 526.1590 Novobiocin infusion.
* * * * *
Sec. 526.1696d [Amended]
0
73. In paragraph (b) of Sec. 526.1696d, remove ``000009'' and in its
place add ``054771''.
Sec. 526.1810 [Amended]
0
74. In paragraph (b) of Sec. 526.1810, remove ``000009'' and in its
place add ``054771''.
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
75. The authority citation for 21 CFR part 529 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
76. In Sec. 529.40, remove paragraph (c); redesignate paragraph (d) as
paragraph (c); and revise newly redesignated paragraph (c)(3) to read
as follows:
Sec. 529.40 Albuterol.
* * * * *
(c) * * *
(3) Not for use in horses intended for food. Federal law restricts
this drug to use by or on the order of a licensed veterinarian.
Sec. 529.56 [Amended]
0
77. In paragraph (b) of Sec. 529.56, remove ``000856 and 000859'' and
in its place add ``000859 and 054771''.
Sec. 529.400 [Amended]
0
78. In Sec. 529.400, revise the section heading; in paragraph (b),
remove ``000856'' and in its place add ``054771''; and in paragraphs
(c)(1), (c)(2), and (c)(3), remove the footnote.
0
79. Add Sec. 529.778 to read as follows:
Sec. 529.778 Doxycycline.
(a) Specifications. Doxycycline hyclate solution contains 8.5
percent doxycycline activity. A syringe of N-methyl-2-pyrrolidone and
poly (DL-lactide) mixed with a syringe of doxycycline produces 0.5
milliliter of solution.
(b) Sponsor. See 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Apply subgingivally to
periodontal pocket(s) of affected teeth.
(2) Indications for use. For treatment and control of periodontal
disease.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 529.1044 [Amended]
0
80. In Sec. 529.1044, remove the word ``sulfate'' in the section
heading.
0
81. In Sec. 529.1044a, revise the section heading and paragraph (b) to
read as follows:
Sec. 529.1044a Gentamicin solution for infusion.
* * * * *
(b) Sponsors. See Nos. 000061, 000859, 054628, 054771, 057561,
058005, and 061623 in Sec. 510.600(c) of this chapter.
* * * * *
0
82. In Sec. 529.1044b, revise the section heading and paragraph (c) to
read as follows:
Sec. 529.1044b Gentamicin solution for dipping eggs.
* * * * *
(c) Conditions of use in turkeys--(1) Amount. The drug is added to
clean water to provide a dip solution with a gentamicin concentration
of 250 to 1,000 parts per million. A concentration of 500 parts per
million is recommended. Clean eggs should be held submerged in the
gentamicin solution under a vacuum of about 27.5 to 38 centimeters of
mercury for 5 minutes followed by additional soaking in gentamicin
solution for approximately 10 minutes at atmospheric pressure. Eggs can
also be treated by warming them for 3 to 6 hours at approximately 100
[deg]F then immediately submerging them in gentamicin solution
maintained at about 40 [deg]F, keeping the eggs submerged for 10 to 15
minutes.
(2) Indications for use. As an aid in the reduction or elimination
of the following microorganisms from turkey-hatching eggs: Arizona
hinshawii (paracolon), Salmonella Saintpaul, and Mycoplasma
meleagridis.
(3) Limitations. For use in the dipping treatment of turkey-
hatching eggs only. Eggs which have been dipped in the drug shall not
be used for food.
0
83. In Sec. 529.1115, remove the footnote in paragraphs (c)(1),
(c)(2), and (c)(3); and revise paragraphs (b) and (c)(3) to read as
follows:
Sec. 529.1115 Halothane.
* * * * *
(b) Sponsor. See Nos. 012164 and 054771 in Sec. 510.600(c) of this
chapter.
(c) * * *
(3) Limitations. Not for use in animals intended for food. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
Sec. 529.1660 [Amended]
0
84. In Sec. 529.1660, in paragraph (b)(1), remove ``046573'' and in
its place add ``054771''; and in paragraph (b)(2), remove ``000069,
048164, and 059130''
[[Page 10974]]
and in its place add ``048164, 054771, and 061623''.
Sec. 529.1940 [Amended]
0
85. In paragraph (b) of Sec. 529.1940, remove ``000009'' and in its
place add ``054771''.
0
86. Revise Sec. 529.2464 to read as follows:
Sec. 529.2464 Ticarcillin.
(a) Specifications. Each vial contains ticarcillin disodium powder
equivalent to 6 grams of ticarcillin for reconstitution with 25
milliliters of sterile water for injection or sterile physiological
saline.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in horses--(1) Amount. Administer 6 grams
daily by intrauterine infusion for 3 consecutive days during estrus.
(2) Indications for use. For the treatment of endometritis caused
by beta-hemolytic streptococci.
(3) Limitations. Do not use in horses intended for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
0
87. Revise Sec. 529.2503 to read as follows:
Sec. 529.2503 Tricaine methanesulfonate.
(a) Specifications. The drug is ethyl-m-amino-benzoate
methanesulfonate.
(b) Sponsor. See Nos. 050378 and 051212 in Sec. 510.600(c) of this
chapter.
(c) Conditions of use--(1) Amount. It is used as follows:
(i) Fish. The drug is added to ambient water at a concentration of
from 15 to 330 milligrams per liter depending upon the degree of
anesthetization or sedation desired, the species and size of the fish,
and the temperature and softness of the water. Preliminary tests of
solutions must be made with small numbers of fish to determine the
desired rates of sedation or anesthesia and the appropriate exposure
times for the specific lots of fish under prevailing conditions.
(ii) Amphibians and other aquatic coldblooded animals. The drug is
added to ambient water in concentrations of from 1:1000 to 1:20,000
depending upon species and stage of development.
(2) Indications for use. For the temporary immobilization of fish,
amphibians, and other aquatic coldblooded animals (poikilotherms) as an
aid in handling during manual spawning (fish stripping), weighing,
measuring, marking, surgical operations, transport, photography, and
research.
(3) Limitations. Do not use within 21 days of harvesting fish for
food. Use in fish intended for food should be restricted to
Ictaluridae, Salmonidae, Esocidae, and Percidae, and water temperature
exceeding 10 [deg]C (50 [deg]F). In other fish and in coldblooded
animals, the drug should be limited to hatchery or laboratory use.
Dated: January 27, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-01958 Filed 2-26-14; 8:45 am]
BILLING CODE 4160-01-P
