Rule2026-07500
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address
Primary source
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Published
April 16, 2026
Effective
April 16, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (CNADAs) during October, November, and December 2025. The animal drug regulations are also being amended to improve their accuracy and readability.
Full Text
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<title>Federal Register, Volume 91 Issue 73 (Thursday, April 16, 2026)</title>
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[Federal Register Volume 91, Number 73 (Thursday, April 16, 2026)]
[Rules and Regulations]
[Pages 20337-20348]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-07500]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 516, 520, 522, 524, and 558
[Docket No. FDA-2025-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawal of Approval of New Animal Drug Application; Change of
Sponsor; Change of Sponsor Address
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs), abbreviated new animal drug
applications (ANADAs), and conditionally approved new animal drug
applications (CNADAs) during October, November, and December 2025. The
animal drug regulations are also being amended to improve their
accuracy and readability.
DATES: This rule is effective April 16, 2026.
FOR FURTHER INFORMATION CONTACT: James Delaney, Center for Veterinary
Medicine, Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740. <a href="/cdn-cgi/l/email-protection#5339323e36207d37363f323d362a133537327d3b3b207d343c25"><span class="__cf_email__" data-cfemail="9df7fcf0f8eeb3f9f8f1fcf3f8e4ddfbf9fcb3f5f5eeb3faf2eb">[email protected]</span></a>, 240-402-5677.
SUPPLEMENTARY INFORMATION:
I. Approval of Applications
FDA is amending the animal drug regulations to reflect approval
actions for NADAs, ANADAs, and CNADAs during October, November, and
December 2025, as listed in table 1. Documentation of environmental
review required under the National Environmental Policy Act, summaries
of the basis of approval under the Freedom of Information Act (FOIA
summaries), and marketing exclusivity and patent information are
available at Animal Drugs @FDA: <a href="https://animaldrugsatfda.fda.gov/adafda/views/#/search">https://animaldrugsatfda.fda.gov/adafda/views/#/search</a>.
Table 1--Original, Conditional, and Supplemental Applications Approved During October, November, and December
2025
----------------------------------------------------------------------------------------------------------------
Application Sponsor (drug Effect of the 21 CFR
Date of approval No. labeler code \1\) Product name action sections
----------------------------------------------------------------------------------------------------------------
October 20, 2025........... 141-581 Elanco US Inc. CREDELIO QUATTRO Supplemental 520.1287
(058198). (lotilaner, Approval.
moxidectin,
praziquantel, and
pyrantel chewable
tablets).
October 21, 2025........... 200-825 Felix Clomipramine Original approval 520.455
Pharmaceuticals Hydrochloride as a generic copy
Pvt. Ltd. Tablets. of NADA 141-120.
(086101).
October 21, 2025........... 141-574 Pharmgate Inc. PENNITRACIN MD 50G Original approval. 558.363
(069254). (bacitracin
methylenedisalicy
late Type A
medicated
article) and
MONTEBAN (narasin
Type A medicated
article).
October 24, 2025........... 141-494 Elanco US Inc. CREDELIO Supplemental 520.1286
(058198). (lotilaner). approval.
December 5, 2025........... 200-710 Dechra Veterinary Maropitant Citrate Original approval 522.1315
Products LLC (maropitant as a generic copy
(017033). citrate) of NADA 141-263.
injectable
solution.
December 17, 2025.......... 141-619 Elanco US Inc. CREDELIO QUATTRO Conditional 516.1287
(058198). CA1 (lotilaner, approval.
moxidectin,
praziquantel, and
pyrantel chewable
tablets).
December 18, 2025.......... 141-614 Anivive LAVERDIA Original approval 520.2700
Lifesciences, (verdinexor from conditional 516.2980
Inc. (086121). tablets). approval.
December 19, 2025.......... 141-576 Dechra, Ltd. COSACTHEN Original approval. 522.500
(043264). (cosyntropin
injection).
December 19, 2025.......... 141-273 Boehringer VETMEDIN Supplemental 520.1780
Ingelheim Animal (pimobendan). approval.
Health USA, Inc.
(000010).
[[Page 20338]]
December 19, 2025.......... 200-823 Dechra Veterinary Zygolide Original approval 520.1705
Products LLC (pergolide as a generic copy
(017033). tablets). of NADA 141-331.
December 22, 2025.......... 200-832 ZyVet Animal Robenacoxib Original approval 520.2075
Health, Inc. (robenacoxib). as a generic copy
(086117). of NADA 141-320.
December 22, 2025.......... 200-834 Felix Praziquantel Original approval 520.1870
Pharmaceuticals Tablets as a generic copy
Pvt. Ltd. (praziquantel of NADA 111-798.
(086101). tablets).
December 22, 2025.......... 200-829 Aurora Klentz Original approval 524.957
Pharmaceutical, (florfenicol, as a generic copy
Inc. (051072). terbinafine, of NADA 141-440.
mometasone
furoate) otic
solution.
----------------------------------------------------------------------------------------------------------------
\1\ See 21 CFR 510.600(c) for sponsor addresses.
II. Changes of Sponsor
The sponsors of the approved applications listed in table 2 have
informed FDA that they have transferred ownership of, and all rights
and interest in, these applications to another sponsor. The regulations
cited in table 3 are amended to reflect these actions.
Table 2--Applications for Which Ownership Was Transferred to Another Sponsor During October, November, and
December 2025
----------------------------------------------------------------------------------------------------------------
Transferring sponsor New sponsor (drug 21 CFR
Application No. Product name (drug labeler code) labeler code) section
----------------------------------------------------------------------------------------------------------------
039-417................... DECCOX ((decoquinate Zoetis (054771)........ Phibro (066104)....... 558.195
Type A medicated
article).
040-209................... ROFENAID 40 Do..................... Do.................... 558.575
(sulfadimethoxine and
ormetoprim Type A
medicated article).
045-348................... DECCOX and ALBAC Do..................... Do.................... 558.195
(decoquinate Type A
medicated article and
bacitracin zinc Type A
medicated article).
097-505................... LINCOMIX 20 and Do..................... Do.................... 558.325
LINCOMIX 50
(lincomycin Type A
medicated article).
111-636................... LINCOMIX Soluble Powder Do..................... Do.................... 520.1263b
(lincomycin
hydrochloride soluble
powder).
138-941................... LINCOMIX and BANMINTH Do..................... Do.................... 558.325
(lincomycin Type A
medicated article and
pyrantel tartrate Type
A medicated article).
140.853................... BMD and MONTEBAN Do..................... Do.................... 558.363
(bacitracin
methylenedisalicylate
Type A medicated
article and narasin
Type A medicated
article).
140-865................... MONTEBAN and BACIFERM Do..................... Do.................... 558.363
or MONTEBAN and ALBAC
(narasin Type A
medicated article and
bacitracin zinc Type A
medicated article).
141-025................... CATTLYST (laidlomycin Do..................... Do.................... 558.305
propionate potassium
Type A medicated
article).
141-102................... DECCOX and BMD Do..................... Do.................... 558.1951
(decoquinate Type A
medicated article and
bacitracin
methylenedisalicylate
Type A medicated
article).
141-148................... DECCOX and Rumensin Do..................... Do.................... 558.1951
(decoquinate Type A
medicated article and
monensin Type A
medicated article).
141-149................... DECCOX and RUMENSIN and Do..................... Do.................... 558.625
TYLAN (decoquinate
Type A medicated
article and monensin
Type A medicated
article and tylosin
phosphate Type A
medicated article).
141-191................... COBAN and LINCOMIX Do..................... Do.................... 558.325
(monensin Type A
medicated article and
lincomycin Type A
medicated article).
141-483................... DECCOX and LINCOMIX Do..................... Do.................... 558.325
decoquinate Type A
medicated article and
lincomycin Type A
medicated articles to
be used in the
manufacture of Type C
medicated feeds.
141-484................... BIO-COX and LINCOMIX Do..................... Do.................... 558.325
(salinomycin sodium
Type A medicated
article and lincomycin
Type A medicated
article).
141-485................... COYDEN and LINCOMIX Do..................... Do.................... 558.325
(clopidol Type A
medicated article and
lincomycin Type A
medicated article).
[[Page 20339]]
141-489................... ZOAMIX and LINCOMIX Do..................... Do.................... 558.325
(zoalene Type A
medicated article and
lincomycin Type A
medicated article).
200-218................... COYDEN and ALBAC Do..................... Do.................... 558.175
(clopidol Type A
medicated article and
bacitracin zinc Type A
medicated article).
200-548................... Actogain (ractopamine Do..................... Do.................... 558.500
hydrochloride).
200-579................... Altrenogest Solution Ceva Sante Animale Diamond Animal Health, 520.48
(altrenogest). (013744). Inc. (053701).
----------------------------------------------------------------------------------------------------------------
III. Change of Sponsor Address
Ivaoes Animal Health (drug labeler code 086064 in 21 CFR
510.600(c)), Kinetic Technologies, LLC, (drug labeler code 051031 in 21
CFR 510.600(c)), and Qbiotics Group Ltd., (drug labeler code 086132 in
21 CFR 510.600(c)) have informed FDA that they have changed their
address. The entries in Sec. 510.600(c) are amended to reflect these
actions.
IV. Technical Amendments
FDA is making the following amendments to improve the accuracy and
readability of the animal drug regulations.
<bullet> 21 CFR 510.600(c) is amended to remove the entries for
Agri Laboratories, Ltd., as the firm is no longer the sponsor of
approved applications, and to add an entry for TriviumVet.
<bullet> 21 CFR 520.1660d is amended to reflect a 2016 and 2018
change of sponsorship for oxytetracycline powder that did not get
recorded in the CFR.
<bullet> 21 CFR 520.2345d is amended to reflect a 2018 change of
sponsorship for tetracycline powder.
<bullet> 21 CFR 522.2100 is revised to clarify the dosage is in
pounds of body weight for all species listed.
<bullet> 21 CFR 524.1055h is amended to add clarity to the dosage
directions for dogs.
<bullet> 21 CFR 558.78 is amended to remove inadvertent text.
<bullet> 21 CFR 558.500 is amended to present additional language
for labeling and to add clarity to indications for use and limitations.
V. Legal Authority
This final rule is issued under section 512(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)). Although deemed
a rule under the FD&C Act, this document does not meet the definition
of ``rule'' in 5 U.S.C. 804(3)(A) because it is a ``rule of particular
applicability'' and is not subject to the congressional review
requirements in 5 U.S.C. 801-808. Likewise, this is not a rule subject
to Executive Order 12866.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 516
Administrative practice and procedure, Animal drugs, Confidential
business information, Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, and 524
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
510, 516, 520, 522, 524, and 558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for part 510 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600:
0
a. In the table in paragraph (c)(1):
0
i. Revise the entries for Ivaoes Animal Health, Kinetic Technologies,
LLC, and Qbiotics Group Ltd.,
0
ii Add in alphabetical order an entry for TriviumVet, and
0
iii. Remove the entry for Agri Laboratories, Ltd.
0
b. In the table in paragraph (c)(2), add an entry in numerical order
for 086169; remove the entry for 057561, and revise the entries for
051031, 086064, and 086132.
The revisions and additions read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * * * *
Ivaoes Animal Health, 1200 NW 78th, Suite 200-D, Doral, 086064
FL 33126...............................................
* * * * * * *
Kinetic Technologies, LLC, 1700 Albany Pl SE, Orange 051031
City, IA 51041.........................................
* * * * * * *
Qbiotics Group Ltd., Level 14, 15 Lakes Street, Cairns, 086132
Queensland, QLD4870, Australia.........................
* * * * * * *
TriviumVet, Unit 3A, Cleaboy Business Park, Old 086169
Kilmeaden Road, Waterford, Waterford, X91 H5FE, Ireland
[[Page 20340]]
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
051031................... Kinetic Technologies, LLC, 1700 Albany Pl SE,
Orange City, IA 51041.
* * * * * * *
086064................... Ivaoes Animal Health, 1200 NW 78th, Suite 200-
D, Doral, FL 33126.
* * * * * * *
086132................... Qbiotics Group Ltd., Level 14, 15 Lakes
Street, Cairns, Queensland, QLD4870,
Australia.
* * * * * * *
086169................... TriviumVet, Unit 3A, Cleaboy Business Park,
Old Kilmeaden Road, Waterford, Waterford,
X91 H5FE, Ireland.
* * * * * * *
------------------------------------------------------------------------
PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
0
3. The authority citation for part 516 continues to read as follows:
Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.
0
4. Add Sec. 516.1287 to read as follows:
Sec. 516.1287 Lotilaner, moxidectin, praziquantel, and pyrantel.
(a) Specifications. Each chewable tablet contains:
(1) 56.25 milligrams (mg) lotilaner, 0.056 mg moxidectin, 14.25 mg
praziquantel, and 14.25 mg pyrantel (as pamoate salt);
(2) 112.5 mg lotilaner, 0.113 mg moxidectin, 28.5 mg praziquantel,
and 28.5 mg pyrantel (as pamoate salt);
(3) 225 mg lotilaner, 0.225 mg moxidectin, 57 mg praziquantel, and
57 mg pyrantel (as pamoate salt);
(4) 450 mg lotilaner, 0.45 mg moxidectin, 114 mg praziquantel, and
114 mg pyrantel (as pamoate salt); or
(5) 900 mg lotilaner, 0.9 mg moxidectin, 228 mg praziquantel, and
228 mg pyrantel (as pamoate salt).
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--
(1) Amount. Administer orally at the minimum dosage of 9 mg/pound
(mg/lb) (20 mg/kilogram (mg/kg)) lotilaner, 0.009 mg/lb (0.02 mg/kg)
moxidectin, 2.28 mg/lb (5 mg/kg) praziquantel, and 2.28 mg/lb (5 mg/kg)
pyrantel (as pamoate salt).
(2) Indications for use. For the treatment of infestations caused
by New World screwworm (Cochliomyia hominivorax) larvae (myiasis) in
dogs and puppies 8 weeks of age and older and weighing 3.3 pounds or
greater.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian. It is a violation of Federal law
to use this product other than as directed in the labeling.
Sec. 516.2980 [Removed]
0
5. Remove Sec. 516.2980.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
6. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 520.48 [Amended]
0
7. In Sec. 520.48, in paragraph (b)(3), remove the text ``No. 013744''
and in its place add the text ``No. 053701''.
Sec. 520.455 [Amended]
0
8. In Sec. 520.455, in paragraph (a), remove the text
``Specifications'' and in its place add the text ``Specifications'',
and in paragraph (b), remove the text ``Nos. 051311 and 086039'' and in
its place add the text ``Nos. 051311, 086039, and 086101''.
0
9. In Sec. 520.1263b,
0
a. Retitle the section,
0
b. In paragraph (b)(1), remove the text ``Nos. 054771 and 061133'' and
in its place add the text ``Nos. 061133 and 066104'', and
0
c. Revise paragraph (d), to read as follows:
Sec. 520.1263b Lincomycin hydrochloride soluble powder.
* * * * *
(b) * * *
(1) Nos. 061133 and 066104 for use as in paragraph (d) of this
section.
* * * * *
(d) * * *
(1) Swine--
(i) Amount. Administer at a dose rate of 250 milligrams (mg) of
lincomycin per gallon of drinking water. In clinical studies, this dose
rate provided an average of 3.8 mg of lincomycin per pound of body
weight per day. The drug should be administered for a minimum of 5
consecutive days beyond the disappearance of symptoms (bloody stools)
up to a maximum of 10 consecutive days. If water treatment is
discontinued prior to this time, a lincomycin treatment program may be
continued with lincomycin Type A medicated article at 100 grams
lincomycin per ton of complete feed as the sole ration according to
label directions. A dose of 3.8 mg lincomycin per pound of body weight
may be maintained by medicating the drinking water at a concentration
of 250 mg per gallon of drinking water when pigs are consuming 1.5
gallons per 100 lb of body weight per day. Under these circumstances
the concentration of lincomycin required in medicated water may be
adjusted to compensate for variations in age and weight of animals, the
nature and severity of disease symptoms, environmental temperature and
humidity, each of which affects water consumption. For use in automatic
water proportioner to deliver 1 ounce of stock solution per gallon of
drinking water. NOTE: After a treatment program is discontinued, a
control program for swine dysentery may be followed by feeding
lincomycin Type A
[[Page 20341]]
medicated article at 40 grams lincomycin per ton of complete feed as
the sole ration.
(ii) Indications for use. For the treatment of swine dysentery
(bloody scours) in swine. Not for use in pregnant swine or swine
intended for breeding.
(iii) Limitations. Discard medicated drinking water if not used
within 2 days. Fresh stock should be prepared daily. Do not use the
water treatment and the feed treatment simultaneously. Do not allow
rabbits, hamsters, guinea pigs, horses, or ruminants access to water
containing lincomycin. Ingestion by these species may result in severe
gastrointestinal effects. If clinical signs of bloody scours (watery,
mucoid, or bloody stools) have not improved during the first 6 days of
medication, discontinue treatment and redetermine the diagnosis. On
rare occasions, some pigs may show reddening of the skin, swelling of
the anus, and irritable behavior. These conditions have been self-
correcting within five to seven days without discontinuing the
lincomycin treatment. The safety of lincomycin has not been
demonstrated for pregnant swine or swine intended for breeding. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
(2) Broiler Chickens--
(i) Amount. Administer at a dose rate of 64 mg of lincomycin per
gallon of drinking water. Start medication as soon as the diagnosis of
necrotic enteritis is determined. The drug should be administered for 7
consecutive days. NOTE: After water medication is discontinued, a
control program for necrotic enteritis may be followed by feeding
lincomycin Type A medicated article at 2 grams lincomycin per ton of
complete feed.
(ii) * * *
(iii) Limitations. Not for use in laying hens or breeder chickens.
Discard medicated drinking water if not used within 2 days. Fresh stock
should be prepared daily. Do not use the water treatment and the feed
treatment simultaneously. Do not allow rabbits, hamsters, guinea pigs,
horses, or ruminants access to water containing lincomycin. Ingestion
by these species may result in severe gastrointestinal effects. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
(3) Honey bees--
(i) Amount. Administer 100 mg lincomycin per hive once weekly for 3
weeks. Mix 250 mg LINCOMIX Soluble Powder (100 mg lincomycin) with 20 g
confectioners'/powder sugar and dust over the top bars of the brood
chamber.
(ii) Indications for use. For the control of American foulbrood
(Paenibacillus larvae) in honey bees.
* * * * *
0
10. In Sec. 520.1286, revise paragraph (c)(1)(ii) to read as follow:
Sec. 520.1286 Lotilaner.
* * * * *
(c) * * *
(1) * * *
(i) * * *
(ii) Indications for use. Kills adult fleas, and for the treatment
and prevention of flea infestations (Ctenocephalides felis), and the
treatment and control of tick infestations (Amblyomma americanum (lone
star tick), Dermacentor variabilis (American dog tick), Ixodes
scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog
tick), and Haemaphysalis longicornis (longhorned tick)) for one month
in dogs and puppies 8 weeks of age and older, and weighing 4.4 pounds
or greater. For the prevention of Borrelia burgdorferi infections as a
direct result of killing Ixodes scapularis vector ticks.
* * * * *
0
11. In Sec. 520.1287, revise paragraph (c)(2) to read as follows:
Sec. 520.1287 Lotilaner, moxidectin, praziquantel, and pyrantel.
* * * * *
(c) * * *
(1) * * *
(2) Indications for use. For the prevention of heartworm disease
caused by Dirofilaria immitis and for the treatment and control of
roundworm (immature adult and adult Toxocara canis and adult Toxascaris
leonina), hookworm (fourth stage larvae, immature adult, and adult
Ancylostoma caninum and adult Uncinaria stenocephala), and tapeworm
(Dipylidium caninum, Taenia pisiformis, and Echinococcus granulosus)
infections. Kills adult fleas and is indicated for the treatment and
prevention of flea infestations (Ctenocephalides felis) and the
treatment and control of tick infestations (Amblyomma americanum (lone
star tick), Dermacentor variabilis (American dog tick), Ixodes
scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog
tick), and Haemaphysalis longicornis (longhorned tick)) for one month
in dogs and puppies 8 weeks of age and older, and weighing 3.3 pounds
or greater. For the prevention of Borrelia burgdorferi infections as a
direct result of killing Ixodes scapularis vector ticks.
* * * * *
0
12. In Sec. 520.1660d,
0
a. Revise paragraph (d)(1)(ii)(A)(3), and
0
b. Revise paragraph (d)(1)(ii)(B)(3) to read as follows:
Sec. 520.1660d Oxytetracycline powder.
* * * * *
(d) * * *
(1) * * *
(ii) Turkeys--
(A) * * *
(3) Do not use in birds producing eggs for human consumption.
Withdraw 5 days prior to slaughter those products sponsored by Nos.
054771 and 061133 in Sec. 510.600(c) of this chapter. Withdraw 4 days
prior to slaughter those products sponsored by No. 016592. Zero-day
withdrawal for those products sponsored by Nos. 016592 and 069254.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
(B) * * *
(3) Do not use in birds producing eggs for human consumption.
Withdraw 5 days prior to slaughter those products sponsored by Nos.
054771 and 061133 in Sec. 510.600(c) of this chapter. Withdraw 4 days
prior to slaughter those products sponsored by No. 016592. Zero-day
withdrawal for those products sponsored by Nos. 016592 and 069254.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
* * * * *
Sec. 520.1705 [Amended]
0
13. In Sec. 520.1705, in paragraph (a), remove the text ``peroglide
(as pergolide mesylate)'' and in its place add the text ``pergolide (as
pergolide mesylate)'', and in paragraph (b), remove the text ``No.
000010'' and in its place add the text ``Nos. 000010 and 017033''.
0
14. In Sec. 520.1780, revise paragraph (c)(2) to read as follows:
Sec. 520.1780 Pimobendan tablets.
* * * * *
(c) * * *
(2) Indications for use. For the delay of onset of congestive heart
failure in dogs with Stage B2 preclinical myxomatous mitral valve
disease. Stage B2 preclinical myxomatous mitral valve disease (MMVD)
refers to dogs with asymptomatic MMVD that have a moderate or loud
mitral murmur due to mitral regurgitation and cardiomegaly. For the
management of the signs of mild, moderate, or severe congestive heart
failure in dogs due to clinical MMVD or dilated cardiomyopathy (DCM);
for use with concurrent therapy for congestive heart failure (e.g.,
[[Page 20342]]
furosemide, etc.,) as appropriate on a case-by-case basis.
* * * * *
0
15. In Sec. 520.1870:
0
a. Revise paragraphs (a) introductory text, revise paragraphs (a)(1)
and (2), and add paragraph (a)(3); and
0
b. Add paragraph (b)(3).
The revisions and additions read as follows:
Sec. 520.1870 Praziquantel tablets.
(a) Specifications.
(1) Each tablet contains 34 milligrams (mg) praziquantel.
(2) Each tablet contains 11.5 or 23 mg praziquantel.
(3) Each chewable tablet contains 23 mg praziquantel.
(b) * * *
(3) No. 086101 for use of product as described in paragraph (a)(3)
of this section as in paragraph (c)(2) of this section.
* * * * *
0
16. In Sec. 520.2075, revise paragraphs (a) and (b) to read as
follows:
Sec. 520.2075 Robenacoxib.
(a) Specifications. Each tablet contains:
(1) 10, 20, or 40 milligrams (mg) robenacoxib for use in dogs; or
(2) 6 mg robenacoxib for use in cats.
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter.
(1) No. 058198 for use of product described in paragraph (a)(1) and
(a)(2) of this section as in paragraph (c)(1) and (c)(2) of this
section.
(2) No. 086117 for use of product described in paragraph (a)(2) of
this section as in paragraph (c)(2) of this section.
* * * * *
Sec. 520.2345d [Amended]
0
17. In Sec. 520.2345d, in paragraph (d)(1)(iii), remove the text ``for
Nos. 016592, 054771, 054925, 057561, and 061133'' and in its place add
the text ``for Nos. 016592, 054771, 054925, and 061133'', and in
paragraph (d)(2)(iii), remove the text ``for Nos. 016592, 054771,
054925, 057561, and 061133'' and in its place add the text ``for Nos.
016592, 054771, 054925, and 061133''.
0
18. Add Sec. 520.2700 to read as follows:
Sec. 520.2700 Verdinexor tablets.
(a) Specifications. Each tablet contains 2.5, 10, 22.5, or 50
milligrams (mg) verdinexor.
(b) Sponsor. See No. 086121 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--
(1) Amount. Administer verdinexor tablets orally at an initial dose
of 1.25 mg per kilogram (mg/kg) of body weight twice per week with at
least 72 hours between doses. If tolerated after 2 weeks, increase the
dose to 1.5 mg/kg twice per week with at least 72 hours between doses.
(2) Indications for use. For the treatment of lymphoma in dogs.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian. It is a violation of Federal law
to use this product other than as directed in the labeling.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
19. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
20. Add Sec. 522.500 to read as follows:
Sec. 522.500 Cosyntropin injection.
(a) Sponsor. See No. 043264 in Sec. 510.600(c) of this chapter.
(b) Specifications. Each milliliter (mL) contains 0.25 milligrams
(mg) cosyntropin, 1 mg glacial acetic acid, 0.82 mg sodium acetate
trihydrate, 8.1 mg sodium chloride, and water for injection (to 100%).
(c) Conditions of use--
(1) Amount. Administer 0.25 mg (1 mL) per dog weighing 10-110
pounds (4.5-50 kilograms) by intravenous or intramuscular injection.
(2) Indications for use. For the evaluation of adrenal function in
dogs.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian. It is a violation of Federal law
to use this product other than as directed in the labeling.
Sec. 522.1315 [Amended]
0
21. In Sec. 522.1315, in paragraph (b), remove the text ``No. 054771''
and in its place add the text ``Nos. 054771 and 017033''.
0
22. In Sec. 522.2100, revise paragraph (c)(3)(i) to read as follows:
Sec. 522.2100 Selenium and vitamin E.
* * * * *
(c) * * *
(3) * * *
(i) Dosage. Calves: 2.5 to 3.75 milliliters per 100 pounds of body
weight. Lambs 2 weeks of age and older: 1 milliliter per 40 pounds of
body weight, minimum 1 milliliter. Ewes: 2.5 milliliters per 100 pounds
of body weight. Sows: 1 milliliter per 40 pounds of body weight.
Weanling pigs: 1 milliliter per 40 pounds of body weight, minimum 1
milliliter.
* * * * *
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
23. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 524.957 [Amended]
0
24. In Sec. 524.957, in paragraph (b), remove the text ``Nos. 017030
and 058198'' and in its place add the text ``Nos. 017030, 051072, and
058198''.
0
25. In Sec. 524.1044h, revise paragraph (c)(1) to read as follows:
Sec. 524.1044h Gentamicin, mometasone, and clotrimazole otic
suspension.
* * * * *
(c) * * *
(1) Amount. For dogs weighing less than 30 pounds (lb), instill 4
drops from the 7.5 gram (g), 15 g, or 30 g bottles (2 drops from the
215 g bottle) once daily into the ear canal. For dogs weighing 30 lb or
more, instill 8 drops from the 7.5 g, 15 g, or 30 g bottles (4 drops
from the 215 g bottle) once daily into the ear canal. Therapy should
continue for 7 consecutive days.
* * * * *
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
26. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
27. In Sec. 558.78, revise paragraph (d)(1)(vii) to read as follows:
Sec. 558.78 Bacitracin zinc.
* * * * *
(d) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Combination in
Bacitracin zinc in grams per ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(vii) 20 to 40.................... ................... Growing-finishing ....................... 054771
swine; improved
feed efficiency.
[[Page 20343]]
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
Sec. 558.175 [Amended]
0
28. In Sec. 558.175, in the table in paragraph (d)(1)(iii), in the
Sponsors column, replace the text ``054771'' and in its place add the
text ``066104''.
0
29. In Sec. 558.195,
0
a. In the tables in (e)(1), (e)(2), and (e)(3), in the ``Sponsor''
column, remove ``054771'' where it occurs, and in its place add
``066104''.
0
b. Revise paragraphs (e)(1)(ii), (e)(1)(iii), and (e)(2)(ii) to read as
follows:
Sec. 558.195 Decoquinate.
* * * * *
(e) * * *
(1) Chickens--
----------------------------------------------------------------------------------------------------------------
Combination in
Decoquinate in grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(ii) 27.2......................... Bacitracin (as Broiler chickens: Feed as the sole 066104
bacitracin For the prevention ration. Do not feed to
methylenedisalicyl of coccidiosis chickens producing
ate), 4 to 50. caused by Eimeria eggs for human
tenella, E. consumption. Do not
necatrix, E. use in feeds
acervulina, E. containing bentonite.
mivati, E. maxima, Bacitracin
and E. brunetti, methylenedisalicylate
and for increased as provided by No.
rate of weight 066104 in Sec.
gain and improved 510.600(c) of this
feed efficiency. chapter.
(iii) 27.2........................ Bacitracin zinc, 10 Broiler chickens: Feed as the sole 066104
to 50. For the prevention ration. Do not feed to
of coccidiosis chickens producing
caused by Eimeria eggs for human
tenella, E. consumption.
necatrix, E. Bacitracin zinc as
acervulina, E. provided by No. 054771
mivati, E. maxima, in Sec. 510.600(c)
and E. brunetti; of this chapter.
and for increased
rate of weight
gain and improved
feed efficiency.
----------------------------------------------------------------------------------------------------------------
(2) Cattle--
----------------------------------------------------------------------------------------------------------------
Combination in
Decoquinate in grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(ii) 12.9 to 90.8................. Monensin, 5 to 30.. Growing beef steers Feed as the sole ration 066104
and heifers fed in to provide 22.7 mg of
confinement for decoquinate per 100 lb
slaughter: For of body weight per day
prevention of and 50 to 360 mg of
coccidiosis caused monensin per head per
by Eimeria bovis day. Feed at least 28
and E. zuernii; days during periods of
and for improved coccidiosis exposure
feed efficiency. or when experience
indicates that
coccidiosis is likely
to be a hazard. Do not
feed to cows producing
milk for human
consumption. A
withdrawal period has
not been established
for this product in
pre-ruminant calves.
Do not use in calves
to be processed for
veal. Also see
paragraph (d)(1) of
this section and Sec.
558.355(d)(9)(i).
Monensin as provided
by No. 016592 or
058198 in Sec.
510.600(c) of this
chapter.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
30. In Sec. 558.305,
0
a. Retitle the section, and
0
b. Revise paragraphs (d)(1) through (d)(3), (e)(1), (e)(2), and (f), to
read as follows:
Sec. 558.305 Laidlomycin propionate potassium.
* * * * *
(d) * * *
(1) Laidlomycin propionate potassium Type B liquid medicated feeds
may be manufactured from dry laidlomycin propionate potassium Type A
medicated articles. The Type B liquid medicated feeds must have a pH of
6.0 to 8.0, dry matter of 62 to 75 percent, and bear appropriate mixing
directions as follows:
* * * * *
(2) The expiration date of the Type B liquid medicated feed is 21
days after date of manufacture. The expiration date for the dry Type C
medicated feed made from the Type B liquid medicated feed is 7 days
after date of manufacture.
(3) Labeling for all Type B medicated feeds (liquid and dry) and
Type C medicated feeds containing laidlomycin propionate potassium
shall bear the following statements:
* * * * *
(e) Conditions of use. It is used in growing beef steers and
heifers fed in confinement for slaughter as follows:
[[Page 20344]]
----------------------------------------------------------------------------------------------------------------
Laidlomycin propionate potassium Combination in
in grams per ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 5............................. ................... For increased rate Feed as the sole ration 066104
of weight gain and Type C medicated feeds
improved feed to provide 30 to 75 mg
efficiency. laidlomycin propionate
potassium per head per
day.
(2) 5-10.......................... ................... For improved feed Feed as the sole ration 066104
efficiency. Type C medicated feeds
to provide 30 to 150
mg laidlomycin
propionate potassium
per head per day.
----------------------------------------------------------------------------------------------------------------
(f) Laidlomycin propionate potassium may also be used in
combination with chlortetracycline as in Sec. 558.128.
0
31. In Sec. 558.325, revise paragraphs (a), (b), (d)(3)(i), (d)(4)(i),
(d)(4)(ii), (e)(1)(i), (e)(1)(iii), (e)(1)(iv), (e)(1)(vii),
(e)(1)(ix), (e)(1)(x), (e)(2)(i), (e)(2)(vii), (e)(2)(xii), and
(e)(2)(xiv) to read as follows:
Sec. 558.325 Lincomycin.
(a) Specifications. Type A medicated articles containing 20 or 50
grams of lincomycin (as lincomycin hydrochloride agricultural grade)
per pound.
(b) Sponsor. See No. 066104 in Sec. 510.600(c) of this chapter.
* * * * *
(d) * * *
(3) * * *
(i) ``Do not allow rabbits, hamsters, guinea pigs, horses, or
ruminants access to feeds containing lincomycin. Ingestion by these
species may result in severe gastrointestinal effects.''
* * * * *
(4) * * *
(i) ``Occasionally, swine fed lincomycin may within the first 2
days after the onset of treatment develop diarrhea and/or swelling of
the anus. On rare occasions, some pigs may show reddening of the skin
and irritable behavior. These conditions have been self-correcting
within 5 to 8 days without discontinuing the lincomycin treatment.''
(ii) ``The effects of lincomycin on swine reproductive performance,
pregnancy, and lactation have not been determined.''
(e) * * *
(1) Chickens--
----------------------------------------------------------------------------------------------------------------
Lincomycin (as lincomycin
hydrochloride agricultural grade) Combination in Indications for use Limitations Sponsor
grams/ton grams/ton
----------------------------------------------------------------------------------------------------------------
(i) 2............................. ................... Broiler chickens: Feed as the sole 066104
For the control of ration. Not for use in
necrotic enteritis laying hens, breeder
caused or chickens, or turkeys.
complicated by
Clostridium spp.
or other organisms
susceptible to
lincomycin.
* * * * * * *
(iii) 2........................... Clopidol, 113.5.... Broiler chickens: Feed as the sole ration 066104
As an aid in the to broiler chickens.
prevention of Do not feed to
coccidiosis caused chickens over 16 weeks
by Eimeria of age. Not for use in
tenella, E. laying hens, breeder
necatrix, E. chickens, or turkeys.
acervulina, E. Consult a veterinarian
maxima, E. or poultry pathologist
brunetti, and E. if losses exceed 0.5%
mivati, and for in a two-day period.
the control of Do not allow rabbits,
necrotic enteritis hamsters, guinea pigs,
caused or horses, or ruminants
complicated by access to feeds
Clostridium spp. containing lincomycin.
or other organisms Ingestion by these
susceptible to species may result in
lincomycin. severe
gastrointestinal
effects. Clopidol as
provided by No. 016592
in Sec. 510.600 of
this chapter.
(iv) 2............................ Decoquinate, 27.2.. Broiler chickens: Feed as the sole 066104
For the prevention ration. Do not feed to
of coccidiosis chickens producing
caused by Eimeria eggs for human
tenella, E. consumption. Do not
necatrix, E. use in feeds
acervulina, E. containing bentonite.
mivati, E. maxima, Not for use in laying
and E. brunetti, hens, breeding
and for the chickens, or turkeys.
control of Do not allow rabbits,
necrotic enteritis hamsters, guinea pigs,
caused or horses, or ruminants
complicated by access to feeds
Clostridium spp. containing lincomycin.
or other organisms Ingestion by these
susceptible to species may result in
lincomycin. severe
gastrointestinal
effects. Decoquinate
as provided by No.
066104 in Sec.
510.600 of this
chapter.
* * * * * * *
(vii) 2........................... Monensin, 90 to 110 Broiler chickens: Feed as the sole 066104
As an aid in the ration. Do not feed to
prevention of chickens producing
coccidiosis caused eggs for human
by Eimeria consumption. Do not
necatrix, E. feed to chickens over
tenella, E. 16 weeks of age. Not
acervulina, E. for use in laying
brunetti, E. hens, breeding
mivati, and E. chickens, or turkeys.
maxima, and for Do not allow horses,
the control of other equines, mature
necrotic enteritis turkeys, or guinea
caused or fowl access to feed
complicated by containing monensin.
Clostridium spp. Ingestion of monensin
or other organisms by horses and guinea
susceptible to fowl has been fatal.
lincomycin in Do not allow rabbits,
broiler chickens hamsters, guinea pigs,
up to 16 weeks of horses, or ruminants
age. access to feeds
containing lincomycin.
Ingestion by these
species may result in
severe
gastrointestinal
effects. Not for
broiler breeder
replacement chickens.
In the absence of
coccidiosis in broiler
chickens, the use of
monensin with no
withdrawal period may
limit feed intake,
resulting in reduced
weight gain. Do not
use this medicated
feed after 90 days
from the date of
manufacture. Monensin
as provided by No.
058198 in Sec.
510.600 of this
chapter.
[[Page 20345]]
* * * * * * *
(ix) 2............................ Salinomycin sodium Broiler chickens: Feed as the sole ration 066104
activity, 40 to 60. For the prevention to broiler chickens.
of coccidiosis Do not feed to
caused by Eimeria chickens producing
tenella, E. eggs for human
necatrix, E. consumption. Not for
acervulina, E use in laying hens,
maxima, E. breeding chickens, or
brunetti, and E. turkeys. May be fatal
mivati, and for if accidentally fed to
the control of adult turkeys or
necrotic enteritis horses. Do not allow
caused or rabbits, hamsters,
complicated by guinea pigs, horses,
Clostridium spp. or ruminants access to
or other organisms feeds containing
susceptible to lincomycin. Ingestion
lincomycin. by these species may
result in severe
gastrointestinal
effects. Do not use in
Type C medicated feeds
containing pellet
binders. Salinomycin
sodium activity as
provided by No. 016592
in Sec. 510.600 of
this chapter.
(x) 2............................. Zoalene, 113.5..... Broiler chickens: Feed as the sole ration 066104
For prevention and from the time chicks
control of are placed in floor
coccidiosis and pens until slaughtered
for the control of for meat. Not for use
necrotic enteritis in laying hens,
caused or breeding chickens, or
complicated by turkeys. Consult a
Clostridium spp. veterinarian or
or other organisms poultry pathologist if
susceptible to losses exceed 0.5% in
lincomycin in a two-day period. Do
broiler chickens. not allow rabbits,
hamsters, guinea pigs,
horses, or ruminants
access to feeds
containing lincomycin.
Ingestion by these
species may result in
severe
gastrointestinal
effects. Zoalene as
provided by No. 066104
in Sec. 510.600 of
this chapter.
----------------------------------------------------------------------------------------------------------------
(2) Swine--
----------------------------------------------------------------------------------------------------------------
Lincomycin (as lincomycin
hydrochloride agricultural grade) Combination in Indications for use Limitations Sponsor
grams/ton grams/ton
----------------------------------------------------------------------------------------------------------------
(i) 40............................ ................... For the control of Feed as sole ration. 066104
swine dysentery For use in swine on
and the control of premises with a
porcine history of swine
proliferative dysentery but where
enteropathies symptoms have not yet
(ileitis) caused occurred, or following
by Lawsonia use of lincomycin at
intracellularis. 100 grams (g)/ton for
the treatment of swine
dysentery and the
control of porcine
proliferative
enteropathies
(ileitis).
* * * * * * *
(vii) 100......................... ................... For the treatment Feed as a sole ration 066104
of swine dysentery for 3 weeks or until
and the control of signs of disease
porcine (watery, mucoid, or
proliferative bloody stools)
enteropathies disappear.
(ileitis) caused
by Lawsonia
intracellularis.
* * * * * * *
(xii) 100 to 200.................. ................... For reduction in Feed as sole ration for 066104
the severity of 21 days.
the effects of
respiratory
disease associated
with Mycoplasma
hyopneumoniae.
* * * * * * *
(xiv) 200......................... Pyrantel tartrate, For reduction in Feed as the sole ration 066104
96. the severity of for 21 days. Not for
the effects of use in swine that
respiratory weigh more than 250
disease associated pounds. Withdraw 6
with Mycoplasma days before slaughter.
hyopneumoniae; to Lincomycin as provided
aid in the by No. 066104;
prevention of pyrantel tartrate as
migration and provided by No. 066104
establishment of in Sec. 510.600(c)
large roundworm of this chapter.
(Ascaris suum)
infections; and to
aid in the
prevention of
establishment of
nodular worm
(Oesophagostomum
spp.) infections
in swine.
----------------------------------------------------------------------------------------------------------------
0
32. In Sec. 558.363,
0
a. Revise paragraph (e)(1)(ii);
0
b. Redesignate paragraphs (e)(1)(iii) and (e)(1)(iv) as (e)(1)(v) and
(e)(1)(vi) respectively;
0
c. Add new paragraphs (e)(1)(iii) and (e)(1)(iv); and
0
d. Revise newly redesignated paragraph (e)(1)(v).
The revision and addition read as follows:
Sec. 558.363 Narasin.
* * * * *
(e) * * *
(1) Chickens--
[[Page 20346]]
----------------------------------------------------------------------------------------------------------------
Combination in
Narasin grams/ton grams/ton Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(ii) 54 to 72..................... Bacitracin (as feed Broiler chickens: Feed as the sole 066104
grade bacitracin For the prevention ration. The narasin
methylenedisalicyl of coccidiosis concentration should
ate), 10 to 50. caused by Eimeria be adjusted to meet
necatrix, E. the severity of the
tenella, E. coccidial challenge,
acervulina, E. which varies with
brunetti, E. environmental and
mivati, and E. management conditions.
maxima, and for Do not allow adult
increased rate of turkeys, horses, or
weight gain and other equines access
improved feed to narasin
efficiency. formulations.
Ingestion of narasin
by these species has
been fatal. Bacitracin
methylenedisalicylate
as provided by No.
066104 in Sec.
510.600(c) of this
chapter.
(iii) 54 to 90.................... Bacitracin (as feed Broiler chickens: Feed as the sole ration 069254
grade bacitracin For increased rate throughout the feeding
methylenedisalicyl of weight gain and period. The narasin
ate), 4 to 50. improved feed concentration should
efficiency, and be adjusted to meet
for the prevention the severity of the
of coccidiosis coccidial challenge,
caused by Eimeria which varies with
necatrix, E. environmental and
tenella, E. management conditions.
acervulina, E. Do not allow adult
brunetti, E. turkeys, horses, or
mivati, and E. other equines access
maxima. to narasin
formulations.
Ingestion of narasin
by these species has
been fatal. Bacitracin
methylenedisalicylate
as provided by No.
069254 in Sec.
510.600(c) of this
chapter.
(iv) 54 to 90..................... Bacitracin (as feed Broiler chickens: Feed as the sole ration 069254
grade bacitracin For the prevention for 28 to 35 days,
methylenedisalicyl of mortality starting from the time
ate), 50. caused by necrotic chicks are placed for
enteritis brooding. The narasin
associated with concentration should
Clostridium be adjusted to meet
perfringens, and the severity of the
for the prevention coccidial challenge,
of coccidiosis which varies with
caused by Eimeria environmental and
necatrix, E. management conditions.
tenella, E. Do not allow adult
acervulina, E. turkeys, horses, or
brunetti, E. other equines access
mivati, and E. to narasin
maxima. formulations.
Ingestion of narasin
by these species has
been fatal. Bacitracin
methylenedisalicylate
as provided by No.
069254 in Sec.
510.600(c) of this
chapter.
(v) 54 to 72...................... Bacitracin (as feed Broiler chickens: Feed as the sole 066104
grade bacitracin For the prevention ration. The narasin
zinc), 4 to 50. of coccidiosis concentration should
caused by Eimeria be adjusted to meet
necatrix, E. the severity of the
tenella, E. coccidial challenge,
acervulina, E. which varies with
brunetti, E. environmental and
mivati, and E. management conditions.
maxima, and for Do not allow adult
increased rate of turkeys, horses, or
weight gain and other equines access
improved feed to narasin
efficiency. formulations.
Ingestion of narasin
by these species has
been fatal. Bacitracin
zinc as provided by
No. 054771 in Sec.
510.600(c) of this
chapter.
(vi) 54 to 72..................... Bambermycins, 1 to Broiler chickens: For broiler chickens 016592
2. For prevention of only. Feed
coccidiosis caused continuously as sole
by Eimeria ration. Do not allow
necatrix, E. adult turkeys, horses,
tenella, E. or other equines
acervulina, E. access to narasin
brunetti, E. formulations.
mivati, and E. Ingestion of narasin
maxima, and for by these species has
increased rate of been fatal.
weight gain and Bambermycins as
improved feed provided by No. 016592
efficiency. in Sec. 510.600(c)
of this chapter.
----------------------------------------------------------------------------------------------------------------
* * * * *
0
33. In Sec. 558.500,
0
a. Revise paragraphs (b)(2), (d)(1), and (d)(2)(i) and (ii),
0
b. Add new paragraphs (d)(2)(iii) and (d)(6),
0
c. Revise the heading in the first column in (e)(1) through (3),
0
d. In the tables in (e)(1) and (e)(2), in the ``Sponsor'' column,
remove ``054771'' where it occurs, and in its place add ``066104'', and
0
e. Revise paragraphs (e)(1)(i), (e)(2)(i), (e)(2)(iii), (e)(2)(vi), and
(e)(3).
The revisions and additions read as follows:
Sec. 558.500 Ractopamine.
* * * * *
(b) * * *
(1) * * *
(2) Nos. 051311 and 066104: Type A medicated articles containing
45.4 g/lb ractopamine hydrochloride.
* * * * *
(d) Special considerations.
(1) Labeling of Type A medicated articles and Type B and Type C
feeds shall bear the following: ``Not for use in animals intended for
breeding.''
(2) Labeling of Type A medicated articles and Type B and Type C
medicated feeds intended for swine shall bear the following:
(i) ``No increased benefit has been shown when ractopamine
hydrochloride concentrations in the diet are greater than 4.5 g/ton (5
ppm).''
(ii) ``Ractopamine hydrochloride use may increase the number of
injured, lame, and/or fatigued pigs during marketing. Behavioral signs
such as hyperactivity, anxiety, and aggression have been reported in
pigs fed ractopamine hydrochloride.''
(iii) ``Additional Recommendations: To help mitigate the signs
identified in the Animal Safety Warnings section, see the Pork Quality
Assurance (PQA Plus) and Transport Quality Assurance (TQA)
recommendations for best practices in swine care during handling,
transport, and marketing.''
* * * * *
(6) Labeling of Type A medicated articles and Type B and Type C
medicated feeds intended for cattle feeds shall bear the following:
(i) ``Behavioral signs such as agitation and decreased feed
consumption have been reported in cattle fed ractopamine
hydrochloride.''
[[Page 20347]]
(ii) ``Additional Recommendations: See the Beef Quality Assurance
(BQA) recommendations for best practices in cattle care and handling
during ractopamine hydrochloride feeding, transport, and marketing to
help mitigate the behavioral signs stated in the Animal Safety Warnings
section above.''
(e) * * *
(1) Swine--
----------------------------------------------------------------------------------------------------------------
Ractopamine hydrochloride in grams/ Combination in
ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 4.5 to 9.0.................... ................... For increased rate Not for use in swine 016592
of weight gain, intended for breeding. 066104
improved feed Feed as sole ration. 058198
efficiency, and
increased carcass
leanness in
finishing swine,
weighing at least
150 lb, fed a
complete ration
containing at
least 16% crude
protein for the
last 45 to 90 lb
of gain prior to
slaughter.
(ii) Reserved.....................
----------------------------------------------------------------------------------------------------------------
(2) Cattle--
----------------------------------------------------------------------------------------------------------------
Ractopamine hydrochloride in grams/ Combination in
ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 8.2 to 24.6................... ................... For increased rate Feed as the sole ration 016592
of weight gain and to provide 70 to 430 051311
improved feed mg of ractopamine 066104
efficiency in hydrochloride per head 058198
growing beef per day during the
steers and heifers last 28 to 42 days on
fed in confinement feed. Not for use in
for slaughter cattle intended for
during the last 28 breeding.
to 42 days on feed.
* * * * * * *
(iii) 9.8 to 24.6................. ................... For increased rate Feed as the sole ration 016592
of weight gain, to provide 90 to 430 051311
improved feed mg ractopamine 066104
efficiency, and hydrochloride per head 058198
increased carcass per day during the
leanness in last 28 to 42 days on
growing beef feed. Not for use in
steers and heifers cattle intended for
fed in confinement breeding.
for slaughter
during the last 28
to 42 days on feed.
* * * * * * *
(vi) 100 to 800................... ................... For increased rate Feed a minimum of 1 lb 016592
of weight gain and per head per day of 051311
improved feed Type C top-dress 066104
efficiency in medicated feed to 058198
growing beef provide 70 to 400 mg
steers and heifers ractopamine
fed in confinement hydrochloride per head
for slaughter per day during the
during the last 28 last 28 to 42 days on
to 42 days on feed. feed. Not for use in
cattle intended for
breeding.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
(3) Turkeys--
----------------------------------------------------------------------------------------------------------------
Ractopamine hydrochloride in grams/ Combination in
ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
Sec. 558.575 [Amended]
0
34. In Sec. 558.575,
0
a. In paragraph (e)(1)(i) and (ii), in the column ``Indications for
Use'', remove the text ``Heterakis gallinarum'' and in its place add
the text ``Haemophilus gallinarum'', and
0
b. In paragraph (e)(1)(i) and (ii), in the column ``Sponsor'', remove
the text ``054771'' and in its place add the text ``066104''.
0
35. In Sec. 558.625, revise paragraph (e)(2)(vi) to read as follows:
Sec. 558.625 Tylosin.
* * * * *
(e) * * *
(2) Cattle--
[[Page 20348]]
----------------------------------------------------------------------------------------------------------------
Combination in
Tylosin grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(vi) 8 to 10...................... Monensin, 5 to 30 Growing beef steers Feed as the sole ration 016592
plus decoquinate, and heifers fed in to provide 22.7 mg of 066104
13.6 to 27.2. confinement for decoquinate per 100
slaughter: For the lb. of body weight per
prevention of day, 50 to 360 mg of
coccidiosis caused monensin per head per
by Eimeria bovis day, and 60 to 90 mg
and E. zuernii, tylosin (as tylosin
for improved feed phosphate). Feed for
efficiency, and at least 28 days
for the reduction during periods of
of incidence of coccidiosis exposure
liver abscesses or when experience
associated with indicates that
Fusobacterium coccidiosis is likely
necrophorum and to be a hazard. Do not
Arcanobacterium allow horses or other
pyogenes. equines access to feed
containing monensin.
Ingestion of monensin
by horses has been
fatal. Monensin
medicated cattle feed
is safe only for use
in cattle. Consumption
by unapproved species
may result in toxic
reactions. Do not
exceed the levels of
monensin recommended
in the feeding
directions, as reduced
average daily gains
may result. If feed
refusals containing
monensin are fed to
other groups of
cattle, the
concentration of
monensin in the
refusals and amount of
refusals fed should be
taken into
consideration to
prevent monensin
overdosing. Do not use
in feeds containing
bentonite. Do not feed
to cows producing milk
for food. A withdrawal
period has not been
established for this
product in pre-
ruminating calves. Do
not use in calves to
be processed for veal.
Tylosin as provided by
No. 016592 or 058198;
monensin as provided
by No. 016592 or
058198; decoquinate as
provided by No. 058198
in Sec. 510.600(c)
of this chapter. See
Sec. Sec.
558.311(d) and
558.355(d).
* * * * * * *
----------------------------------------------------------------------------------------------------------------
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-07500 Filed 4-15-26; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on April 16, 2026.
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