cfr 2000 title21 vol6 part558

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21 CFR Ch. I (4100 Edition)Pt. 558

PART 558NEW ANIMAL DRUGSFOR USE IN ANIMAL FEEDS

Subpart AGeneral Provisions

Sec.558.3 Definitions and general considerations

applicable to this part.558.4 Requirement of a medicated feed mill

license.558.5 New animal drug requirements for liq-

uid Type B feeds.558.15 Antibiotic, nitrofuran, and sul-

fonamide drugs in the feed of animals.

Subpart BSpecific New Animal Drugs ForUse in Animal Feeds

558.35 Aklomide.558.55 Amprolium.558.58 Amprolium and ethopabate.558.59 Apramycin.558.60 Arsanilate sodium.558.62 Arsanilic acid.558.76 Bacitracin methylene disalicylate.558.78 Bacitracin zinc.558.95 Bambermycins.558.105 [Reserved]558.115 Carbadox.558.120 Carbarsone (not U.S.P.).558.128 Chlortetracycline.558.140 Chlortetracycline and

sulfamethazine.558.145 Chlortetracycline, procaine peni-

cillin, and sulfamethazine.558.155 Chlortetracycline, sulfathiazole,

penicillin.558.175 Clopidol.558.185 Coumaphos.558.195 Decoquinate.558.198 Diclazuril.558.205 Dichlorvos.558.235 Efrotomycin.558.248 Erythromycin thiocyanate.558.254 Famphur.558.258 Fenbendazole.558.265 Halofuginone hydrobromide.558.274 Hygromycin B.558.295 Iodinated casein.558.300 Ivermectin.558.305 Laidlomycin propionate potassium.558.311 Lasalocid.558.315 Levamisole hydrochloride (equiva-

lent).558.325 Lincomycin.558.340 Maduramicin ammonium.558.342 Melengestrol acetate.558.348 Mibolerone.558.355 Monensin.558.360 Morantel tartrate.558.363 Narasin.558.364 Neomycin sulfate.558.365 Nequinate.558.366 Nicarbazin.558.369 Nitarsone.558.376 Nitromide and sulfanitran.

558.415 Novobiocin.558.430 Nystatin.558.435 Oleandomycin.558.450 Oxytetracycline.558.460 Penicillin.558.464 Poloxalene.558.465 Poloxalene free-choice liquid Type C

feed.558.485 Pyrantel tartrate.558.500 Ractopamine.558.515 Robenidine hydrochloride.558.530 Roxarsone.558.550 Salinomycin.558.555 Semduramicin.558.575 Sulfadimethoxine, ormetoprim.558.579 Sulfaethoxypyridazine.558.582 Sulfamerazine.558.586 Sulfaquinoxoline.558.600 Tiamulin.558.615 Thiabendazole.558.618 Tilmicosin.558.625 Tylosin.558.630 Tylosin and sulfamethazine.558.635 Virginiamycin.558.680 Zoalene.

AUTHORITY: 21 U.S.C. 360b, 371.

SOURCE: 40 FR 13959, Mar. 27, 1975, unlessotherwise noted.

Subpart AGeneral Provisions

558.3 Definitions and general consid-erations applicable to this part.

(a) Regulations in this part providefor approved uses of drugs and com-binations of drugs in animal feeds. Ap-proved combinations of such drugs arespecifically identified or incorporatedby cross-reference. Unless specificallyprovided for by the regulations, a com-bination of two or more drugs is notapproved.

(b) The following definitions apply toterms used in this part:

(1) New animal drugs approved foruse in animal feed are placed in twocategories as follows:

(i) Category IThese drugs requireno withdrawal period at the lowest uselevel in each species for which they areapproved.

(ii) Category IIThese drugs requirea withdrawal period at the lowest uselevel for at least one species for whichthey are approved or are regulated on a``no-residue'' basis or with a ``zero'' tol-erance because of a carcinogenic con-cern regardless whether a withdrawalperiod is required.

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355

Food and Drug Administration, HHS 558.4

(2) A ``Type A medicated article'' isintended solely for use in the manufac-ture of another Type A medicated arti-cle or a Type B or Type C medicatedfeed. It consists of a new animaldrug(s), with or without carrier (e.g.,calcium carbonate, rice hull, corn, glu-ten) with or without inactive ingredi-ents. The manufacture of a Type Amedicated article requires an applica-tion approved under 514.105 of thischapter.

(3) A ``Type B medicated feed'' is in-tended solely for the manufacture ofother medicated feeds (Type B or TypeC). It contains a substantial quantityof nutrients including vitamins and/orminerals and/or other nutritional in-gredients in an amount not less than 25percent of the weight. It is manufac-tured by diluting a Type A medicatedarticle or another Type B medicatedfeed. The maximum concentration ofanimal drug(s) in a Type B medicatedfeed is 200 times the highest continuoususe level for Category I drugs and 100times the highest continuous use levelfor Category II drugs. The term ``high-est continuous use level'' means thehighest dosage at which the drug is ap-proved for continuous use (14 days ormore), or, if the drug is not approvedfor continuous use, it means the high-est level used for disease prevention orcontrol. If the drug is approved formultiple species at different use levels,the highest approved level of use wouldgovern under this definition. The man-ufacture of a Type B medicated feedfrom a Category II, Type A medicatedarticle requires a medicated feed milllicense application approved under 515.20 of this chapter.

(4) A ``Type C medicated feed'' is in-tended as the complete feed for the ani-mal or may be fed ``top dressed'' (addedon top of usual ration) on or offered``free-choice'' (e.g., supplement) in con-junction with other animal feed. Itcontains a substantial quantity of nu-trients including vitamins, minerals,

and/or other nutritional ingredients. Itis manufactured by diluting a Type Amedicated article or a Type B medi-cated feed. A Type C medicated feedmay be further diluted to produce an-other Type C medicated feed. The man-ufacture of a Type C medicated feedfrom a Category II, Type A medicatedarticle requires a medicated feed milllicense application approved under 515.20 of this chapter.

(5) A Type B or Type C medicatedfeed manufactured from a drug compo-nent (bulk or ``drum-run'' (dried crudefermentation product)) requires an ap-plication approved under 514.105 ofthis chapter.

[51 FR 7392, Mar. 3, 1986, as amended at 52 FR2682, Jan. 26, 1987; 54 FR 51386, Dec. 15, 1989;56 FR 19268, Apr. 26, 1991; 64 FR 63206, Nov. 19,1999]

558.4 Requirement of a medicatedfeed mill license.

(a) A feed manufacturing facilitymust possess a medicated feed mill li-cense in order to manufacture a Type Bor Type C medicated feed from a Cat-egory II, Type A medicated article.

(b) The manufacture of the followingtypes of feed are exempt from the re-quired license, unless otherwise speci-fied:

(1) Type B or Type C medicated feedusing Category I, Type A medicated ar-ticles or Category I, Type B or Type Cmedicated feeds; and

(2) Type B or Type C medicated feedusing Category II, Type B or Type Cmedicated feeds.

(c) The use of Type B and Type Cmedicated feeds shall also conform tothe conditions of use provided for insubpart B of this part and in 510.515and 558.15 of this chapter.

(d) This paragraph identifies eachdrug by category, the maximum levelof drug in Type B medicated feeds, andthe assay limits for the drug in Type Amedicated articles and Type B andType C medicated feeds, as follows:

CATEGORY I

DrugAssay limits

percent 1 typeA

Type B maximum (200x) Assay limits percent 1type B/C 2

Aklomide .................................................. 90110 22.75 g/lb (5.0%) ..................................... 85120.Amprolium with Ethopabate .................... 94114 22.75 g/lb (5.0%) ..................................... 80120.Bacitracin methylene disalicylate ............ 85115 25.0 g/lb (5.5%) ....................................... 70130.


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21 CFR Ch. I (4100 Edition) 558.4

CATEGORY IContinued

DrugAssay limits

percent 1 typeA

Type B maximum (200x) Assay limits percent 1type B/C 2

Bacitracin zinc ......................................... 84115 5.0 g/lb (1.1%) ......................................... 70130.Bambermycins ......................................... 90110 800 g/ton (0.09%) .................................... 80120/70130.Buquinolate .............................................. 90110 9.8 g/lb (2.2%) ......................................... 80120.Chlortetracycline ...................................... 85115 40.0 g/lb (8.8%) ....................................... 80115/70130.Coumaphos ............................................. 95115 6.0 g/lb (1.3%) ......................................... 80120.Decoquinate ............................................ 90105 2.72 g/lb (0.6%) ....................................... 80120.Dichlorvos ................................................ 100115 33.0 g/lb (7.3%) ....................................... 90120/80130.Diclazuril .................................................. 90110 182 g/t (0.02%) ........................................ 85115/70120.Efrotomycin .............................................. 94113 1.45 g/lb (0.32%) ..................................... 80120.Erythromycin (thiocyanate salt) ............... 85115 9.25 g/lb (2.04%) ..................................... 20g/ton 75125.Iodinated casein ...................................... 85115 20.0 g/lb (4.4%) ....................................... 75125.Laidlomycin propionate potassium .......... 90110 1 g/lb (0.22%) .......................................... 90115/85115.Lasalocid ................................................. 95115 40.0 g/lb (8.8%) ....................................... Type B (cattle and

sheep): 80120; TypeC (all): 75125.

Lincomycin ............................................... 90115 20.0 g/lb (4.4%) ....................................... 80130.Melengestrol acetate ............................... 90110 10.0 g/ton (0.0011%) ............................... 70120.Monensin ................................................. 90110 40.0 g/lb (8.8%) ....................................... Chickens, turkeys, and

quail: 75125; Cattle:510 g/ton 80120;Cattle: 1030 g/ton 85115; Goats: 20 g/ton85115; Liq. feed: 80120.

Narasin .................................................... 90110 7.2 g/lb (1.6%) ......................................... 85115/75125.Nequinate ................................................ 95112 1.83 g/lb (0.4%) ....................................... 80120.Niclosamide ............................................. 85120 225g/lb (49.5%) ....................................... 80120.Nystatin .................................................... 85125 5.0 g/lb (1.1%) ......................................... 75125.Oleandomycin .......................................... 85120 1.125 g/lb (0.25%) ................................... 11.25 g/ton 75125.Oxytetracycline ........................................ 90120 20.0 g/lb (4.4%) ....................................... 75125/65135.Penicillin .................................................. 80120 10.0 g/lb (2.2%) ....................................... 65135.Poloxalene ............................................... 90110 54.48 g/lb (12.0%) ................................... Liq. feed: 85115.Ractopamine ........................................... 85105 1.8 g/lb (0.4%) ......................................... 80110.Salinomycin ............................................. 95115 6.0 g/lb (1.3%) ......................................... 80120.Semduramicin .......................................... 90110 2.25 g/lb (0.50%) ..................................... 80110.Tiamulin ................................................... 113.4 g/lb,

1001083.5 g/lb (0.8%) ......................................... 90115.

5 and 10 g/1b, 90115

.................................................................. 70130.

Tylosin ..................................................... 80120 10.0 g/lb (2.2%) ....................................... 75125.Virginiamycin ........................................... 85115 10.0 g/lb (2.2%) ....................................... 70130.Zoalene .................................................... 92104 11.35 g/lb (2.5%) ..................................... 85115.

1 Percent of labeled amount.2 Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limits, the

first set is for a Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have beenassigned in order to provide for the possibility of dilution of a Type B medicated feed with lower assay limits to make Type Cmedicated feed.

CATEGORY II

DrugAssay limits

percent 1Type A

Type B maximum (100x) Assay limits percent 1Type B/C 2

Amprolium ............................................... 94114 11.35 g/lb (2.5%) ..................................... 80120.Apramycin ................................................ 88112 7.5 g/lb (1.65%) ....................................... 80120.Arsanilate sodium .................................... 90110 4.5 g/lb (1.0%) ......................................... 85115/75125.Arsanilic acid ........................................... 90110 4.5 g/lb (1.0%) ......................................... 85115/75125.Carbadox ................................................. 90110 2.5 g/lb (0.55%) ....................................... 75125.Carbarsone .............................................. 93102 17.0 g/lb (3.74%) ..................................... 85115.Clopidol .................................................... 94106 11.4 g/lb (2.5%) ....................................... 90115/80120.Famphur .................................................. 100110 5.5 g/lb (1.21%) ....................................... 90115/80120.Fenbendazole .......................................... 93113 8.87 g/lb (1.96%) ..................................... 75125Halofuginone hydrobromide .................... 90115 272.0 g/ton (.03%) ................................... 75125.Hygromycin B .......................................... 90110 1,200 g/ton (0.13%) ................................. 75125.Ivermectin ................................................ 95105 1,180 g/ton (0.13%) ................................. 80110.Levamisole .............................................. 85120 113.5 g/lb (25%) ...................................... 85125.Maduramicin ammonium ......................... 90110 545 g/ton (.06%) ...................................... 80120.


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CATEGORY IIContinued

DrugAssay limits

percent 1Type A

Type B maximum (100x) Assay limits percent 1Type B/C 2

Morantel tartrate ...................................... 90110 66.0 g/lb (14.52%) ................................... 85115.Neomycin ................................................. 80120 7.0 g/lb (1.54%) ....................................... 70125.

Oxytetracycline .................................... 80120 10.0 g/lb (2.2%) ....................................... 65135.Neomycin sulfate ..................................... 80120 100 g/lb (22.0%) ...................................... 70125.Nicarbazin (granular) ............................... 90110 5.675 g/lb (1.25%) ................................... 85115/75125

Narasin ................................................. 90110 5.675 g/lb (1.25%) ................................... 85115/75125Nicarbazin (powder) ................................ 98106 5.675 g/lb (1.25%) ................................... 85115/80120Nitarsone ................................................. 90110 8.5 g/lb (1.87%) ....................................... 85120.Nitromide ................................................. 90110 11.35 g/lb (2.5%) ..................................... 80120.

Sulfanitran ............................................ 85115 13.6 g/lb (3.0%) ....................................... 75125.Nitromide ................................................. 90110 11.35 g/lb (2.5%) ..................................... 85115.

Sulfanitran ............................................ 85115 5.65 g/lb (1.24%) ..................................... 75125.Roxarsone ............................................ 90110 2.275 g/lb (0.5%) ..................................... 85120.

Novobiocin ............................................... 85115 17.5 g/lb (3.85%) ..................................... 80120.Pyrantel tartrate ....................................... 90110 36 g/lb (7.9%) .......................................... 75125.Robenidine .............................................. 95115 1.5 g/lb (0.33%) ....................................... 80120.Ronnel ..................................................... 85115 27.2 g/lb (6.0%) ....................................... 80120.Roxarsone ............................................... 90110 2.275 g/lb (0.5%) ..................................... 85120.Roxarsone ............................................... 90110 2.275 g/lb (0.5%) ..................................... 85120.

Aklomide .............................................. 90110 11.35 g/lb (2.5%) ..................................... 85120.Roxarsone ............................................... 90110 2.275 g/lb (0.5%) ..................................... 85120.

Clopidol ................................................ 94106 11.35 g/lb (2.5%) ..................................... 80120.Bacitracin methylene disalicylate ......... 85115 5.0 g/lb (1.1%) ......................................... 70130.

Roxarsone ............................................... 90110 2.275 g/lb (0.5%) ..................................... 85120.Monensin ............................................. 90110 5.5 g/lb (1.2%) ......................................... 75125.

Sulfadimethoxine ..................................... 95115 5.675 g/lb (1.25%) ................................... 85115/75125.Ormetoprim (5/3) ................................. 95115 3.405 g/lb (0.75%) ................................... 85115.

Sulfadimethoxine ..................................... 95115 85.1 g/lb (18.75%) ................................... 85115/75125.Ormetoprim (5/1) ................................. 95115 17.0 g/lb (3.75%) ..................................... 85115.

Sulfaethoxypyridazine ............................. 95105 50.0 g/lb (11.0%) ..................................... 85115.Sulfamerazine .......................................... 85115 18.6 g/lb (4.0%) ....................................... 85115.Sulfamethazine ........................................ 85115 10.0 g/lb (2.2%) ....................................... 80120.

Chlortetracycline .................................. 85115 10.0 g/lb (2.2%) ....................................... 85125/70130.Penicillin ............................................... 85115 5.0 g/lb (1.1%) ......................................... 85125/70130.

Sulfamethazine ........................................ 85115 10.0 g/lb (2.2%) ....................................... 80120.Chlortetracycline .................................. 85115 10.0 g/lb (2.2%) ....................................... 85125/70130.

Sulfamethazine ........................................ 85115 10.0 g/lb (2.2%) ....................................... 80120.Tylosin .................................................. 80120 10.0 g/lb (2.2%) ....................................... 75125.

Sulfanitran ............................................... 85115 13.6 g/lb (3.0%) ....................................... 75125.Aklomide .............................................. 90110 11.2 g/lb (2.5%) ....................................... 85120.

Sulfanitran ............................................... 85115 13.6 g/lb (3.0%) ....................................... 75125.Aklomide .............................................. 90110 11.2 g/lb (2.5%) ....................................... 85120.Roxarsone ............................................ 90110 2.715 g/lb (0.60%) ................................... 85120.

Sulfanitran ............................................... 85115 13.6 g/lb (3.0%) ....................................... 75125.Aklomide .............................................. 90110 11.2 g/lb (2.5%) ....................................... 85120.Roxarsone ............................................ 90110 2.27 g/lb (0.5%) ....................................... 85120.

Sulfaquinoxaline ...................................... 98106 11.2 g/lb (2.5%) ....................................... 85115.Sulfathiazole ............................................ 85115 10.0 g/lb (2.2%) ....................................... 80120.

Chlortetracycline .................................. 85125 10.0g/lb (2.2%) ........................................ 70130.Penicillin ............................................... 80120 5.0 g/lb (1.1%) ......................................... 70130.

Thiabendazole ......................................... 94106 45.4 g/lb (10.0%) ..................................... >7% 85115;

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21 CFR Ch. I (4100 Edition) 558.5

558.5 New animal drug requirementsfor liquid Type B feeds.

(a) Information available to the Com-missioner of Food and Drugs showsthat certain drugs are unstable whenadded to some liquid Type B medicatedfeeds. The demonstrated instability ofthese drugs gives rise to the questionof the stability of other drugs whenadded to liquid Type B medicatedfeeds, except where specific approvalhas been granted for such use. There-fore, the labeling of a drug to providefor its use in a liquid Type B medicatedfeed causes the drug to be a new animaldrug for such use for which an ap-proved new animal drug application isrequired pursuant to section 512(b) ofthe Federal Food, Drug, and CosmeticAct.

(b) The addition of a drug to a liquidType B medicated feed causes suchType B feed to become an animal feedbearing or containing a new animaldrug for which an approved applicationis required pursuant to section 512(m)of the act.

(c) Each drug product, intended fororal administration to animals, whichcontains any of the drugs listed inparagraph (d) of this section and whichbears labeling for its use in animal feedand/or drinking water shall also in-clude in such labeling the followingstatement: ``FOR USE IN ONLY. NOT FOR USE IN LIQUIDTYPE B MEDICATED FEEDS,'' theblank being filled in with the words``DRY FEEDS,'' ``DRINKING WATER,''``DRY FEEDS AND DRINKINGWATER'' as applicable, unless:

(1) Such drug product is the subjectof an approved new animal drug appli-cation providing for its use in liquidType B medicated feeds, or;

(2) The labeling provisions of thisparagraph have been waived on thebasis of approval of a petition which in-cludes a copy of the product label; a de-scription of the formulation; and infor-mation which establishes that thephysical, chemical, or other propertiesof the particular drug product are suchthat it cannot reasonably be expectedto be diverted for use in liquid Type Bmedicated feeds. Such petitions shallbe submitted to the Food and Drug Ad-ministration, Center for Veterinary

Medicine, 7500 Standish Pl., Rockville,MD 20855.

(d) The labeling provisions of para-graph (c) of this section apply to allforms of bacitracin, oxytetracycline,and chlortetracycline.

(e) For any drug which is the subjectof an approved new animal drug appli-cation, the labeling provisions of para-graph (c) of this section may be imple-mented without prior approval as pro-vided for in 514.8(d) and (e) of thischapter.

[40 FR 13959, Mar. 27, 1975, as amended at 52FR 2684, Jan. 26, 1987; 57 FR 6475, Feb. 25,1992]

558.15 Antibiotic, nitrofuran, and sul-fonamide drugs in the feed of ani-mals.

(a) The Commissioner of Food andDrugs will propose to revoke currentlyapproved subtherapeutic (increasedrate of gain, disease prevention. etc.)uses in animal feed of antibiotic andsulfonamide drugs whether granted byapproval of new animal drug applica-tions, master files and/or antibiotic orfood additive regulations, by no laterthan April 20, 1975, or the nitrofurandrugs by no later than September 5,1975, unless data are submitted whichresolve conclusively the issues con-cerning their safety to man and ani-mals and their effectiveness under spe-cific criteria established by the Foodand Drug Administration based on theguidelines included in the report of theFDA task force on the use of anti-biotics in animal feeds. All persons orfirms previously marketing identical,related, or similar products except thenitrofuran drugs not the subject of anapproved new animal drug applicationmust submit a new animal drug appli-cation by July 19, 1973, or by December4, 1973, in the case of nitrofuran drugs,if marketing is to continue during theinterim. New animal drug entities withantibacterial activity not previouslymarketed, now pending approval orsubmitted for approval prior to, on, orfollowing the effective date of this pub-lication, shall satisfy such criteriaprior to approval.

(b) Any person interested in devel-oping data which will support retainingapproval for such uses of such anti-biotic, nitrofuran, and sulfonamide


359


drugs pursuant to section 512(l) of theFederal Food, Drug, and Cosmetic Actshall submit to the Commissioner thefollowing:

(1) By July 19, 1973, records and re-ports of completed, ongoing, or plannedstudies, including protocols, on thetetracyclines, streptomycin, dihydro-streptomycin, penicillin, and thesulfonamides; for all other antibioticsby October 17, 1973; and for thenitrofuran drugs by March 4, 1974. TheFood and Drug Administration encour-ages sponsors to consult with the Cen-ter for Veterinary Medicine on protocoldesign and plans for future studies.

(2) By April 20, 1974, data from com-pleted studies on the tetracyclines,streptomycin, dihydrostreptomycin,the sulfonamides, and penicillin assess-ing the effect of the subtherapeutic useof the drug in feed on the salmonellareservoir in the target animal as com-pared to that in nonmedicated con-trols. Failure to complete the sal-monella studies for any of these drugsby that time will be grounds for pro-ceeding to immediately withdraw ap-proval.

(3) By April 20, 1975, data satisfyingall other specified criteria for safetyand effectiveness, including the effecton the salmonella reservoir for any an-tibiotic or sulfonamide drugs and bySeptember 5, 1975, for the nitrofurandrugs, approved for subtherapeutic usein animal feeds. Drug efficacy datashall be submitted for any feed-usecombination product containing suchdrug and any feed-use single ingredientantibiotic, nitrofuran, or sulfonamidenot reviewed by the National Academyof SciencesNational Research Coun-cil, Drug Efficacy Study covering drugsmarketed between 1938 and 1962.

(4) Progress reports on studies under-way every January 1 and July 1 untilcompletion.

(c) Failure on the part of any sponsorto comply with any of the provisions ofparagraph (b) of this section for any ofthe antibacterial drugs included inparagraph (b)(1) of this section, or in-terim results indicating a health haz-ard, will be considered as grounds forimmediately proceeding to withdraw

approval of that drug for use in animalfeeds under section 512(l) of the act inthe case of failure to submit requiredrecords and reports and under section512(e) where new information showsthat such drug is not shown to be safe.

(d) Criteria based upon the guidelineslaid down by the task force may be ob-tained from the Food and Drug Admin-istration, Center for Veterinary Medi-cine, 7500 Standish Pl., Rockville, MD20855.

(e) Reports as specified in this sec-tion shall be submitted to: Food andDrug Administration, Center for Vet-erinary Medicine, Office of New AnimalDrug Evaluation (HFV100), 7500 Stand-ish Pl., Rockville, MD 20855.

(f) Following the completion of therequirements of paragraphs (a) and (b)of this section and the studies providedfor therein:

(1) Those antibiotic, nitrofuran, andsulfonamide drugs which fail to meetthe prescribed criteria for subthera-peutic uses but which are found to beeffective for the therapeutic purposeswill be permitted in feed only for high-level, short-term therapeutic use andonly by or on the order of a licensedveterinarian.

(2) Animal feeds containing anti-bacterial drugs permitted to remain inuse for subtherapeutic purposes shallbe labeled to include a statement ofthe quantity of such drugs.

(g) The submission of applicationsand data required by paragraphs (a)and (b) of this section is not requiredfor the continued manufacture of anyType A medicated article which is pro-duced solely from a Type A article thatis in compliance with the requirementsof this section: Provided, That the TypeA medicated article contains no drugingredient whose use in or on animalfeed requires an approved applicationpursuant to section 512(m) of the actand/or where the Type A article is ap-proved by regulation in this part.

(1) The following antibacterial TypeA articles manufactured by the des-ignated sponsors are eligible for in-terim marketing based on their com-pliance with the requirements of thissection:


360

21 CFR Ch. I (4100 Edition) 558.15

Drug sponsor Type A article Species Use levels Indications for use

Pitman-Moore, Inc. .................... Bacitracin zinc ..... Chickens, turkeys,swine, pheas-ants, quail, andcattle.

Sec. 558.78 ......... Sec. 558.78.

A. L. Laboratories, Inc .............. ......do ................... Chickens, turkeys,pheasants, andquail.

......do ................... Do.

A.L. Laboratories, Inc.,Fermenta Animal Health Co..

Bacitracin meth-ylene disalicy-late.

Chicken turkeys,swine, and cat-tle.

Sec. 558.76 ......... Sec. 558.76.

Elanco Products Co .................. Hygromycin B ...... Chickens andswine.

Sec. 558.274 ....... Sec. 558.274.

Do ...................................... Tylosin ................. Chickens, swine,and beef cattle.

Sec. 558.625 ....... Sec. 558.625.

Sanofi Animal Health, Inc. ........ Erythromycin ........ Chickens, turkeys,and swine.

Sec. 558.248 ....... Sec. 558.248.

The Upjohn Co .......................... Lincomycin ........... Chickens .............. Sec. 558.325 ....... Sec. 558.325.Pfizer, Inc .................................. Oleandomycin ...... Chickens, turkeys,

and swine.Sec. 558.435 ....... Sec. 558.435.

Hoechst-Roussel Agri-Vet, Inc .. Bambermycins ..... Chickens .............. Sec. 558.95 ......... Sec. 558.95.Elanco Products Co .................. Tylosin and

sulfamethazine.Swine ................... Sec. 558.630 ....... Sec. 558.630.

American Cyanamid Co.,Fermenta Animal Health Co.,Feed Specialties Co., Inc.,Pfizer, Inc., PennField OilCo., and VPO, Inc..

Chlortetracycline .. Chickens, turkeys,swine, and cat-tle.

Sec. 558.128 ....... Sec. 558.128.

Merck Sharp & Dohme Re-search Labs., and SolvayVeterinary, Inc.

Procaine Penicillin Chickens, turkeys,swine, pheas-ants, and quail.

Sec. 558.460 ....... Sec. 558.460.

Pfizer, Inc., PennField Oil Co. .. Oxytetracycline .... Sec. 558.450 ....... Sec. 558.450 ....... Sec. 558.450.American Cyanamid Co ............ Chlortetracycline

andsulfamethazine.

Cattle ................... Sec. 558.128 ....... Sec. 558.128.

Sanofi Animal Health, Inc. ........ Erythromycin ........ Cattle ................... 37 mg per headper day.

Sec. 558.248.

Hoffman-La Roche, Inc ............. Sulfadimethoxineand ormetoprim.

Chickens and tur-keys..

Sec. 558.575 ....... Sec. 558.575.

Pfizer, Inc. ................................. Oxytetracyclineand neomycin.

Chickens, turkeys,swine, andcalves.

As provided inparagraph (g)(2)of this section.

As provided in paragraph(g)(2) of this section.

American Cyanamid Co. andPfizer, Inc.

Chlortetracycline,sulfamethazine,and penicillin.

Swine ................... ......do ................... Do.

Boehringer IngelheimVetmedica, Inc..

Chlortetracycline,sulfathiazole,and penicillin.

......do ................... ......do ................... Do.

(2) The following is a list of drugcombinations permitted when preparedfrom antibacterial Type A articles list-ed in paragraph (g)(1) of this section.Drug combinations listed in subpart Bof this part name their sponsors and

are incorporated herein by referencesince they are safe and effective bycontemporary standards, or such spon-sors have been notified of any addi-tional safety or efficacy data requiredon an individual basis:


Boehringer IngelheimVetmedica, Inc..

Chlortetracyclineand arsanilicacid.

Swine ................... 10 to 50 g/ton and0.005 to 0.01percent.

Enhancement of growth andfeed efficiency.

American Cyanamid Co ............ Chlortetracyclineandsulfamethazine.

Cattle ................... Sec. 558.128 ....... Sec. 558.128.


361



Pfizer, Inc., PennField Oil Co.,and VPO, Inc.

Oxytetracyclineand neomycinbase.

Chickens .............. 50 g/ton and 35 to140 g/ton.

Prevention of diseases fromoxytetracycline susceptibleorganisms during periods ofstress. As an aid in the pre-vention of bacterial enteritisand in the control of neomy-cin-sensitive organisms as-sociated with bluecomb(mud fever or nonspecificenteritis).

Do ...................................... ......do ................... Chickens (first 2weeks).

50 to 100 g/tonand 35 to 140g/ton.

Prevention of early chick mor-tality due to oxytetracycline-susceptible organisms. Asan aid in the prevention ofbacterial enteritis and in thecontrol of neomycin-sensitiveorganisms associated withbluecomb (mud fever or non-specific enteritis).

Do ...................................... ......do ................... Chickens .............. ......do ................... To extend period of high eggproduction, to improve feedefficiency, to improve eggproduction and feed effi-ciency in presence of dis-ease and at time of stress.As an aid in maintaining andimproving hatchability wherebirds are suffering stressfrom moving, vaccinations,culling, extreme temperaturechanges, and worming; toimprove livability of progenywhen losses are due to oxy-tetracycline-susceptible orga-nisms, to improve egg shellquality, prevention ofbluecomb (mud fever or non-specific enteritis). As an aidin the prevention of bacterialenteritis and in the control ofnermycon-sensitive orga-nisms associated withbluecomb (mud fever or non-specific enteritis).

Do ...................................... ......do ................... ......do ................... 100 to 200 g/tonand 35 to 140g/ton.

Prevention of complicatedchronic respiratory disease(air-sac infection) and controlof complicated chronic res-piratory disease by loweringmortality and severity duringoutbreaks. As an aid in theprevention of bacterial enter-itis and in the control of neo-mycin-sensitive organismsassociated with bluecomb(mud fever or nonspecificenteritis).

Do ...................................... ......do ................... Turkeys ................ 50 g/ton and 35 to140 g/ton.

As an aid in the prevention ofdisease from oxytetracyclinesusceptible organisms duringperiods of stress. As an aidin the prevention of bacterialenteritis and in the control ofneomycin-sensitive orga-nisms associated withbluecomb (mud fever or non-specific enteritis).


362

21 CFR Ch. I (4100 Edition) 558.15



To extend periord of high eggproduction, to improve eggproduction, to improve feedefficiency, to improve fertility,to improve egg productionand feed efficiency in pres-ence of disease and time ofstress; as an aid in maintain-ing and improving hatch-ability where birds are suf-fering from stress, exposure,moving, vaccination, culling,extreme losses due to oxy-tetracycline-susceptible orga-nisms, and to improve eggshell quality prevention ofhexamitiasis. As an aid inthe prevention of bacterialenteritis and in the control ofneomycin-sensitive orga-nisms associated withbluecomb (mud fever or non-specific enteritis).

Do ...................................... ......do ................... Turkeys (first 4weeks).

......do ................... As an aid in the prevention ofearly poult mortality due tooxytetracycline-susceptibleorganisms. As an aid in theprevention of bacterial enter-itis and in the control of neo-mycin-sensitive organismsassociated with bluecomb(mud fever or nonspecificenteritis).


As an aid in reducing mortalityin birds which have sufferedan attack of air-sacculitis (itis recommended, whereverpossible, to feed from timeof attack to marketing).

Do ...................................... ......do ................... Turkeys ................ ......do ................... As an aid in the prevention ofbacterial enteritis and in thecontrol of neomycin-sensitiveorganisms associated withbluecomb (mud fever or non-specific enteritis).


Control of bluecomb (mudfever or nonspecific enter-itis), infectious sinusitis andhexamitiasis, prevention ofinfectious synovitis. As anaid in the prevention of bac-terial enteritis and in thecontrol of neomycin-sensitiveorganisms associated withbluecomb (mud fever or non-specific enteritis).

Do ...................................... ......do ................... ......do ................... 200 g/ton and 70to 140 g/ton.

Control of infectious synovitis.For the treatment of bacterialenteritis and bluecomb (mudfever or nonspecific enter-itis).

Do ...................................... ......do ................... Swine ................... 50 g/ton and 35 to140 g/ton.

As an aid in the prevention ofbacterial enteritis (scours),baby pig diarrhea (in babypigs only), vibrionic dys-entery, bloody dysentery,and salmonellosis (necro ornecrotic enteritis).


363




As an aid in the maintenanceof weight gains and feedconsumption in the presenceof atrophic rhinitis. As an aidin the treatment of bacterialenteritis.

Do ...................................... ......do ................... Calves .................. 50 g/ton and 35 to140 g/ton.

As an aid in the prevention ofbacterial enteritis (scours).

Do ...................................... ......do ................... ......do ................... 100 g/ton and 70to 140 g/ton.

As an aid in the treatment ofbacterial enteritis (scours).

Do ...................................... ......do ................... ......do ................... 8 to 100 mg/galand 100 to 200mg/gal reconsti-tuted milk re-placer.

As an aid in the prevention ofbacterial diarrhea (scours).

Do ...................................... ......do ................... ......do ................... 40 to 200 mg/galand 200 to 400mg/gal reconsti-tuted milk re-placer.

As an aid in the treatment ofbacterial diarrhea (scours).

The Upjohn Co. ......................... Lincomycin,amprolium, andethopabate.

Chickens .............. Secs. 558.58 and558.325.

Secs. 558.58 and 558.325.

Do ...................................... Lincomycin andzoalene.

......do ................... Secs. 558.325and 558.680.

Secs. 558.325 and 558.680.

Do ...................................... Lincomycin,amprolium,ethopabate, androxarsone.

......do ................... Secs. 558.58,558.325, and558.530.

Secs. 558.58, 558.325, and558.530.

Do ...................................... Lincomycin,monensin, androxarsone.

......do ................... Secs. 558.325,558.355, and558.530.

Secs. 558.325, 558.355, and558.530.

Do ...................................... Nicarbazin andprocaine peni-cillin.

Chickens .............. 0.01 to 0.02 per-cent and 2.4 to50 g/ton.

Do.

Do ...................................... Nicarbazin andbacitracin meth-ylene disalicy-late.

.....do .................... 0.01 to 0.02 per-cent and 4 to 50g/ton.

Do.

Do ...................................... Nicarbazin, baci-tracin methylenedisalicylate, androxarsone.

.....do .................... 0.01 to 0.02 per-cent, 4 to 50 g/ton, and 0.0025to 0.005 percent.

Do.

Do ...................................... Nicarbazin, pro-caine penicillin,and roxarsone.

.....do .................... 0.01 to 0.02 per-cent, 2.4 to 50g/ton, and0.0025 to 0.025percent.

Do.

Do ...................................... Amprolium andbacitracin meth-ylene disalicy-late.

Chickens and tur-keys.

0.0125 to 0.025percent and 4 to50 g/ton.

Secs. 558.55 and 558.76.

Do ...................................... Amprolium,ethopabate, andbacitracin meth-ylene disalicy-late.

Chickens .............. 0.0125 to 0.025percent, 0.0004percent, and 4to 50 g/ton.

Secs. 558.58 and 558.76.

Do ...................................... Amprolium,ethopabate,bacitracin meth-ylene disalicy-late, androxarsone.

.....do .................... 0.0125 to 0.025percent, 0.0004percent, 4 to 50g/ton, and0.0025 to 0.005percent.

Secs. 558.58, 558.76, and558.530.

Do ...................................... Amprolium andprocaine peni-cillin.

Chickens and tur-keys.

0.004 to 0.025percent and 2.4to 50 g/ton.

Secs. 558.55 and 558.460.

Do ...................................... Amprolium, pro-caine penicillin,and roxarsone.

Chickens .............. 0.004 to 0.025percent, 2.4 to50 g/ton, and0.0025 to 0.005percent.

Secs. 558.55, 558.460, and558.530.


364

21 CFR Ch. I (4100 Edition) 558.15


Do ...................................... Amprolium,ethopabate, pro-caine penicillin,and erythro-mycin.

......do ................... 0.0125 to 0.025percent, 0.0004percent, 2.4 to50 g/ton, and4.6 to 18.5 g/ton.

Secs. 558.58 and 558.460.

Do ...................................... Amprolium anderythromycin.

......do ................... 0.0125 to 0.025percent and 4.6to 18.5 g/ton.

Sec. 558.55.

Do ...................................... Amprolium andethopabate.

......do ................... 0.0125 to 0.025percent and0.0004 percent.

Sec. 558.58.

Do ...................................... Amprolium,arsanilic acid,and erythro-mycin.

......do ................... 0.0125 to 0.025percent, 0.01percent, and 4.6to 18.5 g/ton.

Sec. 558.55.

Do ...................................... Amprolium,arsanilic acid,and ethopabate.

......do ................... 0.0125 to 0.025percent, 0.01percent, and0.0004 percent.

Sec. 558.58.

Do ...................................... Amprolium,ethopabate, andbacitracin meth-ylene disalicy-late.

......do ................... 0.0125 percent,0.004 percent,and 4 to 50 g/ton.

Do.

Do ...................................... Amprolium,ethopabate,bacitracin meth-ylene disalicy-late, androxarsone.

......do ................... 0.0125 percent,0.004 percent, 5to 35 g/ton, and0.00375 percent.

Do.

Pitman-Moore, Inc. .................... Bacitracin zinc,amprolium, andethopabate.

......do ................... 4 to 50 g/ton,0.0125 to 0.025percent, and0.0004 percent.

Prevention of coccidiosis.Growth promotion and feedefficiency. Sec.558.78.

Do ...................................... Bacitracin zinc,amprolium,ethopabate, androxarsone.

......do ................... 4 to 50 g/ton,0.0125 to 0.025percent, 0.0004percent, and0.0025 to 0.005percent.

Prevention of coccidiosis.Growth promotion and feedefficiency. Improving pig-mentation. Sec. 558.78.

Do ...................................... Bacitracin zincand arsanilicacid.

Swine ................... 10 to 50 g/ton and0.005 to 0.01percent.

Increased rate of weight gainand improved feed effi-ciency.

Merck Sharp & Dohme Re-search Labs.

Amprolium,ethopabate, pro-caine penicillin,and roxarsone.

Chickens .............. 0.125 to 0.025percent, 0.0004percent, 2.4 to50 g/ton, and0.0025 to 0.005percent.

Secs. 558.58, 558.460 and558.530.

A. L. Laboratories, Inc. ............. Zoalene and baci-tracin methylenedisalicylate.

Chickens .............. 0.0125 percentand 4 to 50 g/ton.

Sec. 558.680.

Do ...................................... Zoalene,roxarsone, andbacitracin meth-ylene disalicy-late.


Do.

Do ...................................... Zoalene and baci-tracin zinc.

......do ................... 0.0125 percentand 4 to 50 g/ton.

Do.

Do ...................................... Zoalene,roxarsone, andbacitracin zinc.

......do ................... 0.0125 percent,0.0025 to 0.005percent, and 4to 50 g/ton.

Do.

Do ...................................... Zoalene and peni-cillin.

......do ................... 0.0125 percentand 2.4 to 50 g/ton.

Do.

Do ...................................... Zoalene,roxarsone, andpenicillin.

......do ................... 0.0125 percent,0.0025 to 0.005percent, and 2.4to 50 g/ton.

Do.


365



Do ...................................... Zoalene, arsanilicacid, and baci-tracin methylenedisalicylate orbacitracin zinc.


Do.

Do ...................................... Zoalene, arsanilicacid, and peni-cillin.

......do ................... 0.0125 percent,0.01 percent,and 2.4 to 50 g/ton.

Do.

Do ...................................... Zoalene, and baci-tracin methylenedisalicylate.

......do ................... 0.004 to 0.0125percent and 4 to50 g/ton.

Do.

Do ...................................... Zoalene,roxarsone, andbacitracin meth-ylene disalicy-late.

......do ................... 0.004 to 0.0125percent, 0.0025to 0.005 per-cent, and 4 to50 g/ton.

Do.

Whitmoyer Labs, Inc ................. Carbarsone andbacitracin.

Turkeys ................ Sec. 558.120 ....... Sec. 558.120.

Elanco Products Co. ................. Hygromycin B andtylosin.

Chickens .............. 8 to 12 g/ton and4 to 50 g/ton.

Sec. 558.274.

Do ...................................... ......do ................... Swine ................... 12 g/ton and 10 to100 g/ton.

Do.

A. L. Laboratories, Inc. ............. Nitarsone andbacitracin zinc.

Turkeys ................ 0.01875 percent,4 to 50 g/ton.

As an aid in the prevention ofblackhead. To increase rateof weight gain and improvefeed efficiency.

[51 FR 8811, Mar. 14, 1986; 51 FR 11014, Apr. 1, 1986, as amended at 51 FR 28547, Aug. 8, 1986;53 FR 20843, June 7, 1988; 54 FR 37098, Sept. 7, 1989; 54 FR 51386, Dec. 15, 1989; 55 FR 8460, 8462,Mar. 8, 1990; 56 FR 41912, Aug. 23, 1991; 56 FR 64702, Dec. 12, 1991; 57 FR 6476, Feb. 25, 1992; 57FR 8577, Mar. 11, 1992; 57 FR 14639, Apr. 22, 1992; 58 FR 17515, Apr. 5, 1993; 58 FR 30119, May26, 1993; 61 FR 51589, Oct. 3, 1996; 64 FR 992, Jan. 7, 1999; 64 FR 37673, July 13, 1999]

Subpart BSpecific New AnimalDrugs for Use in Animal Feeds

558.35 Aklomide.

(a) Approvals. Type A medicated arti-cles: to 053501 in 510.600(c) of thischapter, as follows:

(1) 50 percent aklomide.(2) 20 percent sulfanitran and 25 per-

cent aklomide.(3) 25 percent aklomide, 20 percent

sulfanitran, and 5 percent roxarsone.(4) 50 percent aklomide and 10 per-

cent roxarsone.(b) Related tolerances. See 556.30 of

this chapter.(c) Conditions of use. It is used in feed

for chickens as follows:(1) Amount per ton. Aklomide, 227

grams (0.025 percent).(i) Indications for use. As an aid in the

prevention of coccidiosis caused by E.tenella and E. necatrix.

(ii) Limitations. Not to be fed to birdslaying eggs for human consumption.

(2) Amount per ton. Aklomide, 227grams (0.025 percent) combined withsulfanitran, 181.6 grams (0.02 percent).

(i) Indications for use. As an aid in theprevention of coccidiosis caused by E.tenella, E. necatrix, and E. acervulina.

(ii) Limitations. Not to be fed to lay-ing chickens; withdraw 5 days beforeslaughter.

(3) Amount per ton. Aklomide, 227grams (0.025 percent) combined withsulfanitran, 181.6 grams (0.02 percent) +roxarsone, 22.745.4 grams (0.00250.005percent).

(i) Indications for use. As an aid in theprevention of coccidiosis caused by E.tenella, E. necatrix, and E. acervulina;growth promition and feed efficiency;improving pigmentation.

(ii) Limitations. Not to be fed to lay-ing chickens; withdraw 5 days beforeslaughter; as sole source of organic ar-senic; chickens should have access todrinking water at all times.

(4) Amount per ton. Aklomide, 227grams (0.025 percent) combined withroxarsone, 22.745.4 grams (0.00250.005percent).

(i) Indications for use. As an aid in theprevention of coccidiosis caused by E.


366

21 CFR Ch. I (4100 Edition) 558.55

tenella, and E. necatrix; growth pro-motion and feed efficiency; improvingpigmentation.

(ii) Limitations. Not to be fed to birdslaying eggs for human consumption;withdraw 5 days before slaughter; assole source of organic arsenic; chickensshould have access to drinking waterat all times.

[40 FR 13959, Mar. 27, 1975, as amended at 41FR 8312, Feb. 25, 1976; 51 FR 7395, Mar. 3, 1986;55 FR 8460, Mar. 8, 1990]

558.55 Amprolium.(a) Approvals. Type A medicated arti-

cles: 25 percent to 050604 in 510.600(c)of this chapter for use as in paragraph(d) of this section.

(b) Special considerations. Do not usein Type B or Type C medicated feedscontaining bentonite.

(c) Related tolerances. See 556.50 ofthis chapter.

(d) Conditions of use(1) Calves. It istop-dressed on or thoroughly mixed inthe daily feed ration as follows:

(i) Amount. 227 milligrams per 100pounds (5 milligrams per kilogram)body weight per day.

(a) Indications for use. As an aid inthe prevention of coccidiosis caused byEimeria bovis and E. zurnii.

(b) Limitations. Administer from aType B feed containing from 0.05 to 1.25percent amprolium with the usualamount of feed consumed in 1 day; feedfor 21 days during periods of exposureor when experience indicates that coc-cidiosis is likely to be a hazard; with-draw 24 hours before slaughter; as solesource of amprolium.

(ii) Amount. 454 milligrams per 100pounds (10 milligrams per kilogram)body weight per day.

(a) Indications for use. As an aid inthe treatment of coccidiosis caused byEimeria bovis and E. zurnii.

(b) Limitations. Administer from aType B feed containing from 0.05 to 1.25percent amprolium with the usualamount of feed consumed in 1 day; feedfor 5 days; for a satisfactory diagnosis,a microscopic examination of the fecesshould be done by a veterinarian or di-agnostic laboratory before treatment;when treating outbreaks, the drugshould be administered promptly afterdiagnosis is determined; withdraw 24hours before slaughter; as sole sourceof amprolium.

(2) Chickens and turkeys. It is used asfollows:

Amprolium in gramsper ton

Combination in gramsper ton Indications for use Limitations Sponsor

(i) 36.3 to 113.5(0.004% to0.0125%).

Replacement chickens; development of ac-tive immunity to coccidiosis.

Feed as follows

Growing conditions Up to 5 weeks ofage

From 5 to 8weeks of age

Over 8 weeksof age

Amproliumgrams per ton



Severe exposure tococcidiosis.

113.5 (0.0125%) 72.6113.5(0.008%0.0125%)

36.3113.5(0.004%0.0125%)

Moderate exposure tococcidiosis.

72.6113.5(0.008%0.0125%)

54.5113.5(0.006%0.0125%)

36.3113.5(0.004%0.0125%)

Slight exposure tococcidiosis.

36.3113.5(0.004%0.0125%)

36.3113.5(0.004%0.0125%)

36.3113.5(0.004%0.0125%)


367




Arsanilate sodium 90(0.01%).

Replacement chickens; devel-opment of active immunity tococcidiosis; growth promotionand feed efficiency; improv-ing pigmentation.

Withdraw 5 d before slaughter;as sole source of organic ar-senic; feed according tosubtable in item (i).

Arsanilic acid 90(0.01%).


Withdraw 5 d before slaughter;as sole source of organic ar-senic; feed according tosubtable in item (i).

Arsanilic acid 90(0.01%) plus eryth-romycin 4.6 to 18.5.


Withdraw 5 d before slaughter;as sole source of organic ar-senic. Feed according tosubtable in item (i).

Arsanilic acid 90(0.01%) plus eryth-romycin 92.5.

1. Replacement chickens; de-velopment of active immunityto coccidiosis; growth pro-motion and feed efficiency;improving pigmentation; asan aid in the prevention ofchronic respiratory diseaseduring periods of stress.

Feed for 2 d before stress and3 to 6 d after stress; with-draw 5 d before slaughter; assole source of organic ar-senic. Feed according tosubtable in item (i).

2. Replacement chickens; de-velopment of active immunityto coccidiosis; growth pro-motion and feed efficiency;improving pigmentation; asan aid in the prevention of in-fectious coryza.

Feed for 7 to 14 d; withdraw 5d before slaughter; as solesource of organic arsenic.Feed according to subtablein item (i).

(i) 36.3 to 113.5(0.004% to0.0125%).

Arsanilic acid 90(0.01%) plus eryth-romycin 185.

Replacement chickens; devel-opment of active immunity tococcidiosis; growth promotionand feed efficiency; improv-ing pigmentation; as an aid inthe prevention and reductionof lesions and in lowering se-verity of chronic respiratorydisease.

Feed for 5 to 8 d; do not use inbirds producing eggs for foodpurposes; withdraw 5 d be-fore slaughter; as solesource of organic arsenic.Feed according to subtablein item (i).

Bacitracin 100 to 200 Replacement chickens; devel-opment of active immunity tococcidiosis; treatment ofchronic respiratory disease(air-sac infection) and bluecomb (nonspecific infectiousenteritis).

As bacitracin methylene disa-licylate or bacitracin zinc.Feed according to subtablein item (i).

Chlortetracycline 100to 200.

Chickens; development of ac-tive immunity to coccidiosis;control of infectious synovitiscaused by Mycoplasmasynoviae susceptible to chlor-tetracycline.

Do not feed to chickens pro-ducing eggs for human con-sumption. Feed for 7 to 14 d.


Chickens; development of ac-tive immunity to coccidiosis;control of chronic respiratorydisease (CRD) and air sacinfection caused by M.gallisepticum and E. coli sus-ceptible to chlortetracycline.


Erythromycin 4.6 to18.5.

Replacement chickens; devel-opment of active immunity tococcidiosis; growth promotionand feed efficiency.

As erythromycin thiocyanate.Feed according to subtablein item (i).

Erythromycin 92.5 ...... 1. Replacement chickens; de-velopment of active immunityto coccidiosis; as an aid inthe prevention of infectiouscoryza.

Feed for 7 to 14 d; withdraw 24h before slaughter. Feed ac-cording to subtable in item (i).


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21 CFR Ch. I (4100 Edition) 558.55



2. Replacement chickens; de-velopment of active immunityto coccidiosis; as an aid inthe prevention of chronic res-piratory disease during peri-ods of stress.

Feed for 2 d before stress and3 to 6 d after stress; with-draw 24 h before slaughter.Feed according to subtablein item (i).

Erythromycin 185 ....... Replacement chickens; devel-opment of active immunity tococcidiosis; as an aid in theprevention and reduction oflesions and in lowering se-verity of chronic respiratorydisease.

Feed for 5 to 8 d; do not use inbirds producing eggs for foodpurposes; withdraw 48 h be-fore slaughter. Feed accord-ing to subtable in item (i).

Hygromycin B 8 to 12 Replacement chickens; devel-opment of active immunity tococcidiosis; control of infesta-tion of large round worms(Ascaris galli), cecal worms(Heterakis gallinae), and cap-illary worms (Capillariaobsignata).

Feed according to subtable initem (i).

Penicillin 2.4 to 50 ..... Replacement chickens; devel-opment of active immunity tococcidiosis; growth promotionand feed efficiency.

As procaine penicillin. Feed ac-cording to subtable in item (i).

Roxarsone 22.7 to45.4 (0.0025% to0.005%).

Replacement chickens; devel-opment of active immunity tococcidiosis; growth pro-motion, and feed efficiency;improving pigmentation.


(ii) 72.6 to 113.5(0.008% to0.0125%).

.................................... Broiler chickens; prevention ofcoccidiosis caused byEimeria tenella only.



Broiler chickens; prevention ofcoccidiosis caused by E.tenella only; growth pro-motion and feed efficiency;improving pigmentation.

Withdraw 5 d before slaughter;as sole source of organic ar-senic.


......do ........................................ ......do ........................................

Bacitracin 100 to 200 Broiler chickens; prevention ofcoccidiosis caused by E.tenella only; treatment ofchronic respiratory disease(air-sac infection) and bluecomb (nonspecific infectiousenteritis).

As bacitracin methylene disa-licylate, or zinc bacitracin.


Chickens; prevention of coccidi-osis caused by E. tenellaonly; control of infectioussynovitis caused by M.synoviae susceptible to chlor-tetracycline.



Chickens; prevention of coccidi-osis caused by E. tenellaonly; control of chronic res-piratory disease (CRD) andair sac infection caused byM. gallisepticum and E. colisusceptible to chlortetra-cycline.


Hygromycin B 8 to 12 Broiler chickens; prevention ofcoccidiosis caused byEimeria tenella only; controlof infestation of large roundworms (Heterakis gallinae),and capillary worms(Capillaria obsignata).


Penicillin 2.4 to 50 ..... Broiler chickens; prevention ofcoccidiosis caused by E.tenella only; growth pro-motion and feed efficiency.

As procaine penicillin ................


369




Roxarsone 22.7 to45.4 (0.0025% to0.005%).

Broiler chickens; prevention ofcoccidiosis caused by E.tenella only; growth pro-motion and feed efficiency;improving pigmentation.


(iii) 113.5 (0.0125%) ... .................................... 1. Laying chickens; preventionof coccidiosis.

...................................................

2. Laying chickens; treatmentof coccidiosis.

For moderate outbreaks of coc-cidiosis; administer for 2weeks.

Bambermycins 1 to 3plus roxarsone 22.8to 34.1 (0.0025% to0.00375%).

Broiler chickens; as an aid inthe prevention of coccidiosis;for increased rate of weightgain, improved feed effi-ciency, and improved pig-mentation.

Feed continuously as the soleration; as sole source ofamprolium and organic ar-senic; roxarsone as providedby No. 053501 in 510.600(c) of this chapter,bambermycins by No.012799; withdraw 5 d beforeslaughter.

Bambermycins 1 to 4 Growing turkeys; prevention ofcoccidiosis; increased rate ofweight gain and improvedfeed efficiency.

Feed continuously as the solesource of amprolium;bambermycins as providedby No. 012799 in 510.600(c) of this chapter.

012799

(iv) 113.5 to 227(0.0125% to0.025%).

.................................... 1. Broiler chickens and replace-ment chickens where immu-nity to coccidiosis is not de-sired; prevention of coccidi-osis.

...................................................

2. Turkeys; prevention of coc-cidiosis.

...................................................


1. Broiler chickens and replace-ment chickens where immu-nity to coccidiosis is not de-sired; prevention of coccidi-osis; growth promotion andfeed efficiency; improvingpigmentation.


2. Turkeys; prevention of coc-cidiosis; growth promotionand feed efficiency; improv-ing pigmentation.

......do ........................................



......do ........................................


......do ........................................

Arsanilic acid 90(0.01%) plus eryth-romycin 92.5.

1. Broiler chickens and replace-ment chickens where immu-nity to coccidiosis is not de-sired; prevention of coccidi-osis; growth promotion andfeed efficiency; improvingpigmentation; as an aid inthe prevention of chronic res-piratory disease during peri-ods of stress.

Feed for 2 d before stress and3 to 6 d after stress; with-draw 5 d before slaughter; assole source of organic ar-senic.

2. Broiler chickens and replace-ment chickens where immu-nity to coccidiosis is not de-sired; prevention of coccidi-osis; growth promotion andfeed efficiency; improvingpigmentation; as an aid inthe prevention of infectiouscoryza.

Feed for 7 to 14 d; withdraw 5d before slaughter; as solesource of organic arsenic.


370

21 CFR Ch. I (4100 Edition) 558.55



Arsanilic acid 90(0.01%) plus eryth-romycin 185.

Broiler chickens and replace-ment chickens where immu-nity to coccidiosis is not de-sired; prevention of coccidi-osis; growth promotion andfeed efficiency; improvingpigmentation; as an aid inthe prevention and reductionof lesions and in lowering se-verity of chronic respiratorydisease.

Feed for 5 to 8 d; do not use inbirds producing eggs for foodpurposes; withdraw 5 d be-fore slaughter; as solesource of organic arsenic.

Arsanilic acid 90(0.01%) plus eryth-romycin 4.6 to 18.5.

Broiler chickens and replace-ment chickens where immu-nity to coccidiosis is not de-sired; prevention of coccidi-osis; growth promotion andfeed efficiency; improved pig-mentation.


Bacitracin 4 to 50 ....... 1. Broiler chickens and replace-ment chickens where immu-nity to coccidiosis is not de-sired; prevention of coccidi-osis; growth promotion andfeed efficiency.

As bacitracin methylene disa-licylate or bacitracin zinc.

1 012769

2. Turkeys; prevention of coc-cidiosis; growth promotionand feed efficiency.

......do ........................................

Bacitracin 100 to 200 1. Broiler chickens and replace-ment chickens where immu-nity to coccidiosis is not de-sired; prevention of coccidi-osis; treatment of chronicrespiratory disease (air-sacinfection), blue comb (non-specific infectious enteritis).

......do ........................................

2. Broiler chickens and replace-ment chickens where immu-nity to coccidiosis is not de-sired; prevention of coccidi-osis; treatment of chronic rydisease (air-sac infection),blue comb (nonspecific infec-tious enteritis).

As bacitracin zinc .....................

Bacitracin 100 to 500 Turkeys; prevention of coccidi-osis; treatment of infectioussinusitis, blue comb (mudfever).

As bacitracin zinc .....................

Bacitracin plus peni-cillin 100 to 500 (ofcombination).

......do ........................................ Feed contains 50% to 75% ofbacitracin but not more than125 g penicillin; as procainepenicillin; as bacitracin zinc.

Carbarsone 227 to340.5.

Turkeys; aid in prevention ofcoccidiosis (Eimeriaadenoeides, E. meleagrimitis,and E. gallopavonis) andblackhead.

Feed continuously 2 weeks be-fore coccidiosis and black-head are expected and con-tinue as long as prevention isneeded; withdraw 5 days be-fore slaughter; use as solesource of amprolium and or-ganic arsenic; do not use asa treatment for outbreaks ofcoccidiosis; carbarsone by046573 in 510.600(c) ofthis chapter.

000006


Chickens where immunity tococcidiosis is not desired;prevention of coccidiosis;control of infectious synovitiscaused by M. synoviae sus-ceptible to chlortetracycline.



371





Chickens where immunity tococcidiosis is not desired;control of chronic respiratorydisease (CRD) and air sacinfection caused by M.gallisepticum and E. coli sus-ceptible to chlortetracycline.



Broiler chickens and replace-ment chickens where immu-nity to coccidiosis is not de-sired; prevention of coccidi-osis; growth promotion andfeed efficiency.

As erythromycin thiocyanate ....

Erythromycin 92.5 ...... 1. Broiler chickens and replace-ment chickens where immu-nity to coccidiosis is not de-sired; prevention of coccidi-osis; as an aid in the preven-tion of chronic respiratorydisease during periods ofstress.

Feed for 2 d before stress and3 to 6 d after stress; with-draw 24 h before slaughter.

2. Broiler chickens and replace-ment chickens where immu-nity to coccidiosis is not de-sired; prevention of coccidi-osis; as an aid in the preven-tion of infectious coryza.

Feed for 7 to 14 d; withdraw 24h before slaughter.

Erythromycin 185 ....... Broiler chickens and replace-ment chickens where immu-nity to coccidiosis is not de-sired; prevention of coccidi-osis; as an aid in the preven-tion and reduction of lesionsand in lowering severity ofchronic respiratory disease.

Feed for 5 to 8 d, do not use inbirds producing eggs for foodpurposes; withdraw 48 h be-fore slaughter.

Hygromycin B 8 to 12 Broiler chickens and replace-ment chickens where immu-nity to coccidiosis is not de-sired; prevention of coccidi-osis; control of infestation oflarge round worms (Heterakisgallinae) and capillary worms(Capillaria obsignata).


Penicillin 2.4 to 50 ..... 1. Broiler chickens and replace-ment chickens where immu-nity to coccidiosis is not de-sired; prevention of coccidi-osis; growth promotion andfeed efficiency.

As procaine penicillin ................

2. Turkeys; prevention of coc-cidiosis; growth promotionand feed efficiency.

......do ........................................

Roxarsone 22.7 to45.4 (0.0025% to0.005%).




......do ........................................

(v) 227 (0.025%) ........ .................................... Laying chickens; treatment ofcoccidiosis.

For severe outbreaks of coc-cidiosis; administer for 2weeks.

(3) Pheasants. It is used as follows: (i) Amount. 0.0175 percent (159 gramsper ton).


372

21 CFR Ch. I (4100 Edition) 558.58

(ii) Indications for use. For the pre-vention of coccidiosis in growingpheasants caused by Eimeria colchici, E.duodenalis, and E. phasiani.

(iii) Limitations. Feed continuously assole ration. Use as sole source ofamprolium. Fertility, hatchability, andother reproductive data are not avail-able on amprolium in breeding pheas-ants. Do not use in feeds containingbentonite.

[41 FR 10985, Mar. 15, 1976]

EDITORIAL NOTE: For FEDERAL REGISTER ci-tations affecting 558.55, see the List of CFRSections Affected in the Finding Aids sec-tion of this volume.

558.58 Amprolium and ethopabate.(a) Approvals. Type A medicated arti-

cles: (1) 25 percent amprolium and 0.8

percent ethopabate; 25 percentamprolium and 8 percent ethopabate; 5percent amprolium and 0.16 percentethopabate; 5 percent amprolium and1.6 percent ethopabate; to 000006.

(2) 0.15 percent amprolium and 0.004percent ethopabate and 0.05 gram perpound bacitracin (as bacitracin meth-ylene disalicylate) to 047019 in 510.600(c) of this chapter.

(b) Special considerations. Do not usein Type B or Type C medicated feedscontaining bentonite.

(c) Related tolerances. See 556.50 and556.260 of this chapter.

(d) Conditions of use. (1) It is used forchickens as follows:

Amprolium andethopabate in grams

per tonCombination ingrams per ton Indications for use Limitations Sponsor

(i) Amprolium 113.5(0.0125 pct) andethopabate 3.6(0.0004 pct).

.................................. Broiler chickens as an aid in theprevention of coccidiosis.

Not for laying hens; as solesource of amprolium.

(ii) Amprolium 113.5(0.0125%) andethopabate 3.6(0.0004%).

Bambermycins 2 to3 plus roxarsone22.8 to 34.1(0.0025% to0.00375%).

Broiler chickens; as an aid in theprevention of coccidiosis; forincreased rate of weight gain,improved feed efficiency, andpigmentation.

Feed continuously as the soleration; as sole source ofamprolium and organic ar-senic; amprolium andethopabate as provided byNo. 050604 in 510.600(c) ofthis chapter, roxarsone by No.046573, bambermycins by No.012799; withdraw 5 d beforeslaughter.

Lincomycin 2 to 4 .... Broiler chickens; for increase inrate of weight gain; improvedfeed efficiency; as an aid inthe prevention of coccidiosis.

Not for laying chickens; as linco-mycin hydrochloridemonohydrate; as sole sourceof amprolium.

Lincomycin 2 to 4plus roxarsone45.4 (0.005%).

Broiler chickens; for increase inrate of weight gain; improvedfeed efficiency and pigmenta-tion; as an aid in the preven-tion of coccidiosis.

Not for laying chickens; as linco-mycin hydrochloridemonohydrate; withdraw 5 dbefore slaughter; as solesource of amprolium and or-ganic arsenic.

Roxarsone 45.4(0.005 pct).

Broiler chickens; to aid in pre-vention of coccidiosis wheresevere exposure to coccidiosisfrom Eimeria acervulina, E.maxima, and E. brunetti islikely to occur; for increasedrate of weight gain in broilerchickens raised in floor pens.

Do not feed to laying chickens;withdraw 5 d before slaughter;as sole source of amprolium;do not use as a treatment foroutbreaks of coccidiosis; feedas sole ration from time chick-ens are placed on litter untilthe past the time when coc-cidiosis is ordinarily a hazard;roxarsone as provided by No.046573 in 510.600(c) of thischapter; combinations as pro-vided by No. 050604.


373




(iii) Amprolium 113.5(0.0125%) andethopabate 36.3(0.004%).

.................................. Broiler chickens and replace-ment chickens where immu-nity to coccidiosis is not de-sired; as an aid in the preven-tion of coccidiosis where se-vere exposure to coccidiosisfrom Eimeria acervulina, E.maxima, and E. brunetti islikely to occur.

Not for chickens over 16 weeksof age.

Arsanilic acid 90(0.01 pct) pluserythromycin 4.6to 18.5.

Broiler chickens and replace-ment chickens where immu-nity to coccidiosis is not de-sired; prevention of coccidi-osis; growth promotion andfeed efficiency; improve pig-mentation.

Not for laying hens; withdraw 5d before slaughter; as solesource of organic arsenic; aserythromycin thiocyanate.

Bacitracin 4 to 50 .... 1. Broiler chickens and replace-ment chickens where immu-nity to coccidiosis is not de-sired; to aid in prevention ofcoccidiosis where severe ex-posure to coccidiosis fromEimeria acervulina, E. maxi-ma, and E. brunetti is likely tooccur; for increased rate ofweight gain in broiler chickensraised in floor pens.

Not for chickens over 16 weeksof age; do not feed to layingchickens; as sole source ofamprolium; not for use as atreatment for outbreaks ofcoccidiosis; as bacitracinmethylene disalicylate as pro-vided by No. 046573 or baci-tracin zinc as provided byNos. 046573 and 063238 in 510.600(c) of this chapter;feed as the sole ration fromthe time chickens are placedon litter until past the timewhen coccidiosis is ordinarilya hazard; combination as pro-vided by No. 050604 in 510.600(c) of this chapter.

.................................. 2. Broiler chickens; as an aid inprevention of coccidiosiswhere severe exposure tococcidiosis from Eimeriaacervulina, E. maxima, and E.brunetti is likely to occur; im-proved feed efficiency.

Not for chickens over 16 weeksof age; do not feed to layingchickens; as sole source ofamprolium; not for use as atreatment for coccidiosis; baci-tracin zinc as provided byNos. 046573 and 063238 in 510.600(c) of this chapter;feed as the sole ration fromthe time chickens are placedon litter until market weight;combination as provided byNos. 046573 and 063238..

046573and

063238

Bacitracin 5 to 35plus roxarsone 34(0.00375%).

Broiler chickens; for increasedrate of weight gain and as anaid in the prevention of coc-cidiosis where severe expo-sure to coccidiosis fromEimeria acervulina, E. maxi-ma, and E. brunetti is likely tooccur in broiler chickensraised in floor pens.

Do not feed to laying chickens;withdraw 5 d before slaughter;as sole source of amproliumand organic arsenic; do notuse as a treatment for out-breaks of coccidiosis; feed asthe sole ration from timechickens are placed on litteruntil past the time when coc-cidiosis is ordinarily a hazard;amprolium and ethopabate asprovided by No. 050604 in 510.600(c) of this chapter;bacitracin methylene disalicy-late as provided by No.046573 or bacitracin zinc asprovided by Nos. 046573 and063238 in 510.600(c) of thischapter; roxarsone as pro-vided by No. 046573 in 510.600(c) of this chapter;combination as provided byNo. 050604 in 510.600(c) ofthis chapter.


374

21 CFR Ch. I (4100 Edition) 558.58



Bacitracin 20 to 35plus roxarsone 34(0.00375%).

Broiler chickens; for increasedrate of weight gain, improvedfeed efficiency, and as an aidin the prevention of coccidi-osis where severe exposure tococcidiosis from Eimeriaacervulina, E. maxima, and E.brunetti is likely to occur inbroiler chickens raised in floorpens.

Do not feed to laying chickens;withdraw 5 d before slaughter;as sole source of amproliumand organic arsenic; do notuse as a treatment for out-breaks of coccidiosis; feed asthe sole ration from timechickens are placed on litteruntil past the time when coc-cidiosis is ordinarily a hazard;amprolium and ethopabate asprovided by No. 050604 in 510.600(c) of this chapter;bacitracin methylene disalicy-late as provided by No.046573 in 510.600(c) of thischapter; roxarsone as pro-vided by No. 046573 in 510.600(c) of this chapter;combination as provided byNo. 050604 in 510.600(c) ofthis chapter.

Bacitracin 10 to 50plus roxarsone15.4 to 45.4(0.0017% to0.005%).

Broiler chickens; as an aid inprevention of coccidiosiswhere severe exposure tococcidiosis from Eimeriaacervulina, E. maxima, and E.brunetti is likely to occur; im-proved feed efficiency.

Do not feed to laying chickens;withdraw 5 d before slaughter;as sole source of amproliumand organic arsenic; do notuse as a treatment for out-breaks of coccidiosis; feed asthe sole ration from timechicks are placed on litter untilpast the time when coccidiosisis ordinarily a hazard;amprolium and ethopabate asprovided by No. 050604 in 510.600(c) of this chapter;bacitracin zinc as provided byNos. 046573 and 063238roxarsone as provided by No.046573 combination as pro-vided by Nos. 046573 and063238.

046573,063238

Bacitracin 10 plusroxarsone 30 to45.4 (0.0033% to0.005%).

Broiler chickens; as an aid inprevention of coccidiosiswhere severe exposure tococcidiosis from E. acervulina,E. maxima, and E. brunetti islikely to occur; improved feedefficiency and improved pig-mentation.

......do ......................................... 063238

Bambermycins 1 to3.

Broiler chickens; as an aid in theprevention of coccidiosiswhere severe exposure tococcidiosis from Eimeriaacervulina, E. maxima, and E.brunetti is likely to occur; forincreased rate of weight gain,and improved feed efficiency.

Feed continuously as the soleration; as sole source ofamprolium; amprolium,ethopabate as provided byNo. 050604 in 510.600(c) ofthis chapter, bambermycins asprovided by No. 012799 in 510.600(c) of this chapter.

Bambermycins 1 to3 plus roxarsone22.8 to 34.1(0.0025% to0.00375%).

Broiler chickens; as an aid in theprevention of coccidiosiswhere severe exposure tococcidiosis from Eimeriaacervulina, E. maxima, and E.brunetti is likely to occur; forincreased rate of weight gain;improved feed efficiency, andimproved pigmentation.

Feed continuously as the soleration; as sole source ofamprolium and organic ar-senic; amprolium andethopabate as provided byNo. 050604 in 510.600(c) ofthis chapter, roxarsone by No.046573 bambermycins by No.012799. Withdraw 5 days be-fore slaughter.


375





Broiler chickens and replace-ment chickens where immu-nity to coccidiosis is not de-sired; prevention of coccidi-osis; growth promotion andfeed efficiency.

Not for laying hens; withdraw 24hours before slaughter; eryth-romycin thiocyanate.

Virginiamycin, 15 ..... Broiler chickens, as an aid in theprevention of coccidiosiswhere severe exposure toEimeria acervulina, E. brunetti,and E. maxima is likely tooccur, for increased rate ofweight gain and improvedfeed efficiency.

Feed continuously as sole ra-tion, do not feed to layinghens, not for chickens over 16weeks of age, as sole sourceof amprolium, amprolium andethopabate as provided by050604 in 510.600(c),virginiamycin as provided by000069.

000069

Virginiamycin, 5 to15.

Broiler chickens, as an aid in theprevention of coccidiosiswhere severe exposure toEimeria acervulina, E. brunetti,and E. maxima is likely tooccur, for increased rate ofweight gain.

......do .........................................

(iv) Amprolium 113.5to 227 (0.0125% to0.025%) andethopabate 3.6(0.0004%).

.................................. For broiler chickens and replace-ment chickens where immu-nity to coccidiosis is not de-sired; prevention of coccidiosis.

Not for laying hens .....................


Broiler chickens and replace-ment chickens where immu-nity to coccidiosis is not de-sired; prevention of coccidi-osis; growth promotion andfeed efficiency; improving pig-mentation.

As sole source of organic ar-senic; withdraw 5 d beforeslaughter; not for laying hens.

Arsanilic acid 90(0.01%) pluserythromycin 92.5.

1. For broiler chickens and re-placement chickens where im-munity to coccidiosis is notdesired; prevention of coccidi-osis; as an aid in the preven-tion of chronic respiratory dis-ease during periods of stress;growth promotion and feed ef-ficiency; improving pigmenta-tion.

Feed for 2 d before stress and 3to 6 d after stress; withdraw 5d before slaughter; as solesource of organic arsenic; notfor laying hens.

2. For broiler chickens and re-placement chickens where im-munity to coccidiosis is notdesired; prevention of coccidi-osis; as an aid in the preven-tion of infectious coryza;growth promotion and feed ef-ficiency; improving pigmenta-tion.

Feed for 7 to 14 d; withdraw 5 dbefore slaughter; as solesource of organic arsenic; notfor laying hens.

Arsanilic acid 90(0.01%) pluserythromycin 185.

For broiler chickens and replace-ment chickens where immu-nity to coccidiosis is not de-sired; prevention of coccidi-osis; as an aid in the preven-tion and reduction of lesionsand in lowering severity ofchronic respiratory disease;growth promotion and feed ef-ficiency; improving pigmenta-tion.

Feed for 5 to 8 d; do not use inbirds producing eggs for foodpurposes; withdraw 5 d beforeslaughter; as sole source oforganic arsenic.

Bacitracin 4 to 50 .... For broiler chickens and replace-ment chickens where immu-nity to coccidiosis is not de-sired; prevention of coccidi-osis; growth promotion andfeed efficiency.

As bacitracin methylene disalicy-late; not for laying hens.


376

21 CFR Ch. I (4100 Edition) 558.58



Bacitracin 100 to200.

1. Broiler chickens and replace-ment chickens where immu-nity to coccidiosis is not de-sired; prevention of coccidi-osis; treatment of chronic res-piratory disease (air-sac infec-tion) and blue comb (nonspe-cific infectious enteritis).

......do .........................................

2. For broiler chickens and re-placement chickens where im-munity to coccidiosis is notdesired; prevention of coccidi-osis; treatment of chronic res-piratory disease (air-sac infec-tion), blue comb (nonspecificinfectious enteritis).

As zinc bacitracin, not for layinghens.

Bacitracin 4 to 50plus roxarsone22.7 to 45.4(0.0025% to0.005%).

Broiler chickens and replace-ment chickens where immu-nity to coccidiosis is not de-sired; prevention of coccidi-osis; growth promotion andfeed efficiency; improving pig-mentation.

As bacitracin methylene disalicy-late; not for laying hens; assole source of organic arsenic;withdraw 5 d before slaughter.


For chickens where immunity tococcidiosis is not desired; pre-vention of coccidiosis; controlof infectious synovitis causedby Mycoplasma synoviae sus-ceptible to chlortetracycline.



For chickens where immunity tococcidiosis is not desired; pre-vention of coccidiosis; controlof chronic respiratory disease(CRD) and air sac infectioncaused by M. gallisepticumand E. coli susceptible tochlortetracycline.

In low calcium feed containing0.8% dietary calcium and1.5% sodium sulfate; feedcontinuously as sole ration for7 to 14 d; do not feed tochickens producing eggs forhuman consumption.

Erythromycin 92.5 ... 1. For broiler chickens and forreplacement chickens whereimmunity to coccidiosis is notdesired; prevention of coccidi-osis; as an aid in the preven-tion of chronic respiratory dis-ease during periods of stress.

Feed for 2 d before stress and 3to 6 d after stress; withdraw24 h before slaughter; not forlaying hens.

2. For broiler chickens and re-placement chickens where im-munity to coccidiosis is notdesired; prevention of coccidi-osis; as an aid in the preven-tion of infectious coryza.

Feed for 7 to 14 d; withdraw 24h before slaughter; not for lay-ing hens.

Erythromycin 185 .... For broiler chickens and replace-ment chickens where immu-nity to coccidiosis is not de-sired; prevention of coccidi-osis; as an aid in the preven-tion and reduction of lesionsand in lowering severity ofchronic respiratory disease.

Feed for 5 to 8 d; do not use inbirds producing eggs for foodpurposes; withdraw 48 h be-fore slaughter.

Penicillin 2.4 to 50 ... For broiler chickens and replace-ment chickens where immu-nity to coccidiosis is not de-sired; prevention of coccidi-osis; growth promotion andfeed efficiency; improving pig-mentation.

Not

cfr 2000 title21 vol6 part558

Documents

animal feeds558

sulfonamide drugs

new animal drug requirements

new animal drugsfor

feed of animals

lowest uselevel

following definitions

liquid type b feeds