CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS (parts 500 to 590) > PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS > SUBPART B—Specific New Animal Drugs for Use in Animal Feeds (§558.55 to §558.680) > 558.76—Bacitracin methylene disalicylate.

558.76—Bacitracin methylene disalicylate.

(a) Approvals. Type A medicated articles: 10, 25, 30, 40, 50, 60, or 75 grams per pound to 046573 in § 510.600(c) of this chapter.
(b) Special considerations. The quantities of antibiotics are expressed in terms of the equivalent amount of antibiotic standard.
(c) Related tolerances. See § 556.70 of this chapter.
(d) Conditions of use. (1) It is used as follows:
Bacitracin methylene disalicylate in grams per ton Combination in gramsper ton Indications for use Limitations Sponsor
(i) 4 to 50 Chickens, turkeys, and pheasants; increased rate of weight gain and improved feed efficiency 1 046573
(ii) 5 to 20 Quail not over 5 weeks of age; increased rate of weight gain and improved feed efficiency 1 046573
(iii) 10 to 25 Chickens; for increased egg production and improved feed efficiency for egg production For first 7 months of production 046573
(iv) 10 to 30 Swine: for increased rate of weight gain and improved feed efficiency For growing and finishing swine 046573
Chlortetracycline approximately 400, varying with body weight and food consumption to provide 10 milligrams per pound of body weight per day Swine; for increased rate of weight gain and improved feed efficiency; for treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline Feed for not more than 14 days; bacitracin methylene disalicylate provided by No. 046573; chlortetracycline provided by Nos. 046573 and 048164 in § 510.600(c) of this chapter 046573048164
Swine; for control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline Feed for not more than 14 days; chlortetracycline and BMD as provided by 046573 in § 510.600(c) of this chapter 046573
(v) [Reserved]
Code of Federal Regulations 408
(vi) 50 Broiler chickens; as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin 046573
Replacement chickens; as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. Feed continuously as sole ration 046573
(vii)-(viii) [Reserved]
(ix) 100 to 200 Broiler chickens; as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin 046573
Replacement chickens; as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. Feed continuously as sole ration. Start at first clinical signs of disease, vary dosage based on severity of infection, administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce medication to prevention level (50 g/t) 046573
(x) 200 Turkeys; as an aid in the control of transmissible enteritis in growing turkeys complicated by organisms susceptible to bacitracin methylene disalicylate 046573
Quail; for the prevention of ulcerative enteritis in growing quail due to Clostridium colinum susceptible to bacitracin methylene disalicylate. From Type A medicated articles containing 25, 40, or 50 grams of bacitracin methylene disalicylate. Feed continuously as the sole ration 046573
(xi) 250 1. Growing/Finishing Swine: For control of swine dysentery associated with Treponema hyodysenteriae on premises with a history of swine dysentery but where signs of the disease have not yet occurred; or following an approved treatment of the disease condition As the sole ration. Not for use in swine weighing more than 250 pounds. Diagnosis should be confirmed by a veterinarian when results are not satisfactory 046573
2. Pregnant sows: For control of clostridial enteritis caused by C. perfringens in suckling piglets As the sole ration. Feed to sows from 14 days before through 21 days after farrowing on premises with a history of clostridial scours. Diagnosis should be confirmed by a veterinarian when results are not satisfactory
1 These conditions are NAS/NRC reviewed and found effective. Applications for these uses may not require effectiveness data as specified by § 514.111 of this chapter, but may require bioequivalency and safety information.
(2) It is used as bacitracin methylene disalicylate in feed for animals as follows:
(i) Amount. 70 milligrams per head per day.
(a) Indications for use. Feedlot beef cattle; reduction in the number of liver condemnations due to abscesses.
(b) Limitations. Administer continuously throughout the feeding period.
(ii) Amount. 250 milligrams per head per day.
(a) Indications for use. Feedlot beef cattle; reduction in the number of liver condemnations due to abscesses.
(b) Limitations. Administer continuously for 5 days then discontinue for subsequent 25 days, repeat the pattern during the feeding period.
(3) Bacitracin methylene disalicylate may also be used with:
(i) Amprolium as in § 558.55.
(ii) Amprolium and ethopabate as in § 558.58.
(iii) Carbarsone (not USP) as in § 558.120.
(iv) Decoquinate alone and with roxarsone as in § 558.195.
(v) Diclazuril alone and with roxarsone as in § 558.198.
(vi) Fenbendazole as in § 558.258.
(vii) Halofuginone hydrobromide alone and with roxarsone as in § 558.265.
(viii) Hygromycin B as in § 588.274.
(ix) Ivermectin as in § 558.300.
(x) Lasalocid sodium alone and with roxarsone as in § 558.311.
(xi) Monensin alone and with roxarsone as in § 588.355.
(xii) Narasin alone and with roxarsone as in § 558.363.
(xiii) Nicarbazin alone or with narasin or roxarsone or with narasin and roxarsone as in § 558.366.
(xiv) Nitarsone as in § 558.369.
(xv) Robenidine alone and with roxarsone as in § 558.515.
(xvi) Salinomycin alone and with roxarsone as in § 558.550.
(xvii) Semduramicin alone and with roxarsone as in § 558.555.
(xviii) Zoalene alone and with arsanilic acid or roxarsone as in § 558.680.

Code of Federal Regulations

[41 FR 10993, Mar. 15, 1976]

Code of Federal Regulations

Editorial Note: For Federal Register citations affecting § 558.76 , see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.