21 C.F.R. § 558.76 Bacitracin methylene disalicylate.
Title 21 - Food and Drugs
(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: (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. [41 FR 10993, Mar. 15, 1976] Editorial Note: For
Title 21: Food and Drugs
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
Subpart B—Specific New Animal Drugs for Use in Animal Feeds
§ 558.76 Bacitracin methylene disalicylate.
---------------------------------------------------------------------------------------------------------------- Bacitracin methylene disalicylate in grams per Combination in grams Indications for use Limitations Sponsor ton per ton----------------------------------------------------------------------------------------------------------------(i) 4 to 50................. ....................... Chickens, turkeys, and ...................... 046573 pheasants; increased rate of weight gain and improved feed efficiency \1\.(ii) 5 to 20................ ....................... Quail not over 5 weeks ...................... 046573 of age; increased rate of weight gain and improved feed efficiency \1\.(iii) 10 to 25.............. ....................... Chickens; for For first 7 months of 046573 increased egg production. production and improved feed efficiency for egg production.(iv) 10 to 30............... ....................... Swine: for increased For growing and 046573 rate of weight gain finishing swine. and improved feed efficiency. Chlortetracycline Swine; for increased Feed for not more than 046573 approximately 400, rate of weight gain 14 days; bacitracin 048164 varying with body and improved feed methylene weight and food efficiency; for disalicylate provided consumption to provide treatment of by No. 046573; 10 milligrams per bacterial enteritis chlortetracycline pound of body weight caused by Escherichia provided by Nos. per day. coli and Salmonella 046573 and 048164 in choleraesuis and § 510.600(c) of bacterial pneumonia this chapter. caused by Pasteurella multocida susceptible to chlortetracycline. Swine; for control of Feed for not more than 046573 porcine proliferative 14 days; enteropathies chlortetracycline and (ileitis) caused by BMD as provided by Lawsonia 046573 in § intracellularis 510.600(c) of this susceptible to chapter. chlortetracycline.(v) [Reserved](vi) 50..................... ....................... Broiler chickens; as ...................... 046573 an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. Replacement chickens; Feed continuously as 046573 as an aid in the sole ration. prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.(vii)-(viii) [Reserved](ix) 100 to 200............. ....................... Broiler chickens; as ...................... 046573 an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. Replacement chickens; Feed continuously as 046573 as an aid in the sole ration. Start at control of necrotic first clinical signs enteritis caused or of disease, vary complicated by dosage based on Clostridium spp. or severity of other organisms infection, administer susceptible to continuously for 5 to bacitracin. 7 days or as long as clinical signs persist, then reduce medication to prevention level (50 g/t).(x) 200..................... ....................... Turkeys; as an aid in ...................... 046573 the control of transmissible enteritis in growing turkeys complicated by organisms susceptible to bacitracin methylene disalicylate. Quail; for the From Type A medicated 046573 prevention of articles containing ulcerative enteritis 25, 40, or 50 grams in growing quail due of bacitracin to Clostridium methylene colinum susceptible disalicylate. Feed to bacitracin continuously as the methylene sole ration. disalicylate.(xi) 250.................... ....................... 1. Growing/Finishing As the sole ration. 046573 Swine: For control of Not for use in swine swine dysentery weighing more than associated with 250 pounds. Diagnosis Treponema should be confirmed hyodysenteriae on by a veterinarian premises with a when results are not history of swine satisfactory. dysentery but where signs of the disease have not yet occurred; or following an approved treatment of the disease condition. 2. Pregnant sows: For As the sole ration. ......... control of Feed to sows from 14 clostridial enteritis days before through caused by C. 21 days after perfringens in farrowing on premises suckling piglets. 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.
