Title 21
SECTION 558.76
558.76 Bacitracin methylenedisalicylate.
§ 558.76 Bacitracin methylenedisalicylate.(a) Specifications. (1) Type A medicated articles containing 10, 25, 30, 40, 50, 60, or 75 grams bacitracin methylenedisalicylate per pound.
(2) Type A medicated article containing 50 grams bacitracin methylenedisalicylate per pound.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter:
(1) No. 054771 for use of products in paragraph (a)(1) of this section as in paragraphs (e)(1)(i), (e)(1)(iii), (e)(1)(v) through (xiii), and (e)(1)(xv) of this section.
(2) No. 069254 for use of products in paragraph (a)(2) of this section as in paragraphs (e)(1)(ii), (e)(1)(iv), (e)(1)(xiv), and (e)(1)(xvi) of this section.
(c) Special considerations. The quantities of antibiotics are expressed in terms of the equivalent amount of antibiotic standard.
(d) Related tolerances. See § 556.70 of this chapter.
(e) Conditions of use. (1) It is used as follows:
| Bacitracin methylenedisalicylate amount | Combination in grams per
ton (g/ton) |
Indications for use | Limitations | Sponsor |
|---|---|---|---|---|
| (i) 4 to 50 g/ton | Chickens, turkeys, and pheasants: For increased rate of weight gain and improved feed efficiency | 054771 | ||
| (ii) 4 to 50 g/ton | Broiler and replacement chickens, growing turkeys, and growing pheasants: For increased rate of weight gain and improved feed efficiency | 069254 | ||
| (iii) 5 to 20 g/ton | Quail not over 5 weeks of age: For increased rate of weight gain and improved feed efficiency | 054771 | ||
| (iv) 5 to 20 g/ton | Growing quail: For increased rate of weight gain and improved feed efficiency | For use in quail not over 5 weeks of age | 069254 | |
| (v) 10 to 25 g/ton | Chickens: For increased egg production and improved feed efficiency for egg production | For first 7 months of production | 054771 | |
| (vi) 10 to 30 g/ton | Swine: For increased rate of weight gain and improved feed efficiency | For growing and finishing swine | 054771 | |
| (vii) 50 g/ton | Broiler chickens: As an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. 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 | 054771 | |
| (viii) 100 to 200 g/ton | Broiler chickens: As an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. 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/ton) | 054771 | |
| (ix) 200 g/ton | Turkeys: As an aid in the control of transmissible enteritis in growing turkeys complicated by organisms susceptible to bacitracin methylenedisalicylate. Quail: For the prevention of ulcerative enteritis in growing quail due to Clostridium colinum susceptible to bacitracin methylenedisalicylate | Feed continuously as the sole ration | 054771 | |
| (x) 250 g/ton | 1. Growing/finishing swine: For control of swine dysentery Treponema hyodysenteriae on premises with 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 a when results are not satisfactory | 054771 | |
| 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 veterinarian when results are not satisfactory | |||
| (xi) To provide 70 mg per head per day | Feedlot beef cattle: For reduction in the number of liver condemnations due to abscesses | Administer continuously throughout the feeding period | 054771 | |
| (xii) To provide 70 mg per head per day | Beef steers and heifers fed in confinement for slaughter: For reduction in the number of liver condemnations due to abscesses | Administer continuously throughout the feeding period | 069254 | |
| (xiii) To provide 250 mg per head per day | Feedlot beef cattle: For reduction in the number of liver condemnations due to abscesses | Administer continuously for 5 days then discontinue for subsequent 25 days, repeat the pattern during the feeding period | 054771 | |
| (xiv) To provide 250 mg per head per day | Beef steers and heifers fed in confinement for slaughter: For reduction in the number of liver condemnations due to abscesses | Administer continuously for 5 days then discontinue for subsequent 25 days, repeat the pattern during the feeding period | 069254 |
(2) Bacitracin methylenedisalicylate may also be used in combination with:
(i) Amprolium as in § 558.55.
(ii) Amprolium and ethopabate as in § 558.58.
(iii) Chlortetracycline as in § 558.128.
(iv) Clopidol as in § 558.175.
(v) Decoquinate as in § 558.195.
(vi) Diclazuril as in § 558.198.
(vii) Fenbendazole as in § 558.258.
(viii) Halofuginone as in § 558.265.
(ix) Ivermectin as in § 558.300.
(x) Lasalocid as in § 558.311.
(xi) Monensin as in § 558.355.
(xii) Narasin as in § 558.363.
(xiii) Narasin and nicarbazin as in § 558.364.
(xiv) Nicarbazin as in § 558.366.
(xv) Robenidine as in § 558.515.
(xvi) Salinomycin as in § 558.550.
(xvii) Semduramicin as in § 558.555.
(xviii) Zoalene as in § 558.680.
[41 FR 10993, Mar. 15, 1976] Editorial Notes1. 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.govinfo.gov.2. At 80 FR 78970, Dec. 18, 2015, § 558.76 was amended by removing and reserving paragraph (d)(3)(xiii); however, the amendment could not be incorporated because the paragraph did not exist.