21 C.F.R. § 558.76

Current through October 31, 2024

Section 558.76 - Bacitracin methylenedisalicylate

(a)Specifications.

(1) Type A medicated articles containing feed grade bacitracin methylenedisalicylate equivalent to 10, 25, 30, 40, 50, 60, or 75 grams bacitracin per pound.

(2) Type A medicated article containing feed grade bacitracin methylenedisalicylate equivalent to 50 grams bacitracin per pound.

(b)Sponsors. See sponsors in § 510.600(c) of this chapter as follows:

(1) No. 054771 for use of products in paragraph (a)(1) of this section as in paragraph (d) of this section.

(2) No. 069254 for use of product in paragraph (a)(2) of this section as in paragraph (d) of this section.

(c)Related tolerances. See § 556.70 of this chapter.

(d)Conditions of use -

(1)Chickens -

Bacitracin in grams per ton	Indications for use	Limitations	Sponsor
(i) 4 to 50	Broiler and replacement chickens: For increased rate of weight gain and improved feed efficiency	Feed continuously as sole ration	054771 069254
(ii) 10 to 25	Laying hens: For increased egg production and improved feed efficiency	Feed continuously as sole ration for the first 7 months of egg production	054771
(iii) 50	Broiler and 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
(iv) 50	Broiler and replacement chickens: For the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens	Feed as the sole ration for 28 to 35 days, starting from the time chicks are placed for brooding	069254
(v) 100 to 200	Broiler and 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 grams/ton)	054771

(2)Turkeys -

Bacitracin in grams per ton	Indications for use	Limitations	Sponsor
(i) 4 to 50	Growing turkeys: For increased rate of weight gain and improved feed efficiency	Feed continuously as sole ration	054771 069254
(ii) 200	Growing turkeys: As an aid in the control of transmissible enteritis complicated by organisms susceptible to bacitracin methylenedisalicylate	Feed continuously as the sole ration	054771

(3)Swine -

Bacitracin in grams per ton	Indications for use	Limitations	Sponsor
(i) 10 to 30	Growing and finishing swine: For increased rate of weight gain and improved feed efficiency		054771
(ii) 250	Growing and finishing swine: For control of swine dysentery (bloody scours) associated with Brachyspira hyodysenteriae in pigs up to 250 lbs body weight	Feed as the sole ration. Feed 250 grams per ton of complete feed 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. Diagnosis should be confirmed by a veterinarian a when results are not satisfactory	054771
(iii) 250	Pregnant sows: For control of clostridial enteritis caused by Clostridium 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	054771

(4)Cattle -

Bacitracin amount	Indications for use	Limitations	Sponsor
(i) 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	054771 069254
(ii) 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	054771 069254

(5)Game birds -

Bacitracin in grams per ton	Indications for use	Limitations	Sponsor
(i) 4 to 50	Growing pheasants: For increased rate of weight gain and improved feed efficiency	Feed continuously as sole ration	054771 069254
(ii) 5 to 20	Growing quail: For increased rate of weight gain and improved feed efficiency in quail not over 5 weeks of age	Feed continuously as sole ration to quail not over 5 weeks of age	054771 069254
(iii) 200	Growing 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

(6) 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 .

21 C.F.R. §558.76

41 FR 10993, Mar. 15, 1976

81 FR 17609, 3/30/2016; 81 FR 94995, 12/27/2016; 82 FR 21691, 5/10/2017; 83 FR 64741, 12/18/2018; 84 FR 39184, 8/9/2019; 85 FR 18121, 4/1/2020; 86 FR 14821, 3/19/2021; 86 FR 57998, 10/20/2021; 88 FR 16549, 3/20/2023

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.