21 C.F.R. § 558.78

Bacitracin zinc

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(a) Specifications. Type A medicated articles containing bacitracin zinc equivalent to 10, 25, 40, or 50 grams per pound bacitracin.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

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

Bacitracin zinc in grams per ton	Indications for use	Limitations	Sponsor
(i) 4 to 50	Chickens: for increased rate of weight gain and improved feed efficiency	Growing chickens	054771
(ii) 4 to 50	Turkeys and pheasants: for increased rate of weight gain and improved feed efficiency	Growing turkeys and pheasants	054771
(iii) 5 to 20	Quail; for increased rate of weight gain and improved feed efficiency	Growing quail; feed as the Type C feed to starting quail through 5 weeks of age	054771
(iv) 10 to 25	Laying chickens; improved feed efficiency and increased egg production		054771
(v) 10 to 50	Swine; increased rate of weight gain and improved feed efficiency	Growing and finishing swine	054771
(vi) 20	Growing-finishing swine; increased rate of weight gain	In Type C feed	054771
(vii) 20 to 40	Growing-finishing swine; improved feed efficiency		054771

(2) It is used in feed for growing cattle at 35 to 70 milligrams per head per day as follows:

(i) To aid in stimulating growth and improving feed efficiency.

(ii) For increased rate of weight gain and improved feed efficiency; see sponsor 054771.

(3) Bacitracin zinc may also be used in combination with:

(i) Amprolium and ethopabate as in § 558.58.

(ii) Clopidol as in § 558.175.

(iii) Decoquinate as in § 558.195.

(iv) Lasalocid as in § 558.311.

(v) Monensin as in § 558.355.

(vi) Naracin as in § 558.363.

(vii) Nicarbazin as in § 558.366.

(viii) Robenidine as in § 558.515.

(ix) Salinomycin as in § 558.550.

[41 FR 10994, Mar. 15, 1976] Editorial Note:For Federal Register citations affecting § 558.78, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

Notes of Decisions

Cited in 2 cases, 1995–2006 · leading case: Alpharma Inc v. Leavitt, Michael, 460 F.3d 1 (D.C. Cir. 2006).

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Alpharma Inc v. Leavitt, Michael, 460 F.3d 1 (D.C. Cir. 2006). “37,043, 37,044 (July 17,1981) (codified at 21 C.F.R. § 558.78 ). On May 28, 1981, Philips Roxane submitted an application to the FDA for approval of its generic version of bacitracin zinc.”

A.L. Pharma, Inc. v. Donna E. Shalala, 62 F.3d 1484 (D.C. Cir. 1995). “37,043 , 37,044 (1981) (codified at 21 C.F.R. § 558.78 (1994)). This regulation provided Philips Roxane with an important shortcut to FDA approval.”

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