[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR520.154a]

[Page 104-105]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 520_ORAL DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec. 520.154a  Soluble bacitracin methylene disalicylate.

    (a) Specifications. Each pound of soluble powder contains the 
equivalent of 50 grams of bacitracin activity for use as in paragraph 
(d)(1) or (d)(2) of this section, or the equivalent of 200 grams of 
bacitracin activity for use as in paragraph (d) of this section.
    (b) Sponsor. See No. 046573 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.70 of this chapter.
    (d) Conditions of use--(1) Growing turkeys--(i) Amount. 400 
milligrams per gallon in drinking water.
    (ii) Indications for use. Aid in the control of transmissible 
enteritis complicated by organisms susceptible to bacitracin methylene 
disalicylate.
    (iii) Limitations. Prepare a fresh solution daily.
    (2) Broiler and replacement chickens--(i) Amount. 100 milligrams per 
gallon in drinking water.
    (A) Indications for use. Aid in the prevention of necrotic enteritis 
caused by Clostridium perfringens susceptible to bacitracin methylene 
disalicylate.
    (B) Limitations. Prepare a fresh solution daily.
    (ii) Amount. 200 to 400 milligrams per gallon in drinking water.
    (A) Indications for use. Aid in the control of necrotic enteritis 
caused by C. perfringens susceptible to bacitracin methylene 
disalicylate.
    (B) Limitations. Prepare a fresh solution daily.
    (3) Swine--(i) Amount. 1 gram per gallon in drinking water.
    (ii) Indications for use. Treatment of swine dysentery associated 
with Treponema hyodysenteriae. Administer

[[Page 105]]

continuously for 7 days or until signs of dysentery disappear.
    (iii) Limitations. Prepare a fresh solution daily. Treatment not to 
exceed 14 days. If symptoms persist after 4 to 5 days consult a 
veterinarian. Not to be given to swine that weigh more than 250 pounds.
    (4) Growing quail--(i) Amount. 400 milligrams per gallon in drinking 
water.
    (ii) Indications for use. For prevention of ulcerative enteritis due 
to Clostridium colinum susceptible to bacitracin methylene disalicylate.
    (iii) Limitations. Prepare fresh solution daily. Use as sole source 
of drinking water.

[57 FR 37322, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at 
63 FR 38474, July 17, 1998; 64 FR 13068, Mar. 17, 1999]