[Title 21 CFR 520.2220a]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)]
[Subchapter E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS]
[Part 520 - ORAL DOSAGE FORM NEW ANIMAL DRUGS]
[Sec. 520.2220a - Sulfadimethoxine oral solution and soluble powder.]
[From the U.S. Government Publishing Office]




  21
  FOOD AND DRUGS
  6
  1996-04-01
  1996-04-01
  false
  
  520.2220a
  Sec. 520.2220a
  
    FOOD AND DRUGS
    FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
    ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
    ORAL DOSAGE FORM NEW ANIMAL DRUGS
  


Sec. 520.2220a  Sulfadimethoxine oral solution and soluble powder.

    (a) Specifications. (1) The oral solution contains 12.5 percent 
(3.75 grams per ounce) sulfadimethoxine.
    (2) Each packet of powder contains the equivalent of 94.6 grams of 
sulfadimethoxine (as the sodium salt).
    (b) Sponsors. See Nos. 000069 and 057561 in Sec. 510.600(c) of this 
chapter.
    (c) Special considerations. Chickens and turkeys that have survived 
fowl cholera outbreaks should not be kept for replacements or breeders.
    (d) Related tolerances. See Sec. 556.640 of this chapter.
    (e) Conditions of use. The oral solution is administered as a cattle 
drench or diluted as directed to prepare drinking water. The powder is 
used to prepare a drench or drinking water. The concentrations and uses 
of the various solutions are as follows:
    (1) Broiler and replacement chickens only. (i) Amount. 1.875 (0.05 
percent) grams per gallon.
    (ii) Indications for use. Treatment of disease outbreaks of 
coccidiosis, fowl cholera, and infectious coryza.
    (iii) Limitations. Administer for 6 consecutive days; do not 
administer to chickens over 16 weeks of age; as sole source of drinking 
water and sulfonamide medication; as sulfadimethoxine solution or 
sulfadimethoxine soluble sodium salt; withdraw 5 days before slaughter.
    (2) Meat-producing turkeys only--(i) Amount. 0.938 (0.025 percent) 
grams per gallon.
    (ii) Indications for use. Treatment of disease outbreaks of 
coccidiosis and fowl cholera.
    (iii) Limitations. Administer for 6 consecutive days; do not 
administer to turkeys over 24 weeks of age; as sole source of drinking 
water and sulfonamide medication; as sulfadimethoxine solution or 
sulfadimethoxine soluble sodium salt; withdraw 5 days before slaughter.
    (3) Dairy calves, dairy heifers, and beef cattle only--(i) Amount. 
1.18 to 2.36 (0.031 to 0.062 percent) grams per gallon.
    (ii) Indications for use. Treatment of shipping fever complex, 
bacterial pneumonia, calf diphtheria, and foot rot.
    (iii) Administer 2.5 grams per 100 pounds of body weight for first 
day, then 1.25 grams per 100 pounds of body weight per day for the next 
4 consecutive days; in drinking water or drench; available as a 
sulfadimethoxine soluble powder or a 12.5 percent sulfadimethoxine 
sodium solution (3.75 grams sulfadimethoxine per fluid ounce); if no 
improvement within 2 to 3

[[Page 215]]

days, reevaluate diagnosis; do not treat beyond 5 days; withdraw 7 days 
before slaughter.

[40 FR 13838, Mar. 27, 1975, as amended at 58 FR 6092, Jan. 26, 1993; 59 
FR 56000, Nov. 10, 1994; 61 FR 4875, Feb. 9, 1996]