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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2018.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2018]
[CITE: 21CFR558.115]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E--ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 558 -- NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

Subpart B--Specific New Animal Drugs for Use in Animal Feeds

Sec. 558.115 Carbadox.

(a) Approvals. Type A medicated articles: 2.2. percent (10 grams per pound) to 066104 in 510.600(c) of this chapter.

(b) Related tolerances. See 556.100 of this chapter.

(c) Special considerations. Do not use in Type B or Type C medicated feeds containing bentonite.

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

(1) Amount per ton. 10-25 grams (0.0011-0.00275 percent).

(i) Indications for use. For increase in rate of weight gain and improvement of feed efficiency.

(ii) Limitations. Not for use in pregnant swine or swine intended for breeding purposes. Do not feed to swine within 42 days of slaughter.

(2) Amount per ton. 50 grams (0.0055 percent).

(i) Indications for use. For control of swine dysentery (vibrionic dysentery, bloody scours, or hemorrhagic dysentery); control of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis ); increased rate of weight gain and improved feed efficiency.

(ii) Limitations. Not for use in pregnant swine or swine intended for breeding purposes. Do not feed to swine within 42 days of slaughter.

(3) Amount per ton. Carbadox 50 grams (0.0055 percent) plus pyrantel tartrate, 96 grams (0.0106 percent).

(i) Indications for use. For control of swine dysentery (vibrionic dysentery, bloody scours, or hemorrhagic dysentery); control of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis ); aid in the prevention of migration and establishment of large roundworm (Ascaris suum ) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum ) infections.

(ii) Limitations. Do not feed to swine over 75 pounds; do not feed within 10 weeks of slaughter; consult a veterinarian before feeding to severely debilitated animals; feed continuously as sole ration. Do not use in complete feeds containing less than 15 percent crude protein.

(4) Carbadox may also be used in combination with oxytetracycline as in 558.450.

[40 FR 13959, Mar. 27, 1975, as amended at 40 FR 45164, Oct. 1, 1975; 40 FR 57798, Dec. 12, 1975; 42 FR 761, Jan. 4, 1977; 51 FR 7396, Mar. 3, 1986; 63 FR 59216, Nov. 3, 1998; 66 FR 47963, Sept. 17, 2001; 69 FR 51173, Aug. 18, 2004; 82 FR 21691, May 10, 2017]

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