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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 Oct 01, 2021.

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]
[CITE: 21CFR520.2345d]



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 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 520.2345d Tetracycline powder.

(a) Specifications. Each pound of powder contains 25, 102.4, or 324 grams tetracycline hydrochloride.

(b) Sponsors. See sponsors listed in § 510.600(c) of this chapter for conditions of use as in paragraph (d) of this section:

(1) No. 054771: 25 grams per pound as in paragraphs (d)(3) and (d)(4) of this section.

(2) No. 066104: 25, 102.4, and 324 grams per pound as in paragraph (d) of this section.

(3) Nos. 016592 and 054771: 25, 102.4, and 324 grams per pound as in paragraph (d) of this section.

(4) Nos. 016592, 054925, 061133, and 076475: 324 grams per pound as in paragraph (d) of this section.

(5) No. 016592: 25 grams per pound as in paragraphs (d)(1) and (d)(2) of this section.

(c) Related tolerances. See § 556.720 of this chapter.

(d) Conditions of use. It is administered in drinking water as follows:

(1) Calves - (i) Amount. 10 milligrams per pound of body weight per day in divided doses.

(ii) Indications for use. Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia (shipping fever complex) associated with Pasteurella spp., Actinobacillus pleuropneumoniae (Haemophilus spp.), and Klebsiella spp., susceptible to tetracycline.

(iii) Limitations. Administer for 3 to 5 days; do not slaughter animals for food within 4 days of treatment for No. 066104 and within 5 days of treatment for Nos. 016592, 054771, 054925, 057561, and 061133; prepare a fresh solution daily; use as the sole source of tetracycline. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Swine - (i) Amount. 10 milligrams per pound of body weight per day in divided doses.

(ii) Indications for use. Control and treatment of bacterial enteritis (scours) caused by E. coli and bacterial pneumonia associated with Pasteurella spp., A. pleuropneumoniae (Haemophilus spp.), and Klebsiella spp., susceptible to tetracycline.

(iii) Limitations. Administer for 3 to 5 days; do not slaughter animals for food within 7 days of treatment for No. 066104 and within 4 days of treatment for Nos. 016592, 054771, 054925, 057561, and 061133; prepare a fresh solution daily; use as the sole source of tetracycline. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(3) Chickens - (i) Amount. Chronic respiratory disease: 400 to 800 milligrams per gallon. Infectious synovitis: 200 to 400 milligrams per gallon.

(ii) Indications for use. Control of chronic respiratory disease (CRD or air-sac disease) caused by Mycoplasma gallisepticum and E. coli ; control of infectious synovitis caused by M. synoviae susceptible to tetracycline.

(iii) Limitations. Administer for 7 to 14 days; do not slaughter for food within 4 days of treatment; not for use in chickens producing eggs for human consumption; prepare a fresh solution daily; use as the sole source of tetracycline. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(4) Turkeys - (i) Amount. For infectious synovitis: 400 milligrams per gallon. For complicating bacterial organisms associated with bluecomb (transmissible enteritis or coronaviral enteritis): 25 milligrams per pound of body weight per day.

(ii) Indications for use. Control of infectious synovitis caused by M. synoviae ; control of bluecomb complicated by organisms sensitive to tetracycline.

(iii) Limitations. Administer for 7 to 14 days; do not slaughter for food within 4 days of treatment; not for use in turkeys producing eggs for human consumption; prepare a fresh solution daily; use as the sole source of tetracycline. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[59 FR 17693, Apr. 14, 1994, as amended at 59 FR 19133, Apr. 22, 1994; 62 FR 5319, Feb. 5, 1997; 62 FR 35076, June 30, 1997; 62 FR 46668, Sept. 4, 1997; 62 FR 55160, Oct. 23, 1997; 64 FR 37673, July 13, 1999; 67 FR 78355, Dec. 24, 2002; 70 FR 16934, Apr. 4, 2005; 70 FR 67353, Nov. 7, 2005; 71 FR 13542, Mar. 16, 2006; 75 FR 10166, Mar. 5, 2010; 75 FR 12981, Mar. 18, 2010; 76 FR 17338, Mar. 29, 2011; 77 FR 20988, Apr. 9, 2012; 78 FR 21060, Apr. 9, 2013; 79 FR 28831, May 20, 2014; 81 FR 17607, Mar. 30, 2016; 81 FR 22523, Apr. 18, 2016; 81 FR 94990, Dec. 27, 2016; 83 FR 48946, Sept. 28, 2018; 84 FR 8973, Mar. 13, 2019]

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