21 C.F.R. § 520.2345d Tetracycline powder.
Title 21 - Food and Drugs
(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. 000069: 25 grams per pound as in paragraphs (d)(3) and (d)(4) of this section. (2) Nos. 000010 and 046573: 102.4 and 324 grams per pound as in paragraph (d) of this section. (3) No. 053501: 102.4 and 324 grams per pound as in paragraphs (d)(1) and (d)(2) of this section. (4) No. 046573: 102.4 and 324 grams per pound as in paragraph (d)(3) of this section. (5) Nos. 054925, 057561, 059130, and 061623: 324 grams per pound as in paragraph (d) 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 (Hemophilus 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 sponsor No. 053501 and within 5 days of treatment for sponsor Nos. 000010, 046573, 054925, 057561, 059130, and 061623; 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. (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 (Hemophilus 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 sponsor No. 053501 and within 4 days of treatment for sponsor Nos. 000010, 046573, 054925, 057561, 059130, and 061623; prepare a fresh solution daily; use as the sole source of tetracycline. (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. (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. [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]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.2345d Tetracycline powder.
