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Code of Federal Regulations (Last Updated: October 10, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter E - Animal Drugs, Feeds, and Related Products |
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Part 520 - Oral Dosage Form New Animal Drugs |
§ 520.1660d - Oxytetracycline powder.
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§ 520.1660d Oxytetracycline powder.
(a) Specifications. The drug is a soluble powder distributed in packets or pails having several concentrations of oxytetracycline hydrochloride (independent of the various net weights) as follows:
(1) Each 18.14 grams of powder contains 1 gram of oxytetracycline hydrochloride (OTC HCl) (packets: 4, 6.4, and 16 oz.).
(2) Each 4.43 grams of powder contains 1 gram of OTC HCl (packets: 4 and 16 oz.).
(3) Each 1.32 grams of powder contains 1 gram of OTC HCl (packets: 2.39, 4.78, and 9.55 oz.; jars: 2.25 lbs.; and pails: 4.5 lbs.).
(4) Each 2.73 grams of powder contains 1 gram of OTC HCl (packets: 2.46 and 9.87 oz, 3.09 and 3.91 lb; pail: 3.09 lb).
(5) Each 4.2 grams of powder contains 1 gram of OTC HCl (packets: 3.8 and 15.2 oz; pails: 4.74 and 23.7 lb).
(6) Each 1.32 grams of powder contains 1 gram of OTC HCl (packet: 4.78 oz.; pail: 5 lb). Each 2.73 grams of powder contains 1 gram of OTC HCl (packet: 9.87 oz).
(7) Each 1.32 grams of powder contains 1 gram of OTC HCl (packet: 4.78 and 9.6 oz.; pails: 2 and 5 lb); each 18.1 grams of powder contains 1 gram of OTC HCl (packet: 6.4 oz.; pails: 2 and 5 lb).
(8) Each 135.5-gram packet (4.78 ounce) contains 102.4 grams of OTC HCl. Each 677.5-gram packet (23.9 ounce) contains 512 grams of OTC HCl.
(9) Each 2.73 grams of powder contains 1 gram of OTC HCl (packets: 9.87 and, 19.75 oz, and 3.91 lb; pails: 3.09 and 5 lb).
(10) Each 2.73 grams of powder contains 1 gram of OTC HCl (packets: 9.87 and 19.74 oz; pails: 5 lb).
(b) Sponsor. See sponsor numbers in § 510.600(c) of this chapter as follows:
(1) No. 054771 for use of OTC HCl concentrations in paragraphs (a)(1), (a)(2), and (a)(3) of this section in chickens, turkeys, swine, cattle, sheep, and honey bees.
(2) No. 016592 for use of OTC HCl concentration in paragraph (a)(4) of this section in chickens, turkeys, and swine.
(3) No. 066104 for use of OTC HCl concentration in paragraph (a)(5) of this section in turkeys and chickens.
(4) No. 016592 for use of OTC HCl concentration in paragraph (a)(6) of this section in chickens, turkeys, and swine.
(5) No. 061133 for use of OTC HCl concentration in paragraph (a)(7) of this section in chickens, turkeys, swine, cattle, sheep, and honeybees.
(6) No. 069254 for use of OTC HCl concentrations in paragraph (a)(8) of this section in chickens, turkeys, swine, cattle, sheep, and honey bees.
(7) No. 061133 for use of OTC HCl concentration in paragraph (a)(9) of this section in chickens, turkeys, and swine.
(c) Related tolerances. See § 556.500 of this chapter.
(d) Conditions of use.
(1) It is used in drinking water as follows:
(i) Chickens -
(A)
(1) Amount. Administer 200 to 400 milligrams/gallon for 7 to 14 days. Not to be used for more than 14 consecutive days.
(2) Indications for use. Control of infectious synovitis caused by Mycoplasma synoviae susceptible to oxytetracycline.
(3) Do not use in birds producing eggs for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(B)
(1) Amount. Administer 400 to 800 milligrams/gallon for 7 to 14 days. Not to be used for more than 14 consecutive days.
(2) Indications for use. Control of chronic respiratory disease (CRD) and air sac infections caused by Mycoplasma gallisepticum and E. coli susceptible to oxytetracycline; control of fowl cholera caused by Pasteurella multocida susceptible to oxytetracycline.
(3) Do not use in birds producing eggs for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(ii) Turkeys -
(A)
(1) Amount. Administer 200 to 400 milligrams/gallon for 7 to 14 days. Not to be used for more than 14 consecutive days.
(2) Indications for use. Control of hexamitiasis caused by Hexamita meleagridis susceptible to oxytetracycline.
(3) Do not use in birds producing eggs for human consumption. Withdraw 5 days prior to slaughter those products sponsored by Nos. 054771 and 061133 in § 510.600(c) of this chapter. Withdraw 4 days prior to slaughter those products sponsored by No. 054628. Zero-day withdrawal for those products sponsored by Nos. 057561 and 069254. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(B)
(1) Amount. Administer 400 milligrams/gallon for 7 to 14 days. Not to be used for more than 14 consecutive days.
(2) Indications for use. Control of infectious synovitis caused by Mycoplasma synoviae susceptible to oxytetracycline.
(3) Do not use in birds producing eggs for human consumption. Withdraw 5 days prior to slaughter those products sponsored by Nos. 054771 and 061133 in § 510.600(c) of this chapter. Withdraw 4 days prior to slaughter those products sponsored by No. 054628. Zero-day withdrawal for those products sponsored by Nos. 057561 and 069254. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(C)
(1) Amount. Administer 25 milligrams per pound of body weight daily for 7 to 14 days. Not to be used for more than 14 consecutive days.
(2) Indications for use. Growing turkeys. Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) susceptible to oxytetracycline.
(3) Do not use in birds producing eggs for human consumption. Withdraw 5 days prior to slaughter those products sponsored by Nos. 054771 and 061133 in § 510.600(c) of this chapter. Withdraw 4 days prior to slaughter those products sponsored by No. 054628. Zero-day withdrawal for those products sponsored by Nos. 057561 and 069254. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(iii) Swine -
(A) Amount. Administer 10 milligrams per pound of body weight daily for in drinking water. Administer up to 14 days. Do ; do not use for more than 14 consecutive days those products sponsored by Nos. 054771, 061133, and 069254. Administer up to 5 days; do not use for more than 5 consecutive days those products sponsored by Nos. 016592 and 061133.
(B) Indications for use. Control and treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline. For breeding swine: Control and treatment of leptospirosis (reducing the incidence of abortions and shedding of leptospira) caused by Leptospira pomona susceptible to oxytetracycline.
(C) Limitations. Withdraw zero days prior to slaughter those products sponsored by Nos. 054771, 057561, 061133, and 069254 in § 510.600(c) of this chapter. Withdraw 4 days prior to slaughter those products sponsored by No. 054628. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(iv) Calves, beef cattle, and nonlactating dairy cattle -
(A) Amount. Administer 10 milligrams per pound of body weight daily for up to 14 days. Do not use for more than 14 consecutive days.
(B) Indications for use. Control and treatment of bacterial enteritis caused by E. coli and bacterial pneumonia (shipping fever complex) caused by P. multocida susceptible to oxytetracycline.
(C) Withdraw 5 days prior to slaughter. A milk discard period has not been established for this product in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(v) Sheep -
(A) Amount. Administer 10 milligrams per pound of body weight daily for up to 14 days. Not to be used for more than 14 consecutive days.
(B) Indications for use. Control and treatment of bacterial enteritis caused by E. coli and bacterial pneumonia (shipping fever complex) caused by P. multocida susceptible to oxytetracycline.
(C) Withdraw 5 days prior to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) It is used in the food of honey bees as follows:
(i) Amount. 200 milligrams per colony, administered via either a 1:1 sugar syrup (equal parts of sugar and water weight to weight) or dusting with a powdered sugar mixture. The drug is administered in 3 applications of sugar syrup or 3 dustings at 4- to 5-day intervals.
(ii) Indications for use. For control of American foulbrood caused by Paenibacillus larvae.
(iii) The drug should be fed early in the spring or fall and consumed by the bees before main honey flow begins to avoid contamination of production honey. Remove at least 6 weeks prior to main honey flow. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[40 FR 13838, Mar. 27, 1975]