21 CFR § 558.450 Oxytetracycline | Code of Federal Regulations | US Law

21 CFR § 558.450

Oxytetracycline

June 25, 2020

CFR

(a) Specifications. Each pound of Type A medicated article contains:

(1) Oxytetracycline (from oxytetracycline quaternary salt) equivalent to 50 or 100 grams oxytetracycline hydrochloride; or oxytetracycline (from oxytetracycline dihydrate base) equivalent to 10, 30, 50, 100, or 200 grams oxytetracycline hydrochloride.

(2) Oxytetracycline (from oxytetracycline dihydrate base) equivalent to 50, 100, or 200 grams oxytetracycline hydrochloride; or 100 grams oxytetracycline hydrochloride.

(b) Sponsors. See sponsors in §510.600(c) of this chapter as follows:

(1) No. 066104: Type A medicated articles as in paragraph (a)(1) of this section.

(2) No. 069254: Type A medicated articles as in paragraph (a)(2) of this section.

(d) Special considerations.

(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See §558.6 for additional requirements.

(2) The expiration date of VFDs for oxytetracycline medicated feeds must not exceed 6 months from the date of issuance. VFDs for oxytetracycline shall not be refilled.

(3) In accordance with §558.5, labeling shall bear the statement: “For use in dry animal feed only. Not for use in liquid feed supplements.”

(e) Conditions of use—(1) Chickens—

Open Table

Oxytetracycline amount	Combination in grams/ton	Indications for use	Limitations	Sponsor
(i) 100 to 200 g/ton		Chickens: For control of infectious synovitis caused by Mycoplasma synoviae and control of fowl cholera caused by Pasteurella multocida susceptible to oxytetracycline	Feed continuously for 7 to 14 days. Do not feed to chickens producing eggs for human consumption. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Zero-day withdrawal period	066104 069254
(ii) 200 g/ton	Monensin, 90 to 110	Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and for the control of complicated chronic respiratory disease (CRD or air sac infection) caused by Mycoplasma gallisepticum and Escherichia coli	Feed continuously as the sole ration. Do not feed to laying chickens. Do not feed to chickens over 16 weeks of age. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 72 hours before slaughter. See §558.355(d) of this chapter Oxytetracycline as provided by No. 066104; monensin as provided by No. 058198 in §510.600(c) of this chapter	066104
(iii) 400 g/ton		Chickens: For control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli susceptible to oxytetracycline	Feed continuously for 7 to 14 days. Do not feed to chickens producing eggs for human consumption. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Zero-day withdrawal period	066104 069254
(iv) 400 g/ton	Robenidine, 30	Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and for the control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli susceptible to oxytetracycline	Feed continuously for 7 to 14 days. Do not feed to chickens producing eggs for human consumption. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 5 days before slaughter. Oxytetracycline as provided by No. 066104; robenidine as provided by No. 054771 in §510.600(c) of this chapter	066104
(v) 500 g/ton		Chickens: For reduction of mortality due to air sacculitis (air sac infection) caused by E. coli susceptible to oxytetracycline	Feed continuously for 5 days. Do not feed to chickens producing eggs for human consumption. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 24 hours before slaughter	066104 069254
(vi) 500 g/ton	Monensin, 90 to 100	Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and as an aid in the reduction of mortality due to air-sacculitis (air sac infection) caused by Escherichia coli sensitive to oxytetracycline	Feed for 5 days as the sole ration. Treat at first clinical signs of the disease. Do not feed to laying chickens. Do not feed to chickens over 16 weeks of age. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 72 hours before slaughter. See §558.355(d) of this chapter. Oxytetracycline as provided by No. 066104; monensin as provided by No. 058198 in §510.600(c) of this chapter	066104
(vii) 500 g/ton	Salinomycin, 40 to 60	Chickens: For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and as an aid in the reduction of mortality due to air-sacculitis (air sac infection) caused by E. coli sensitive to oxytetracycline	Feed for 5 days as the sole ration. Treat at first clinical signs of the disease. Do not feed to laying chickens. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 24 hours before slaughter. Oxytetracycline as provided by No. 066104; salinomycin as provided by No. 016592 in §510.600(c) of this chapter	066104 016592

(2) Turkeys—

Open Table

Oxytetracycline amount	Indications for use	Limitations	Sponsor
(i) 100 g/ton	Turkeys: For control of hexamitiasis caused by Hexamita meleagridis susceptible to oxytetracycline	Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption. Zero-day withdrawal period	066104 069254
(ii) 200 g/ton	Turkeys: For control of infectious synovitis caused by M. synoviae susceptible to oxytetracycline	Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption. For No. 066104, withdraw 5 days before slaughter. For No. 069254, zero-day withdrawal period	066104 069254
(iii) 25 mg/lb of body weight daily	Turkeys: For control of complicating bacterial organisms associated with bluecomb (transmissible enteritis; coronaviral enteritis) susceptible to oxytetracycline	Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption. For No. 066104, withdraw 5 days before slaughter. For No. 069254, zero-day withdrawal period	066104 069254

(3) Swine—

Open Table

Oxytetracycline amount	Combination in grams/ton	Indications for use	Limitations	Sponsor
(i) 10 mg/lb of body weight daily		1. Swine: For treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis susceptible to oxytetracycline and treatment of bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline	Feed continuously for 7 to 14 days	066104 069254
		2. Breeding swine: For control and treatment of leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to oxytetracycline	Feed continuously for 14 days	066104 069254
(ii) 10 mg/lb of body weight daily	Carbadox, 10 to 25	Swine: For treatment of bacterial enteritis caused by E. coli and Salmonella choleraesuis susceptible to oxytetracycline and treatment of bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline; and for increased rate of weight gain and improved feed efficiency	Feed continuously as the sole ration for 7 to 14 days. Not for use in pregnant swine or swine intended for breeding purposes. Do not mix in feeds containing bentonite. Do not feed to swine within 42 days of slaughter. Oxytetracycline and carbadox as provided by No. 066104 in §510.600(c) of this chapter	066104

(4) Cattle—

Open Table

Oxytetracycline amount	Combination in grams/ton	Indications for use	Limitations	Sponsor
(i) 10 mg/lb of body weight daily		1. Calves and beef and nonlactating dairy cattle: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida susceptible to oxytetracycline	Feed continuously for 7 to 14 days. For No. 069254, withdraw 5 days before slaughter. For No. 066104, zero-day withdrawal period	066104 069254
		2. Calves: For treatment of bacterial enteritis caused by E. coli susceptible to oxytetracycline	Feed continuously for 7 to 14 days in milk replacer or starter feed. This product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. For No. 069254, withdraw 5 days before slaughter. For No. 066104, zero-day withdrawal period	066104 069254
(ii) 75 mg/head/day		Growing cattle (over 400 lb): For reduction of incidence of liver abscesses	Feed continuously	066104 069254
(iii) 75 mg/head/day	Lasalocid 25 to 30	Heifers fed in confinement for slaughter (over 400 lb): For reduction of incidence of liver abscesses; and for increased rate of weight gain and improved feed efficiency	Feed continuously to provide 250 to 360 mg lasalocid and 75 mg of oxytetracycline per head per day. Lasalocid as provided by No. 054771 in §510.600(c) of this chapter	054771
(iv) 75 mg/head/day	Melengestrol acetate, 0.25 to 2.0	Heifers fed in confinement for slaughter (over 400 lb): For reduction of incidence of liver abscesses; and for increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat)	Feed continuously to provide 0.25 to 0.5 mg of melengestrol acetate and 75 mg of oxytetracycline per head per day. Melengestrol as provided by No. 054771 in §510.600(c) of this chapter	054771
(v) 0.5 to 2.0 g/head/day		Cattle: For prevention and treatment of the early stages of shipping fever complex	Feed 3 to 5 days before and after arrival in feedlots	066104 069254

(5) Minor species—

Open Table

Oxytetracycline amount	Indications for use	Limitations	Sponsor
(i) 10 mg/lb of body weight daily	Sheep: For treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida susceptible to oxytetracycline	Feed continuously for 7 to 14 days; withdraw 5 days before slaughter	066104 069254
(ii) 200 mg/colony	Honey bees: For control of American foulbrood caused by Paenibacillus larvae and European foulbrood caused by Streptococcus pluton susceptible to oxytetracycline	Remove at least 6 weeks prior to main honey flow	066104 069254
(iii) 2.5 to 3.75 g/100 lb of fish/day	1. Salmonids: For control of ulcer disease caused by Haemophilus piscium, furunculosis caused by Aeromonas salmonicida, bacterial hemorrhagic septicemia caused by A. hydrophila, and pseudomonas disease	Administer in mixed ration for 10 days; do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed	066104
	2. Catfish: For control of bacterial hemorrhagic septicemia caused by A. hydrophila and pseudomonas disease	Administer in mixed ration for 10 days; do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed; do not administer when water temperature is below 16.7 °C (62 °F)	066104
(iv) 3.75 g/100 lb of fish/day.	3. Freshwater-reared salmonids weighing up to 55 grams: For marking the skeletal tissue	Feed for 10 days. Immediate release is permitted following the last feeding of medicated feed	066104
(v) 11.35 g/100 lb of fish/day.	Pacific salmon not over 30 grams body weight: For marking of skeletal tissue	Administer medicated feed as the sole ration for 4 consecutive days. Do not liberate for at least 7 days following last feeding of medicated feed	066104
(vi) 1 g/lb of medicated feed	Lobsters: For control of gaffkemia caused by Aerococcus viridans	Administer as sole ration for 5 consecutive days; withdraw medicated feed 30 days before harvesting lobsters	066104

[81 FR 95009, Dec. 27, 2016, as amended at 82 FR 11512, Feb. 24, 2017; 83 FR 48948, Sept. 28, 2018; 84 FR 12502, Apr. 2, 2019]

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