21 C.F.R. § 558.450

Current through September 30, 2024
Section 558.450 - Oxytetracycline
(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.
(c)Related tolerances. See § 556.500 of this chapter.
(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 -

Oxytetracycline amountCombination in grams/tonIndications for useLimitationsSponsor
(i) 100 to 200 g/tonChickens: For control of infectious synovitis caused by Mycoplasma synoviae and control of fowl cholera caused by Pasteurella multocida susceptible to oxytetracyclineFeed 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 period066104
069254
(ii) 200 g/tonMonensin, 90 to 110Broiler 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 coliFeed 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 chapter066104
(iii) 400 g/tonChickens: For control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli susceptible to oxytetracyclineFeed 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 period066104
069254
(iv) 400 g/tonRobenidine, 30Broiler 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 oxytetracyclineFeed 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 chapter066104
(v) 500 g/tonChickens: For reduction of mortality due to air sacculitis (air sac infection) caused by E. coli susceptible to oxytetracyclineFeed 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 slaughter066104
069254
(vi) 500 g/tonMonensin, 90 to 100Broiler 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 oxytetracyclineFeed 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 chapter066104
(vii) 500 g/tonSalinomycin, 40 to 60Chickens: 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 oxytetracyclineFeed 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 chapter066104
016592

(2)Turkeys -

Oxytetracycline amount Indications for use Limitations Sponsor
(i) 100 g/tonTurkeys: For control of hexamitiasis caused by Hexamita meleagridis susceptible to oxytetracyclineFeed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption. Zero-day withdrawal period066104
069254
(ii) 200 g/tonTurkeys: For control of infectious synovitis caused by M. synoviae susceptible to oxytetracyclineFeed 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 period066104
069254
(iii) 25 mg/lb of body weight dailyTurkeys: For control of complicating bacterial organisms associated with bluecomb (transmissible enteritis; coronaviral enteritis) susceptible to oxytetracyclineFeed 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 period066104
069254

(3)Swine -

Oxytetracycline amountCombination in grams/tonIndications for useLimitationsSponsor
(i) 10 mg/lb of body weight dailySwine: 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 oxytetracyclineFeed continuously for 7 to 14 days066104
069254
(ii) 10 mg/lb of body weight dailyBreeding swine: For control and treatment of leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to oxytetracyclineFeed continuously for not more than 14 days066104
069254
(iii) 10 mg/lb of body weight dailyCarbadox, 10 to 25Swine: 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 efficiencyFeed 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 chapter066104

(4)Cattle -

Oxytetracycline amountCombination in grams/tonIndications for useLimitationsSponsor
(i) 10 mg/lb of body weight dailyCalves 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 oxytetracyclineFeed continuously for 7 to 14 days. This drug 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 period066104
069254
(ii) 10 mg/lb of body weight dailyCalves: For treatment of bacterial enteritis caused by E. coli susceptible to oxytetracyclineFeed continuously for 7 to 14 days in milk replacer or starter feed. This drug 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 period066104
069254
(iii) 75 mg/head/dayGrowing cattle (over 400 lb): For reduction of incidence of liver abscessesFeed continuously. This drug 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 cows066104
069254
(iv) 75 mg/head/dayLasalocid 25 to 30Heifers 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 efficiencyFeed 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 chapter054771
(v) 75 mg/head/dayMelengestrol acetate, 0.25 to 2.0Heifers 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 chapter054771
(vi) 0.5 to 2.0 g/head/dayCattle: For prevention and treatment of the early stages of shipping fever complexFeed 3 to 5 days before and after arrival in feedlots. This drug 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 cows066104
069254

(5)Minor species -

Oxytetracycline amount Indications for use Limitations Sponsor
(i) 10 mg/lb of body weight dailySheep: For treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida susceptible to oxytetracyclineFeed continuously for 7 to 14 days; withdraw 5 days before slaughter066104
069254
(ii) 200 mg/colony as a dust (200 mg/oz) or syrup (200 mg/5 lb)Honey bees: For control of American foulbrood caused by Paenibacillus larvae and European foulbrood caused by Melissococcus plutonius susceptible to oxytetracyclineApply every 4 to 5 days for a total of three applications. Remove at least 6 weeks prior to main honey flow066104
069254
(iii) 800 mg/colony as an extender patty (800 mg/patty)Honey bees: For control of American foulbrood caused by Paenibacillus larvae and European foulbrood caused by Melissococcus plutonius susceptible to oxytetracyclineUse as a single application. Remove at least 6 weeks prior to main honey flow066104
069254
(iv) 2.5 to 3.75 g/100 lb of fish/day1. Freshwater-reared salmonids: For control of ulcer disease caused by Haemophilus piscium, furunculosis caused by Aeromonas salmonicida, bacterial hemorrhagic septicemia caused by A. hydrophila, and pseudomonas diseaseAdminister in mixed ration for 10 days. Do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed066104
2. Catfish: For control of bacterial hemorrhagic septicemia caused by A. hydrophila and pseudomonas diseaseAdminister 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
(v) 3.75 g/100 lb of fish/day1. Freshwater-reared salmonids: For control of mortality due to coldwater disease associated with Flavobacterium psychrophilum or for control of mortality due to columnaris disease associated with Flavobacterium columnareAdminister in mixed ration for 10 days. Do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed066104
2. Freshwater-reared salmonids weighing up to 55 grams: For marking the skeletal tissueFeed for 10 days. Immediate release is permitted following last feeding of medicated feed066104
3. Catfish: For control of mortality due to columnaris disease associated with Flavobacterium columnareAdminister 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
(vi) 11.35 g/100 lb of fish/dayPacific salmon not over 30 grams body weight: For marking of skeletal tissueAdminister medicated feed as the sole ration for 4 consecutive days. Do not liberate for at least 7 days following last feeding of medicated feed066104
(vii) 1 g/lb of medicated feedLobsters: For control of gaffkemia caused by Aerococcus viridansAdminister as sole ration for 5 consecutive days; withdraw medicated feed 30 days before harvesting lobsters066104

21 C.F.R. §558.450

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; 86 FR 14825, Mar. 19, 2021; 87 FR 10972, Feb. 28, 2022; 87 FR 76423, Dec. 14, 2022; 88 FR 14907, Mar. 10, 2023; 88 FR 55571, Aug. 16, 2023
81 FR 17609, 3/30/2016; 81 FR 95009, 12/27/2016; as amended at 82 FR 11512, 2/24/2017; 83 FR 48948, 9/28/2018; 84 FR 12502, 4/2/2019; 86 FR 14825, 3/19/2021; 87 FR 10972, 2/28/2022; 87 FR 76423, 12/14/2022; 88 FR 14907, 3/10/2023; 88 FR 55571, 8/16/2023