21 C.F.R. § 558.455

Current through September 30, 2024
Section 558.455 - Oxytetracycline and neomycin
(a)Specifications. Type A medicated articles containing oxytetracycline equivalent to 50 grams per pound (g/lb) oxytetracycline hydrochloride and 50 g/lb neomycin sulfate or oxytetracycline equivalent to 100 g/lb oxytetracycline hydrochloride and 100 g/lb neomycin sulfate.
(b)Sponsors. See Nos. 066104 and 069254 in § 510.600(c) of this chapter.
(c)Related tolerances. See §§ 556.430 and 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 and neomycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for oxytetracycline and neomycin shall not be refilled.
(3) Cattle feeds shall bear the following warning statement: "Use of more than one product containing neomycin or failure to follow withdrawal times may result in illegal drug residues."
(e)Indications for use -
(1)Chickens. It is used in feed as follows:

Oxytetracycline and neomycin sulfate amount in grams per ton of feed Indications for use Limitations Sponsors
(i) 100 to 200Chickens: For control of infectious synovitis caused by Mycoplasma synoviae; control of fowl cholera caused by Pasteurella multocida susceptible to oxytetracycline.Feed continuously for 7 to 14 d; do not feed to chickens producing eggs for human consumption; in low calcium feed, withdraw 3 d before slaughter.066104
069254
(ii) 400Chickens: For control of chronic respiratory disease (CRD) and air sac infection caused by M. gallisepticum and Escherichia coli susceptible to oxytetracycline.Feed continuously for 7 to 14 d; do not feed to chickens producing eggs for human consumption; in low calcium feeds, withdraw 3 d before slaughter.066104
069254
(iii) 500Chickens: For reduction of mortality due to air sacculitis (air-sac- infection) caused by E. coli susceptible to oxytetracycline.Feed continuously for 5 d; do not feed to chickens producing eggs for human consumption; withdraw 24 hours before slaughter; in low calcium feeds withdraw 3 d before slaughter.066104
069254

(2)Turkeys. It is used in feed as follows:

Oxytetracycline and neomycin sulfate amount Indications for use Limitations Sponsors
(i) 100 g/ton of feedTurkeys: For control of hexamitiasis caused by Hexamita meleagridis susceptible to oxytetracycline.Feed continuously for 7 to 14 d; do not feed to turkeys producing eggs for human consumption.066104
069254
(ii) 200 g/ton of feedTurkeys: For control of infectious synovitis caused by M. synoviae susceptible to oxytetracycline.Feed continuously for 7 to 14 d; withdraw 5 d before slaughter; do not feed to turkeys producing eggs for human consumption.066104
069254
(iii) To provide 25 milligrams per pound (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 d; withdraw 5 d before slaughter; do not feed to turkeys producing eggs for human consumption.066104
069254

(3)Swine. It is used in feed as follows:

Oxytetracycline and neomycin sulfate amount Limitations Sponsors
(i) To provide 10 mg/lb of body weight dailySwine: For treatment of bacterial enteritis caused by E. coli and Salmonella choleraesuis and treatment of bacterial pneumonia caused by P. multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycinFeed continuously for 7 to 14 d; withdraw 5 d before slaughter066104
069254
(ii) To provide 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 d; withdraw 5 d before slaughter066104
069254

(4)Cattle. It is used in feed as follows:

Oxytetracycline and neomycin sulfate amount Indications for use Limitations Sponsors
(i) To provide 10 mg/lb of body weight dailyCalves and beef and nonlactating dairy cattle: For treatment of bacterial enteritis caused by E. coli and bacterial pneumonia (shipping fever complex) caused by P. multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycinFeed continuously for 7 to 14 d; in feed or milk replacers. Treatment should continue 24 to 48 hours beyond remission of disease symptoms. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older. Withdraw 5 d before slaughter066104
069254
(ii) To provide 10 mg/lb of body weight dailyCalves (up to 250 lb): For treatment of bacterial enteritis caused by E. coli susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycinFeed continuously for 7 to 14 d; in milk replacers or starter feed. Treatment should continue 24 to 48 hours beyond remission of disease symptoms. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older. Withdraw 5 d before slaughter066104
069254
(iii) To provide 75 mg/head/dayGrowing cattle (over 400 lb): For the reduction of the incidence of liver abscessesFeed continuously066104
069254
(iv) To provide 0.5 to 2.0 g/head/ dayCattle: For prevention and treatment of the early stages of shipping fever complexFeed 3 to 5 d before and after arrival in feedlots. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older066104
069254

(5)Sheep. It is used in feed as follows:

Oxytetracycline and neomycin sulfate amount Indications for use Limitations Sponsors
(i) To provide 10 mg/lb of body weight dailySheep: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycinFeed continuously for 7 to 14 days. Treatment should continue 24 to 48 hours beyond remission of clinical signs of disease. Withdraw 5 days before slaughter066104
069254

(ii) [Reserved]

21 C.F.R. §558.455

71 FR 16225, Mar. 31, 2006, as amended at 74 FR 40724, Aug. 13, 2009; 80 FR 13232, Mar. 13, 2015; 81 FR 95012, Dec. 27, 2016; 87 FR 76423, Dec. 14, 2022; 88 FR 27701, May 3, 2023
81 FR 95012, 12/27/2016; 87 FR 76423, 12/14/2022; 88 FR 27701, 5/3/2023