CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS (parts 500 to 590) > PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS > SUBPART B—Specific New Animal Drugs for Use in Animal Feeds (§558.55 to §558.680) > 558.455—Oxytetracycline and neomycin.

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. 048164 and 066104 in § 510.600(c) of this chapter.
(c) Related tolerances. See §§ 556.430 and 556.500 of this chapter.
(d) Special considerations. 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) 10 to 50 Chickens: For increased rate of weight gain and improved feed efficiency. Feed continuously; do not feed to chickens producing eggs for human consumption; in low calcium feeds withdraw 3 days before slaughter. 048164066104
(ii) 100 to 200 Chickens: 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. 048164066104
(iii) 400 Chickens: 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. 048164066104
(iv) 500 Chickens: 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. 048164066104
(2) Turkeys. It is used in feed as follows:
Oxytetracycline and neomycin sulfate amount Indications for use Limitations Sponsors
(i) 10 to 50 grams per ton (g/ton) of feed Growing turkeys: For increased rate of weight gain and improved feed efficiency. Feed continuously; do not feed to turkeys producing eggs for human consumption. 048164066104
(ii) 100 g/ton of feed Turkeys: 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. 048164066104
(iii) 200 g/ton of feed Turkeys: 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. 048164066104
(iv) 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. 048164066104
(3) Swine. It is used in feed as follows:
Oxytetracycline and neomycin sulfate amount Indications for use Limitations Sponsors
(i) 10 to 50 g/ton of feed Swine: For increased rate of weight gain and improved feed efficiency. Feed continuously. 048164066104
(ii) To provide 10 mg/lb of body weight daily. 1. Swine: 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 neomycin. Feed continuously for 7 to 14 d; withdraw 5 d before slaughter. 048164066104
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 not more than 14 d; withdraw 5 d before slaughter. 048164066104
(4) Cattle and sheep. It is used in feed as follows:
Oxytetracycline and neomycin sulfate amount Indications for use Limitations Sponsors
(i) 10 to 20 g/ton of feed Sheep: For increased rate of weight gain and improved feed efficiency. Feed continuously. 048164066104
(ii) To provide 0.05 to 0.1 mg/lb of body weight daily. Calves (up to 250 lb): For increased rate of weight gain and improved feed efficiency. Feed continuously; in milk replacers or starter feed. 048164066104
(iii) To provide 10 mg/lb of body weight daily. 1. Calves 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 neomycin. Feed continuously for 7 to 14 d; in feed or milk replacers. If symptoms persist after using for 2 or 3 days, consult a veterinarian. 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 slaughter. 048164066104
2. Calves (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 neomycin. Feed continuously for 7 to 14 d; in milk replacers or starter feed. If symptoms persist after using for 2 or 3 days, consult a veterinarian. 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 slaughter. 048164066104
3. Sheep: For treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin. Feed continuously for 7 to 14 d. If symptoms persist after using for 2 or 3 days, consult a veterinarian. Treatment should continue 24 to 48 hours beyond remission of disease symptoms. Withdraw 5 d before slaughter. 048164066104
(iv) To provide 25 mg/head/day Calves (250 to 400 lb): For increased rate of weight gain and improved feed efficiency. Feed continuously. 048164066104
(v) To provide 75 mg/head/day Growing cattle (over 400 lb): For increased rate of weight gain; improved feed efficiency, and reduction of liver condemnation due to liver abscesses. Feed continuously. 048164066104
(vi) To provide 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 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 older. 048164066104

Code of Federal Regulations

[71 FR 16225, Mar. 31, 2006, as amended at 74 FR 40724, Aug. 13, 2009]