21 CFR § 558.455
Oxytetracycline and neomycin
June 25, 2020
(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:
Open Table
| Oxytetracycline and neomycin sulfate amount in grams per ton of feed | Indications for use | Limitations | Sponsors |
|---|---|---|---|
| (i) [Reserved] | |||
| (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. | 066104 069254 |
| (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. | 066104 069254 |
| (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. | 066104 069254 |
(2) Turkeys. It is used in feed as follows:
Open Table
| Oxytetracycline and neomycin sulfate amount | Indications for use | Limitations | Sponsors |
|---|---|---|---|
| (i) [Reserved] | |||
| (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. | 066104 069254 |
| (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. | 066104 069254 |
| (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. | 066104 069254 |
(3) Swine. It is used in feed as follows:
Open Table
| Oxytetracycline and neomycin sulfate amount | Indications for use | Limitations | Sponsors |
|---|---|---|---|
| (i) [Reserved] | |||
| (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. | 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 not more than 14 d; withdraw 5 d before slaughter. | 066104 069254 |
(4) Cattle and sheep. It is used in feed as follows:
Open Table
| Oxytetracycline and neomycin sulfate amount | Indications for use | Limitations | Sponsors |
|---|---|---|---|
| (i)-(ii) [Reserved] | |||
| (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. | 066104 069254 |
| 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. | 066104 069254 |
|
| 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. | 066104 069254 |
|
| (iv) [Reserved] | |||
| (v) To provide 75 mg/head/day | Growing cattle (over 400 lb): For reduction of liver condemnation due to liver abscesses. | Feed continuously. | 066104 069254 |
| (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. | 066104 069254 |
[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]
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