#### § 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](/on/2024-09-23/title-21/section-510.600#p-510.600(c)).

(c) *Related tolerances.* See [§§ 556.430](/on/2024-09-23/title-21/section-556.430) and [556.500 of this chapter](/on/2024-09-23/title-21/section-556.500).

(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](/on/2024-09-23/title-21/section-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 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 |
| (ii) 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 |
| (iii) 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:

| Oxytetracycline and neomycin sulfate amount | Indications for use | Limitations | Sponsors |
| --- | --- | --- | --- |
| (i) 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 |
| (ii) 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 |
| (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 daily | 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 |
| (ii) To provide 10 mg/lb of body weight daily | 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.* 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 daily | 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. 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 |
| (ii) To provide 10 mg/lb of body weight daily | 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. 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 |
| (iii) To provide 75 mg/head/day | Growing cattle (over 400 lb): For the reduction of the incidence of liver abscesses | Feed continuously | 066104 069254 |
| (iv) 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 |

(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 daily | Sheep: 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 neomycin | Feed continuously for 7 to 14 days. Treatment should continue 24 to 48 hours beyond remission of clinical signs of disease. Withdraw 5 days before slaughter | 066104 069254 |

(ii) [Reserved]

[[71 FR 16225](https://www.federalregister.gov/citation/71-FR-16225), Mar. 31, 2006, as amended at [74 FR 40724](https://www.federalregister.gov/citation/74-FR-40724), Aug. 13, 2009; [80 FR 13232](https://www.federalregister.gov/citation/80-FR-13232), Mar. 13, 2015; [81 FR 95012](https://www.federalregister.gov/citation/81-FR-95012), Dec. 27, 2016; [87 FR 76423](https://www.federalregister.gov/citation/87-FR-76423), Dec. 14, 2022; [88 FR 27701](https://www.federalregister.gov/citation/88-FR-27701), May 3, 2023]