21 C.F.R. § 558.450 Oxytetracycline.
Title 21 - Food and Drugs
(a) Approvals. Type A medicated articles: (1) 10, 20, 30, 50, 100, and 200 grams per pound to 066104 in §510.600(c) of this chapter. (2) 50 and 100 grams per pound to 048164 in §510.600(c) of this chapter. (b) Special considerations. (1) In accordance with §558.5 labeling shall bear the statement: “FOR USE IN DRY ANIMAL FEED ONLY. NOT FOR USE IN LIQUID FEED SUPPLEMENTS.” (2) The articles in paragraph (a)(1) of this section contain an amount of mono-alkyl (C8–C18) trimethylammonium oxytetracycline expressed in terms of an equivalent amount of oxytetracycline hydrochloride or an amount of oxytetracycline dihydrate base expressed in terms of an equivalent amount of oxytetracycline hydrochloride. (3) The articles in paragraph (a)(2) of this section contain an amount of mono-alkyl (C8–C18) trimethylammonium oxytetracycline expressed in terms of an equivalent amount of oxytetracycline hydrochloride. (c) Related tolerances. See §556.500 of this chapter. (d)(1) Conditions of use. It is used in feed as follows: (2) It is used in fish feed as follows: (3) Oxytetracycline may be used in accordance with the provisions of this section in the combinations provided as follows: (i) Carbadox as in §558.115 of this chapter. (ii) Lasalocid as in §558.311. (iii) Melengestrol acetate as in §558.342. (iv) Robenidine hydrochloride in accordance with §558.515. (v) Salinomycin as in §558.550. [61 FR 51590, Oct. 3, 1996, as amended at 63 FR 41192, Aug. 3, 1998; 66 FR 32740, June 18, 2001; 66 FR 45167, Aug. 28, 2001; 66 FR 47963, Sept. 17, 2001; 67 FR 51081, Aug. 7, 2002; 69 FR 28821, May 19, 2004; 69 FR 51173, Aug. 18, 2004; 69 FR 62407, Oct. 26, 2004; 71 FR 27958, May 15, 2006; 71 FR 44887, Aug. 8, 2006]
Title 21: Food and Drugs
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
Subpart B—Specific New Animal Drugs for Use in Animal Feeds
§ 558.450 Oxytetracycline.
Table 1---------------------------------------------------------------------------------------------------------------- Oxytetracycline amount Combination Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 10 to 20 grams per ton (g/ .................... Sheep; increased rate ................... 066104, ton). of weight gain and 048164 improved feed efficiency..(ii) 10 to 50 g/ton.............. .................... 1. Chickens; increased Do not feed to Do. rate of weight gain chickens producing and improved feed eggs for human efficiency.. consumption. .................... 2. Growing turkeys; Do not feed to Do. increased rate of turkeys producing weight and improved eggs for human feed efficiency.. consumption. .................... 3. Swine; increased ................... Do. rate of weight and improved feed efficiency..(iii) 100 g/ton.................. .................... Turkeys; control of Feed continuously Do. hexamitiasis caused by for 7 to 14 days Hexamita meleagridis (d); do not feed susceptible to to turkeys oxytetracycline.. producing eggs for human consumption.(iv) 100 to 200 g/ton............ .................... Chickens; control of Feed continuously Do. infectious synovitis for 7 to 14 d; do caused by Mycoplasma not feed to synoviae; control of chickens producing fowl cholera caused by eggs for human Pasteurella multocida consumption; in susceptible to low calcium feed, oxytetracycline.. withdraw 3 d before slaughter.(v) 200 g/ton.................... .................... Turkeys; control of Feed continuously 066104, infectious synovitis for 7 to 14 d; 048164 caused by M. synoviae withdraw 5 d susceptible to before slaughter; oxytetracycline.. do not feed to turkeys producing eggs for human consumption.(vi) 400 g/ton................... .................... Chickens; control of Feed continuously Do. chronic respiratory for 7 to 14 d; do disease (CRD) and air not feed to sac infection caused chickens producing by M. gallisepticum eggs for human and Escherichia coli consumption; in susceptible to low calcium feeds, oxytetracycline.. withdraw 3 d before slaughter.(vii) 500 g/ton.................. .................... Chickens; reduction of Feed continuously 066104, mortality due to air for 5 d; do not 048164 sacculitis (air-sac- feed to chickens infection) caused by producing eggs for E. coli susceptible to human consumption; oxytetracycline.. withdraw 24 hours before slaughter; in low calcium feeds withdraw 3 d before slaughter.(viii) 0.05 to 0.1 milligram/ .................... Calves (up to 250 lb); Feed continuously; 066104, pound (mg/lb) of body weight for increased rate of in milk replacers 048164 daily.. weight gain and or starter feed. improved feed efficiency..(ix) 10 mg/lb of body weight .................... 1.Calves and beef and Feed continuously Do. daily.. nonlactating dairy for 7 to 14 d; in cattle; treatment of feed or milk bacterial enteritis replacers; for No. caused by E. coli and 048164, withdraw 5 bacterial pneumonia d before (shipping fever slaughter; for No. complex) caused by P. 066104, 0-day multocida susceptible withdrawal. to oxytetracycline.. .................... 2. Calves (up to 250 Feed continuously Do. lb); treatment of for 7 to 14 d; in bacterial enteritis milk replacers or caused by E. coli starter feed; for susceptible to No. 048164, oxytetracycline.. withdraw 5 d before slaughter; for No. 066104, 0- day withdrawal. .................... 3. Sheep; treatment of Feed continuously Do. bacterial enteritis for 7 to 14 d; caused by E. coli and withdraw 5 d bacterial pneumonia before slaughter. caused by P. multocida susceptible to oxytetracycline.. .................... 4. Swine; treatment of Feed continuously Do. bacterial enteritis for 7 to 14 d; for caused by E. coli and No. 048164, Salmonella withdraw 5 d choleraesuis before slaughter; susceptible to for No. 066104, oxytetracycline and zero-day treatment of bacterial withdrawal. pneumonia caused by P. multocida susceptible to oxytetracycline.. .................... 5. Breeding swine; Feed continuously Do. control and treatment for not more than of leptospirosis 14 d; for No. (reducing the 048164, withdraw 5 incidence of abortion d before and shedding of slaughter; for No. leptospirae) caused by 066104, zero-day Leptospira pomona withdrawal. susceptible to oxytetracycline..(x) 25 mg/lb of body weight...... .................... Turkeys; control of Feed continuously Do. complicating bacterial for 7 to 14 d; organisms associated withdraw 5 d with bluecomb before slaughter; (transmissible do not feed to enteritis; coronaviral turkeys producing enteritis) susceptible eggs for human to oxytetracycline.. consumption.(xi) 25 mg/head/day.............. .................... Calves (250 to 400 lb); ................... Do. increased rate of weight gain and improved feed efficiency..(xii) 75 mg/head/day............. .................... Growing cattle (over ................... Do. 400 lb); increased rate of weight gain; improved feed efficiency, and reduction of liver condemnation due to liver abscesses..(xiii) 0.5 to 2.0 g/head/day..... .................... Cattle; prevention and Feed 3 to 5 d Do. treatment of the early before and after stages of shipping arrival in fever complex.. feedlots.(xiv) 200 mg/colony.............. .................... Honey bees; control of Remove at least 6 Do. American foulbrood weeks prior to caused by Bacillus main honey flow. larvae and European foulbrood caused by Streptococcus pluton susceptible to oxytetracycline..----------------------------------------------------------------------------------------------------------------
Table 2---------------------------------------------------------------------------------------------------------------- Oxytetracycline amount Combination Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 250 mg/kilogram of fish/d .................... Pacific salmon for For salmon not over 066104 (11.35 g/100 lb of fish/d).. marking of skeletal 30 g body weight; tissue.. administer as sole ration for 4 consecutive days; fish not to be liberated for at least 7 d following the last administration of medicated feed..(ii) 2.5 to 3.75 g/100 lb of fish/ .................... 1. Salmonids; control Administer in mixed 066104 d.. of ulcer disease ration for 10 d; caused by Hemophilus do not liberate piscium, furunculosis fish or slaughter caused by Aeromonas fish for food for salmonicida, bacterial 21 d following the hemorrhagic septicemia last caused by A. administration of liquefaciens, and medicated feed; do pseudomonas disease.. not administer when water temperature is below 9 °C (48.2 °F).. .................... 2. Catfish; control of Administer in mixed 066104 bacterial hemorrhagic ration for 10 d; septicemia caused by do not liberate A. liquefaciens and fish or slaughter pseudomonas disease.. fish for food for 21 d following the last administration of medicated feed; do not administer when water temperature is below 16.7 °C (62 °F).(iii) 1 g/lb of medicated feed... .................... Lobsters; control of Administer as sole 066104 gaffkemia caused by ration for 5 Aerococcus viridans.. consecutive days; withdraw medicated feed 30 d before harvesting lobsters..----------------------------------------------------------------------------------------------------------------
