Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 558  /  Sec. 558.450 Oxytetracycline.

(a) Approvals. Type A medicated articles:

(1) 10, 20, 30, 50, 100, and 200 grams per pound to No. 066104 in Sec. 510.600(c) of this chapter.

(2) 50, 100, and 200 grams per pound to No. 069254 in Sec. 510.600(c) of this chapter.

(b) Special considerations. (1) In accordance with Sec. 558.5 labeling shall bear the statement: ``FOR USE IN DRY ANIMAL FEED ONLY. NOT FOR USE IN LIQUID FEED SUPPLEMENTS.''

(1) In accordance with Sec. 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) 50-, 100-, and 200-gram per pound articles in paragraph (a)(2) of this section contain oxytetracycline dihydrate expressed in terms of an equivalent amount of oxytetracycline hydrochloride. Another 100-gram per pound article in paragraph (a)(2) of this section contains oxytetracycline hydrochloride.

(c) Related tolerances. See Sec. 556.500 of this chapter.

(d) Conditions of use--(1) Chickens-- ----------------------------------------------------------------------------------------------------------------

(i) 10 to 50 grams per ton (g/ton)....... Chickens: For increased rate Feed continuously; do not 066104,

of weight gain and improved feed to chickens producing 069254

feed efficiency.. eggs for human consumption..----------------------------------------------------------------------------------------------------------------(ii) 100 to 200 g/ton.................... Chickens: For control of Feed continuously for 7 to 066104,

infectious synovitis caused 14 days (d); do not feed to 069254

by Mycoplasma synoviae and chickens producing eggs for

control of fowl cholera human consumption; in low

caused by Pasteurella calcium feeds, withdraw 3 d

multocida susceptible to before slaughter..

oxytetracycline..----------------------------------------------------------------------------------------------------------------(iii) 400 g/ton.......................... Chickens: For control of Feed continuously for 7 to 066104,

chronic respiratory disease 14 d; do not feed to 069254

(CRD) and air sac infection chickens producing eggs for

caused by Mycoplasma human consumption; in low

gallisepticum and calcium feeds, withdraw 3 d

Escherichia coli before slaughter..

susceptible to

oxytetracycline..----------------------------------------------------------------------------------------------------------------(iv) 500 g/ton........................... Chickens: For reduction of Feed continuously for 5 d; 066104,

mortality due to air do not feed to chickens 069254

sacculitis (air sac producing eggs for human

infection) caused by E. consumption; withdraw 24

coli susceptible to hours before slaughter; in

oxytetracycline.. low calcium feeds, withdraw

3 d before slaughter..----------------------------------------------------------------------------------------------------------------

(2) Turkeys-- ----------------------------------------------------------------------------------------------------------------

(i) 10 to 50 g/ton.................. Growing turkeys: For Feed continuously; do not 066104,

increased rate of feed to turkeys 069254

weight gain and producing eggs for human

improved feed consumption..

efficiency..----------------------------------------------------------------------------------------------------------------(ii) 100 g/ton...................... Turkeys: For control of Feed continuously for 7 066104,

hexamitiasis caused by to 14 d; do not feed to 069254

Hexamita meleagridis turkeys producing eggs

susceptible to for human consumption..

oxytetracycline..----------------------------------------------------------------------------------------------------------------(iii) 200 g/ton..................... Turkeys: For control of Feed continuously for 7 066104,

infectious synovitis to 14 d; for No. 066104 069254

caused by M. synoviae withdraw 5 d before

susceptible to slaughter; for No.

oxytetracycline.. 069254 zero-day

withdrawal time; do not

feed to turkeys

producing eggs for human

consumption..----------------------------------------------------------------------------------------------------------------(iv) 25 milligrams/pound (mg/lb) of Turkeys: For control of Feed continuously for 7 066104,

body weight daily. complicating bacterial to 14 d; for No. 066104 069254

organisms associated withdraw 5 d before

with bluecomb slaughter; for No.

(transmissible 069254 zero-day

enteritis; coronaviral withdrawal time; do not

enteritis) susceptible feed to turkeys

to oxytetracycline.. producing eggs for human

consumption..----------------------------------------------------------------------------------------------------------------

(3) Swine-- ----------------------------------------------------------------------------------------------------------------

(i) 10 to 50 g/ton.................. Swine: For increased Feed continuously........ 066104,

rate of weight gain 069254

and improved feed

efficiency..----------------------------------------------------------------------------------------------------------------

(ii) 10 mg/lb of body weight daily.. 1. Swine: For treatment Feed continuously for 7 066104,

of bacterial enteritis to 14 d.. 069254

caused by E. coli and

Salmonella

choleraesuis

susceptible to

oxytetracycline and

treatment of bacterial

pneumonia caused by P.

multocida susceptible

to oxytetracycline..

2. Breeding swine: For Feed continuously for 14 066104,

control and treatment d.. 069254

of leptospirosis

(reducing the

incidence of abortion

and shedding of

leptospirae) caused by

Leptospira pomona

susceptible to

oxytetracycline..----------------------------------------------------------------------------------------------------------------

(4) Cattle-- ----------------------------------------------------------------------------------------------------------------

(i) 0.05 to 0.1 mg/lb of body weight Calves (up to 250 lb): Feed continuously in milk 066104,

daily. For increased rate of replacer or starter 069254

weight gain and feed..

improved feed

efficiency..----------------------------------------------------------------------------------------------------------------(ii) 10 mg/lb of body weight daily.. 1. Calves and beef and Feed continuously for 7 066104,

nonlactating dairy to 14 d; for No. 069254, 069254

cattle: For treatment withdraw 5 d before

of bacterial enteritis slaughter; for No.

caused by E. coli and 066104, zero-day

bacterial pneumonia withdrawal time..

(shipping fever

complex) caused by P.

multocida susceptible

to oxytetracycline..

2. Calves: For Feed continuously for 7 066104,

treatment of bacterial to 14 d in milk replacer 069254

enteritis caused by E. or starter feed; for No.

coli susceptible to 069254, withdraw 5 d

oxytetracycline.. before slaughter; for

No. 066104, zero-day

withdrawal time..----------------------------------------------------------------------------------------------------------------(iii) 25 mg/head/day................ Calves (250 to 400 lb): Feed continuously........ 066104,

For increased rate of 069254

weight gain and

improved feed

efficiency..----------------------------------------------------------------------------------------------------------------(iv) 75 mg/head/day................. Growing cattle (over Feed continuously........ 066104,

400 lb): For increased 069254

rate of weight gain,

improved feed

efficiency, and

reduction of liver

condemnation due to

liver abscesses..----------------------------------------------------------------------------------------------------------------(v) 0.5 to 2.0 g/head/day........... Cattle: For prevention Feed 3 to 5 d before and 066104,

and treatment of the after arrival in 069254

early stages of feedlots..

shipping fever

complex..----------------------------------------------------------------------------------------------------------------

(5) Minor species-- ----------------------------------------------------------------------------------------------------------------

(i) 10 to 20 g/ton.................. Sheep: For increased Feed continuously........ 066104,

rate of weight gain 069254

and improved feed

efficiency..----------------------------------------------------------------------------------------------------------------(ii) 10 mg/lb of body weight daily.. Sheep: For treatment of Feed continuously for 7 066104,

bacterial enteritis to 14 d; withdraw 5 d 069254

caused by E. coli and before slaughter..

bacterial pneumonia

caused by P. multocida

susceptible to

oxytetracycline..----------------------------------------------------------------------------------------------------------------(iii) 200 mg/colony................. Honey bees: For control Remove at least 6 weeks 066104,

of American foulbrood prior to main honey 069254

caused by flow..

Paenibacillus larvae

and European foulbrood

caused by

Streptococcus pluton

susceptible to

oxytetracycline..----------------------------------------------------------------------------------------------------------------(iv) 250 mg/kilogram of fish/day Pacific salmon: For For salmon not over 30 g 066104

(11.35 g/100 lb of fish/day). marking of skeletal body weight; administer

tissue.. as sole ration for 4

consecutive days; fish

not to be liberated for

at least 7 d following

the last administration

of medicated feed..----------------------------------------------------------------------------------------------------------------(v) 2.5 to 3.75 g/100 lb of fish/day 1. Salmonids: For Administer in mixed 066104

control of ulcer ration for 10 d; do not

disease caused by liberate fish or

Hemophilus piscium, slaughter fish for food

furunculosis caused by for 21 d following the

Aeromonas salmonicida, last administration of

bacterial hemorrhagic medicated feed..

septicemia caused by

A. liquefaciens, and

pseudomonas disease..

2. Catfish: For control Administer in mixed 066104

of bacterial ration for 10 d; do not

hemorrhagic septicemia liberate fish or

caused by A. slaughter fish for food

liquefaciens and for 21 d following the

pseudomonas disease.. last administration of

medicated feed; do not

administer when water

temperature is below

16.7 [deg]C (62 [deg]F)..----------------------------------------------------------------------------------------------------------------(vi) 3.75 g/100 lb of fish/day...... 1. Freshwater-reared Administer in mixed 066104

salmonids: For control ration for 10 d; do not

of mortality due to liberate fish or

coldwater disease slaughter fish for food

associated with for 21 d following the

Flavobacterium last administration of

psychrophilum.. medicated feed..

2. Freshwater-reared Administer in mixed 066104

Oncorhynchus mykiss: ration for 10 d; do not

For control of liberate fish or

mortality due to slaughter fish for food

columnaris disease for 21 d following the

associated with last administration of

Flavobacterium medicated feed..

columnare..----------------------------------------------------------------------------------------------------------------(vii) 1 g/lb of medicated feed...... Lobsters: For control Administer as sole ration 066104

of gaffkemia caused by for 5 consecutive days;

Aerococcus viridans.. withdraw medicated feed

30 d before harvesting

lobsters..----------------------------------------------------------------------------------------------------------------

(6) Oxytetracycline may be used in accordance with the provisions of this section in the combinations as follows:

(i) Carbadox as in Sec. 558.115.

(ii) Lasalocid as in Sec. 558.311.

(iii) Melengestrol acetate as in Sec. 558.342.

(iv) Robenidine hydrochloride as in Sec. 558.515.

(v) Salinomycin as in Sec. 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; 71 FR 53006, Sept. 8, 2006; 72 FR 70774, Dec. 13, 2007; 73 FR 45875, Aug. 7, 2008; 80 FR 13232, Mar. 13, 2015]