[Title 21 CFR 558.128] [Code of Federal Regulations (annual edition) - April 1, 1996 Edition] [Title 21 - FOOD AND DRUGS] [Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)] [Subchapter E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS] [Part 558 - NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS] [Subpart B - Specific New Animal Drugs for Use in Animal Feeds] [Sec. 558.128 - Chlortetracycline.] [From the U.S. Government Publishing Office]21 FOOD AND DRUGS 6 1996-04-01 1996-04-01 false Chlortetracycline. 558.128 Sec. 558.128 FOOD AND DRUGS FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS Specific New Animal Drugs for Use in Animal Feeds Sec. 558.128 Chlortetracycline. (a) Approvals. Type A medicated articles: 10 to 100 grams per pound chlortetracycline to 010042 in Sec. 510.600(c) of this chapter; 35 grams chlortetracycline with 7.7 percent (35 [[Page 403]] grams) sulfamethazine to 010042 in Sec. 510.600(c) of this chapter. (b) Related tolerances. See Sec. 556.150 of this chapter. (c) Conditions of use. (1) It is used in the feed for cockatoos, macaws, and parrots as follows: (i) Amount. 10 milligrams per gram of finished feed. (ii) Indications for use. Treatment of psittacine birds (cockatoos, macaws, and parrots) suspected or known to be infected with psittacosis caused by Chlamydia psittaci sensitive to chlortetracycline. (iii) Limitations. Feed continuously for 45 days. As chlortetracycline calcium complex equivalent to chlortetracycline hydrochloride. Each bird should consume daily an amount of medicated feed equal to one fifth of its body weight. Warning: ``Psittacosis, avian chlamydiosis, or ornithosis is a reportable communicable disease, transmissible between wild and domestic birds, other animals, and man. Contact appropriate public health and regulatory officials.'' (2) It is used in the feed for laboratory mice as follows: (i) Amount. Not less than 100 grams per ton of feed. (ii) Indications for use. As an aid in reducing the incidence of bacterial diarrhea. (3) It is used in feeds as follows: Table 1--In Type C Feed ---------------------------------------------------------------------------------------------------------------- Chlortetracycline in grams Combination in grams per ton per ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 10 to 50................ ....................... 1. Chickens and As chlortetracycline turkeys; growth hydrochloride. promotion and feed efficiency. 2. Swine; growth ......do.............. promotion and feed efficiency. (ii) 20 to 50............... ....................... 1. Lambs and growing ......do.............. sheep; growth promotion and feed efficiency. 2. Mink; growth ......do.............. promotion and feed efficiency; as an aid in increasing pelt size. (iii) 50 to 100............. ....................... 1. Chickens and ......do.............. turkeys; during times of stress, for prevention of diseases named in this section caused by organisms susceptible to the indicated levels of the cycline salt. 2. For chickens; ......do.............. prevention of chronic respiratory disease (air-sac infection). 3. For turkeys; ......do.............. prevention of infectious sinusitis, hexamitiasis. 4. For laying ......do.............. chickens; maintaining or increasing egg production or hatchability of eggs. 5. For chicks; ......do.............. prevention of early mortality due to organisms susceptible to chlortetracycline. 6. Swine; maintenance ......do.............. of weight gain in the presence of atrophic rhinitis; reduction of the incidence of cervical abscesses; prevention of bacterial swine enteritis; prevention of bacterial swine enteritis during times of stress. (iv) 100 to 200............. ....................... 1. For chickens; Not to be fed to treatment of chronic laying chickens; as respiratory disease chlortetracycline (air-sac infection), hydrochloride. blue comb (nonspecific infectious enteritis); prevention of synovitis. 2. For turkeys; As chlortetracycline treatment of blue hydrochloride. comb (nonspecific infectious enteritis, mud fever), infectious sinusitis, hexamitiasis; prevention of synovitis. [[Page 404]] 3. For chickens; Not to be fed to treatment of chronic laying chickens; as respiratory disease chlortetracycline (air-sac infection), hydrochloride as blue comb follows: In low- (nonspecific calcium feed infectious containing 0.8% enteritis); dietary calcium, not prevention of to be fed synovitis. continuously for more than 8 weeks; in low- calcium feed containing 0.40% to 0.55% dietary calcium, not to be fed continuously for more than 5 d; in low- calcium feed containing 0.8% dietary calcium and 1% to 1.5% sodium sulfate, to be fed continuously for not more than the 1st 3 weeks of life. 4. Swine; treatment of As chlortetracycline bacterial swine hydrochloride. enteritis. (v) 200..................... ....................... 1. For chickens; Not to be fed to prevention and laying chickens; as control of chlortetracycline coccidiosis caused by hydrochloride in low- Eimeria necatrix and calcium feed E. tenella. containing 0.8% dietary calcium, not to be fed continuously for more than 8 weeks; in low- calcium feed containing 0.8% dietary calcium and 1.0% to 1.5% sodium sulfate, to be fed continuously for not more than the first 3 weeks of life. 2. For chickens; Not to be fed to treatment of laying chickens; as coccidiosis caused by chlortetracycline Eimeria necatrix and hydrochloride in low- E. tenella. calcium feed containing 0.4% to 0.55% dietary calcium, not to be fed continuously for more than 5 d. 3. For chickens; Not to be fed to control of synovitis. laying chickens; as chlortetracycline hydrochloride. 4. For turkeys; As chlortetracycline control of synovitis. hydrochloride. 5. For broiler In low calcium feed chickens; treatment containing 0.8% of chronic dietary calcium and respiratory disease 1.5% sodium sulfate; caused by strains of feed continuously as Mycoplasma sole ration for not gallisepticum more than the 1st 3 susceptible to weeks of life. chlortetracycline. 6. Swine; as an aid in Sole medication; as reducing spread of chlortetracycline leptospirosis. hydrochloride. (vi) 200 to 400............. ....................... For ducks; for the Feed in complete control and treatment ration to provide of fowl cholera from 8 to 28 mg per caused by Pasteurella pound of body weight multocida susceptible per day depending to chlortetracycline. upon age and severity of disease, for not more than 21 d; as the calcium complex of chlortetracycline equivalent to chlortetracycline hydrochloride. (vii) 400................... ....................... 1. For turkey poults In low calcium feed not over 4 weeks of containing 1% total age; aid in reducing calcium with not less mortality due to than 0.45% calcium paratyphoid caused by from calcium sulfate; Salmonella as chlortetracycline typhimurium. hydrochloride. 2. Swine; as an aid in To be fed for 14 d as reducing shedding of sole medication; as leptospirae; as an chlortetracycline aid in reducing the hydrochloride. abortion rate of swine and the mortality rate of newborn pigs when leptospirosis is present. [[Page 405]] (viii) 500.................. ....................... For chickens; aid in Not to be fed to the reduction of laying chickens; as mortality due to E. chlortetracycline coli infections hydrochloride; in susceptible to such feed containing 0.8% treatment. dietary calcium; not to be fed continuously for more than 5 d; withdraw 24 h prior to slaughter. ---------------------------------------------------------------------------------------------------------------- Table 2--In Type B Feed ---------------------------------------------------------------------------------------------------------------- Combination in Chlortetracycline milligrams per head per Indications for use Limitations Sponsor day ---------------------------------------------------------------------------------------------------------------- milligrams per pound of body weight per day (i) 0.1..................... ....................... For calves up to 250 ...................... lb in weight in milk replacers or starter feeds; growth promotion and feed efficiency. (ii) 0.5.................... ....................... 1. For beef cattle Not to be administered over 1,500 lb in within 48 h of weight; aid in slaughter. prevention of anaplasmosis. 2. For calves up to In milk replacers or 250 lb in weight; aid starter feeds. in the prevention of bacterial diarrhea. (iii) 5.0................... ....................... For beef cattle; aid Feed for 60 days; for ......... in the elimination of use in the carrier the carrier state of state only; not to be anaplasmosis. fed within 10 d of slaughter. Labeling shall include a statement that a positive complement- flixation test at conclusion of a 60-d feeding period does not necessarily establish that anaplasmosis carrier state is still active. To positively establish that the carrier state has been eliminated, inject blood from a suspected carrier into a splenectomized (susceptible) calf. milligrams per head per day (iv) 25 to 70............... ....................... For calves in finished ...................... feed; growth promotion and feed efficiency. (v) 70...................... ....................... 1. For feedlot cattle; ...................... aid in prevention of liver abscesses. 2. For beef cattle up ...................... to 700 lb in weight; aid in reduction of bacterial diarrhea; aid in prevention of foot rot. 3. For growing cattle ...................... in finished feed; growth promotion and feed efficiency. (vi) 85..................... ....................... For horses up to 1 yr Do not slaughter for of age; growth food purposes. promotion and feed efficiency. (vii) 100................... ....................... For beef cattle over ...................... 700 lb in weight; aid in reduction of bacterial diarrhea; aid in prevention of foot rot. [[Page 406]] (viii) 350.................. ....................... 1. For beef cattle; Not to be administered aid in prevention of within 48 h of bacterial pneumonia slaughter. and shipping fever (hemorrhagic septicemia); aid in reduction of losses due to respiratory infection (infectious rhinotracheitis, shipping fever complex). 2. For beef cattle up Not to be administered to 700 lb in weight; within 48 h of aid in prevention of slaughter. anaplasmosis. Sulfamethazine 350..... For beef cattle; aid Feed for 28 d; in the maintenance of withdraw 7 d prior to weight gains in the slaughter. presence of respiratory disease such as shipping fever. (ix) 500.................... ....................... For beef cattle 700 to Not to be administered ......... 1,000 lb in weight; within 48 h of aid in prevention of slaughter. anaplasmosis. (x) 750..................... ....................... For beef cattle 1,000 ......do.............. ......... to 1,500 lb in weight; aid in prevention of anaplasmosis. ---------------------------------------------------------------------------------------------------------------- (4) It is used in free-choice cattle feeds such as feed blocks or salt-mineral mixes manufactured from approve Type A articles; such feeds are given to beef cattle and nonlactating dairy cattle to provide a daily minimum intake of 0.5 milligram of chlortetracycline per pound of body weight to aid in the prevention of anaplasmosis; the use of these Type A articles to make specific free-choice feed formulations must be approved under section 512(b) of the act and be based on a demonstration of drug stability and consumption which is consistent with the effective dose; the specific free-choice feed formulations approved in this paragraph can be manufactured under section 512(m) of the act. (5) Chlortetracycline may be used in accordance with the provisions of this section in the combinations provided as follows: (i) Amprolium in accordance with Sec. 558.55. (ii) Amprolium plus ethopabate in accordance with Sec. 558.58. (iii) [Reserved]. (iv) Clopidol in accordance with Sec. 558.175. (v) Decoquinate in accordance with Sec. 558.195. (vi) Hygromycin B in accordance with Sec. 558.274. (vii) Monensin in accordance with Sec. 558.355. (viii) Roxarsone and salinomycin in accordance with Sec. 558.550. (ix) Robenidine hydrochloride in accordance with Sec. 558.515. (x) Roxarsone in accordance with Sec. 558.530. (xi) Salinomycin in accordance with Sec. 558.550. (xii) Zoalene in accordance with Sec. 558.680. [41 FR 10995, Mar. 15, 1976, as amended at 42 FR 18617, Apr. 8, 1977; 42 FR 36995, July 19, 1977; 47 FR 9399, Mar. 5, 1982; 47 FR 51563, Nov. 16, 1982; 48 FR 11429, Mar. 18, 1983; 51 FR 7396, Mar. 3, 1986; 52 FR 2684, Jan. 26, 1987; 53 FR 31316, Aug. 18, 1988; 54 FR 24901, June 12, 1989; 54 FR 25115, June 13, 1989; 54 FR 26732, June 26, 1989; 59 FR 8134, Feb. 18, 1994; 60 FR 39847, Aug. 4, 1995]