21 C.F.R. § 558.305   Laidlomycin.


Title 21 - Food and Drugs


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

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§ 558.305   Laidlomycin.

(a) Specifications. Type A medicated articles containing 50 grams laidlomycin propionate potassium per pound.

(b) Approvals. See No. 046573 in §510.600(c) of this chapter.

(c) Tolerances. See §556.346 of this chapter.

(d) Special considerations. (1) Laidlomycin liquid Type B feeds may be manufactured from dry laidlomycin Type A articles. The liquid Type B feeds must have a pH of 6.0 to 8.0, dry matter of 62 to 75 percent, and bear appropriate mixing directions as follows:

(i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for no less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.

(ii) For liquid feeds stored in mechanical, air, or other agitation type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.

(2) The expiration date for the liquid Type B feed is 21 days after date of manufacture. The expiration date for the dry Type C feed made from the liquid Type B feed is 7 days after date of manufacture.

(3) Labeling for all Type B feeds (liquid and dry) and Type C feeds containing laidlomycin shall bear the following statements:

(i) Do not allow horses or other equines access to feeds containing laidlomycin propionate potassium.

(ii) The safety of laidlomycin propionate potassium in unapproved species has not been established.

(iii) Not for use in animals intended for breeding.

(e) Conditions of use. It is used in cattle being fed in confinement for slaughter as follows:

 ----------------------------------------------------------------------------------------------------------------                                   Combination in grams   Laidlomycin in grams per ton           per ton          Indications for use        Limitations       Sponsor----------------------------------------------------------------------------------------------------------------(1) 5............................  ....................  For improved feed        Feed continuously       046573                                                          efficiency and           in a Type C feed                                                          increased rate of        at a rate of 30 to                                                          weight gain..            75 mg/head/day..(2) 5............................  Chlortetracycline10   For improved feed        Feed continuously       046573                                    mg/lb body weight.    efficiency and           at a rate of 30 to                                                          increased rate of        75 mg laidlomycin                                                          weight gain; and for     propionate                                                          treatment of bacterial   potassium per head                                                          enteritis caused by      per day for not                                                          Echerichia coli and      more than 5 days.                                                          bacterial pneumonia      A withdrawal                                                          caused by Pasteurella    period has not                                                          multocida organisms      been established                                                          susceptible to           for this product                                                          chlortetracycline..      in pre-ruminating                                                                                   calves. Do not use                                                                                   in calves to be                                                                                   processed for                                                                                   veal..(3) 5............................  Chlortetracycline     For improved feed        Feed continuously       046573                                    350 mg/head/day.      efficiency and           at a rate of 30 to                                                          increased rate of        75 mg laidlomycin                                                          weight gain; and for     propionate                                                          control of bacterial     potassium per head                                                          pneumonia associated     per day. A                                                          with shipping fever      withdrawal period                                                          complex caused by        has not been                                                          Pasteurella spp.         established for                                                          susceptible to           this product in                                                          chlortetracycline..      pre-ruminating                                                                                   calves. Do not use                                                                                   in calves to be                                                                                   processed for                                                                                   veal..(4) 5 to 10......................  ....................  For improved feed        Feed continuously       046573                                                          efficiency..             in a Type C feed                                                                                   at a rate of 30 to                                                                                   150 milligrams/                                                                                   head/day..(5) 5 to 10......................  Chlortetracycline 10  For improved feed        Feed continuously       046573                                    mg/pound body         efficiency; and for      at a rate of 30 to                                    weight.               treatment of bacterial   150 mg laidlomycin                                                          enteritis caused by E.   propionate                                                          coli and bacterial       potassium per head                                                          pneumonia caused by P.   per day for not                                                          multocida organisms      more than 5 days.                                                          susceptible to           A withdrawal                                                          chlortetracycline..      period has not                                                                                   been established                                                                                   for this product                                                                                   in pre-ruminating                                                                                   calves. Do not use                                                                                   in calves to be                                                                                   processed for                                                                                   veal..(6) 5 to 10......................  Chlortetracycline     For improved feed        Feed continuously       046573                                    350 mg/head/day.      efficiency; and for      at a rate of 30 to                                                          control of bacterial     150 mg laidlomycin                                                          pneumonia associated     propionate                                                          with shipping fever      potassium per head                                                          complex caused by        per day. A                                                          Pasteurella spp.         withdrawal period                                                          susceptible to           has not been                                                          chlortetracycline..      established for                                                                                   this product in                                                                                   pre-ruminating                                                                                   calves. Do not use                                                                                   in calves to be                                                                                   processed for                                                                                   veal..----------------------------------------------------------------------------------------------------------------

[59 FR 18297, Apr. 18, 1994, as amended at 60 FR 53509, Oct. 16, 1995; 62 FR 9929, Mar. 5, 1997; 63 FR 27845, May 21, 1998; 66 FR 46706, Sept. 7, 2001; 68 FR 13839, Mar. 21, 2003; 68 FR 42590, July 18, 2003; 69 FR 30198, May 27, 2004]

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