[Code of Federal Regulations] [Title 21, Volume 6] [Revised as of January 1, 2003] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR558.305] [Page 415-416] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS--Table of Contents Subpart B--Specific New Animal Drugs for Use in Animal Feeds Sec. 558.305 Laidlomycin. (a) Specifications. Type A medicated articles containing 50 grams laidlomycin propionate potassium per pound. (b) Approvals. See No. 046573 in Sec. 510.600(c) of this chapter. (c) 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 Type B 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 Type B 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. [[Page 416]] (d) Conditions of use. It is used in cat- tle being fed in confinement for slaugh- ter as follows: ------------------------------------------------------------------------ Laidlomycin Combination in grams per in grams per Indications Limitations Sponsor ton ton for use ------------------------------------------------------------------------ (1) 5 ............ For improved Feed 046573 feed continuous efficiency ly in a and increased Type C rate of feed at a weight gain. rate of 30 to 75 mg/ head/day. (2) 5 Chlortetracy For improved Feed 046573 cline10 mg/ feed continuous lb body efficiency ly at a weight and increased rate of 30 rate of to 75 mg weight gain; laidlomyci and for n treatment of propionate bacterial potassium enteritis per head caused by per day Echerichia for not coli and more than bacterial 5 days. A pneumonia withdrawal caused by period has Pasteurella not been multocida establishe organisms d for this susceptible product in to pre- chlortetracyc ruminating line. calves. Do not use in calves to be processed for veal. (3) 5 Chlortetracy For improved Feed 046573 cline 350 feed continuous mg/head/day efficiency ly at a and increased rate of 30 rate of to 75 mg weight gain; laidlomyci and for n control of propionate bacterial potassium pneumonia per head associated per day. A with shipping withdrawal fever complex period has caused by not been Pasteurella establishe spp. d for this susceptible product in to pre- chlortetracyc ruminating line. calves. Do not use in calves to be processed for veal. (4) 5 to 10 ............ For improved Feed 046573 feed continuous efficiency. ly in a Type C feed at a rate of 30 to 150 milligrams/ head/day. (5) 5 to 10 Chlortetracy For improved Feed 046573 cline 10 mg/ feed continuous pound body efficiency; ly at a weight and for rate of 30 treatment of to 150 mg bacterial laidlomyci enteritis n caused by E. propionate coli and potassium bacterial per head pneumonia per day caused by P. for not multocida more than organisms 5 days. A susceptible withdrawal to period has chlortetracyc not been line. establishe d for this product in pre- ruminating calves. Do not use in calves to be processed for veal. (6) 5 to 10 Chlortetracy For improved Feed 046573 cline 350 feed continuous mg/head/day efficiency; ly at a and for rate of 30 control of to 150 mg bacterial laidlomyci pneumonia n associated propionate with shipping potassium fever complex per head caused by per day. A Pasteurella withdrawal spp. period has susceptible not been to establishe chlortetracyc d for this line. 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]