[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR558.305]

[Page 411]
 
                        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 propionate potassium.

    (a) Approvals. Type A medicated articles: 50 grams per pound to 
063238 in Sec. 510.600(c) of this chapter.
    (b) 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.
    (c) [Reserved]
    (d) Conditions of use. Used in cattle feed as follows:
    (1) Amount. Laidlomycin propionate potassium, 5 grams per ton.
    (i) Indications for use. For improved feed efficiency and increased 
rate of weight gain.
    (ii) Limitations. Feed only to cattle being fed in confinement for 
slaughter. Feed continuously in a Type C feed at a rate of 30 to 75 
milligrams per head per day.
    (2) Amount. Laidlomycin propionate potassium, 5 to 10 grams per ton.
    (i) Indications for use. For improved feed efficiency.
    (ii) Limitations. Feed only to cattle being fed in confinement for 
slaughter. Feed continuously in a Type C feed at a rate of 30 to 150 
milligrams per head per day.
    (3) Additional limitations. (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.

[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]