[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: 21CFR558.364]

[Page 443-445]
 
                        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.  558.364  Neomycin sulfate.

    (a) Approvals. Type A medicated article: 325 grams per pound to 
000009 in Sec.  510.600(c) of this chapter.
    (b) Related tolerances. See Sec.  556.430 of this chapter.
    (c) [Reserved]
    (d) Conditions of use. Neomycin sulfate is used as follows:

[[Page 444]]




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   Neomycin Sulfate         Combination        Indications for Use        Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 250 to 2,250       .....................  Cattle, swine, sheep,  To provide 10          000009
 grams per ton (g/t)                           and goats. For         milligrams (mg) of
 of dry type C feed.                           treatment and          neomycin sulfate per
                                               control of             pound of body weight
                                               colibacillosis         per day for a
                                               (bacterial             maximum of 14 days.
                                               enteritis) caused by   The concentration of
                                               Escherichia coli       neomycin sulfate
                                               susceptible to         required in
                                               neomycin.              medicated feed must
                                                                      be adjusted to
                                                                      compensate for
                                                                      variation in age and
                                                                      weight of animal,
                                                                      the nature and
                                                                      severity of disease
                                                                      signs, and
                                                                      environmental
                                                                      temperature and
                                                                      humidity, each of
                                                                      which affects feed
                                                                      consumption. If
                                                                      symptoms persist
                                                                      after using for 2 or
                                                                      3 days, consult a
                                                                      veterinarian.
                                                                      Treatment should
                                                                      continue 24 to 48
                                                                      hours beyond
                                                                      remission of disease
                                                                      symptoms.
                                                                      Discontinue
                                                                      treatment prior to
                                                                      slaughter as
                                                                      follows: Cattle 1
                                                                      day, swine 3 days,
                                                                      sheep 2 days, and
                                                                      goats 3 days. A
                                                                      withdrawal period
                                                                      has not been
                                                                      established for use
                                                                      in preruminating
                                                                      calves. Do not use
                                                                      in calves to be
                                                                      processed for veal.
                                                                      A milk discard time
                                                                      has not been
                                                                      established for use
                                                                      in lactating dairy
                                                                      cattle or lactating
                                                                      dairy goats. Do not
                                                                      use in female dairy
                                                                      cattle 20 months of
                                                                      age or older or
                                                                      female dairy goats
                                                                      12 months of age or
                                                                      older. For use in
                                                                      dry feeds only. Not
                                                                      for use in liquid
                                                                      feed supplements.

[[Page 445]]


(2) 400 to 2,000 g/t   .....................  Do.                    To provide 10 mg of    000009
 of type C milk                                                       neomycin sulfate per
 replacer.                                                            pound of body weight
                                                                      per day for a
                                                                      maximum of 14 days.
                                                                      Amount consumed will
                                                                      vary depending on
                                                                      animal's consumption
                                                                      and weight. If
                                                                      symptoms persist
                                                                      after using for 2 or
                                                                      3 days, consult a
                                                                      veterinarian.
                                                                      Treatment should
                                                                      continue 24 to 48
                                                                      hours beyond
                                                                      remission of disease
                                                                      symptoms.
                                                                      Discontinue
                                                                      treatment prior to
                                                                      slaughter as
                                                                      follows: Cattle 1
                                                                      day, swine 3 days,
                                                                      sheep 2 days, and
                                                                      goats 3 days. A
                                                                      withdrawal period
                                                                      has not been
                                                                      established for use
                                                                      in preruminating
                                                                      calves. Do not use
                                                                      in calves to be
                                                                      processed for veal.
                                                                      A milk discard time
                                                                      has not been
                                                                      established for use
                                                                      in lactating dairy
                                                                      cattle or lactating
                                                                      dairy goats. Do not
                                                                      use in female dairy
                                                                      cattle 20 months of
                                                                      age or older or
                                                                      female dairy goats
                                                                      12 months of age or
                                                                      older. For use in
                                                                      milk replacers only.
----------------------------------------------------------------------------------------------------------------


[64 FR 70576, Dec. 17, 1999, as amended at 65 FR 45881, July 26, 2000]