21 C.F.R. § 558.364   Neomycin sulfate.


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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§ 558.364   Neomycin sulfate.

(a) Approvals. Type A medicated article: 325 grams per pound to 000009 in §510.600(c) of this chapter.

(b) Related tolerances. See §556.430 of this chapter.

(c) [Reserved]

(d) Conditions of use. Neomycin sulfate is used as follows:

 ----------------------------------------------------------------------------------------------------------------         Neomycin Sulfate               Combination        Indications for Use        Limitations       Sponsor----------------------------------------------------------------------------------------------------------------(1) 250 to 2,250 grams per ton (g/ ....................  Cattle, swine, sheep,    To provide 10           000009 t) of dry type C feed..                                  and goats. For           milligrams (mg) of                                                          treatment and control    neomycin sulfate                                                          of colibacillosis        per pound of body                                                          (bacterial enteritis)    weight per day for                                                          caused by Escherichia    a maximum of 14                                                          coli susceptible to      days. The                                                          neomycin..               concentration of                                                                                   neomycin sulfate                                                                                   required in                                                                                   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..(2) 400 to 2,000 g/t of type C     ....................  Do.....................  To provide 10 mg of     000009 milk replacer..                                                                   neomycin sulfate                                                                                   per 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]

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