[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR520.182]

[Page 105-106]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 520_ORAL DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec. 520.182  Bicyclohexylammonium fumagillin.

    (a) Specifications. The drug is a sol- uble powder containing 
bicyclohexylammonium fumagillin and appropriate phosphate buffers.
    (b) Sponsor. See No. 059620 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used for the prevention of 
nosema in honey bees.\1\
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    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec. 514.111 of this chapter, but may require 
bioequivalency and safety information.
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    (2) It is administered usually in a 2:1 sugar sirup containing a 
concentration of from 75 to 100 milligrams of fumagillin activity per 
gallon of sugar sirup.\1\
    (3) Colonies used for package production should be fed medicated 
sirup as a principal food supply for a month prior

[[Page 106]]

to stocking nuclei or shaking packages for market.\1\
    (4) The medicated sirup should not be fed immediately before or 
during the honey flow.

[40 FR 13838, Mar. 27, 1975, as amended at 42 FR 65151, Dec. 30, 1977; 
56 FR 43699, Sept. 4, 1991; 58 FR 5608, Jan. 22, 1993]