[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: 21CFR510.105]

[Page 39-40]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 510--NEW ANIMAL DRUGS--Table of Contents
 
        Subpart B--Specific Administrative Rulings and Decisions
 
Sec.  510.105  Labeling of drugs for use in milk-producing animals.


    (a) Part 526 of this chapter provides for new animal drugs intended 
for intramammary use in animals and includes conditions of use intended 
to prevent the contamination of milk from the use of such drugs.
    (b) Preparations containing antibiotics and other potent drugs 
labeled with directions for use in milk-producing animals will be 
misbranded under section 502(f)(2) of the act unless their labeling 
bears appropriate warnings and directions for use to avoid adulteration 
of milk under section 402(a)(2)(c)(ii) of the act.
    (c) It is the position of the Food and Drug Administration that the 
labeling for such preparations should bear a clear warning that either:
    (1) The article should not be administered to animals producing 
milk, since to do so would result in contamination of the milk; or
    (2) The label should bear the following statement: ``Warning: Milk 
that has been taken from animals during

[[Page 40]]

treatment and for ---- hours after the latest treatment must not be used 
for food'', the blank being filled in with the figure that the 
manufacturer has determined by appropriate investigation is needed to 
insure that the milk will not carry violative residues resulting from 
use of the preparation. If the use of the preparation as recommended 
does not result in contamination of the milk, neither of the above 
warning statements is required.

[40 FR 13807, Mar. 27, 1975, as amended at 63 FR 32980, June 17, 1998; 
64 FR 51241, Sept. 22, 1999]