[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: 21CFR510.112]

[Page 41]
 
                        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.  510.112  Antibiotics used in veterinary medicine and for nonmedical purposes; required data.

    (a) An ad hoc committee, Committee on the Veterinary Medical and 
Nonmedical Uses of Antibiotics, was formed by the Food and Drug 
Administration to study, and advise the Commissioner on, the use of 
antibiotics in veterinary medicine and for various nonmedical purposes 
as such uses may affect the enforcement of the Federal Food, Drug, and 
Cosmetic Act with respect to the safety and effectiveness of such 
substances. A copy of the report may be obtained from the Food and Drug 
Administration, Office of Public Affairs, Room 15-05, Parklawn Building, 
5600 Fishers Lane, Rockville, MD 20857.
    (b) On the basis of the report of the Committee and other 
information, sponsors of drugs containing any antibiotic intended for 
use in food-producing animals shall submit data for determining whether 
or not such antibiotics and their metabolites are present as residues in 
edible tissues, milk, and eggs from treated animals; however, in the 
case of a drug for which such data have already been submitted and for 
which a regulation has been promulgated under section 409 of the act, 
only such data as has been accumulated since the issuance of the 
regulation need be submitted.
    (c) The required data shall be submitted within 180 days of the date 
of publication of this section in the Federal Register; except that in 
the case of data on intramammary infusion preparations the data shall be 
submitted within 60 days of such publication. Data demonstrating the 
absence in milk of residues of intramammary infusion preparations when 
used as directed in their labeling are needed within the 60-day period 
because of the importance of milk in the human diet.
    (d) Regulatory proceedings including revocation of prior sanctions, 
or actions to suspend or amend new drug or antibiotic approvals granted 
prior to passage of the Food Additives Amendment of 1958 (72 Stat. 
1784), may be initiated with regard to the continued marketing of any 
antibiotic preparation on which the required information is not 
submitted within the period of time prescribed by paragraph (c) of this 
section.
    (e) Questions relating to the acceptability of proposed research 
protocols and assay methods for determining the amount of antibiotic 
residues in food should be directed to the Director, Center for 
Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855.

[40 FR 13807, Mar. 27, 1975, as amended at 46 FR 8460, Jan. 27, 1981; 54 
FR 18280, Apr. 28, 1989; 57 FR 6475, Feb. 25, 1992]

Subpart C [Reserved]

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