[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: 21CFR530.5]

[Page 334-335]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 530_EXTRALABEL DRUG USE IN ANIMALS--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 530.5  Veterinary records.

    (a) As a condition of extralabel use permitted under this part, to 
permit FDA to ascertain any extralabel use or intended extralabel use of 
drugs that the agency has determined may present a risk to the public 
health, veterinarians shall maintain the following records of extralabel 
uses. Such records shall be legible, documented in an accurate and 
timely manner, and be readily accessible to permit prompt retrieval of 
information. Such records shall be adequate to substantiate the 
identification of the animals and shall be maintained either as 
individual records or, in food animal practices, on a group, herd, 
flock, or per-client basis. Records shall be adequate to provide the 
following information:
    (1) The established name of the drug and its active ingredient, or 
if formulated from more than one ingredient, the established name of 
each ingredient;
    (2) The condition treated;
    (3) The species of the treated animal(s);
    (4) The dosage administered;
    (5) The duration of treatment;
    (6) The numbers of animals treated; and
    (7) The specified withdrawal, withholding, or discard time(s), if 
applicable, for meat, milk, eggs, or any food which might be derived 
from any food animals treated.

[[Page 335]]

    (b) A veterinarian shall keep all required records for 2 years or as 
otherwise required by Federal or State law, whichever is greater.
    (c) Any person who is in charge, control, or custody of such records 
shall, upon request of a person designated by FDA, permit such person 
designated by FDA to, at all reasonable times, have access to, permit 
copying, and verify such records.