[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: 21CFR510.301]

[Page 44]
 
                        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 D--Records and Reports
 
Sec.  510.301  Records and reports concerning experience with animal feeds bearing or containing new animal drugs for which an approved medicated feed mill 
          license application is in effect.

    Records and reports of clinical and other experience with the new 
animal drug will be maintained and reported, appropriately identified 
with the new animal drug application(s) to which they relate, to the 
Center for Veterinary Medicine in duplicate in accordance with the 
following:
    (a) Immediately upon receipt by the applicant, complete records or 
reports covering information of the following kinds:
    (1) Information concerning any mixup in the new animal drug or its 
labeling with another article.
    (2) Information concerning any bacteriological, or any significant 
chemical, physical, or other change or deterioration in the drug, or any 
failure of one or more distributed batches of the drug to meet the 
specifications established for it in the new animal drug application.
    (b) As soon as possible, and in any event within 15 working days of 
its receipt by the applicant, complete records or reports concerning any 
information of the following kinds:
    (1) Information concerning any unexpected side effect, injury, 
toxicity, or sensitivity reaction or any unexpected incidence or 
severity thereof associated with clinical uses, studies, investigations, 
or tests, whether or not determined to be attributable to the new animal 
drug, except that this requirement shall not apply to the submission of 
information described in a written communication to the applicant from 
the Food and Drug Administration as types of information that may be 
submitted at other designated intervals. Unexpected as used in this 
paragraph refers to conditions or developments not previously submitted 
as part of the new animal drug application or not encountered during 
clinical trials of the drug, or conditions or developments occurring at 
a rate higher than shown by information previously submitted as part of 
the new animal drug application or at a rate higher than encountered 
during such clinical trials.
    (2) Information concerning any unusual failure of the new animal 
drug to exhibit its expected pharmacological activity.

[40 FR 13807, Mar. 27, 1975, as amended at 54 FR 18280, Apr. 28, 1989]