[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: 21CFR514.3]

[Page 64-65]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 514--NEW ANIMAL DRUG APPLICATIONS--Table of Contents
 
                      Subpart A--General Provisions
 
Sec.  514.3  Definitions.

    The definition and interpretation of terms contained in this section 
apply to those terms as used throughout subchapter E.
    Adverse drug experience is any adverse event associated with the use 
of a new animal drug, whether or not considered to be drug related, and 
whether or not the new animal drug was used in accordance with the 
approved labeling (i.e., used according to label directions or used in 
an extralabel manner, including but not limited to different route of 
administration, different species, different indications, or other than 
labeled dosage). Adverse drug experience includes, but is not limited 
to:
    (1) An adverse event occurring in animals in the course of the use 
of an animal drug product by a veterinarian or by a livestock producer 
or other animal owner or caretaker.
    (2) Failure of a new animal drug to produce its expected 
pharmacological or clinical effect (lack of expected effectiveness).
    (3) An adverse event occurring in humans from exposure during 
manufacture, testing, handling, or use of a new animal drug.
    ANADA is an abbreviated new animal drug application including all 
amendments and supplements.
    Applicant is a person or entity who owns or holds on behalf of the 
owner the approval for an NADA or an ANADA, and is responsible for 
compliance with applicable provisions of the act and regulations.
    Increased frequency of adverse drug experience is an increased rate 
of occurrence of a particular serious adverse drug event, expected or 
unexpected,

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after appropriate adjustment for drug exposure.
    NADA is a new animal drug application including all amendments and 
supplements.
    Nonapplicant is any person other than the applicant whose name 
appears on the label and who is engaged in manufacturing, packing, 
distribution, or labeling of the product.
    Product defect/manufacturing defect is the deviation of a 
distributed product from the standards specified in the approved 
application, or any significant chemical, physical, or other change, or 
deterioration in the distributed drug product, including any microbial 
or chemical contamination. A manufacturing defect is a product defect 
caused or aggravated by a manufacturing or related process. A 
manufacturing defect may occur from a single event or from deficiencies 
inherent to the manufacturing process. These defects are generally 
associated with product contamination, product deterioration, 
manufacturing error, defective packaging, damage from disaster, or 
labeling error. For example, a labeling error may include any incident 
that causes a distributed product to be mistaken for, or its labeling 
applied to, another product.
    Serious adverse drug experience is an adverse event that is fatal, 
or life-threatening, or requires professional intervention, or causes an 
abortion, or stillbirth, or infertility, or congenital anomaly, or 
prolonged or permanent disability, or disfigurement.
    Unexpected adverse drug experience is an adverse event that is not 
listed in the current labeling for the new animal drug and includes any 
event that may be symptomatically and pathophysiologically related to an 
event listed on the labeling, but differs from the event because of 
greater severity or specificity. For example, under this definition 
hepatic necrosis would be unexpected if the labeling referred only to 
elevated hepatic enzymes or hepatitis.

[68 FR 15365, Mar. 31, 2003]

    Effective Date Note: At 68 FR 15365, Mar. 31, 2003, Sec.  514.3 was 
added, effective June 30, 2003.