[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: 21CFR510.440]

[Page 45]
 
                        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 E--Requirements for Specific New Animal Drugs
 
Sec.  510.440  Injectable iron preparations.

    There has been an increasing interest in the use of injectable iron 
compounds for the prevention or treatment of iron-deficiency anemia in 
animals. Although some such preparations have been shown to be safe, 
such articles are regarded as new animal drugs within the meaning of the 
Federal Food, Drug, and Cosmetic Act. Accordingly, an approved new 
animal drug application is required prior to the marketing of such 
preparations within the jurisdiction of the act. In addition to the need 
for demonstrating the safety of such articles, the labeling of such 
preparations should not only recommend appropriate dosages of iron but 
also declare the amount (in milligrams) of available iron (Fe) per 
milliliter of the subject product.