[Code of Federal Regulations]
[Title 40, Volume 27]
[Revised as ofJuly 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR439.21]

[Page 406]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 439--PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY--Table of Contents
 
                     Subpart B--Extraction Products
 
Sec. 439.21  Special definitions.

    For the purpose of this subpart:
    (a) Extraction means process operations that derive pharmaceutically 
active ingredients from natural sources such as plant roots and leaves, 
animal glands, and parasitic fungi by chemical and physical extraction.
    (b) Product means any substance manufactured by an extraction 
process, including blood fractions, vaccines, serums, animal bile 
derivatives, endocrine products and medicinal products such as alkaloids 
that are isolated from botanical drugs and herbs.

[68 FR 12272, Mar. 13, 2003]