[Code of Federal Regulations]
[Title 40, Volume 29]
[Revised as of July 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR439.41]

[Page 405-406]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 439_PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY
--Table of Contents
 
              Subpart D_Mixing/Compounding and Formulation
 
Sec. 439.41  Special definitions.

    For the purpose of this subpart:
    (a) Mixing, compounding, and formulating operations means processes 
that put pharmaceutical products in dosage forms.
    (b) Product means any pharmaceutical product manufactured by 
blending, mixing, compounding, and formulating pharmaceutical 
ingredients. The term includes pharmaceutical preparations for both 
human and veterinary use such as ampules,

[[Page 406]]

tablets, capsules, vials, ointments, medicinal powders, solutions, and 
suspensions.

[68 FR 12274, Mar. 13, 2003]