[Code of Federal Regulations]
[Title 40, Volume 27]
[Revised as ofJuly 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR439.41]

[Page 409-410]
 
                   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 410]]

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

[68 FR 12274, Mar. 13, 2003]