[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR226.42]

[Page 147]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 226--CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES--Table of Contents
 
                   Subpart C--Product Quality Control
 
Sec. 226.42  Components.

    (a) Drug components, including undiluted drugs and any intermediate 
mixes containing drugs used in the manufacture and processing of Type A 
medicated article(s), shall be received, examined or tested, stored, 
handled, and otherwise controlled in a manner to maintain the integrity 
and identification of such articles. Appropriate receipt and inventory 
records shall be maintained for 2 years, and such records shall show the 
origin of any drug components, the manufacturer's control number (if 
any), the dates and batches in which they were used, and the results of 
any testing of them.
    (b) Nondrug components shall be stored and otherwise handled in a 
manner to avoid contamination, including cross-contamination from 
manufacturing operations.