[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR226.80]

[Page 149]
 
                        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 D--Packaging and Labeling
 
Sec. 226.80  Packaging and labeling.


    (a) Packaging and labeling operations shall be adequately 
controlled:
    (1) To assure that only those Type A medicated article(s) that have 
met the specifications established in the master-formula records shall 
be distributed.
    (2) To prevent mixups during the packaging and labeling operations.
    (3) To assure that correct labeling is employed for each Type A 
medicated article(s).
    (4) To identify Type A medicated article(s) with lot or control 
numbers that permit determination of the history of the manufacture and 
control of the batch of Type A medicated article(s).
    (b) Packaging and labeling operations shall provide:
    (1) For storage of labeling in a manner to avoid mixups.
    (2) For careful checking of labeling for identity and conformity to 
the labeling specified in the batch-production records.
    (3) For adequate control of the quantities of labeling issued for 
use with the Type A medicated article(s).
    (c) Type A medicated article(s) shall be distributed in suitable 
containers to insure the safety, identity, strength, and quality of the 
finished product.