[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: 21CFR211.125]

[Page 126-127]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS--Table of Contents
 
                Subpart G--Packaging and Labeling Control
 
Sec. 211.125  Labeling issuance.

    (a) Strict control shall be exercised over labeling issued for use 
in drug product labeling operations.
    (b) Labeling materials issued for a batch shall be carefully 
examined for identity and conformity to the labeling specified in the 
master or batch production records.
    (c) Procedures shall be used to reconcile the quantities of labeling 
issued, used, and returned, and shall require evaluation of 
discrepancies found between the quantity of drug product finished and 
the quantity of labeling

[[Page 127]]

issued when such discrepancies are outside narrow preset limits based on 
historical operating data. Such discrepancies shall be investigated in 
accordance with Sec. 211.192. Labeling reconciliation is waived for cut 
or roll labeling if a 100-percent examination for correct labeling is 
performed in accordance with Sec. 211.122(g)(2).
    (d) All excess labeling bearing lot or control numbers shall be 
destroyed.
    (e) Returned labeling shall be maintained and stored in a manner to 
prevent mixups and provide proper identification.
    (f) Procedures shall be written describing in sufficient detail the 
control procedures employed for the issuance of labeling; such written 
procedures shall be followed.

[43 FR 45077, Sept. 29, 1978, as amended at 58 FR 41354, Aug. 3, 1993]