[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR211.122]

[Page 124-125]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS--Table of Contents
 
                Subpart G--Packaging and Labeling Control
 
Sec. 211.122  Materials examination and usage criteria.


    (a) There shall be written procedures describing in sufficient 
detail the receipt, identification, storage, handling, sampling, 
examination, and/or testing of labeling and packaging materials; such 
written procedures shall be followed. Labeling and packaging materials 
shall be representatively sampled, and examined or tested upon receipt 
and before use in packaging or labeling of a drug product.
    (b) Any labeling or packaging materials meeting appropriate written 
specifications may be approved and released for use. Any labeling or 
packaging materials that do not meet such specifications shall be 
rejected to prevent their use in operations for which they are 
unsuitable.
    (c) Records shall be maintained for each shipment received of each 
different labeling and packaging material indicating receipt, 
examination or testing, and whether accepted or rejected.
    (d) Labels and other labeling materials for each different drug 
product, strength, dosage form, or quantity of contents shall be stored 
separately with suitable identification. Access to the storage area 
shall be limited to authorized personnel.

[[Page 125]]

    (e) Obsolete and outdated labels, labeling, and other packaging 
materials shall be destroyed.
    (f) Use of gang-printed labeling for different drug products, or 
different strengths or net contents of the same drug product, is 
prohibited unless the labeling from gang-printed sheets is adequately 
differentiated by size, shape, or color.
    (g) If cut labeling is used, packaging and labeling operations shall 
include one of the following special control procedures:
    (1) Dedication of labeling and packaging lines to each different 
strength of each different drug product;
    (2) Use of appropriate electronic or electromechanical equipment to 
conduct a 100-percent examination for correct labeling during or after 
completion of finishing operations; or
    (3) Use of visual inspection to conduct a 100-percent examination 
for correct labeling during or after completion of finishing operations 
for hand-applied labeling. Such examination shall be performed by one 
person and independently verified by a second person.
    (h) Printing devices on, or associated with, manufacturing lines 
used to imprint labeling upon the drug product unit label or case shall 
be monitored to assure that all imprinting conforms to the print 
specified in the batch production record.

[43 FR 45077, Sept. 29, 1978, as amended at 58 FR 41353, Aug. 3, 1993]