[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR111.127]

[Page 244]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 111_CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS--Table of Contents
 
   Subpart F_Production and Process Control System: Requirements for 
                             Quality Control
 
Sec.  111.127  What quality control operations are required for packaging and labeling operations?

    Quality control operations for packaging and labeling operations 
must include:
    (a) Reviewing the results of any visual examination and 
documentation to ensure that specifications established under Sec.  
111.70(f) are met for all products that you receive for packaging and 
labeling as a dietary supplement (and for distribution rather than for 
return to the supplier);
    (b) Approving, and releasing from quarantine, all products that you 
receive for packaging or labeling as a dietary supplement (and for 
distribution rather than for return to the supplier) before they are 
used for packaging or labeling;
    (c) Reviewing and approving all records for packaging and label 
operations;
    (d) Determining whether the finished packaged and labeled dietary 
supplement conforms to specifications established in accordance with 
Sec.  111.70(g);
    (e) Conducting any required material review and making any required 
disposition decision;
    (f) Approving or rejecting any repackaging of a packaged dietary 
supplement;
    (g) Approving or rejecting any relabeling of a packaged and labeled 
dietary supplement; and
    (h) Approving for release, or rejecting, any packaged and labeled 
dietary supplement (including a repackaged or relabeled dietary 
supplement) for distribution.