[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: 21CFR111.130]

[Page 244-245]
 
                        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.  111.130  What quality control operations are required for returned dietary supplements?

    Quality control operations for returned dietary supplements must 
include:
    (a) Conducting any required material review and making any required 
disposition decision; including:
    (1) Determining whether tests or examination are necessary to 
determine compliance with product specifications established in 
accordance with Sec.  111.70(e); and
    (2) Reviewing the results of any tests or examinations that are 
conducted to determine compliance with product specifications 
established in accordance with Sec.  111.70(e);
    (b) Approving or rejecting any salvage and redistribution of any 
returned dietary supplement;

[[Page 245]]

    (c) Approving or rejecting any reprocessing of any returned dietary 
supplement; and
    (d) Determining whether the reprocessed dietary supplement meets 
product specifications and either approving for release, or rejecting, 
any returned dietary supplement that is reprocessed.