[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: 21CFR111.90]

[Page 241]
 
                        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 E_Requirement to Establish a Production and Process Control 
                                 System
 
Sec.  111.90  What requirements apply to treatments, in-process adjustments, and reprocessing when there is a deviation or unanticipated occurrence or when a 
          specification established in accordance with Sec.  111.70 is 
          not met?

    (a) You must not reprocess a rejected dietary supplement or treat or 
provide an in-process adjustment to a component, packaging, or label to 
make it suitable for use in the manufacture of a dietary supplement 
unless:
    (1) Quality control personnel conduct a material review and make a 
disposition decision to approve the reprocessing, treatment, or in-
process adjustment; and
    (2) The reprocessing, treatment, or in-process adjustment is 
permitted by Sec.  111.77;
    (b) You must not reprocess any dietary supplement or treat or 
provide an in-process adjustment to a component to make it suitable for 
use in the manufacture of a dietary supplement, unless:
    (1) Quality control personnel conduct a material review and make a 
disposition decision that is based on a scientifically valid reason and 
approves the reprocessing, treatment, or in-process adjustment; and
    (2) The reprocessing, treatment or in-process adjustment is 
permitted by Sec.  111.77;
    (c) Any batch of dietary supplement that is reprocessed, that 
contains components that you have treated, or to which you have made in-
process adjustments to make them suitable for use in the manufacture of 
the dietary supplement must be approved by quality control personnel and 
comply with Sec.  111.123(b) before releasing for distribution.