[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: 21CFR111.83]

[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.  111.83  What are the requirements for reserve samples?

    (a) You must collect and hold reserve samples of each lot of 
packaged and labeled dietary supplements that you distribute.
    (b) The reserve samples must:
    (1) Be held using the same container-closure system in which the 
packaged and labeled dietary supplement is distributed, or if 
distributing dietary supplements to be packaged and labeled, using a 
container-closure system that provides essentially the same 
characteristics to protect against contamination or deterioration as the 
one in which it is distributed for packaging and labeling elsewhere;
    (2) Be identified with the batch, lot, or control number;
    (3) Be retained for 1 year past the shelf life date (if shelf life 
dating is used), or for 2 years from the date of distribution of the 
last batch of dietary supplements associated with the reserve sample, 
for use in appropriate investigations; and
    (4) Consist of at least twice the quantity necessary for all tests 
or examinations to determine whether or not the dietary supplement meets 
product specifications.