[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: 21CFR111.160]

[Page 246]
 
                        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 G_Production and Process Control System: Requirements for 
 Components, Packaging, and Labels and for Product That You Receive for 
              Packaging or Labeling as a Dietary Supplement
 
Sec.  111.160  What requirements apply to packaging and labels received?

    (a) You must visually examine each immediate container or grouping 
of immediate containers in a shipment for appropriate content label, 
container damage, or broken seals to determine whether the container 
condition may have resulted in contamination or deterioration of the 
packaging and labels.
    (b) You must visually examine the supplier's invoice, guarantee, or 
certification in a shipment to ensure that the packaging or labels are 
consistent with your purchase order.
    (c) You must quarantine packaging and labels before you use them in 
the manufacture of a dietary supplement until:
    (1) You collect representative samples of each unique shipment, and 
of each unique lot within each unique shipment, of packaging and labels 
and, at a minimum, conduct a visual identification of the immediate 
containers and closures;
    (2) Quality control personnel review and approve the results of any 
tests or examinations conducted on the packaging and labels; and
    (3) Quality control personnel approve the packaging and labels for 
use in the manufacture of a dietary supplement and release them from 
quarantine.
    (d)(1) You must identify each unique lot within each unique shipment 
of packaging and labels in a manner that allows you to trace the lot to 
the supplier, the date received, the name of the packaging and label, 
the status of the packaging and label (e.g., quarantined, approved, or 
rejected); and to the dietary supplement that you distributed; and
    (2) You must use this unique identifier whenever you record the 
disposition of each unique lot within each unique shipment of packaging 
and labels.
    (e) You must hold packaging and labels under conditions that will 
protect against contamination and deterioration, and avoid mixups.