[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: 21CFR111.165]

[Page 246-247]
 
                        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.  111.165  What requirements apply to a product received for packaging or labeling as a dietary supplement (and for distribution rather than for return to 
          the supplier)?

    (a) You must visually examine each immediate container or grouping 
of immediate containers in a shipment of product that you receive for 
packaging or labeling as a dietary supplement (and for distribution 
rather than for return to the supplier) for appropriate content label, 
container damage, or broken seals to determine whether the container 
condition may have resulted in contamination or deterioration of the 
received product.
    (b) You must visually examine the supplier's invoice, guarantee, or 
certification in a shipment of the received product to ensure that the 
received

[[Page 247]]

product is consistent with your purchase order.
    (c) You must quarantine the received product until:
    (1) You collect representative samples of each unique shipment, and 
of each unique lot within each unique shipment, of received product;
    (2) Quality control personnel review and approve the documentation 
to determine whether the received product meets the specifications that 
you established under Sec.  111.70(f); and
    (3) Quality control personnel approve the received product for 
packaging or labeling as a dietary supplement and release the received 
product from quarantine.
    (d)(1) You must identify each unique lot within each unique shipment 
of received product in a manner that allows you to trace the lot to the 
supplier, the date received, the name of the received product, the 
status of the received product (e.g., quarantined, approved, or 
rejected), and to the product that you packaged or labeled and 
distributed as a dietary supplement.
    (2) You must use this unique identifier whenever you record the 
disposition of each unique lot within each unique shipment of the 
received product.
    (e) You must hold the received product under conditions that will 
protect against contamination and deterioration, and avoid mixups.