[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: 21CFR111.155]

[Page 245-246]
 
                        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.  111.155  What requirements apply to components of dietary supplements?

    (a) You must visually examine each immediate container or grouping 
of immediate containers in a shipment that you receive for appropriate 
content label, container damage, or broken seals to determine whether 
the container condition may have resulted in contamination or 
deterioration of the components;
    (b) You must visually examine the supplier's invoice, guarantee, or 
certification in a shipment you receive to ensure the components are 
consistent with your purchase order;

[[Page 246]]

    (c) You must quarantine components before you use them in the 
manufacture of a dietary supplement until:
    (1) You collect representative samples of each unique lot of 
components (and, for components that you receive, of each unique 
shipment, and of each unique lot within each unique shipment);
    (2) Quality control personnel review and approve the results of any 
tests or examinations conducted on components; and
    (3) Quality control personnel approve the components for use in the 
manufacture of a dietary supplement, including approval of any treatment 
(including in-process adjustments) of components to make them suitable 
for use in the manufacture of a dietary supplement, and releases them 
from quarantine.
    (d)(1) You must identify each unique lot within each unique shipment 
of components that you receive and any lot of components that you 
produce in a manner that allows you to trace the lot to the supplier, 
the date received, the name of the component, the status of the 
component (e.g., quarantined, approved, or rejected); and to the dietary 
supplement that you manufactured and distributed.
    (2) You must use this unique identifier whenever you record the 
disposition of each unique lot within each unique shipment of components 
that you receive and any lot of components that you produce.
    (e) You must hold components under conditions that will protect 
against contamination and deterioration, and avoid mixups.