[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: 21CFR111.1]

[Page 228]
 
                        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 A_General Provisions
 
Sec.  111.1  Who is subject to this part?


    (a) Except as provided by paragraph (b) of this section, you are 
subject to this part if you manufacture, package, label, or hold a 
dietary supplement, including:
    (1) A dietary supplement you manufacture but that is packaged or 
labeled by another person; and
    (2) A dietary supplement imported or offered for import in any State 
or territory of the United States, the District of Columbia, or the 
Commonwealth of Puerto Rico.
    (b) The requirements pertaining to holding dietary supplements do 
not apply to you if you are holding those dietary supplements at a 
retail establishment for the sole purpose of direct retail sale to 
individual consumers. A retail establishment does not include a 
warehouse or other storage facility for a retailer or a warehouse or 
other storage facility that sells directly to individual consumers.