[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: 21CFR111.255]

[Page 248-249]
 
                        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 I_Production and Process Control System: Requirements for the 
                         Batch Production Record
 
Sec.  111.255  What is the requirement to establish a batch production record?


    (a) You must prepare a batch production record every time you 
manufacture a batch of a dietary supplement;
    (b) Your batch production record must include complete information 
relating to the production and control of each batch;
    (c) Your batch production record must accurately follow the 
appropriate master manufacturing record and you

[[Page 249]]

must perform each step in the production of the batch; and
    (d) You must make and keep batch production records in accordance 
with subpart P of this part.