[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR80.39]

[Page 436]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 80--COLOR ADDITIVE CERTIFICATION--Table of Contents
 
                   Subpart B--Certification Procedures
 
Sec. 80.39  Records of distribution.

    (a) The person to whom a certificate is issued shall keep complete 
records showing the disposal of all the color additive from the batch 
covered by such certificate. Upon the request of any officer or employee 
of the Food and Drug Administration or of any other officer or employee 
acting on behalf of the Secretary of Health and Human Services, such 
person, at all reasonable hours until at least 2 years after disposal of 
all such color additive, shall make such records available to any such 
officer or employee, and shall accord to such officer or employee full 
opportunity to make inventory of stocks of such color additive on hand 
and otherwise to check the correctness of such records.
    (b) The records required to be kept by paragraph (a) of this section 
shall show:
    (1) Each quantity used by such person from such batch and the date 
and kind of such use.
    (2) The date and quantity of each shipment or delivery from such 
batch, and the name and post-office address of the person to whom such 
shipment or delivery was made.
    (c) The records required to be kept by paragraph (a) of this section 
shall be kept separately from all other records.