[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
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.