0216 21 Cfr 80 39

[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2007]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR80.39]

[Page 433]

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.