[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

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

[CITE: 21CFR1.345]



[Page 41]

 

                        TITLE 21--FOOD AND DRUGS

 

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 1_GENERAL ENFORCEMENT REGULATIONS--Table of Contents

 

    Subpart J_Establishment, Maintenance, and Availability of Records

 

Sec.  1.345  What information must nontransporters establish and maintain 

to identify the nontransporter and transporter immediate subsequent 

recipients of food?



    (a) If you are a nontransporter, you must establish and maintain the 

following records for food you release:

    (1) The name of the firm, address, telephone number, and, if 

available, the fax number and e-mail address of the nontransporter 

immediate subsequent recipient, whether domestic or foreign;

    (2) An adequate description of the type of food released, to include 

brand name and specific variety (e.g., brand x cheddar cheese, not just 

cheese; or romaine lettuce, not just lettuce);

    (3) The date you released the food;

    (4) For persons who manufacture, process, or pack food, the lot or 

code number or other identifier of the food (to the extent this 

information exists);

    (5) The quantity and how the food is packaged (e.g., 6 count 

bunches, 25 lb carton, 12 oz bottle, 100 gal tank);

    (6) The name of the firm, address, telephone number, and, if 

available, the fax number and e-mail address of the transporter 

immediate subsequent recipient (the transporter who transported the food 

from you); and

    (b) Your records must include information reasonably available to 

you to identify the specific source of each ingredient used to make 

every lot of finished product.



     Requirements for Transporters To Establish and Maintain Records