[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: 21CFR1.360]



[Page 42-43]

 

                        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.  1.360  What are the record retention requirements?



    (a) You must create the required records when you receive and 

release food, except to the extent that the information is contained in 

existing records.

    (b) If you are a nontransporter, you must retain for 6 months after 

the dates you receive and release the food all required records for any 

food having a significant risk of spoilage, loss of value, or loss of 

palatability within 60 days after the date you receive or release the 

food.

    (c) If you are a nontransporter, you must retain for 1 year after 

the dates you receive and release the food all required records for any 

food for which a significant risk of spoilage, loss of value, or loss of 

palatability occurs only after a minimum of 60 days, but within 6 

months, after the date you receive or release the food.

    (d) If you are a nontransporter, you must retain for 2 years after 

the dates you receive and release the food all required records for any 

food for which a significant risk of spoilage, loss of value, or loss of 

palatability does not occur sooner than 6 months after the date you 

receive or release the food, including foods preserved by freezing, 

dehydrating, or being placed in a hermetically sealed container.

    (e) If you are a nontransporter, you must retain for 1 year after 

the dates you receive and release the food all required records for 

animal food, including pet food.

    (f) If you are a transporter or nontransporter retaining records on 

behalf of a transporter, you must retain for 6 months after the dates 

you receive and release the food all required records for any food 

having a significant risk of spoilage, loss of value, or loss of 

palatability within 60 days after the date the transporter receives or 

releases the food. If you are a transporter, or nontransporter retaining 

records on behalf of a transporter, you must retain for 1 year after the 

dates you receive and release the food, all required records for any 

food for which a significant risk of spoilage, loss of value, or loss of 

palatability occurs only after a minimum of 60 days after the date the 

transporter receives or releases the food.

    (g) You must retain all records at the establishment where the 

covered activities described in the records occurred (onsite) or at a 

reasonably accessible location.



[[Page 43]]



    (h) The maintenance of electronic records is acceptable. Electronic 

records are considered to be onsite if they are accessible from an 

onsite location.