CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 1]

[CITE: 21CFR1.1345]

TITLE 21--FOOD AND DRUGS

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

SUBCHAPTER A - GENERAL

PART 1 -- GENERAL ENFORCEMENT REGULATIONS

Subpart S - Additional Traceability Records for Certain Foods

Records of Critical Tracking Events

Sec. 1.1345 What records must I keep when I receive a food on the Food Traceability List?

(a) Except as specified in paragraphs (b) and (c) of this section, for each traceability lot of a food on the Food Traceability List you receive, you must maintain records containing the following information and linking this information to the traceability lot:

(1) The traceability lot code for the food;

(2) The quantity and unit of measure of the food (e.g., 6 cases, 25 reusable plastic containers, 100 tanks, 200 pounds);

(3) The product description for the food;

(4) The location description for the immediate previous source (other than a transporter) for the food;

(5) The location description for where the food was received;

(6) The date you received the food;

(7) The location description for the traceability lot code source, or the traceability lot code source reference; and

(8) The reference document type and reference document number.

(b) For each traceability lot of a food on the Food Traceability List you receive from a person to whom this subpart does not apply, you must maintain records containing the following information and linking this information to the traceability lot:

(1) The traceability lot code for the food, which you must assign if one has not already been assigned (except that this paragraph does not apply if you are a retail food establishment or restaurant);

(2) The quantity and unit of measure of the food (e.g., 6 cases, 25 reusable plastic containers, 100 tanks, 200 pounds);

(3) The product description for the food;

(4) The location description for the immediate previous source (other than a transporter) for the food;

(5) The location description for where the food was received (i.e., the traceability lot code source), and (if applicable) the traceability lot code source reference;

(6) The date you received the food; and

(7) The reference document type and reference document number.

(c) This section does not apply to receipt of a food that occurs before the food is initially packed (if the food is a raw agricultural commodity not obtained from a fishing vessel) or to the receipt of a food by the first land-based receiver (if the food is obtained from a fishing vessel).