Skip to main content
Find a Lawyer

Code of Federal Regulations Title 21. Food and Drugs § 21.507.105 Requirement to establish and implement a supply-chain program

Current as of January 02, 2025 | Updated by Findlaw Staff

(a)(1) Except as provided by paragraphs (a)(2) and (3) of this section, the receiving facility must establish and implement a risk-based supply-chain program for those raw materials and other ingredients for which the receiving facility has identified a hazard requiring a supply-chain-applied control.

(2) A receiving facility that is an importer, is in compliance with the foreign supplier verification requirements under part 1, subpart L of this chapter, and has documentation of verification activities conducted under § 1.506(e) of this chapter (which provides assurance that the hazards requiring a supply-chain-applied control for the raw material or other ingredient have been significantly minimized or prevented) need not conduct supplier verification activities for that raw material or other ingredient.

(3) The requirements in this subpart do not apply to animal food that is supplied for research or evaluation use, provided that such animal food:

(i) Is not intended for retail sale and is not sold or distributed to the public;

(ii) Is labeled with the statement “Animal food for research or evaluation use”;

(iii) Is supplied in a small quantity that is consistent with a research, analysis, or quality assurance purpose, the animal food is used only for this purpose, and any unused quantity is properly disposed of;  and

(iv) Is accompanied with documents, in accordance with the practice of the trade, stating that the animal food will be used for research or evaluation purposes and cannot be sold or distributed to the public.

(b) The supply-chain program must be written.

(c) When a supply-chain-applied control is applied by an entity other than the receiving facility's supplier (e.g., when a non-supplier applies controls to certain produce (i.e., produce covered by part 112 of this chapter), because growing, harvesting, and packing activities are under different management), the receiving facility must:

(1) Verify the supply-chain-applied control;  or

(2) Obtain documentation of an appropriate verification activity from another entity, review and assess the entity's applicable documentation, and document that review and assessment.

Previous Part of Code Next Part of Code
Back to Chapter List

Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.507.105 Requirement to establish and implement a supply-chain program - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-507-105/

FindLaw Codes may not reflect the most recent version of the law in your jurisdiction. Please verify the status of the code you are researching with the state legislature before relying on it for your legal needs.

Was this helpful?

Welcome to FindLaw's Cases & Codes

A free source of state and federal court opinions, state laws, and the United States Code. For more information about the legal concepts addressed by these cases and statutes, visit FindLaw’s Learn About the Law.

Go to Learn About the Law

Latest Blog Posts

For Legal Professionals

Learn About The Law

Get help with your legal needs

FindLaw’s Learn About the Law features thousands of informational articles to help you understand your options. And if you’re ready to hire an attorney, find one in your area who can help.

Go to Learn About the Law

Need to Find an Attorney?

Search our directory by legal issue

Enter information in one or both fields (Required)

Copied to clipboard