21 CFR § 507.215 - Special requirements applicable to a written assurance.

---
identifier: "/us/cfr/t21/s507.215"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 507.215 - Special requirements applicable to a written assurance."
title_number: 21
title_name: "Food and Drugs"
section_number: "507.215"
section_name: "Special requirements applicable to a written assurance."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "507"
part_name: "CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271."
regulatory_source: "80 FR 56337, Sept. 17, 2015, unless otherwise noted."
cfr_part: "507"
---


# 507.215 Special requirements applicable to a written assurance.

(a) Any written assurance required by this part must contain the following elements:

(1) Effective date;

(2) Printed names and signatures of authorized officials;

(3) The applicable assurance under:

(i) § 507.36(a)(2);

(ii) § 507.36(a)(3);

(iii) § 507.36(a)(4);

(iv) § 507.130(c)(2);

(v) § 507.130(d)(2); or

(vi) § 507.130(e)(2).

(b) A written assurance required under § 507.36(a)(2), (3) or (4) must include:

(1) Acknowledgement that the facility that provides the written assurance assumes legal responsibility to act consistently with the assurance and document its actions taken to satisfy the written assurance; and

(2) Provision that if the assurance is terminated in writing by either entity, responsibility for compliance with the applicable provisions of this part reverts to the manufacturer/processor as of the date of termination.