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 6]

[CITE: 21CFR507.39]

TITLE 21--FOOD AND DRUGS

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

SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 507 -- CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS

Subpart C - Hazard Analysis and Risk-Based Preventive Controls

Sec. 507.39 Preventive control management components.

(a) Except as provided by paragraphs (b) and (c) of this section, the preventive controls required under § 507.34 are subject to the following preventive control management components as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system:

(1) Monitoring in accordance with § 507.40;

(2) Corrective actions and corrections in accordance with § 507.42; and

(3) Verification in accordance with § 507.45.

(b) The supply-chain program established in subpart E of this part is subject to the following preventive control management components as appropriate to ensure the effectiveness of the supply-chain program, taking into account the nature of the hazard controlled before receipt of the raw material or other ingredient:

(1) Corrective actions and corrections in accordance with § 507.42, taking into account the nature of any supplier non-conformance;

(2) Review of records in accordance with § 507.49(a)(4)(ii); and

(3) Reanalysis in accordance with § 507.50.

(c) The recall plan established in § 507.38 is not subject to the requirements of paragraph (a) of this section.