21 CFR Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
Part 507 of title 21 runs to 57 sections across 6 subparts, and sits in subchapter E, Animal Drugs, Feeds, and Related Products. Every section is reproduced in full and is current to 2026-09-10.
- Sections
- 57
- Subparts
- 6
- Words of regulation
- 19,278
- Current to
- 2026-09-10
Subpart A: General Provisions
- 507.1 Applicability and status8
- 507.3 Definitions60
- 507.4 Qualifications of individuals who manufacture, process, pack, or hold animal food7
- 507.5 Exemptions30
- 507.7 Requirements that apply to a qualified facility25
- 507.10 Applicability of subparts C and E of this part to a facility solely engaged in the storage of unexposed packaged animal food2
- 507.12 Applicability of this part to the holding and distribution of human food by-products for use as animal food5
Subpart B: Current Good Manufacturing Practice
Subpart C: Hazard Analysis and Risk-Based Preventive Controls
- 507.31 Food safety plan11
- 507.33 Hazard analysis24
- 507.34 Preventive controls15
- 507.36 Circumstances in which the owner, operator, or agent in charge of a manufacturing/processing facility is not required to implement a preventive control24
- 507.37 Provision of assurances required under § 507.36(a)(2), (3), and (4)1
- 507.38 Recall plan8
- 507.39 Preventive control management components9
- 507.40 Monitoring6
- 507.42 Corrective actions and corrections23
- 507.45 Verification7
- 507.47 Validation15
- 507.49 Verification of implementation and effectiveness26
- 507.50 Reanalysis14
- 507.51 Modified requirements that apply to a facility solely engaged in the storage of unexposed packaged animal food16
- 507.53 Requirements applicable to a preventive controls qualified individual and a qualified auditor13
- 507.55 Implementation records required for this subpart16
Subpart D: Withdrawal of a Qualified Facility Exemption
- 507.60 Circumstances that may lead FDA to withdraw a qualified facility exemption7
- 507.62 Issuance of an order to withdraw a qualified facility exemption4
- 507.65 Contents of an order to withdraw a qualified facility exemption14
- 507.67 Compliance with, or appeal of, an order to withdraw a qualified facility exemption7
- 507.69 Procedure for submitting an appeal4
- 507.71 Procedure for requesting an informal hearing4
- 507.73 Requirements applicable to an informal hearing11
- 507.75 Presiding officer for an appeal and for an informal hearing1
- 507.77 Timeframe for issuing a decision on an appeal4
- 507.80 Revocation of an order to withdraw a qualified facility exemption4
- 507.83 Final agency action1
- 507.85 Reinstatement of a qualified facility exemption that was withdrawn6
Subpart E: Chain Program
- 507.105 Requirement to establish and implement a supply-chain program11
- 507.110 General requirements applicable to a supply-chain program25
- 507.115 Responsibilities of the receiving facility13
- 507.120 Using approved suppliers4
- 507.125 Determining appropriate supplier verification activities (including determining the frequency of conducting the activity)1
- 507.130 Conducting supplier verification activities for raw materials and other ingredients23
- 507.135 Onsite audit7
- 507.175 Records documenting the supply-chain program51
Subpart F: Requirements Applying to Records That Must Be Established and Maintained
- 507.200 Records subject to the requirements of this subpart5
- 507.202 General requirements applying to records12
- 507.206 Additional requirements applying to the food safety plan1
- 507.208 Requirements for record retention5
- 507.212 Use of existing records2
- 507.215 Special requirements applicable to a written assurance13
Read 21 CFR part 507 at the eCFR · All of 21 CFR for food safety
Questions
- What does 21 CFR part 507 cover?
- 21 CFR part 507 is Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals. It runs to 57 sections across 6 subparts and sits in subchapter E of chapter I, Animal Drugs, Feeds, and Related Products.
Every section of part 507 is a clause somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.