Code of Federal Regulations (Last Updated: November 8, 2024) |
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 |
Part 507 - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
Subpart A - General Provisions |
§ 507.1 - Applicability and status. |
§ 507.3 - Definitions. |
§ 507.4 - Qualifications of individuals who manufacture, process, pack, or hold animal food. |
§ 507.5 - Exemptions. |
§ 507.7 - Requirements that apply to a qualified facility. |
§ 507.10 - Applicability of subparts C and E of this part to a facility solely engaged in the storage of unexposed packaged animal food. |
§ 507.12 - Applicability of this part to the holding and distribution of human food by-products for use as animal food. |
Subpart B - Current Good Manufacturing Practice |
§ 507.14 - Personnel. |
§ 507.17 - Plant and grounds. |
§ 507.19 - Sanitation. |
§ 507.20 - Water supply and plumbing. |
§ 507.22 - Equipment and utensils. |
§ 507.25 - Plant operations. |
§ 507.27 - Holding and distribution. |
§ 507.28 - Holding and distribution of human food by-products for use as animal food. |
Subpart C - Hazard Analysis and Risk-Based Preventive Controls |
§ 507.31 - Food safety plan. |
§ 507.33 - Hazard analysis. |
§ 507.34 - Preventive controls. |
§ 507.36 - Circumstances in which the owner, operator, or agent in charge of a manufacturing/processing facility is not required to implement a preventive control. |
§ 507.37 - Provision of assurances required under § 507.36(a)(2), (3), and (4). |
§ 507.38 - Recall plan. |
§ 507.39 - Preventive control management components. |
§ 507.40 - Monitoring. |
§ 507.42 - Corrective actions and corrections. |
§ 507.45 - Verification. |
§ 507.47 - Validation. |
§ 507.49 - Verification of implementation and effectiveness. |
§ 507.50 - Reanalysis. |
§ 507.51 - Modified requirements that apply to a facility solely engaged in the storage of unexposed packaged animal food. |
§ 507.53 - Requirements applicable to a preventive controls qualified individual and a qualified auditor. |
§ 507.55 - Implementation records required for this subpart. |
Subpart D - Withdrawal of a Qualified Facility Exemption |
§ 507.60 - Circumstances that may lead FDA to withdraw a qualified facility exemption. |
§ 507.62 - Issuance of an order to withdraw a qualified facility exemption. |
§ 507.65 - Contents of an order to withdraw a qualified facility exemption. |
§ 507.67 - Compliance with, or appeal of, an order to withdraw a qualified facility exemption. |
§ 507.69 - Procedure for submitting an appeal. |
§ 507.71 - Procedure for requesting an informal hearing. |
§ 507.73 - Requirements applicable to an informal hearing. |
§ 507.75 - Presiding officer for an appeal and for an informal hearing. |
§ 507.77 - Timeframe for issuing a decision on an appeal. |
§ 507.80 - Revocation of an order to withdraw a qualified facility exemption. |
§ 507.83 - Final agency action. |
§ 507.85 - Reinstatement of a qualified facility exemption that was withdrawn. |
Subpart E - Supply-Chain Program |
§ 507.105 - Requirement to establish and implement a supply-chain program. |
§ 507.110 - General requirements applicable to a supply-chain program. |
§ 507.115 - Responsibilities of the receiving facility. |
§ 507.120 - Using approved suppliers. |
§ 507.125 - Determining appropriate supplier verification activities (including determining the frequency of conducting the activity). |
§ 507.130 - Conducting supplier verification activities for raw materials and other ingredients. |
§ 507.135 - Onsite audit. |
§ 507.175 - Records documenting the supply-chain program. |
Subpart F - Requirements Applying to Records That Must Be Established and Maintained |
§ 507.200 - Records subject to the requirements of this subpart. |
§ 507.202 - General requirements applying to records. |
§ 507.206 - Additional requirements applying to the food safety plan. |
§ 507.208 - Requirements for record retention. |
§ 507.212 - Use of existing records. |
§ 507.215 - Special requirements applicable to a written assurance. |