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
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.