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
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.
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