Title 21

PART 507

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 Authority:21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271. Source:80 FR 56337, Sept. 17, 2015, unless otherwise noted.

21:6.0.1.1.4.1SUBPART A
Subpart A - General Provisions
21:6.0.1.1.4.1.1.1SECTION 507.1
   507.1 Applicability and status.
21:6.0.1.1.4.1.1.2SECTION 507.3
   507.3 Definitions.
21:6.0.1.1.4.1.1.3SECTION 507.4
   507.4 Qualifications of individuals who manufacture, process, pack, or hold animal food.
21:6.0.1.1.4.1.1.4SECTION 507.5
   507.5 Exemptions.
21:6.0.1.1.4.1.1.5SECTION 507.7
   507.7 Requirements that apply to a qualified facility.
21:6.0.1.1.4.1.1.6SECTION 507.10
   507.10 Applicability of subparts C and E of this part to a facility solely engaged in the storage of unexposed packaged animal food.
21:6.0.1.1.4.1.1.7SECTION 507.12
   507.12 Applicability of this part to the holding and distribution of human food by-products for use as animal food.
21:6.0.1.1.4.2SUBPART B
Subpart B - Current Good Manufacturing Practice
21:6.0.1.1.4.2.1.1SECTION 507.14
   507.14 Personnel.
21:6.0.1.1.4.2.1.2SECTION 507.17
   507.17 Plant and grounds.
21:6.0.1.1.4.2.1.3SECTION 507.19
   507.19 Sanitation.
21:6.0.1.1.4.2.1.4SECTION 507.20
   507.20 Water supply and plumbing.
21:6.0.1.1.4.2.1.5SECTION 507.22
   507.22 Equipment and utensils.
21:6.0.1.1.4.2.1.6SECTION 507.25
   507.25 Plant operations.
21:6.0.1.1.4.2.1.7SECTION 507.27
   507.27 Holding and distribution.
21:6.0.1.1.4.2.1.8SECTION 507.28
   507.28 Holding and distribution of human food by-products for use as animal food.
21:6.0.1.1.4.3SUBPART C
Subpart C - Hazard Analysis and Risk-Based Preventive Controls
21:6.0.1.1.4.3.1.1SECTION 507.31
   507.31 Food safety plan.
21:6.0.1.1.4.3.1.2SECTION 507.33
   507.33 Hazard analysis.
21:6.0.1.1.4.3.1.3SECTION 507.34
   507.34 Preventive controls.
21:6.0.1.1.4.3.1.4SECTION 507.36
   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.
21:6.0.1.1.4.3.1.5SECTION 507.37
   507.37 Provision of assurances required under § 507.36(a)(2), (3), and (4).
21:6.0.1.1.4.3.1.6SECTION 507.38
   507.38 Recall plan.
21:6.0.1.1.4.3.1.7SECTION 507.39
   507.39 Preventive control management components.
21:6.0.1.1.4.3.1.8SECTION 507.40
   507.40 Monitoring.
21:6.0.1.1.4.3.1.9SECTION 507.42
   507.42 Corrective actions and corrections.
21:6.0.1.1.4.3.1.10SECTION 507.45
   507.45 Verification.
21:6.0.1.1.4.3.1.11SECTION 507.47
   507.47 Validation.
21:6.0.1.1.4.3.1.12SECTION 507.49
   507.49 Verification of implementation and effectiveness.
21:6.0.1.1.4.3.1.13SECTION 507.50
   507.50 Reanalysis.
21:6.0.1.1.4.3.1.14SECTION 507.51
   507.51 Modified requirements that apply to a facility solely engaged in the storage of unexposed packaged animal food.
21:6.0.1.1.4.3.1.15SECTION 507.53
   507.53 Requirements applicable to a preventive controls qualified individual and a qualified auditor.
21:6.0.1.1.4.3.1.16SECTION 507.55
   507.55 Implementation records required for this subpart.
21:6.0.1.1.4.4SUBPART D
Subpart D - Withdrawal of a Qualified Facility Exemption
21:6.0.1.1.4.4.1.1SECTION 507.60
   507.60 Circumstances that may lead FDA to withdraw a qualified facility exemption.
21:6.0.1.1.4.4.1.2SECTION 507.62
   507.62 Issuance of an order to withdraw a qualified facility exemption.
21:6.0.1.1.4.4.1.3SECTION 507.65
   507.65 Contents of an order to withdraw a qualified facility exemption.
21:6.0.1.1.4.4.1.4SECTION 507.67
   507.67 Compliance with, or appeal of, an order to withdraw a qualified facility exemption.
21:6.0.1.1.4.4.1.5SECTION 507.69
   507.69 Procedure for submitting an appeal.
21:6.0.1.1.4.4.1.6SECTION 507.71
   507.71 Procedure for requesting an informal hearing.
21:6.0.1.1.4.4.1.7SECTION 507.73
   507.73 Requirements applicable to an informal hearing.
21:6.0.1.1.4.4.1.8SECTION 507.75
   507.75 Presiding officer for an appeal and for an informal hearing.
21:6.0.1.1.4.4.1.9SECTION 507.77
   507.77 Timeframe for issuing a decision on an appeal.
21:6.0.1.1.4.4.1.10SECTION 507.80
   507.80 Revocation of an order to withdraw a qualified facility exemption.
21:6.0.1.1.4.4.1.11SECTION 507.83
   507.83 Final agency action.
21:6.0.1.1.4.4.1.12SECTION 507.85
   507.85 Reinstatement of a qualified facility exemption that was withdrawn.
21:6.0.1.1.4.5SUBPART E
Subpart E - Supply-Chain Program
21:6.0.1.1.4.5.1.1SECTION 507.105
   507.105 Requirement to establish and implement a supply-chain program.
21:6.0.1.1.4.5.1.2SECTION 507.110
   507.110 General requirements applicable to a supply-chain program.
21:6.0.1.1.4.5.1.3SECTION 507.115
   507.115 Responsibilities of the receiving facility.
21:6.0.1.1.4.5.1.4SECTION 507.120
   507.120 Using approved suppliers.
21:6.0.1.1.4.5.1.5SECTION 507.125
   507.125 Determining appropriate supplier verification activities (including determining the frequency of conducting the activity).
21:6.0.1.1.4.5.1.6SECTION 507.130
   507.130 Conducting supplier verification activities for raw materials and other ingredients.
21:6.0.1.1.4.5.1.7SECTION 507.135
   507.135 Onsite audit.
21:6.0.1.1.4.5.1.8SECTION 507.175
   507.175 Records documenting the supply-chain program.
21:6.0.1.1.4.6SUBPART F
Subpart F - Requirements Applying to Records That Must Be Established and Maintained
21:6.0.1.1.4.6.1.1SECTION 507.200
   507.200 Records subject to the requirements of this subpart.
21:6.0.1.1.4.6.1.2SECTION 507.202
   507.202 General requirements applying to records.
21:6.0.1.1.4.6.1.3SECTION 507.206
   507.206 Additional requirements applying to the food safety plan.
21:6.0.1.1.4.6.1.4SECTION 507.208
   507.208 Requirements for record retention.
21:6.0.1.1.4.6.1.5SECTION 507.212
   507.212 Use of existing records.
21:6.0.1.1.4.6.1.6SECTION 507.215
   507.215 Special requirements applicable to a written assurance.