TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B – FOOD FOR HUMAN CONSUMPTION
Subpart A – General Provisions
§ 117.1 – Applicability and status.
§ 117.3 – Definitions.
§ 117.4 – Qualifications of individuals who manufacture, process, pack, or hold food.
§ 117.5 – Exemptions.
§ 117.7 – Applicability of subparts C, D, and G of this part to a facility solely engaged in the storage of unexposed packaged food.
§ 117.8 – Applicability of subpart B of this part to the off-farm packing and holding of raw agricultural commodities.
§ 117.9 – Records required for this subpart.
Subpart B – Current Good Manufacturing Practice
§ 117.10 – Personnel.
§ 117.20 – Plant and grounds.
§ 117.35 – Sanitary operations.
§ 117.37 – Sanitary facilities and controls.
§ 117.40 – Equipment and utensils.
§ 117.80 – Processes and controls.
§ 117.93 – Warehousing and distribution.
§ 117.95 – Holding and distribution of human food by-products for use as animal food.
§ 117.110 – Defect action levels.
Subpart C – Hazard Analysis and Risk-Based Preventive Controls
§ 117.126 – Food safety plan.
§ 117.130 – Hazard analysis.
§ 117.135 – Preventive controls.
§ 117.136 – Circumstances in which the owner, operator, or agent in charge of a manufacturing/processing facility is not required to implement a preventive control.
§ 117.137 – Provision of assurances required under 117.136(a)(2), (3), and (4).
§ 117.139 – Recall plan.
§ 117.140 – Preventive control management components.
§ 117.145 – Monitoring.
§ 117.150 – Corrective actions and corrections.
§ 117.155 – Verification.
§ 117.160 – Validation.
§ 117.165 – Verification of implementation and effectiveness.
§ 117.170 – Reanalysis.
§ 117.180 – Requirements applicable to a preventive controls qualified individual and a qualified auditor.
§ 117.190 – Implementation records required for this subpart.
Subpart D – Modified Requirements
§ 117.201 – Modified requirements that apply to a qualified facility.
§ 117.206 – Modified requirements that apply to a facility solely engaged in the storage of unexposed packaged food.
Subpart E – Withdrawal of a Qualified Facility Exemption
§ 117.251 – Circumstances that may lead FDA to withdraw a qualified facility exemption.
§ 117.254 – Issuance of an order to withdraw a qualified facility exemption.
§ 117.257 – Contents of an order to withdraw a qualified facility exemption.
§ 117.260 – Compliance with, or appeal of, an order to withdraw a qualified facility exemption.
§ 117.264 – Procedure for submitting an appeal.
§ 117.267 – Procedure for requesting an informal hearing.
§ 117.270 – Requirements applicable to an informal hearing.
§ 117.274 – Presiding officer for an appeal and for an informal hearing.
§ 117.277 – Timeframe for issuing a decision on an appeal.
§ 117.280 – Revocation of an order to withdraw a qualified facility exemption.
§ 117.284 – Final agency action.
§ 117.287 – Reinstatement of a qualified facility exemption that was withdrawn.
Subpart F – Requirements Applying to Records That Must Be Established and Maintained
§ 117.301 – Records subject to the requirements of this subpart.
§ 117.305 – General requirements applying to records.
§ 117.310 – Additional requirements applying to the food safety plan.
§ 117.315 – Requirements for record retention.
§ 117.320 – Requirements for official review.
§ 117.325 – Public disclosure.
§ 117.330 – Use of existing records.
§ 117.335 – Special requirements applicable to a written assurance.
Subpart G – Supply-Chain Program
§ 117.405 – Requirement to establish and implement a supply-chain program.
§ 117.410 – General requirements applicable to a supply-chain program.
§ 117.415 – Responsibilities of the receiving facility.
§ 117.420 – Using approved suppliers.
§ 117.425 – Determining appropriate supplier verification activities (including determining the frequency of conducting the activity).
§ 117.430 – Conducting supplier verification activities for raw materials and other ingredients.
§ 117.435 – Onsite audit.
§ 117.475 – Records documenting the supply-chain program
All information on this page is current as of September 12, 2022.