21 CFR PART 117

21 CFR Part 117

21 CFR PART 117

21 CFR Part 117 is known as The FDA Food Safety Modernization Act (FSMA) Produce Safety replacing 21 CFR Part 110 governing food and beverage products. FSMA is now final and enforcement of compliance is to begin in the September 2016. The rule establishes, for the first time, science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption.

REJIMUS can provide support for and preparation of operational compliance with FSMA requirements, in addition to resolving matters stemming from non-compliance following a regulatory inspection. An absolutely critical understanding of this new regulation, is that because Dietary Supplements are defined as a class of Foods, under this new regulation, there are and will be compliance requirements resulting from FSMA that can be enforced on Dietary Ingredient and Dietary Supplement Manufacturers. Are you prepared?

Food Safety Modernization Act

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.

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