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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2017.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION
 
PART 117CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD
 

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.

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 56145, Sept. 17, 2015, unless otherwise noted.

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