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Electronic Code of Federal Regulations

e-CFR data is current as of October 10, 2019

Title 21Chapter ISubchapter BPart 117


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION

PART 117—CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD

rule

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.
rule

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.
rule

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.
rule

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.
rule

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.
rule

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.
rule

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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