e-CFR data is current as of October 20, 2020
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
Subpart A—GENERAL PROVISIONS
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| Applicability and status. |
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| Qualifications of individuals who manufacture, process, pack, or hold food. |
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| Applicability of subparts C, D, and G of this part to a facility solely engaged in the storage of unexposed packaged food. |
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| Applicability of subpart B of this part to the off-farm packing and holding of raw agricultural commodities. |
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| Records required for this subpart. |
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Subpart B—CURRENT GOOD MANUFACTURING PRACTICE
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| Sanitary facilities and controls. |
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| Warehousing and distribution. |
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| Holding and distribution of human food by-products for use as animal food. |
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Subpart C—HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS
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| Circumstances in which the owner, operator, or agent in charge of a manufacturing/processing facility is not required to implement a preventive control. |
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| Provision of assurances required under §117.136(a)(2), (3), and (4). |
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| Preventive control management components. |
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| Corrective actions and corrections. |
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| Verification of implementation and effectiveness. |
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| Requirements applicable to a preventive controls qualified individual and a qualified auditor. |
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| Implementation records required for this subpart. |
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Subpart D—MODIFIED REQUIREMENTS
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| Modified requirements that apply to a qualified facility. |
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| Modified requirements that apply to a facility solely engaged in the storage of unexposed packaged food. |
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Subpart E—WITHDRAWAL OF A QUALIFIED FACILITY EXEMPTION
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| Circumstances that may lead FDA to withdraw a qualified facility exemption. |
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| Issuance of an order to withdraw a qualified facility exemption. |
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| Contents of an order to withdraw a qualified facility exemption. |
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| Compliance with, or appeal of, an order to withdraw a qualified facility exemption. |
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| Procedure for submitting an appeal. |
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| Procedure for requesting an informal hearing. |
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| Requirements applicable to an informal hearing. |
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| Presiding officer for an appeal and for an informal hearing. |
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| Timeframe for issuing a decision on an appeal. |
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| Revocation of an order to withdraw a qualified facility exemption. |
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| Reinstatement of a qualified facility exemption that was withdrawn. |
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Subpart F—REQUIREMENTS APPLYING TO RECORDS THAT MUST BE ESTABLISHED AND MAINTAINED
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| Records subject to the requirements of this subpart. |
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| General requirements applying to records. |
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| Additional requirements applying to the food safety plan. |
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| Requirements for record retention. |
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| Requirements for official review. |
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| Special requirements applicable to a written assurance. |
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Subpart G—SUPPLY-CHAIN PROGRAM
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| Requirement to establish and implement a supply-chain program. |
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| General requirements applicable to a supply-chain program. |
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| Responsibilities of the receiving facility. |
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| Using approved suppliers. |
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| Determining appropriate supplier verification activities (including determining the frequency of conducting the activity). |
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| Conducting supplier verification activities for raw materials and other ingredients. |
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| Records documenting the supply-chain program. |
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