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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 E--ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
 
PART 507CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS
 

Subpart A--General Provisions
   § 507.1 - Applicability and status.
   § 507.3 - Definitions.
   § 507.4 - Qualifications of individuals who manufacture, process, pack, or hold animal food.
   § 507.5 - Exemptions.
   § 507.7 - Requirements that apply to a qualified facility.
   § 507.10 - Applicability of subparts C and E of this part to a facility solely engaged in the storage of unexposed packaged animal food.
   § 507.12 - Applicability of this part to the holding and distribution of human food by-products for use as animal food.

Subpart B--Current Good Manufacturing Practice
   § 507.14 - Personnel.
   § 507.17 - Plant and grounds.
   § 507.19 - Sanitation.
   § 507.20 - Water supply and plumbing.
   § 507.22 - Equipment and utensils.
   § 507.25 - Plant operations.
   § 507.27 - Holding and distribution.
   § 507.28 - Holding and distribution of human food by-products for use as animal food.

Subpart C--Hazard Analysis and Risk-Based Preventive Controls
   § 507.31 - Food safety plan.
   § 507.33 - Hazard analysis.
   § 507.34 - Preventive controls.
   § 507.36 - Circumstances in which the owner, operator, or agent in charge of a manufacturing/processing facility is not required to implement a preventive control.
   § 507.37 - Provision of assurances required under 507.36(a)(2), (3), and (4).
   § 507.38 - Recall plan.
   § 507.39 - Preventive control management components.
   § 507.40 - Monitoring.
   § 507.42 - Corrective actions and corrections.
   § 507.45 - Verification.
   § 507.47 - Validation.
   § 507.49 - Verification of implementation and effectiveness.
   § 507.50 - Reanalysis.
   § 507.51 - Modified requirements that apply to a facility solely engaged in the storage of unexposed packaged animal food.
   § 507.53 - Requirements applicable to a preventive controls qualified individual and a qualified auditor.
   § 507.55 - Implementation records required for this subpart.

Subpart D--Withdrawal of a Qualified Facility Exemption
   § 507.60 - Circumstances that may lead FDA to withdraw a qualified facility exemption.
   § 507.62 - Issuance of an order to withdraw a qualified facility exemption.
   § 507.65 - Contents of an order to withdraw a qualified facility exemption.
   § 507.67 - Compliance with, or appeal of, an order to withdraw a qualified facility exemption.
   § 507.69 - Procedure for submitting an appeal.
   § 507.71 - Procedure for requesting an informal hearing.
   § 507.73 - Requirements applicable to an informal hearing.
   § 507.75 - Residing officer for an appeal and for an informal hearing.
   § 507.77 - Timeframe for issuing a decision on an appeal.
   § 507.80 - Revocation of an order to withdraw a qualified facility exemption.
   § 507.83 - Final agency action.
   § 507.85 - Reinstatement of a qualified facility exemption that was withdrawn.

Subpart E--Supply-Chain Program
   § 507.105 - Requirement to establish and implement a supply-chain program.
   § 507.110 - General requirements applicable to a supply-chain program.
   § 507.115 - Responsibilities of the receiving facility.
   § 507.120 - Using approved suppliers.
   § 507.125 - Determining appropriate supplier verification activities (including determining the frequency of conducting the activity).
   § 507.130 - Conducting supplier verification activities for raw materials and other ingredients.
   § 507.135 - Onsite audit.
   § 507.175 - Records documenting the supply-chain program.

Subpart F--Requirements Applying to Records That Must Be Established and Maintained
   § 507.200 - Records subject to the requirements of this subpart.
   § 507.202 - General requirements applying to records.
   § 507.206 - Additional requirements applying to the food safety plan.
   § 507.208 - Requirements for record retention.
   § 507.212 - Use of existing records.
   § 507.215 - Special requirements applicable to a written assurance.

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 56337, Sept. 17, 2015, unless otherwise noted.

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