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21 CFR Part 507

Current Good Manufacturing Practice and Preventive Controls for Food for Animals

The FSMA rule establishing cGMP and hazard-analysis / risk-based preventive controls for animal food (feed and pet food). It parallels the human-food preventive-controls rule (21 CFR 117), requiring a food-safety plan, preventive controls, monitoring, corrective actions, and verification for animal-food facilities.

LAST REVISED
September 2015
PRODUCT AREAS
VeterinaryFood

What this does not cover

stated in the document's own scope
  • Covers animal food (livestock feed and pet food); the parallel rule for human food is 21 CFR Part 117.
  • Applies to general animal food; medicated feeds that contain approved new animal drugs are additionally governed by 21 CFR Part 225 for their medicated content.
  • Sets facility cGMP and preventive controls, not the approval of animal drugs or the nutritional-adequacy claims, which fall under separate frameworks.
SOURCE & PROVENANCE
ISSUING BODY
Food and Drug Administration
JURISDICTION
United States
DOCUMENT ID
21 CFR Part 507
Official site — Food and Drug Administration

Always verify against the current published text before relying on it for a submission or inspection.

Overview

21 CFR Part 507 is the FDA Food Safety Modernization Act rule setting current good manufacturing practice and hazard-analysis / risk-based preventive controls for food for animals — livestock feed and pet food. It has two halves: a cGMP baseline for animal-food facilities, and a preventive-controls program in which a facility analyses hazards, and where a hazard requires a preventive control, implements it and manages it through monitoring, corrective actions, and verification under a written food-safety plan prepared by a preventive-controls qualified individual. It is the animal-food parallel of the human-food preventive-controls rule.

Scope & applicability

Facilities that manufacture, process, pack, or hold animal food — cGMP plus hazard analysis and risk-based preventive controls.

Legal basis & how it acquires force

Part 507 is a binding regulation in Title 21 CFR, issued by the FDA under the Federal Food, Drug, and Cosmetic Act as amended by the FDA Food Safety Modernization Act of 2011. It implements FSMA’s preventive-controls mandate for animal food and is administered by the Center for Veterinary Medicine. Compliance is a legal obligation for covered animal-food facilities registered under the Act; the written food-safety plan and the preventive-controls program are the codified requirements, with tiered timelines and exemptions defined in the rule.

Document structure

PartCovers
General provisionsDefinitions, applicability, and exemptions, including the qualified-individual requirement
Current good manufacturing practiceThe cGMP baseline for personnel, plant, equipment, and processes in animal food
Hazard analysis and preventive controlsAnalysing hazards and applying preventive controls where required
Food safety plan and managementThe written plan and its monitoring, corrective actions, and verification
Supply-chain programSupply-chain-applied controls for hazards controlled by an upstream supplier
RecordsThe documentation that evidences the cGMP and preventive-controls program

Key requirements

  • Apply cGMP to animal-food manufacturing and holding
  • Conduct hazard analysis and implement risk-based preventive controls
  • Monitor controls with corrective actions and verification
  • Maintain a food-safety plan under a preventive-controls qualified individual

Implementation tips

  • Treat medicated-feed carryover and nutrient over/under-formulation as priority hazards
  • Reuse your human-food (Part 117) plan structure where you run both
  • Keep the qualified-individual training records current — inspectors check them

Revision notes

Finalised under FSMA in 2015 with staggered compliance dates from 2016–2018; modernised animal-food manufacturing controls.

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International alignment

Part 507 is the animal-food counterpart of 21 CFR Part 117, the human-food preventive-controls rule, and shares its hazard-analysis-and-preventive-controls architecture; the two were issued together as part of the FSMA rulemaking. Its supply-chain-program provisions connect to the FSVP rule for imported animal food. Administered by the Center for Veterinary Medicine, it is a US food-safety regulation rather than part of the drug-GMP harmonisation system.

21 CFR Part 507: frequently asked questions

Quick answers to common questions about 21 CFR Part 507.

What does 21 CFR Part 507 require?

Current good manufacturing practice for animal-food facilities, plus a hazard-analysis and risk-based preventive-controls program — a written food-safety plan with preventive controls, monitoring, corrective actions, and verification where a hazard requires it.

How does Part 507 relate to Part 117?

Part 507 is the animal-food version of the human-food preventive-controls rule (Part 117). They were issued together under FSMA and share the same hazard-analysis-and-preventive-controls structure.

Does Part 507 cover medicated feeds?

Part 507 sets general cGMP and preventive controls for animal food. Medicated feeds containing approved new animal drugs are additionally governed by 21 CFR Part 225 for their medicated content.