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GUIDANCE DOCUMENT

CVM GFI #246 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program June 2018

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2018-D-1861
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

The purpose of this guidance is to help a receiving facility comply with the requirements of 21 CFR part 507, subpart E of the preventive controls for animal food (PCAF) regulation for establishing and implementing a supply-chain program for its suppliers. See section III.B and the list of terms in Appendix A for the definition of a “receiving facility.” This guidance also is intended to help an entity other than the receiving facility conduct certain activities on behalf of a receiving facility, provided that the receiving facility complies with applicable requirements in subpart E to review and assess the entity’s applicable documentation, and document that review and assessment.

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2018-D-1861.

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