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

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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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