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Guidance Issuing OfficeCenter 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.
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:
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.