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Compliance References
Regulatory Procedures Manual 2008
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RPM News

Contents:    2008    2007    2006    

Update (October 1, 2007) in Compliance References of the Regulatory Procedures Manual (RPM) has been revised:

-Chapters 4 (Advisory Actions), 5 (Administrative Actions), and 6 (Judicial Actions) were revised to remove references to HFA-224.

-Chapter 4 was further revised as follows:

  • Section 4-1-4 Center Concurrence and Letters Issued By Centers, Paragraph 5 Center for Veterinary Medicine (CVM), was revised to reflect the Regulatory/Administrative guidance in Compliance Program 7371.006:
    • Subparagraph b. was revised to read: "b. Tissue residue violations involving meat and poultry where no tolerance has been established, extra-label use is documented, and/or those which involve the use of compounded drugs or other drug adulteration;" and the footnoote in subparagraph b. that had allowed CVM to grant districts direct reference authority on a case-by-case basis was deleted.
    • New subparagraph c. was added to require CVM concurrence for:  "c.  Tissue residue violations involving aquacultured seafood, and other animal-derived products."
    • The remaining subparagraphs c-f were renumbered as d-g.
  • Section 4-1-18 Tracking; 1. Identification of Warning Letters was revised  to reference the use of the Compliance Management System (CMS) for Tracking Warning Letters.
  • New Section 4-2-2 Tracking; 1. Identification of Untitled Letters was added to reference the use of the CMS for tracking Untitled Letters.

Exhibt 4.1 revised to add Seafood HACCP model letters to the audit review program


RPM electronic (Internet) edition "March 2007" supersedes hardcopy "March 2006" for chapters as noted in Transmittal notice and in master list.

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