10/01/2007 |
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.
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