CVM Update Regarding Records And Reports Rule Withdrawn

December 23, 2003

On August 22, 2003, a CVM UPDATE was issued for the purpose of clarifying certain aspects of FDA’s requirements regarding records and reports concerning experience with approved new animal drugs as codified in Title 21, Code of Federal Regulations (CFR) Part 514.80. In particular, the August 22 release discussed the applicability of the rule to Type B and Type C medicated feeds.

This CVM Update rescinds the CVM UPDATE of August 22, 2003, “Clarification of Records and Reports for Animal Feeds.” CVM is reconsidering its position on this topic and intends to issue guidance in the near future to provide clarification on such issues as the application of the records and reports requirements to approved Type A medicated articles incorporated in animal feeds [21 CFR 514.80(a)(4)].

FDA requirements for records and reports that apply to medicated feeds are currently provided under Title 21, CFR 510.301. These requirements relate to records and reports concerning experience with animal feeds bearing or containing new animal drugs for which an approved medicated feed mill license application is in effect.

Further information on the records and reports rule may be obtained from Dr. Mohammad I. Sharar at 301-827-0159, e-mail msharar@cvm.fda.gov or Dr. Glenn A. Peterson at 301-827-0224, e-mail gpeterson@cvm.fda.gov.