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U.S. Department of Health and Human Services

Animal & Veterinary

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TECHNICAL AMENDMENT

FDA Veterinarian Newsletter January/February 1998 Volume XIII, No I

FDA published a technical amendment concerning the use of animal drugs in medicated feeds [Title 21, Section 558.4(d) of the Code of Federal Regulations] to reflect the correct assay limits for lasalocid in Type A medicated articles. These assay limits are 95 to 115 percent of the labeled amount. Although the original approval for new animal drug application (NADA) 96-298 provided for a 10 percent overage (an assay limit of 100 to 120 percent), a supplemental approval dated August 25, 1992, revised that overage to 5 percent (95 to 115 percent). The regulation in Section 558.4(d) is amended in the table entitled "Category I" in the entry for "Lasalocid," accordingly. Federal Register, November 12, 1997.