Testing of veterinary biologics in the United States.

The National Veterinary Services Laboratories (NVSL) in Ames, Iowa, are responsible for the confirmatory testing of veterinary biologics produced in the United States and regulated by the United States Department of Agriculture. There were 22.101 serials of biological products produced and submitted to the NVSL during fiscal year (FY) 1991 (October 1, 1990, to September 30, 1991). All serials were tested by the manufacturer; and 2.086 (9.44 percent) were also tested by the NVSL for purity, safety, or potency of at least one component. Of the serials tested, 97.84 percent were found to be satisfactory. The total number of tests conducted during FY 1991 was 4.283. The criteria for establishing test rates and test methods are discussed. In addition to the testing of finished biological products, the NVSL tested 129 bacterial or viral master seeds and 31 master cell stocks during FY 1991 for identity and freedom from extraneous bacterial and viral agents. These master seeds and master cell stocks will be used to make future biological products.