Frequent Questions

Can data developed by the supplier of the standard be accepted? If not, can it be used on an "interim" basis until the standard is adequate characterized?

Information developed by a supplier can be used to support characterization requirements, but the compliance statement for the overall study must state whether such data were developed under GLPS. Any data not developed under GLPS may be rejected by the Agency. Analyses must be performed to characterize the reference substance before it is used. In the case that a standard is used before it is analyzed, this is a violation of 40 CFR 160.105(a), which requires such determinations to be made before the standard is used in the study.
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