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HUMAN INSULIN CERTIFICATION WILL BEGIN UPON AVAILABILITY OF REFERENCE STANDARD

Executive Summary

HUMAN INSULIN CERTIFICATION WILL BEGIN UPON AVAILABILITY OF REFERENCE STANDARD, which FDA said is expected "sometime during the second quarter of 1985." The agency stated in an April 11 Federal Register notice that a monograph for human insulin is included in the latest revision of the United States Pharmacopeia, which became official Jan. 1, 1985. However, the agency said the USP human insulin reference standard required to perform several of the certification tests set forth in this monograph is not yet available from the USP convention. The agency also announced that it would begin selectively testing samples of batches of insulin submitted to FDA for certification instead of replicating all required tests conducted by the mfr. "There appears to be no public health reason to continue, as a condition for certification, replicating routine tests, such as sterility, pH, loss on drying, nitrogen content, zinc content, isophane ratio, and the test for insulin not extracted by buffered acetone," the notice stated. The agency explained that "improved analytical procedures and techniques now give results with lower variability than those used a few years ago." In addition, FDA said, "many of these same or similar tests are performed routinely by mfrs. on other injectable drug products without FDA review of the mfrs.' results or testing of samples of the drug products before they are introduced into interstate commerce." The change in certification testing procedure will take effect "sometime during the second quarter of 1985," FDA said. FDA said it would continue to replicate the insulin potency assay for both human and animal insulins. The agency noted that it would use the high performance liquid chormotography (HPLC) test in addition to the current rabbit bioassay for assigning human insulin potency when USP's reference standard is available. Until that time, FDA said it would use only the rabbit bioassay, which is also the sole potency assay for animal insulins.
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