SUPAC-MR guidance increases allowable Level 1 content variation from 2% to 5%.

Executive Summary

FDA SUPAC-MR GUIDANCE INCREASES CONTENT VARIATION FROM 2% TO 5% for Level 1 release-controlling excipients for all extended- and delayed-release solid oral dosage forms. The Oct. 6 Scale-Up and Post-Approval Changes final guidance for Modified-Release Solid Oral Dosage Forms states that for Level 1 components and composition changes, "the total additive effect of all release-controlling excipient changes should not be more than 5% [by weight] of the total release-controlling excipients in the original approved formulation." Component and composition changes would be filed in a company annual report.