Medicaid Program; Time Limitation on Price Recalculations and Recordkeeping Requirements Under the Drug Rebate Program; Correction

This document corrects the effective date of a final rule with comment period published in the Federal Register on August 29, 2003 (68 FR 51912). That rule finalizes separately, in an accelerated timeframe, two specific provisions of the September 19, 1995 proposed rule. It establishes new recordkeeping requirements for drug manufacturers under the Medicaid drug rebate program. It also sets forth a 3-year time limitation during which manufacturers must report changes to average manufacturer price and best price for purposes of reporting data to us. In addition, it announces the pressing need for codification of fundamental recordkeeping requirements. It also announces our intention to continue to work on finalizing the complete drug rebate regulation for the Medicaid drug rebate program. This document corrects the effective date.