# Medicaid Program; Time Limitation on Recordkeeping Requirements Under the Drug Rebate Program
> **Centers for Medicare and Medicaid Services** · Final rule. · Published 2004-11-26 · Effective 2005-01-01 · 69 FR 68815
## Document
- **Document number:** 04-25969
- **Category:** medicaid
- **Sub-agency:** Centers for Medicare and Medicaid Services
- **Federal Register citation:** 69 FR 68815
- **CFR reference:** 42 CFR 447
- **Publication date:** 2004-11-26
- **Effective date:** 2005-01-01
- **HHS docket:** CMS-2175-F
## Abstract

This final rule finalizes 10-year recordkeeping requirements for drug manufacturers under the Medicaid drug rebate program. Manufacturers must retain records for 10 years from the date the manufacturer reports data to us for a rebate period. This final rule also finalizes the requirement that manufacturers must retain records beyond the 10-year period if the records are known by the manufacturer to be the subject of an audit or a government investigation. Furthermore, this final rule responds to public comments on the January 6, 2004 interim final rule with comment period and the proposed rule pertaining to the 10-year recordkeeping requirements, respectively.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2004/11/26/04-25969/medicaid-program-time-limitation-on-recordkeeping-requirements-under-the-drug-rebate-program)
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