# Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures; Delay of Effective Date; Reopening of Administrative Record
> **Food and Drug Administration** · Final rule; delay of effective date; reopening of administrative record. · Published 2000-05-03 · 65 FR 25639
## Document
- **Document number:** 00-10920
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 65 FR 25639
- **CFR reference:** 21 CFR 203
- **Publication date:** 2000-05-03
- **HHS docket:** Docket Nos. 92N-0297 and 88N-0258
## Abstract

The Food and Drug Administration (FDA) is delaying until October 1, 2001, the effective date and reopening the administrative record to receive additional comments regarding certain requirements of a final rule published in the Federal Register of December 3, 1999 (64 FR 67720). The other provisions of the final rule become effective on December 4, 2000. The final rule implements the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA) and the FDA Modernization Act of 1997 (the Modernization Act). FDA is delaying the effective date for certain requirements relating to wholesale distribution of prescription drugs by distributors that are not authorized distributors of record. FDA is also delaying the effective date of another requirement that would prohibit blood centers functioning as "health care entities" to act as wholesale distributors of blood derivatives. The agency is taking this action to address numerous concerns about the provisions raised by affected parties.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2000/05/03/00-10920/prescription-drug-marketing-act-of-1987-prescription-drug-amendments-of-1992-policies-requirements)
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