Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures; Delay of Effective Date

概要

The Food and Drug Administration (FDA) is further delaying, until April 1, 2002, the effective date regarding certain requirements of the final rule published in the Federal Register of December 3, 1999 (64 FR 67720). The final rule implements the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA), and the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). FDA is further delaying the effective date for certain requirements in the PDMA final rule relating to wholesale distribution of prescription drugs by distributors that are not authorized distributors of record, and distribution of blood derivatives by entities that meet the definition of a "health care entity" in the final rule. In the Federal Register of May 3, 2000 (65 FR 25639), the agency previously delayed until October 1, 2001, the effective date of these requirements. The other provisions of the final rule became effective on December 4, 2000. The agency is taking this action to address concerns about the requirements raised by affected parties. FDA believes that this further delay of the effective date of certain requirements in the P