Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administration Procedures; Public Hearing

概要

The Food and Drug Administration (FDA) is announcing a public hearing to discuss certain requirements of the final rule implementing 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 (Modernization Act), which published in the Federal Register of December 3, 1999 (64 FR 67720), (hereinafter referred to as the PDMA final rule). The purpose of the hearing is to elicit comment from interested persons, including professional groups and associations, the regulated industry, health care professionals, and consumers, on the potential impact of 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 PDMA final rule. The agency will use information obtained from the hearing and the comments to this document to determine what steps, if any, should be taken to modify the requirements in the PDMA final rule.