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Prescription Drug Marketing Act Archived Actions


FDA publishes final rule providing clarification of the federal regulations for registered blood establishments and comprehensive hemophilia diagnostic centers that are also health care entities. This allows these establishments to continue their core mission work in several areas that were previously threatened by narrow exclusions to 21 CFR 203 – Prescription Drug Marketing.


FDA announces an additional delay in the date by which registered blood establishments must comply with provisions in the PDMA that involve wholesale distribution of blood derivatives by health care entities. Registered blood establishments are given until Dec. 1, 2008, to meet the new requirements, allowing FDA additional time to address comments received in response to the proposed rule issued in February as part of the PDMA implementation process.