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DRUG DIVERSION REGS "SPECIFIC TO" BULK PHARMACEUTICALS SHOULD BE ESTABLISHED

Executive Summary

DRUG DIVERSION REGS "SPECIFIC TO" BULK PHARMACEUTICALS SHOULD BE ESTABLISHED if the Prescription Drug Marketing Act is to be applied to bulk pharmaceutical chemicals, the Generic Pharmaceutical Industry Association maintains in comments on FDA's proposed regulations implementing PDMA. "If BPCs are to be included in the proposed regulations, the proposed rule should be amended to include regulations specific to and appropriate to BPCs that address the problems of diversion and counterfeiting," GPIA said.

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