In the E.U., the FMD establishes a common approach to protecting patients from illegitimate pharmaceutical products—an approach each of the member states is obligated to follow and enforce. E.U. member states have the option, up to a point, of creating additional requirements.
In the U.S., the DSCSA establishes a single approach, enforced by state and federal governments alike, to protecting the pharmaceutical supply chain from the introduction of illegitimate products. Unlike their counterparts in the E.U., state governments in the U.S. may not create additional requirements that exceed those of the DSCSA.
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