Congress’ 2013 passage of Title II of the Drug Quality and Security Act’s Drug Supply Chain Security Act creates novel and significant obligations throughout the distribution supply chain.  HPM’s attorneys can assist clients with interpretation of the Act’s provisions, and its applicability to their business.  HPM’s clients for whom it provides counseling on supply chain integrity matters include manufacturers, wholesale distributors, third party logistics providers, and pharmacies.  HPM routinely counsels these clients on track and trace, labeling, suspect product, reporting and serialization provisions.

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  • Regulatory and Statutory Interpretation
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