Wholesale Distribution

HPM advises drug and device wholesale distributors on FDA, DEA and state statutory and regulatory compliance issues including registration and licensing, storage and handling, recordkeeping, reporting, track and trace, and drug serialization.  HPM has conducted numerous  investigations and due diligence auditsfor clients related to compliance with federal and state laws and regulations.  HPM has also represented wholesale distributors in federal and state administrative and civil enforcement actions.

Registration and Licensing

HPM assists clients on issues related to federal and state licensing including:

• DEA registration and show cause actions
• State wholesale distributor and 3PL licensing requirements
• VAWD accreditation and certification

Controlled Substances and Listed Chemicals

HPM lawyers have unprecedented experience in advising wholesale distributors on compliance issues related to controlled substances and listed chemicals:

• Security, recordkeeping and reporting
• Inspections, investigations and accountability audits
• Suspicious order identification and reporting
• Administrative and civil penalty litigation

Drug Supply Chain and Security Act

HPM routinely assists clients with requirements related to emerging requirements related to protecting the drug supply chain:

• Transactional requirements
• Track and trace
• Serialization
• Counterfeit and adulterated product

To view other enforcement matters frequently handled by our attorneys, click on Enforcement.