DEA compliance is key for healthcare providers who prescribe and dispense Controlled Substances (Schedules II through V). Our attorneys are trailblazers at the forefront of the battle against opioid abuse and recognized authorities in DEA compliance. Creators of industry-respected program integrity guidelines to ensure regulatory compliance, Nelson Hardiman works with clients to address DEA audits and compliance actions and assists clients in ensuring strict compliance with DEA requirements.
Nelson Hardiman attorneys leverage decades of government enforcement experience to represent healthcare providers during investigations, audits, and administrative actions by the federal Drug Enforcement Administration (DEA). We help clients understand federal (DEA) and state (California Bureau of Narcotics Enforcement, BNE) regulatory compliance requirements and avoid the risks of monetary penalties, loss of DEA certification, licensing actions, or even criminal sanctions. Nelson Hardiman works with healthcare providers to ensure DEA compliance proactively and in response to DEA actions.
Our Work Involves:
- Audits Audited a medical practice with issues in drug ordering procedures and assisted our client in addressing compliance issues to retain DEA certification.
- DEA Audit Request Responded to DEA audit request for a large healthcare provider to demonstrate compliance with DEA regulations and address alleged violations of the Controlled Substances Act.
- DEA Investigation Resolved a DEA investigation for a large healthcare system, restructured controlled substance practices, and implemented a quality improvement program to reduce medication errors and improve patient safety.
- Digital Medicine Advised on Internet prescribing requirements to comply with DEA regulations.
- Investigative Action Defense Defended civil and administrative investigative actions by DEA and state licensing agencies about alleged violations of DEA requirements for importation, purchase, and use of medication.
- Litigation Defended a pharmacy against a DEA license suspension for allegedly selling excessive amounts of a controlled substance.
- Opioid Overdose Regulations Guided a drug and alcohol rehabilitation center on the legal requirements for storing and administering Naloxone at its facilities in different states.
- Advised a telehealth company regarding regulatory and operational issues for providing telemedicine services across state lines.