Parker Hudson offers comprehensive legal services in Controlled Substance Enforcement & Diversion, guiding clients through the complexities of the Controlled Substances Act (CSA), the Food Drug & Cosmetics Act (FD&C Act), and other federal and state drug laws and regulations related to controlled substances and other prescription drugs with abuse potential. We use our cross-disciplinary expertise to advise manufacturers, distributors, pharmacies, and healthcare providers throughout the country in designing compliance programs related to controlled substances, assisting providers in healthcare transactions with due diligence related to potential violations, conducting internal investigations related to drug diversion incidents, and defending clients in Drug Enforcement Administration (DEA), Department of Health and Human Services-Office of the Inspector General (HHS-OIG), and Department of Justice (DOJ) investigations.
Our Experience
In response to the opioid crisis, the DEA, DOJ and state regulators have significantly increased enforcement efforts related to controlled substances throughout the closed-loop supply chain. Our team has unique experience among law firms throughout the country, which allows Parker Hudson to assist every type of DEA registrant in identifying, preventing, and addressing controlled substance issues. Our team includes former Department of Justice officials who have handled some of the most significant criminal and civil DEA diversion control enforcement actions in the United States, including DEA Civil Monetary Penalty cases, FDA civil litigation under the FD&C Act, as well as criminal prosecutions of health care providers and pharmacists. We have developed significant relationships with government enforcement agencies over the years that give us the credibility to effectively advocate for our clients and reduce exposure wherever possible.
Our Approach
We emphasize a proactive approach to compliance, helping clients navigate federal and state regulations to remain compliant with the CSA, DEA regulations, state prescription drug monitoring programs (PDMP), and other laws. Our services include policy development, risk assessments, prevention training, and the implementation of monitoring programs to mitigate risk. And when the government does investigate, we employ the same proactive approach to respond to government subpoenas or DEA Administrative Inspection Warrants (AIWs), to address any issues identified by regulators, and remediate any diversion compliance issues. With deep experience, a successful track record, and best-in-class compliance counseling, our Controlled Substances Enforcement & Diversion practice is committed to collaborating with registrants to address the ongoing challenges of controlled substances diversion and the heightened scrutiny of compliance by regulators.
