DEA Compliance & Litigation
Our DEA Compliance & Litigation Practice Group helps members of the pharmaceutical and health care industry fulfill their obligations under the Controlled Substances Act (CSA) and DEA’s implementing regulations. Our attorneys are committed to developing our clients into industry leaders in DEA compliance while facilitating innovation in the delivery of controlled substances and listed chemicals throughout the supply chain.
DEA compliance is complex, costly, and not without substantial risk. Given the current regulatory environment, health care companies and organizations need the most effective and experienced legal representation available. The DEA Compliance & Litigation Practice Group at Quarles & Brady has been built to address the most comprehensive and complex needs of organizations that operate in the highly regulated pharmaceutical environment. We look forward to working together with you to fully address your individual objectives and concerns.
A brief summary of the services we provide includes:
- Advising on all aspects of litigation and compliance regarding CSA and DEA regulations, including registration, recordkeeping, reporting, and proper handling of controlled substances and listed chemicals.
- Representing clients in administrative or other enforcement proceedings before the DEA.
- Representing clients in cases involving civil penalties sought by the government, pursuant to the CSA.
- Overseeing document production in response to warrants or subpoenas issued by DEA.
- Advising on investigations conducted by DEA regarding alleged diversion of controlled substances and/or listed chemicals.
- Developing standard operating procedures involving controlled substances and listed chemicals.
- Assisting clients with seeking manufacturing and procurement quotas from DEA.
- Assessing internal procedures and practices relating to DEA compliance issues.
- Conducting training for senior management and other employees responsible for, or with access to, controlled substances and listed chemicals.
- Petitioning DEA for rulemaking or comment on proposed rules.
Below are a few examples of our DEA team’s representative experience:
- We have handled civil penalty cases under the Controlled Substances Act, including negotiating settlements.
- Our team has conducted client reviews and audits for clients with DEA registrations, to assist them in identifying and addressing any potential regulatory issues.
- We have responded to letters of admonition from DEA on behalf of clients.
- We regularly advise companies, including their compliance officers and boards of directors, on DEA compliance issues.
- We regularly represent clients in government investigations, and our team often leads internal investigations.
- We have extensive experience guiding companies through government subpoenas and warrants.
- Our team has negotiated potential civil penalty assessments regarding records of distribution and receipt, as well as DEA order forms.
- We have assisted clients, including pharmacies and distribution centers, in obtaining DEA registrations.
- Our team has handled registration issues for international pharmaceutical manufacturers and distributors, relating to corporate reorganizations and spinoffs.
- We have represented clients in cases regarding their alleged failure to report suspicious orders.
- Our team regularly advises clients on completing theft and loss reports.
- We assist DEA registrants, including drug manufacturers, in negotiations with the DEA over quota issues.
- We have experience communicating with DEA regarding the scheduling of new molecular entities.
- Our team advises clients regarding pending legislation and proposed rules on the handling of controlled substances and scheduled listed chemical products.
- Our team members regularly speak at pharmacy schools and pharmaceutical industry conferences on various DEA-related topics.
While the Drug Enforcement Administration’s (DEA’s) enforcement actions over the past several years have generally focused on individual practitioners, pharmacies, and distributors, diversion is certainly not limited to those members of the pharmaceutical industry. Diversion can, and does, occur at any location where controlled substances are present. This includes hospitals and hospital-owned clinics and pharmacies.
Diversion at hospitals can occur in a variety of ways, including prescribing controlled substances for illegitimate purposes, the theft of controlled substances by practitioners who “short” patients and do not administer the amount ordered for the patient, thefts of controlled substances that are intended to be wasted or destroyed, and improper access and removal from automated dispensing machines.
We have recently noticed an uptick in DEA enforcement actions against hospitals and hospital-owned facilities. There have been several news articles in the past year discussing settlements reached with the government for controlled substance violations and ongoing DEA investigations of hospitals.
DEA compliance in a hospital setting can be difficult to manage. In addition to the myriad security and recordkeeping obligations, it is easy for hospitals to run afoul of the state license and DEA registration obligations. This is especially true where the hospital is situated as part of a larger campus or medical complex. It is not atypical for the hospital’s ground to stretch across several blocks and be comprised of several buildings. It is also typical for many locations within the hospital’s complex to have a need to store, administer, or dispense controlled substances. Ensuring that the various facilities are properly licensed and registered and the transfer of drugs between the facilities is done properly can be a daunting task.
Our hospital services include:
- comprehensive review of written policies and procedures
- onsite inspection of drug-security and drug-handling procedures
- inspection of records required to be kept by the registrant
- review of all licensing and registration requirements for the various facilities
- senior management meetings to discuss particular areas of concern
- general walk-through of facilities to identify drug diversion risks (even if the registrant is technically complying with the requirements)
- follow-up recommendations training/discussion with appropriate employees and management to assist the client with issue-spotting in the future