Cote Law PLLC provides members of the health care and pharmaceutical industries with comprehensive compliance counseling to ensure that our clients meet their obligations under the Controlled Substances Act (CSA) and the attendant DEA regulations. We understand that our clients’ interests are best safeguarded by implementing compliance programs that lead the industry. At the same time, we work with our clients on innovative ways to deliver, throughout the supply chain, controlled substances and listed chemicals that are both compliant and cost-effective.
That said, however comprehensive the design of a compliance program, litigation cannot always be avoided. DEA litigation can be intricate, expensive, and fraught with risk. It is essential that companies in the health care and pharmaceutical spaces rely on the counsel of attorneys with the skill set and experience to navigate these dangerous waters. Cote Law PLLC provides just this kind of effective legal representation, borne of experience, that health care and pharmaceutical market players require.
What follows is a brief summary of the services we provide:
We advise our clients on all compliance matters regarding the CSA and DEA regulations, including the following:
- Proper handling of controlled substances and listed chemicals
- Reporting requirements
- Development of standard operating procedures
- Analyzing current internal procedures and practices
- Training senior management and relevant employees on implementation of compliance programs
- Conduct compliance audits that mimic a typical DEA inspection
We represent our clients in several different venues and contexts, including the following:
- Administrative and other enforcement proceedings before the DEA
- Cases involving civil penalties sought by the government, pursuant to the CSA
- Oversight of document productions in response to subpoenas or warrants issued by the DEA or other governmental entities
- Seeking manufacturing and procurement quotas from DEA
- Petition DEA on behalf of our clients for rule-making or comment on proposed new rules.
We take the lead in advising our clients on DEA diversion investigations and assist our clients in conducting internal investigations designed to discover diversion issues within their entities.
DEA enforcement actions in recent years have most often involved pharmacies, individual practitioners, and distributors. But diversion is by no means limited to these entities. Anywhere controlled substances are stored and/or administered hold the potential for drug diversion. And we have seen an increase of late in DEA enforcement actions against hospitals and facilities/pharmacies owned by hospitals. This is not merely anecdotal. Several news articles over recent years have documented DEA investigations of hospitals and some resulting settlements.
Diversion at hospitals can take many forms: theft by practitioners who do not administer the prescribed amount of controlled substances to their patients, unauthorized access to automated dispensing machines, resulting in the improper removal of controlled substances, the prescribing of controlled substances for illegitimate purposes, among others.
Hospitals face a unique set of challenges when it comes to DEA compliance. Heavy record-keeping and security obligations are compounded by state license and DEA requirements. The more extensive the campus, the greater the likelihood that there will be multiple locations in which controlled substances will need to be stored and administered. Cote Law PLLC works with our hospital clients to ensure that all such locations are properly licensed and registered and that any transfer of controlled substances is done in compliance with all relevant regulations.
Our hospital services include the following:
- Create Opioid Stewardship Programs
- Review of all written policies and procedures
- Onsite inspection of facilities to identify drug-diversion risks and review drug-handling and transfer protocols
- Meetings with senior hospital management for counseling on risks and procedures
- Inspection of all required records
- Review of all registration and licensing requirements for all locations on hospital campus that store and/or administer controlled substances
- Training of management and relevant employees on drug-handling procedures and drug-diversion risks