DEA Compliance & Litigation


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.

DEA Litigation & Compliance Hospital Services 

• 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