Temporary Exceptions to DEA Regulations Permitting Flexibility in Distributing and Dispensing Controlled Substances in Wake of COVID-19
In an effort to facilitate continuity of patient care and to respond appropriately to the circumstances that have arisen during the COVID-19 pandemic, the Drug Enforcement Administration (“DEA”) has recently announced three exceptions to DEA regulations for DEA-registered hospitals and clinics that will remain effective until the end of public health emergency crisis.
Given the urgency of the situation, the DEA is providing DEA-registered hospital/clinics with the flexibility to utilize alternate satellite hospital/clinic locations under their current registrations to handle controlled substances as long as certain conditions are met. In furtherance of this exception, the DEA is providing flexibility to permit distributors to ship controlled substances directly to these nonregistered satellite hospitals/clinics locations under certain conditions.
Additionally, the DEA has learned that narcotic treatment programs are concerned about signing invoices for narcotics at the time of delivery, as is required under current DEA regulation. As such, the DEA has temporarily relaxed the rules and will allow narcotic treatment programs to accept deliveries of narcotics without needing to provide a signature at the time of delivery provided that certain conditions are met.
Lastly, there has been an increasing demand of controlled substances used for treatment during the COVID-19 pandemic. Therefore, to allow for an adequate and uninterrupted supply of medically necessary controlled substances, the DEA is allowing DEA-registered dispensers, such as hospitals, pharmacies and physicians to distribute controlled substances beyond the 5% limit of the total number of dosage units of all controlled substances that the practitioner dispenses and distributes during the same calendar year without needing to register as a distributor.
For additional guidance, Frier Levitt attorneys are available to assist providers and distributors in navigating the new temporary DEA regulatory changes resulting from the COVID-19 crisis.