On April 11, 2022, the Drug Enforcement Administration (DEA) released a final rule which amends DEA regulations to now require all applications for DEA registrations, and renewal of those registrations, to be submitted online. The final rule is effective May 11, 2022.
On January 7, 2021, DEA published a notice of proposed rulemaking (NPRM) that proposed requiring that all applications for DEA registrations, and renewal of those registrations, be submitted online. DEA is promulgating this rule as proposed in the NPRM with one exception: DEA is clarifying that Automated Clearing House (ACH) fund transfers will be accepted as payment for registrations and renewals.
With this new requirement to submit registrations and renewal applications online, DEA seeks to mitigate issues created by paper applications and simplify the process by which registrants submit or renew applications for registration. The final rule should reduce inefficiencies in DEA’s application review process. However, it also serves as an important reminder for registrants to keep a valid email address on file with DEA to ensure receipt of renewal notices from DEA. After the time period for a renewal (plus any grace period) expires, a registrant must apply for a new DEA registration. DEA’s current policy is to afford registrants a “30-day” grace period after its registration expires to submit a renewal application. However, after this time DEA averages between 4-6 weeks to issue a new DEA registration. During this time frame, the registrant is without authority to prescribe (or otherwise handle) controlled substances.
A failure of a prescriber to timely renew his/her DEA registration may have a trickle-down effect on dispensers. A prescription for a controlled substance is not valid unless the prescriber has an active DEA registration at the time of issuance. Thus, a pharmacy’s dispensing of a controlled substance pursuant to such an invalid prescription may pose unintended consequences on the pharmacy, including allegations of false claims submission by third-party payors and/or the recoupment of previously paid claims.