“It’s In the Mail” Will Soon No Longer Apply to DEA Registration Applications

Effective May 11, 2022, the Drug Enforcement Administration (“DEA”) will require all applications and renewals for registration to be submitted electronically.  DEA issued a final rule on April 11, 2022, eliminating the “mail-in” option, believing that initial and renewal applications submitted online will be more effective for the agency and registrants.  Requiring Online Submission of Applications for and Renewals of DEA Registration, 87 Fed. Reg. 21,019, 21,020 (Apr. 11, 2022).  Applicants will be required to submit all applications through DEA’s secure online portal.  The agency has determined that “[r]egulatory changes are needed to modernize DEA’s approach to registration and renewal applications” and requiring online submission will eliminate “inefficient paper applications” whose typographical errors and incomplete information have “routinely resulted in delayed or rejected applications.”  Id.

DEA had proposed this change in its January 7, 2021, notice of proposed rulemaking. Amending Regulations To Require Online Submission of Applications for and Renewals of DEA Registration, 86 Fed. Reg. 1,030 (Jan. 7, 2021).  DEA noted that the National Association of Chain Drug Stores (“NACDS”) and three other individuals commented on the proposed rule.  NACDS observed that DEA did not propose to modify nor address “batch” renewals for multiple locations holding multiple registrations, and expressed its desire for the agency to continue allowing registrants to submit batch renewals.  Id. at 21,020- 21,021.  DEA confirmed that the batch renewal process would not be affected, opining that batch renewals streamline the process for both registrants and the agency, and that the online portal would continue to accept batch applications and single payments.  Id. at 21,020- 21,021.

NACDS also commented that the proposed rule was unclear on whether DEA’s rejection of a single, deficient application within a batch would cause rejection of the entire batch.  DEA countered that the existing process already ensures that only completed applications are processed while incomplete applications are rejected, thereby precluding the possibility of rejecting an entire batch due to a defective application.  Id. at 21,021.

Lastly, DEA addressed NACDS’ final observation that the proposed rule listed credit cards as the only payment option, noting that some batch renewal payments exceed $1,000,000, and payment by credit card would run afoul of corporate policies requiring large transaction payment via certified bank check.  Id.  In response, DEA amended the proposed rule to allow online payment by Automated Clearing House (“ACH”) fund transfer, credit card or other means that may be available at submission using the secure application portal.  DEA will not accept bank checks for the foreseeable future.  Id.

It is worth noting that in June 2020, DEA had stopped mailing renewal notifications to registrants and instead stated that it would send out electronic reminders to renew at 60, 45, 30, 15, and 5 days prior to the expiration date of the registration to the associated email address.  Renewal Applications are available here.  DEA’s policy has been to allow a registrant to continue operations if a renewal has been submitted in a timely manner.  However, registrants will now need to be very careful to meet the online deadline and will no longer be able to argue that “it’s in the mail.”

There is no doubt that this change will significantly reduce the administrative burden on DEA in processing the applications and renewals.  We would hope that this will also mean that registrants will receive their renewal or new registration certificates on a more-timely basis.  Delays in issuing these certificates have caused issues for registrants when asked to verify their renewals to suppliers or customers.