The DEA April 11 issued a final rule requiring all applications for registration with the agency and all registration renewals to be submitted online. The rule is effective May 11 (87 Fed. Reg. 21019).

According to the DEA, the final rule will mitigate the issues created by paper applications “by simplifying the process by which registrants submit new applications for registration or renew current registrations.”

In the past, the agency’s regulations permitted DEA registration forms to be submitted either through a secure online portal or by delivery to agency headquarters.

The final rule amends seven sections of existing DEA regulations to require all registration and renewal applications to be submitted only through the agency’s online portal.

A notice of proposed rulemaking (NPRM) for requiring online submissions of registration applications and registration renewal applications was published in the Federal Register on Jan. 7, 2021 (86 Fed. Reg. 1030).

Payments Options Expanded

The final rule promulgates the online registration and renewal requirements as proposed in the NPRM with one exception. The agency added language clarifying that Automated Clearing House (ACH) fund transfers will be accepted as payment for registrations and renewals, in addition to credit cards and other forms of payment that may become available.

The added language responded to a comment on the NPRM submitted by the National Association of Chain Drug Stores (NACDS), which had noted that the only payment method listed in the proposed rule was by credit card (proposed 21 C.F.R. §1309.12(b)).

The association noted that having only the credit card option would be troublesome for payments made for batch renewals — renewals in which companies seek to renew their registrations for multiple locations with a single packet covering a number of DEA registrations and licenses. Batch renewals usually contain a single signed affidavit and a single payment for all the registration renewals being sought.

In particular, NACDS noted that corporate policies often demand that large financial transactions be conducted through certified bank checks.

The DEA in response modified proposed Section 1309.12(b) to provide that payment can be made online by ACH funds transfer, by credit card, “or by any other means made available at the time of submission using the secure application portal at www.DEAdiversion.usdoj.gov.”

“DEA recognizes that some companies may be required to alter their payment methods based on this rule change, as bank checks may be the most convenient option for some registrants,” the agency said. “DEA believes, however, that the expansion of this rule to permit ACH transfers will mitigate many of the issues typically surrounding the financial, procedural or security concerns for applicants.”

In keeping with “its broader policy of reducing reliance on tangible forms of payment,” the DEA said, the agency “will not accept bank checks for the foreseeable future.”

Other Batch Renewal Concerns

In its comments on the proposed rule, NACDS also expressed its concern about what the association perceived as ambiguity as to whether the DEA would accept online batch renewals — specifically, whether an entire batch of online applications would be denied if one application were denied, and whether alternative payments options would be accepted.

In response to the association’s concerns, the DEA said that its online portal will accept online batch applications and single payments for batch renewals. The agency also determined that it was “not necessary to amend the proposed regulations on this point.”

“Only completed applications actually are processed, including for payment,” the agency said. “Since this process ensures that applicants will not be able to submit incomplete applications, NACDS’ concern that entire batches could be rejected based on individual application deficiencies is moot.”

The DEA forms affected by the final rule included the following (“XXXa” forms are used for registration renewals):

• DEA Form 224/224a — for retail pharmacies, hospitals, clinics, practitioners teaching institutions and mid-level practitioners;
• DEA Form 225/225a — for manufacturers, distributors, researchers, analytical laboratories, importers and exporters;
• DEA Form 363/363a — for narcotic treatment programs; and
• DEA Form 510/510a — for domestic handlers of List I chemicals.

Additional information on the DEA’s registration and registration renewal processes is available online.