The DEA has issued a notice of proposed rulemaking (NPRM) that would require all Controlled Substance Ordering System (CSOS) applications and supporting materials to be submitted online through the secure portal of the agency’s Diversion Control Division.

The proposed changes to the DEA’s electronic orders regulations (21 C.F.R. Part 1311) “would increase the efficiency of the enrollment, modification and revocation processes, and ensure DEA’s receipt of accurate documentation in a more timely and organized manner,” the agency said in the preamble to the NPRM, which was published in the Federal Register Feb. 2 (88 Fed. Reg. 7033).

Background

DEA registrants use CSOS to track orders of Schedule I and Schedule II controlled substances. The system allows for secure orders without the need to use a paper order form (DEA Form 222).

The system requires suppliers and purchasers to enroll with the DEA to obtain a CSOS digital certificate.

“System enhancements will allow electronic documentation submission, self-service support options, and electronic processing of single and bulk applications, renewals and revocations,” the agency said. “Users will be able to electronically search for, revoke, report, retrieve and renew secure digital certificates.”

The current CSOS system enrollment procedure is based on “a labor-intensive manual process which relies on paper applications,” the DEA noted. The proposed rule, it said, would “simplify the application process by requiring all CSOS enrollment applications to be submitted online.”

The DEA also said that the NPRM addresses the need “to conform existing DEA regulations regarding the submission of the paper CSOS system enrollment forms to DEA’s current requirements that other DEA forms be submitted online.”

Proposed Enrollment Process

According to the NPRM, if the proposed changes are enacted, an enrollment applicant would follow a link on the Diversion Control Division website to the CSOS log-in page.

From there, the applicant would be redirected to Login.gov for identification verification. If the applicant does not have a Login.gov account, the applicant could create an account by providing an email address and creating a password. Login.gov requires photos of one or more forms of identification specified by the government as well as the applicant’s Social Security number.

The Login.gov site would then provide a Personal Key to the applicant and direct the applicant back to the CSOS website, where the applicant could apply for one of three system user roles: Registrant, Coordinator, or Power of Attorney.

The agency estimated that the total registrant cost savings each year resulting from moving to online registrant applications would be nearly $10.7 million.

Comments on the NPRM are due by April 3 and may be submitted online (Docket No. DEA-732).