As of Nov. 3, the DEA will require registrants to submit all Controlled Substance Ordering System (CSOS) enrollment applications and supporting materials electronically. The system allows for secure electronic transmission of controlled substance orders.

A final rule updating the agency’s regulations to conform with a DEA CSOS modernization effort was published in the Federal Register pm Oct. 2 (90 Fed. Reg. 47566). The final rule will revise the agency’s regulations at 21 C.F.R. Part 1311.

In the past, the regulations had required registrants who wish to participate in the CSOS system to enroll using what the DEA characterized as “a labor-intensive manual process” that relied on paper applications. “The paper application must be notarized and the package mailed to DEA,” the agency noted in the Federal Register notice, “creating delays in the enrollment process and putting applications at risk of being lost.”

Background

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

CSOS permits electronic documentation submission, self-service support options, and electronic processing of single and bulk applications, renewals, and revocations. Users can electronically search for, revoke, report, retrieve, and renew secure digital certificates.

The system requires that each individual supplier and purchaser enroll with the DEA to acquire a CSOS digital certificate.

New Online Procedure

Under the final rule, the DEA announced, applicants for enrollment will follow the CSOS link on the deadiversion.gov website to the CSOS log-in page.

Creating a Login.gov account. From the CSOS login page, the applicant will be redirected to Login.gov for identification verification. There, the applicant will be asked to create a Login.gov account by entering a valid email address, selecting a default language, and agreeing to Login.gov’s Rules of Behavior. A confirmation email will then be sent to the applicant.

Once the email has been confirmed, the applicant must create a Login.gov password by providing a telephone number to which a verification code can be sent. Once the code is sent and the applicant enters the code provided on the Login.gov website, the applicant must agree to the site’s security statement.

Next, Login.gov requires applicants to upload photographs of one or more forms of identification as specified by Login.gov and to enter a Social Security number, after which the applicant is asked to verify the information given.

The applicant then must re-enter its Login.gov password to receive a personal key via a separate message. The applicant is then asked to enter that personal key and review the applicant’s submitted information. Once the information is verified, the applicant is then directed back to the CSOS website.

CSOS website. At the CSOS website, the applicant is asked to agree to the CSOS user agreement and can apply for one of three system user roles: Registrant, Coordinator, or Power of Attorney, in descending order of superiority.

After the Registrant role is established, all subordinate applications for enrollment must be approved by the Registrant. Upon establishment of a Coordinator, all subordinate applications for enrollment for the Power of Attorney role must be approved in the system by the responsible Coordinator.

Changes to Recordkeeping Mandates

The DEA noted that under the final rule it is eliminating certain recordkeeping requirements, “as those records will now be accessible as a digital version in the system.”

Also, the agency said, the changes under the final rule remove the requirement of the CSOS certificate holder to maintain a copy of the subscriber agreement “by enabling registrants to sign and access a digital version of the agreement in the online portal.”

Comments on Proposed Rule

In February 2023, the DEA issued a notice of proposed rulemaking (NPRM) for requiring CSOS enrollment applications and supporting materials to be submitted online (88 Fed. Reg. 7033).

According to the agency, the commenters “were mostly supportive of the proposed rule.” The DEA’s responses to individual comments are outlined in the Oct. 2 Federal Register notice.