Controlled Substances Ordering System (CSOS) Modernization

<RULE> DEPARTMENT OF JUSTICE <SUBAGY>Drug Enforcement Administration</SUBAGY> <CFR>21 CFR Part 1311</CFR> <DEPDOC>[Docket No. DEA-732]</DEPDOC> <RIN>RIN 1117-AB79</RIN> <SUBJECT>Controlled Substances Ordering System (CSOS) Modernization</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Drug Enforcement Administration, Department of Justice. <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> This rule is amending the Drug Enforcement Administration's (DEA) regulations to conform to the Controlled Substances Ordering System (CSOS) modernization effort by requiring all CSOS enrollment applications and supporting materials to be submitted through the Diversion Control Division secure online portal. These amendments improve the enrollment process by aligning it with DEA's current requirements for other online form submissions. The online submission of enrollment applications and supporting material through the secure online portal increases the efficiency of the enrollment, modification, and revocation processes, and ensures DEA's receipt of accurate documentation in a more timely and organized manner. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This Final Rule is effective November 3, 2025. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Heather E. Achbach, Regulatory Drafting and Policy Support Section, Diversion Control Division, Drug Enforcement Administration; Telephone: (571) 776-2265. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION</HD> <HD SOURCE="HD1">Legal Authority</HD> The Controlled Substances Act (CSA) grants the Attorney General authority to promulgate rules and regulations relating to: the registration and control of the manufacture, distribution, and dispensing of controlled substances and listed chemicals; reporting changes to professional or business addresses; and the efficient execution of his statutory functions. <SU>1</SU> <FTREF/> The Attorney General is further authorized by the CSA to promulgate rules and regulations relating to the registration and control of importers and exporters of controlled substances and listed chemicals. <SU>2</SU> <FTREF/> The Attorney General has delegated this authority to the Administrator of DEA. <SU>3</SU> <FTREF/> <FTNT> <SU>1</SU>  21 U.S.C. 821, 822(a), 823, 827 (h), 871(b). </FTNT> <FTNT> <SU>2</SU>  21 U.S.C. 957(a), 958(f). </FTNT> <FTNT> <SU>3</SU>  28 CFR 0.100(b). </FTNT> The CSA defines “distribute” as “to deliver (other than by administering or dispensing) a controlled substance or a listed chemical” and “distributor” as “a person who so delivers a controlled substance or a listed chemical.”  <SU>4</SU> <FTREF/> The CSA further provides that it “shall be unlawful for any person to distribute a controlled substance in schedule I or II to another except in pursuance of a written order of the person to whom such substance is distributed, made on a form to be issued by the Attorney General in blank in accordance with subsection (d) [of 21 U.S.C. 828] and regulations prescribed by him pursuant to [21 U.S.C. 828].”  <SU>5</SU> <FTREF/> “Every person who gives an order required under subsection (a) [of 21 U.S.C. 828] shall, at or before the time of giving such order, make or cause to be made a duplicate thereof on a form to be issued by the Attorney General in blank in accordance with subsection (d) [of 21 U.S.C. 828] and regulations prescribed by him pursuant to [21 U.S.C. 828], and shall, if such order is accepted, preserve such duplicate for a period of two years and make it available for inspection and copying. . . . ”  <SU>6</SU> <FTREF/> “The Attorney General shall issue forms . . . only to persons validly registered under [21 U.S.C. 823] (or exempted from registration under [21 U.S.C. 822(d)). Whenever any such form is issued to a person, the Attorney General shall, before delivery thereof, insert therein the name of such person, and it shall be unlawful for any other person (A) to use such form for the purpose of obtaining controlled substances or (B) to furnish such form to any person with intent thereby to procure the distribution of such substances.”  <SU>7</SU> <FTREF/> <FTNT> <SU>4</SU>  21 U.S.C. 802(11). </FTNT> <FTNT> <SU>5</SU>  21 U.S.C. 828(a). </FTNT> <FTNT> <SU>6</SU>  21 U.S.C. 828(c)(2). </FTNT> <FTNT> <SU>7</SU>  21 U.S.C. 828(d)(1). </FTNT> <HD SOURCE="HD1">Implementation of the CSA Written Order Form Requirement</HD> <HD SOURCE="HD1">Paper DEA Form 222</HD> In 1971 DEA implemented the CSA's written order form requirement by publishing a final rule requiring triplicate paper DEA Form 222s. <SU>8</SU> <FTREF/> In 2019, DEA amended its regulations to create a new single-sheet format for the paper DEA Form 222s. <SU>9</SU> <FTREF/> The rule contained transition provisions allowing registrants to continue to use their existing stocks of the triplicate paper DEA Form 222s until October 30, 2021. <SU>10</SU> <FTREF/> <FTNT> <SU>8</SU>   <E T="03">Regulations Implementing the Comprehensive Drug Abuse Prevention and Control Act of</E> 1970, 36 FR 7776, 7797 (Apr. 24, 1971). </FTNT> <FTNT> <SU>9</SU>   <E T="03">New Single-Sheet Format for U.S. Official Order Form for Schedule I and II Controlled Substances (DEA Form 222),</E> 84 FR 5395 (Feb. 21, 2019); <E T="03">New Single-Sheet Format for U.S. Official Order Form for Schedule I and II Controlled Substances (DEA Form 222),</E> 84 FR 51368 (Sept. 30, 2019). </FTNT> <FTNT> <SU>10</SU>  21 CFR 1305.20. </FTNT> <HD SOURCE="HD1">Electronic DEA Form 222</HD> In 2005, DEA published a final rule amending its regulations to provide an electronic equivalent to the DEA Form 222 (also known as CSOS). <SU>11</SU> <FTREF/> The amendments allowed registrants to order schedule I and II controlled substances electronically and maintain records of these orders electronically. The intent of these amendments was to reduce paperwork and transaction times for DEA registrants who sell or buy controlled substances. <FTNT> <SU>11</SU>   <E T="03">Electronic Orders for Controlled Substances,</E> 68 FR 38557 (June 27, 2003), and <E T="03">Electronic Orders for Controlled Substances,</E> 70 FR 16901, (Apr. 1, 2005). </FTNT> <HD SOURCE="HD1">Summary of Current CSOS Regulations</HD> The current CSOS regulations are found in 21 CFR parts 1305 and 1311. DEA Registrants use CSOS as a secure system to track schedule I and II controlled substance orders. The system allows for secure electronic controlled substance orders without the need for a paper order form (DEA Form 222). Using Public Key Infrastructure (PKI), CSOS requires that each individual supplier and purchaser enroll with DEA to acquire a CSOS digital certificate. System enhancements allow electronic documentation submission, self-service support options, and electronic processing of single and bulk applications, renewals, and revocations. Users are able to electronically search for, revoke, report, retrieve, and renew secure digital certificates. <HD SOURCE="HD1">Purpose of Rule</HD> Current regulations require registrants who wish to participate in the CSOS system to enroll using a labor-intensive manual process which relies on paper applications. The paper application must be notarized and the package mailed to DEA, creating delays in the enrollment process and putting applications at risk of being lost. <SU>12</SU> <FTREF/> The purpose of this rule is to simplify the application process by requiring all CSOS enrollment applications to be submitted online. <SU>13</SU> <FTREF/> All applicants for enrollment will follow the CSOS link on the <E T="03">deadiversion.gov</E> website to the CSOS log-in page. From the CSOS log-in page the applicant will be redirected to <E T="03">Login.gov</E> for Identification Verification. Upon arrival at the site, the applicant will be asked to create a <E T="03">Login.gov</E> account by entering a valid email address, selecting a default language, and agreeing to <E T="03">Login.gov</E> 's Rules of Behavior. A confirmation email will then be sent to the applicant's selected email. Once the email has been confirmed, the applicant must create a <E T="03">Login.gov</E> password by providing a telephone number to which a verification code can be sent. Once the code is sent and the applicant enters the given code on the <E T="03">Login.gov</E> website, the applicant must agree to the site's security statement. <E T="03">Login.gov</E> next requires applicants to upload photographs of one or more forms of identification as specified by <E T="03">Login.gov</E> and to enter a Social Security Number, after which the applicant is asked to verify the given information. The applicant is next asked to re-enter their <E T="03">Login.gov</E> password to receive a Personal Key by separate message. The applicant is then asked to enter that Personal Key and review their information. Upon review of the information, the applicant is then directed back to the CSOS website for further processing. Upon return to 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) with enrollment requests approved or rejected by the superior role. 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. <FTNT> <SU>12</SU>  21 CFR part 1311 <E T="03">et seq.</E> </FTNT> <FTNT> <SU>13</SU>  CSOS 2.0 was successfully deployed for public use on December 9, 2024. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 98k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━