The Drug Enforcement Administration (DEA) recently released an updated Practitioner’s Manual on June 14, 2023. This is the first updated version of the manual since 2006. The Practitioner’s Manual provides guidance for all DEA registrants handling controlled substances—including behavioral health centers and physicians—on compliance with the Controlled Substance Act (CSA) and DEA regulations. The Practitioner’s Manual can be found here.
Some of the most significant updates include the following:
Registration Requirements
Generally, every practitioner who dispenses, which includes by definition administering and prescribing, controlled substances in schedules II through V, must be registered with DEA. To register or reregister as a practitioner, a DEA Form 224 or Form 224a, respectively, must be completed. The manual includes clarifying information about how practitioners can order, use, fill out, copy, store, cancel, and return the DEA Form 222 used to order, distribute and transfer Schedule I and II controlled substances. The manual also incorporates the optional Controlled Substance Ordering System (CSOS) as a viable alternative to the paper Form 222.
Telemedicine
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (hereafter referred to as the “Ryan Haight Act” or the “Act”) amended the CSA by adding several new provisions to prevent the illegal distribution and dispensing of controlled substances by means of the internet. Until the Ryan Haight Act, the CSA did not address telemedicine. The manual describes the exceptions DEA has recognized to the Ryan Haight Act’s requirement for at least one in-person medical evaluation before prescribing or dispensing controlled substances via the internet.
2023 Changes to CSA
The manual incorporates the Consolidated Appropriations Act (CAA) of 2023’s changes to the CSA, including the emphasis on expanded access to medications for opioid use disorder and the elimination of the “DATA-Waiver” that was previously required for practitioners to dispense schedule III, IV, and V controlled substances for maintenance or detoxification treatment. The CAA defines the term “qualified practitioner” as a practitioner who (i) is licensed under state law to prescribe controlled substances; and (ii) is not solely veterinarian. 21 U.S.C.823(l)(4)(B). Additionally, qualified practitioners are registered with DEA to dispense controlled substances, and are qualified through not less than eight (8) hours of specialized training and/or certification to dispense, including prescribing narcotics in schedule III-V, or a combination of such drugs, approved by the FDA specifically for use in narcotic maintenance or detoxification treatment.
Electronic Prescriptions
DEA regulations give practitioners the option to write prescriptions for controlled substances electronically and permit pharmacies to receive, dispense, and archive electronic prescriptions The manual outlines the various security requirements for electronic prescriptions for controlled substances, such as third-party software auditing, two-factor authentication and identity proofing by institutional practitioners.
Although the Practitioner’s Manual is a helpful tool, Hamill Little has significant experience advising clients on controlled substance compliance and enforcement matters and is available to assist practitioners as they implement this new guidance into their practices.
If you have questions regarding this blog post or would like to speak with counsel regarding your prescription practices, you may contact us at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.
*Disclaimer: Thoughts shared here do not constitute legal advice.