On June 14, the Drug Enforcement Administration (DEA) released an updated Practitioner’s Manual, the first new version of the manual since 2006. The Practitioner’s Manual provides guidance for all DEA registrants handling controlled substances—including health systems, hospitals, behavioral health centers, pharmacies and physicians—on compliance with the Controlled Substance Act (CSA) and DEA regulations.

Because the regulatory and medical environments have changed considerably since 2006, the updated manual includes key new pieces of DEA guidance. Some of the major updates address:

  1. Telemedicine. Given the implementation of the Ryan Haight Act and the rapid increase in the use of telemedicine during the COVID-19 pandemic, the manual includes a section on the CSA’s requirements related to the distribution and dispensing of controlled substances through telemedicine. The manual also 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.
  2. 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. Under the CAA, “qualified practitioners” who (1) are licensed under state law to prescribe controlled substances, (2) are not veterinarians, (3) are registered with DEA to dispense, and (4) have completed at least 8 hours of specialized training may now dispense schedule III, IV and V controlled substances for maintenance or detoxification treatment without any need for a waiver or specialized identification numbers.
  3. Form 222. The manual also includes more 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.
  4. Electronic Prescriptions. The increased use of electronic prescriptions by practitioners has also necessitated additional guidance on the requirements for the safe and secure transmission of electronic prescriptions for controlled substances (EPCS).  The manual outlines the various security requirements for EPCS, such as third-party software auditing, two-factor authentication and identity proofing by institutional practitioners.

The Practitioner’s Manual provides frontline practitioners with needed guidance on many of the new challenges they face when prescribing, dispensing and administering controlled substances, and identifies potential areas of scrutiny during DEA onsite inspections, which are on the rise. Although the Practitioner’s Manual is a helpful tool, Bass, Berry & Sims has significant experience advising clients on CSA compliance and enforcement matters and stands ready to help practitioners as they implement this new guidance into their practices.