DEA Federal Register Notice

Federal Register Notice

DEA is pleased to announce the July 27, 2023 final rule, Transfer of Electronic Prescriptions for Schedules II-V Controlled Substances between Pharmacies for Initial Filling, which was developed to provide clarity on existing Federal regulatory requirements, as well as to facilitate the proper dispensing of electronic prescriptions for controlled substances. This final rule, effective on August 28, 2023, amends DEA regulations to allow the transfer of electronic prescriptions for schedules II-V controlled substances between registered retail pharmacies for initial filling, upon request from the patient, on a one-time basis. The final rule requires that the transfer must be communicated directly between two licensed pharmacists, the prescription must remain in its electronic form, and the prescription information required by 21 CFR part 1306 must not be altered during the transmission. The final rule also stipulates that the transfer of electronic prescriptions for controlled substances (EPCS) for initial filling is permissible only if allowable under existing State or other applicable law.

In addition, the final rule describes the recordkeeping requirements for pharmacies transferring EPCS for initial filling, as well as pharmacies receiving and filling such prescriptions. The final rule only addresses the transfer of EPCS for initial filling and does not address the transfer of EPCS for refill dispensing, which is outlined in 21 CFR 1306.25.

Further, the final rule does not change the existing requirements for all prescriptions, as outlined in 21 CFR part 1306, nor the requirements for electronic prescription and pharmacy applications, as outlined in 21 CFR part 1311.
We hope this information is helpful.

If you have any questions pertaining to this rule, please contact

Scott A Brinks, Regulatory Drafting and Policy Support Section, Diversion Control Division, Drug Enforcement Administration; Telephone: (571) 776-3882; Email: [email protected].
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