On November 19, 2021, the Drug Enforcement Administration (“DEA”) issued a Notice of Proposed Rulemaking (“NPRM”) “to allow the transfer of electronic prescriptions for schedule II-V controlled substances between registered retail pharmacies for initial filling on a one-time basis.”
This proposed rule aligns with the regulatory guidance provided by DEA in October 2017, that specifically restricted the transfer of unfilled prescriptions for controlled substances to electronic prescriptions.
DEA is proposing to allow for the transfer of unfilled, electronic prescriptions for controlled substances, on a one-time basis, but will not allow for the transfer of hard copy prescriptions. DEA’s rationale for excluding paper or hard copy prescriptions from this regulation is that paper prescriptions “are inherently portable due to the format of the prescription itself.”
The NPRM proposes the following laundry list of obligations or regulatory requirements imposed on pharmacies wishing to transfer unfilled, electronic prescriptions for controlled substances:
- the patient must request the transfer
- the transfer must be communicated directly between two licensed pharmacists
- the prescription must remain in its electronic form
- the contents of the prescription required by part 1306 must be unaltered during the transmission
- the transfer must be allowed under State law
- the pharmacist transferring the electronic prescription must update the electronic prescription record to note that the prescription was transferred
- the transferring pharmacist must also update the prescription record with the following information: the name, address, and DEA registration number of the pharmacy to which the prescription was transferred; the name of the pharmacist receiving the transfer; the name of the transferring pharmacist; and the date of the transfer
- the pharmacist receiving the transferred electronic prescription must record the transferring pharmacy’s name, address, and DEA registration number, the name of the transferring pharmacist, the date of the transfer, and the name of the pharmacist receiving the transfer
- all records documenting the transfer must be maintained for two years
Comments to the NPRM are due on or before January 18, 2022, or sixty days from the date the NPRM is published in the Federal Register.