Innovations-Magazine-NovDec-2023 - 4

POLICY PERSPECTIVES
DEA Updates: Three New Rules Every Pharmacist Should Know
Jonathan A. Keller,
PharmD, JD, RPh
Faegre Drinker Biddle
& Reath LLP
Winnie R. McBride, JD
Faegre Drinker Biddle
& Reath LLP
In July and August 2023, Drug Enforcement
Administration (DEA) issued three final
rules regarding the regulation of controlled
substances (CS) that have direct impacts
on registrants, especially pharmacies and
pharmacists that dispense CS. Here is a
summary of these rules and a look at notable
commentary by DEA.
Final Rule: Reporting Theft
or Significant Loss of CS
On June 22, 2023, DEA published a final
rule amending the regulations regarding
DEA Form 106, used by DEA registrants
to formally report the discovery of thefts or
significant losses of CS, to require that all
such forms be submitted electronically and
to clarify that registrants have 45 calendar
days (instead of the originally proposed
15-calendar-day time frame) to submit the
necessary documentation. This final rule
became effective on July 24, 2023.
The final rule does not change the
requirement that registrants must still
preliminarily notify the DEA field division
office in their area, in writing, of the theft or
significant loss of any CS within one business
day of discovering such theft or loss. In the
commentary to the final rule, DEA explained
that its two-step reporting requirement, the
initial one-day reporting and the subsequent
DEA Form 106 reporting, allows DEA to
know right away about the theft or loss, to have
an immediate record of the initial incident,
and to promptly institute any actions deemed
appropriate to address the situation.
DEA also used the promulgation of the final
rule as an opportunity to address comments
raised regarding the terms " significant loss "
2 | NOV/DEC 2023
and " discovery, " as used in the rule. DEA
explained that its regulations require registrants
to provide effective controls and procedures to
guard against theft and diversion of CS, but the
regulations do not provide a specific definition
of " significant loss. " Instead, what constitutes
a significant loss for one registrant may be
construed as comparatively insignificant for
another. Thus, the distinction between a
significant loss and a normal loss is case and
circumstance specific, and DEA believes
registrants are best positioned to determine
whether a loss rises to the level of a significant
loss that requires reporting. Consequently,
DEA declined to define the term " significant
loss " in the final rule.
DEA also acknowledged that there is some
confusion as to when the " discovery " of the
significant loss or theft occurs and recognized
that the discovery may occur in incremental
stages. DEA noted that it plans to address
the definition of " discovery " in a future
rulemaking and thus will not be providing
any additional clarification regarding how
or when a registrant is to determine when a
discovery of a significant loss or theft occurs.
Final Rule: Transfer of Schedule II-V
EPCS Between Pharmacies for
Initial Filling
Recognizing that more practitioners are
issuing CS prescriptions electronically, DEA
realized there was a need to address how
a pharmacy should handle an electronic
prescription for controlled substances
(EPCS) that it receives but cannot fill.
On July 27, 2023, DEA issued a final
rule amending its regulations to allow, upon
request from the patient, the transfer of
Schedule II-V EPCS between registered retail
pharmacies for initial filling on a one-time
basis. The final rule also clarified that any
authorized refills included on an EPCS for
a Schedule III, IV, or V CS are transferred
with the original prescription.
It should be noted that current DEA
regulations (issued prior to this final rule)
already permit the transfer of CS prescription
refills for Schedules III, IV, and V CS on
a one-time basis, if allowed under existing
state or other applicable law. The final rule
is not meant to change or address any of the
existing requirements for transferring EPCS
for refill dispensing. This final rule became
effective on August 28, 2023.
The final rule established the specific
procedure and requirements that must be
met when EPCS are transferred between
pharmacies for initial dispensing. The
requirements are that the transfer must
be communicated between two licensed
pharmacists; the prescription must be
transferred in its electronic form and may
not be converted to another form (eg, paper,
facsimile) for the transmission; and the
prescription information contained
on the EPCS cannot be changed during
the transmission.
In addition, the final rule described the
documentation requirements for pharmacies
transferring EPCS for initial filling. A
pharmacist transferring an EPCS 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. Similarly, the pharmacist
receiving the transferred 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.
In lieu of manual data entry by the
pharmacist, the transferring or receiving
pharmacy's prescription processing software
may, if capable, capture the aforementioned
required information from the electronic
prescription and automatically populate the
corresponding data fields to document the
transfer. However, the transferring or receiving
pharmacist, as applicable, must ensure that
the populated information is complete and
accurate. The final rule requires the electronic
records documenting EPCS transfers to be
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