Innovations-Magazine-NovDec-2023 - 5

POLICY PERSPECTIVES
maintained for a period of two years from
the date of the transfer by both the pharmacy
transferring the prescription and the pharmacy
receiving and filling the prescription.
In the commentary to the final rule, DEA
also clarified several questions regarding the
partial filling of EPCS. The agency explained
that its regulations currently permit the partial
filling of prescriptions for CS in Schedule
III-V. Existing regulations also permit partial
filling of a prescription for a Schedule II CS
if the pharmacy is unable to supply the full
quantity. In addition, DEA published a final
rule on July 21, 2023, that amended 21 Code
of Federal Regulations §1306.13 to allow
a pharmacist to partially fill a prescription
for a Schedule II CS at the request of the
prescribing practitioner or the patient. At
this time, however, no DEA regulation
permits a partially filled CS prescription
to be transferred from one DEA-registered
pharmacy to another for dispensing of the
remaining portion of the prescription. DEA
confirmed in its commentary that the final
rule does not change this prohibition.
Final Rule: Partial Filling of
Prescriptions for Schedule II CS
As noted above, on July 21, 2023, DEA
issued a final rule in connection with the
Comprehensive Addiction and Recovery Act
of 2016 (CARA). The final rule amends DEA
regulations to conform to CARA and provide
guidance on gaps not addressed by CARA,
such as addressing the details around partial
fill requests by the practitioner or patients
and record-keeping requirements for partial
fill requests for Schedule II CS. The final rule
became effective on August 21, 2023.
Consistent with CARA, the final rule
allows the partial filling of Schedule II
CS when requested by the practitioner or
patient if all following conditions are
fulfilled: the partial filling must not be
prohibited by state law; the prescription
must be written and filled in accordance
with the Controlled Substances Act, DEA
regulations, and state law; and the total
quantity dispensed in partial fillings must
not exceed the total quantity prescribed.
Also aligned with CARA, the final rule
allows for the remaining quantity of a partially
filled prescription for Schedule II CS to be
. . . DEA realized there was
a need to address how a
pharmacy should handle
an EPCS that it receives but
cannot fill.
filled no later than 30 days after the date on
which the prescription is written; or, in the case
where a prescription is issued as an emergency
oral prescription, the remaining quantity must
be filled no later than 72 hours after it was
issued. In the commentary to the final rule,
DEA clarified that when the state has provided
an exception or exemption, it will not consider
a prescription for a Schedule II CS to be invalid
when written in excess of the state limit.
In connection with requests for a partial
fill by a practitioner for Schedule II CS, the
final rule requires that the practitioner specify
the quantity of CS to be dispensed on the
face of the written prescription, in the written
record of the emergency oral prescription, or
in the record of the electronic prescription.
This information must be included on the
prescription at the time it is signed by the
practitioner. In the case of an emergency oral
prescription, this information must be given
when the prescription is being communicated
by the prescribing practitioner to the
pharmacist. The commentary to the final rule
clarifies that a practitioner may make a partial
fill request during subsequent communication
between the pharmacist and practitioner
following the date after the prescription
was issued. The final rule requires that the
pharmacist add the partial fill request to the
prescription by notating on the prescription
" Authorized by Practitioner to Partial Fill. "
The annotation must also include the name
of the practitioner they spoke with, the date
and time of the communication, and the
pharmacist's initials.
A patient may also request that their
Schedule II CS prescription be partially filled.
The final rule does not require an in-person
request but allows a patient to make a request
and specify the quantity to be filled by
alternate means, including a phone call to the
pharmacist. The final rule additionally allows
a caregiver named in an adult patient's medical
power of attorney or a parent/legal guardian
of a patient who is a minor to request that a
prescription be partially filled. In the event
that a practitioner has requested the partial fill
of a prescription, neither the patient, a parent
or legal guardian, or the caregiver may request
a partial filling in an amount greater than
specified by the practitioner.
In connection with recording requirements,
the final rule provides that, for a practitioner's
partial fill request of a Schedule II CS, the
pharmacist must make a notation of the
quantity dispensed on the face of the written
prescription or in the pharmacy's electronic
record. The commentary clarifies that
electronic prescriptions must list the quantity
and date dispensed, and the dispenser must
be linked to the electronic record of the
prescription. Additionally, the commentary
explains that DEA updated the regulations
to allow pharmacists to use the pharmacy's
electronic record-keeping system to fulfill
record-keeping requirements for paper or
emergency oral prescriptions.
The final rule also provides that for a
prescription at the request of a patient,
caregiver of an adult patient, or a parent or legal
guardian of a minor patient, the pharmacist
must notate the following on the face of the
written prescription or in the pharmacy's
electronic records, in the written record or the
pharmacy's electronic records of the emergency
oral prescription, or in the record of the
electronic prescription: " The [patient, parent or
legal guardian of a minor patient, or caregiver
of an adult patient named in a medical power
of attorney] requested partial fill on [date such
request was made] " and the quantity dispensed.
Further, the pharmacy must maintain a
record of dispensing that includes the date of
each dispensing, the name or initials of the
individual who dispensed the substance, and
certain other information.
This article was written by Jonathan Keller,
PharmD, JD, RPh, and Winnie R. McBride, JD,
with Faegre Drinker Biddle & Reath LLP. Please
note, the opinions and views expressed by Faegre
Drinker Biddle & Reath do not necessarily reflect
the official views, opinions, or policies of NABP or
any member board unless expressly stated.
NOV/DEC 2023 | 3
Innovations-Magazine-NovDec-2023

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