[Federal Register Volume 88, Number 143 (Thursday, July 27, 2023)]
[Rules and Regulations]
[Pages 48365-48380]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-15847]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1306
[Docket No. DEA-637]
RIN 1117-AB64
Transfer of Electronic Prescriptions for Schedules II-V
Controlled Substances Between Pharmacies for Initial Filling
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
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SUMMARY: The Drug Enforcement Administration (DEA) is amending its
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. This amendment specifies the procedure that must be
followed and the information that must be documented when transferring
such electronic controlled substance prescriptions between DEA-
registered retail pharmacies.
DATES: This rule is effective August 28, 2023.
FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting
and Policy Support Section, Diversion Control Division, Drug
Enforcement Administration; Mailing Address: 8701 Morrissette Drive,
Springfield, Virginia 22152; Telephone: (571) 776-3882.
SUPPLEMENTARY INFORMATION:
Executive Summary
On November 19, 2021, the Drug Enforcement Administration (DEA)
published a notice of proposed rulemaking (NPRM) proposing to permit
the transfer of electronic prescriptions for controlled substances
(EPCS) in schedules II-V between registered retail pharmacies for
initial filling on a one-time basis only.\1\ In this rulemaking, DEA is
finalizing the regulatory text proposed in the NPRM with modifications
to address concerns brought forth by commenters.
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\1\ 86 FR 64881.
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The final rule amends DEA regulations to explicitly state that an
electronic prescription for a controlled substance in schedule II-V may
be transferred between retail pharmacies for initial filling on a one-
time basis only, upon request from the patient, and clarifies that any
authorized refills included on a prescription for a schedule III, IV,
or V controlled substance are transferred with the original
prescription. 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 contents of
the prescription required by 21 CFR part 1306 must be unaltered during
the transmission. The final rule also stipulates that the transfer of
EPCS for initial dispensing is permissible only if allowable under
existing State or other applicable law.
In addition, the final rule describes the information that must be
recorded to document transfer of EPCS between pharmacies for initial
dispensing. It also clarifies that, in lieu of manual data entry, the
transferring and/or receiving pharmacy's prescription processing
software may, if capable, capture the required information from the
electronic prescription and automatically populate the corresponding
data fields to document the transfer. The transferring and/or receiving
pharmacist, as applicable, must ensure that the populated information
is complete and accurate. The electronic records documenting EPCS
transfers must be maintained by both pharmacies for two years from the
date of the transfer. The existing requirements for all prescriptions,
as outlined in 21 CFR part 1306, Prescriptions, and the requirements
for prescribing and pharmacy applications, as outlined in 21 CFR part
1311, Requirements for Electronic Orders and Prescriptions, remain
unchanged in this final rule.
[[Page 48366]]
Legal Authority
The Controlled Substances Act (CSA) grants the Attorney General the
authority to promulgate and enforce any rules, regulations, and
procedures that he may deem necessary and appropriate for the efficient
executions of his functions under subchapter I (Control and
Enforcement) of the CSA.\2\ The Attorney General has delegated this
authority to the Administrator of the DEA.\3\
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\2\ 21 U.S.C. 871(b).
\3\ 28 CFR 0.100(b).
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Purpose
DEA is revising its regulations to state that, upon request from
the patient, a registered retail pharmacy may transfer an electronic
controlled substance prescription in schedules II-V to another
registered retail pharmacy for initial filling. This final rule
specifies the procedures that retail pharmacies must follow and the
information that must be documented when transferring EPCS. DEA
believes that allowing the electronic transfer of controlled substance
prescriptions will decrease the potential for duplicate prescriptions
and thus reduce the opportunity for diversion or misuse.
Background
The CSA and its implementing regulations specify the requirements
for issuing and filling prescriptions for controlled substances. DEA
regulations permit a pharmacist to dispense a controlled substance
prescription in schedule II only pursuant to a written prescription
(including an electronic prescription), except in limited emergency
situations, when dispensing pursuant to an oral prescription is
permitted.\4\ No prescription for a controlled substance in schedule II
may be refilled.\5\ DEA regulations permit a pharmacist to dispense a
controlled substance in schedules III, IV, and V pursuant to a signed
paper prescription, a facsimile of a signed paper prescription, an
electronic prescription, or an oral prescription made by an individual
practitioner and promptly reduced to writing by the pharmacist.\6\
Prescriptions for controlled substances in schedules III and IV may not
be filled or refilled more than six months after the date of issuance
or be refilled more than five times.\7\
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\4\ 21 CFR 1306.11(a) and (d).
\5\ 21 U.S.C. 829(a) and 21 CFR 1306.12(a).
\6\ 21 CFR 1306.21(a).
\7\ 21 CFR 1306.22(a).
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The CSA does not address the transfer of paper or electronic
prescriptions for controlled substances in any schedule between
pharmacies for initial filling. DEA regulations address the transfer of
controlled substance prescriptions (schedules III-V) between pharmacies
for refill dispensing, but not for initial dispensing.\8\
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\8\ 21 CFR 1306.25.
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Unlike paper prescriptions which are issued directly to the
patient, electronic prescriptions are transmitted directly from the
practitioner to the pharmacy in the form of an electronic data file.\9\
If a paper prescription is presented at a pharmacy that is unable to
fill it, the paper prescription could be returned to the patient, and
the patient could then take the prescription to another pharmacy.
However, because the pharmacy receives an electronic prescription as an
electronic data file and not a physical paper prescription, it cannot
give the prescription to the patient to take to another pharmacy. In
this scenario, the pharmacy can only inform the patient that the
prescription cannot be filled. The patient could then call the
prescribing practitioner to request that a new prescription be sent to
a different pharmacy.
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\9\ An electronic prescription is defined as ``a prescription
generated on an electronic application and transmitted as an
electronic data file.'' 21 CFR 1300.03.
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DEA realizes that this scenario creates the potential for
duplication of prescriptions, if the practitioner transmits a new
prescription to a different pharmacy and does not cancel or void the
original prescription that was sent to the first pharmacy. It also
recognizes that this scenario creates additional burden for patients,
who have to get back in touch with the prescribing practitioner to
request a new prescription. As more practitioners are issuing
controlled substance prescriptions electronically (as discussed below),
there is an increasing need to address how a pharmacy should handle an
electronic controlled substance prescription that it receives but
cannot fill.
DEA's March 2010 interim final rule (IFR), Electronic Prescriptions
for Controlled Substances, provides practitioners with the option of
issuing, and pharmacies with the option of receiving, dispensing, and
archiving EPCS in schedules II-V.\10\ In a request for information
(RFI) published in August 2020, the Centers for Medicare and Medicaid
Services (CMS) reported that it has seen a steady increase in the
volume of controlled substance prescriptions submitted electronically
since DEA published the EPCS IFR.\11\ Additionally, the Substance Use-
Disorder Prevention that Promotes Opioid Recovery and Treatment for
Patients and Communities Act (``SUPPORT Act'') mandates electronic
prescribing of schedules II-V controlled substances (with some
exceptions) covered under Medicare Part D, beginning January 1,
2021.\12\ Further, Surescripts, a health information network and
electronic prescribing intermediary, stated in its 2021 National
Progress Report that as of January 2022, 35 States require, or will
soon require, electronic prescribing of opioids, all controlled
substances, or all prescriptions.\13\ In the same report, Surescripts
also reported that the rate of electronic prescribing of controlled
substances increased from 38 percent in 2019 to 58 percent in 2020 and
to 73 percent in 2021. Thus, procedures for transferring EPCS between
pharmacies for initial dispensing are needed urgently. In this final
rule, DEA is amending its regulations to allow, upon request of the
patient, the transfer of electronic prescriptions for schedules II-V
controlled substances between registered retail pharmacies for initial
filling on a one-time basis.
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\10\ 75 FR 16236 (Mar. 31, 2010). DEA subsequently reopened the
comment period in 2020 to solicit public comment on certain issues.
85 FR 22018 (Apr. 21, 2020).
\11\ Medicare Program: Electronic Prescribing of Controlled
Substances; RFI, 85 FR 47151 (August 4, 2020).
\12\ Public Law 115-271, sec. 2003(a)(b) (Oct. 24, 2018). This
requirement is codified at 42 U.S.C. 1395w-104(e)(7).
\13\ Surescripts, National Progress Report 2021 (https://surescripts.com/docs/default-source/national-progress-reports/2021-national-progress-report.pdf?sfvrsn=71fcbe15_12) (accessed June 2,
2022).
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Summary of the Notice of Proposed Rulemaking
DEA published a notice of proposed rulemaking (NPRM) in the Federal
Register on November 19, 2021.\14\ The NPRM proposed to permit the
transfer of EPCS in schedules II-V between registered retail pharmacies
for initial filling on a one-time basis only. The NPRM also proposed
the procedures that would need to be followed and the information to be
documented when transferring EPCS for initial filling. The proposed
rule focused only on the transfer of EPCS for initial dispensing. The
NPRM did not propose changes to 21 CFR 1306.25, which permits the
transfer of paper, oral, or electronic prescriptions in schedules III,
IV, and V for refill dispensing, or the existing requirements for
prescriptions (paper or electronic) in 21 CFR part 1306, Prescriptions,
and 21 CFR part 1311, Requirements for Electronic Orders and
Prescriptions. DEA invited comments
[[Page 48367]]
from the public to be submitted on or before January 18, 2022.
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\14\ 86 FR 64881.
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Discussion of Public Comments
DEA received 183 comments in response to the NPRM.\15\ The
commenters included practitioner and professional organizations,
pharmacy organizations, pharmacists' associations, State boards of
pharmacy, a home delivery pharmacy, a health service organization, a
health system, a health information technology developer, a standards
developer, and members of the general public. DEA thanks all commenters
for their input during the rulemaking process.
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\15\ A total of 183 comments were received; however, five
commenters submitted duplicate comments.
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The majority of commenters expressed support for the rule. In fact,
89 comments were general statements of support, with no discussion of
the proposed regulatory changes. Thirty-seven commenters shared
personal accounts of occasions when they or a family member had an
electronic prescription sent to the wrong pharmacy or a pharmacy that
could not fill the prescription. While most commenters supported the
rule in its entirety, some supported the rule's general purpose but
were opposed to certain provisions and proposed changes to those
particular provisions. Other commenters raised issues of concern,
without proposing changes, or sought clarification. Only one commenter
opposed the entire rule. Five comments were outside the scope of the
rule. These comments, along with DEA's responses, are discussed below.
Patients' Consent for EPCS Transfers
Comments. Two commenters expressed concern that the proposed rule
appears to allow the pharmacy to decide when and where a prescription
is transferred instead of the patient. One commenter stated that
patients should be allowed to request transfers of their prescriptions.
Another commenter stated that the rule should require the transferring
pharmacy to do the following: (1) Inform the patient of the need to
transfer the prescription and the name and location of the pharmacy
where the prescription will be transferred, and (2) obtain and document
the patient's consent to transfer the prescription to the specified
pharmacy location.
DEA Response. To prevent treatment delays, reduce patient burden,
and minimize opportunities for diversion, DEA is allowing the transfer
of EPCS between pharmacies for initial filling upon the patients'
request. If a patient is notified by a pharmacy that the pharmacy is
unable to fill an EPCS, the patient may ask to have the prescription
transferred to another pharmacy, chosen by the patient, that is able to
fill the prescription. For additional clarity, DEA is adding ``upon
request from the patient'' to 21 CFR 1306.08(e) in this final rule.
However, DEA believes requiring a pharmacy to obtain and document a
patient's consent to transfer a prescription would be unnecessarily
burdensome.
Initial Dispensing Only
Comments. Two commenters expressed concern that the NPRM proposed
allowing the transfer of EPCS between pharmacies for initial dispensing
only, and did not address the transfer of EPCS for refill dispensing.
DEA Response. DEA currently permits the transfer of prescription
information for refill dispensing of prescriptions for schedule III,
IV, and V controlled substances on a one-time basis, if allowed under
existing State or other applicable law.\16\ DEA notes that
prescriptions for controlled substances in schedule II may not be
refilled. The existing requirements for transferring EPCS for refill
dispensing remain unchanged by this final rule.
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\16\ See 21 CFR 1306.25.
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EPCS Transferred as Electronic Data Files
Comments. Seventeen commenters mentioned the proposed provision in
21 CFR 1306.08(f)(1), which requires that the prescription be
transferred from one pharmacy to another pharmacy in its electronic
form. Two commenters supported this provision; one stated that they
would no longer support the rule if this provision is removed. Eleven
commenters expressed concern that most pharmacies' applications and
prescription management software do not have the technology needed to
transfer prescriptions electronically. Two commenters noted that
pharmacies within the same chain may be able to transfer controlled
substance prescriptions electronically because they share a common
database but independent community pharmacies are not integrated in
this way. Thus, one commenter stated that independent pharmacies would
be disproportionately burdened by the rule, and the other commenter
stated that the rule appears to be written in favor of keeping a
prescription within a chain pharmacy network. One commenter noted that
although this functionality became available when the National Council
for Prescription Drug Programs (NCPDP) released the SCRIPT Standard
Version 2017071, the technology standard that facilitates electronic
prescribing, many pharmacy vendors have not implemented the
functionality. However, another commenter stated that the SCRIPT
Standard Version 2017071 does not facilitate the electronic transfer of
controlled substance prescription information at this time and noted
that an updated version of the standard that would facilitate this
transfer has been approved by NCPDP. The commenter also stated that
implementation of the updated version of the standard will likely be a
multi-year process. NCPDP confirmed in its comment that the recently
approved changes to the standard include support for the one-time
transfer of EPCS between pharmacies.
Two commenters stated that DEA should allow the electronic transfer
of controlled substance prescriptions for initial filling as one
option, but should not mandate electronic transfer as the only option
for transferring EPCS. Six commenters suggested that the final rule
should allow the transfer of EPCS between pharmacies through
pharmacist-to-pharmacist communication by phone or via facsimile. One
commenter, noting that pharmacists have been transferring prescriptions
successfully for a long time, stated that pharmacists should be trusted
and allowed to transfer EPCS by oral communication between the two
pharmacists, or by transmitting via facsimile a printed copy of the
prescription, annotated with all the required documentation to indicate
that the prescription was transferred.
DEA Response. DEA disagrees with the commenter's suggestion that
the rule is written in favor of keeping a prescription within a chain
pharmacy network and does not believe independent pharmacies will be
disproportionately burdened by this rule. DEA has always required,
since it began allowing controlled substances to be prescribed
electronically, that all records related to such prescriptions must be
retained electronically.\17\ The final rule permits the transfer of
EPCS between pharmacies for initial filling upon request from the
patient.\18\ Thus, the patient decides if, and to which pharmacy, a
prescription is transferred. In addition, NCPDP confirmed in its
comment that the new SCRIPT Standard Version 2017071, which is
available to both independent and chain
[[Page 48368]]
pharmacies, enables the transfer of prescriptions between pharmacies.
DEA acknowledges that some pharmacies may need to coordinate with their
pharmacy technology vendors to have certain SCRIPT transactions,
including the transaction used to transfer prescriptions between
pharmacies, incorporated into their pharmacy applications. The cost
associated with this incorporation, if any, is not set by DEA and is
beyond the scope of DEA's authority. Further, in 2018, CMS adopted
SCRIPT 2017071 as the official electronic prescribing standard for
prescriptions covered under Medicare Part D.\19\ Consequently,
pharmacies that wish to transfer EPCS covered under a Medicare Part D
drug plan are already required to have and use the SCRIPT 2017071
transaction that facilitates the transfer of prescriptions between
pharmacies.\20\ Hence, the final rule continues to require that once a
controlled substance prescription is created electronically, it must
remain in its electronic format and all records related to the
prescription must be retained electronically.
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\17\ See 75 FR 16235 at 16243 and 21 CFR 1311.305(a).
\18\ New 21 CFR 1306.08(e).
\19\ Medicare Program; Contract Year 2019 Policy and Technical
Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-
For-Service, the Medicare Prescription Drug Benefit Programs, and
the PACE Program, 83 FR 16440 (April 16, 2018).
\20\ 42 CFR 423.160(b)(2)(iv).
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Transfer of EPCS for Initial Filling on a One-Time Basis Only
Comments. Six commenters mentioned the provision that permits the
transfer of EPCS between pharmacies for initial dispensing on a ``one-
time basis only.'' Two commenters opposed the one-time only limitation.
The commenters stated that DEA should at a minimum, allow pharmacies
that share a real-time online database, if not all pharmacies, to
transfer EPCS for initial dispensing more than once, if needed. One of
the commenters also noted that DEA permits pharmacies that share a
real-time, online database to transfer prescriptions for schedule III-V
controlled substances for refill dispensing up to the maximum number of
refills permitted by law and the prescriber's authorization. Four
commenters asked DEA to clarify the applicability of the one-time only
limitation in specific scenarios. For example, two commenters noted
that a prescription could be transferred from one pharmacy that cannot
fill it to another pharmacy that is also unable to fill the
prescription. One of the commenters stated that as written, the rule
would not allow the prescription to be transferred again and thus the
patient would be burdened with having to contact the prescribing
practitioner to request a new prescription, which is the specific
scenario the rule seeks to prevent. Two commenters asked about the
transfer of EPCS issued with authorized refills. The commenters asked
whether the refills would be transferred with the prescription or
remain at the pharmacy that received the prescription from the
prescribing practitioner. Another commenter asked if the one-time only
transfer allowed for initial dispensing is in addition to the transfer
allowed for refill dispensing under 21 CFR 1306.25. One commenter asked
if the one-time only limit prohibits the transfer of subsequent
controlled substance prescriptions issued to the same pharmacy that
transferred the previous prescription to an alternate pharmacy for
initial dispensing.
DEA Response. DEA believes the one-time transfer allowance is
sufficient to accommodate most situations in which a transfer would be
needed for initial dispensing. In an article discussing the adoption of
the SCRIPT Standard Version 2017071, Surescripts notes that the
receiving pharmacy has to initiate the prescription transfer, when a
transfer is requested.\21\ In the interest of patient care, as well as
good business practice, DEA believes a pharmacy would not request the
transfer of a prescription that it cannot fill. As such, the scenario
described by the commenters in which a prescription is transferred from
one pharmacy to another pharmacy that is also unable to fill the
prescription should occur rarely, if ever. Nonetheless, DEA recommends
that the patient confirms the ability of the receiving pharmacy to fill
the prescription before requesting the transfer.
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\21\ Swartz, L. and Whittemore, K. A giant leap: The industry
adopts a new version of the national e-prescribing standard.
November 2019. https://surescripts.com/docs/default-source/intelligence-in-action/ncpa-surescripts_script_2017071_pharmacist_ce_article_11-2019.pdf
(accessed April 14, 2023).
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DEA wishes to clarify that the one-time basis stipulation for
transferring EPCS for initial filling is per prescription. In other
words, each prescription transmitted from a practitioner to a retail
pharmacy may be transferred one time, upon request from the patient,
regardless of whether any previous EPCS were transferred. If the
prescription being transferred includes authorized refills, the refills
are transferred with the prescription to the pharmacy receiving the
transfer. This final rule adds additional text to 21 CFR 1306.08(e) to
provide this clarification. As proposed in the NPRM, this final rule
permits the transfer of EPCS between pharmacies for initial dispensing
on a one-time basis only. This is consistent with the current
regulations at 21 CFR 1306.25 for the transfer of prescription
information between pharmacies for refill dispensing of schedule III-V
EPCS on a one-time basis only.\22\ DEA notes that 21 CFR 1306.25
remains unchanged by this final rule.
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\22\ 21 CFR 1306.25(a).
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Comments. One commenter asked that DEA clarify in the final rule
that a pharmacy that receives transfers of EPCS will not be held
responsible for filling a transferred prescription that may have been
transferred multiple times.
DEA Response. Pharmacists continue to have a corresponding
responsibility to ensure they are filling valid controlled substance
prescriptions; nothing in DEA's regulations on EPCS alters a pharmacy's
responsibilities to ensure the validity of a controlled substance
prescription.\23\ Therefore, DEA does not believe any further
clarifications are needed in this final rule.
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\23\ 21 CFR 1306.04(a) and 1311.100(f).
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Transfers Communicated Between Two Licensed Pharmacists
Comments. One commenter suggested that DEA allow the transfer of
EPCS to be communicated between pharmacy personnel (e.g., pharmacy
technicians, pharmacist interns, etc.), as permitted by State laws,
instead of requiring the communication to be between two licensed
pharmacists.
DEA Response. Existing DEA regulations ``. . . include any other
person (e.g., pharmacist intern) authorized by a State to dispense
controlled substances under the supervision of a pharmacist licensed by
such State'' in the definition of a pharmacist.\24\ As such, DEA does
not believe any further clarification is needed, as the existing
regulations include the allowance requested by the commenter. However,
DEA emphasizes that a pharmacist continues to have a corresponding
responsibility to fill only those prescriptions that conform in all
respects with the requirements of DEA regulations.\25\
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\24\ 21 CFR 1300.01(b).
\25\ 21 CFR 1306.04(a).
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Pharmacy Software that Automatically Populates Prescription Data
Comments. Five commenters asked that DEA allow the transferring and
receiving pharmacies' prescription processing software, if capable, to
[[Page 48369]]
capture the required information from the electronic prescription and
automatically populate the corresponding data fields to document
prescription transfers on behalf of the pharmacists.
DEA Response. In light of the comments received on this issue, DEA
is revising this final rule to permit a transferring or receiving
pharmacy's prescription processing software, if capable, to capture the
information required from the electronic prescription and automatically
populate the corresponding data fields to document the transfer of
prescriptions between pharmacies. However, the transferring or
receiving pharmacist must ensure that the populated information is
complete and accurate. This provision is added in a new paragraph
(f)(6) in 21 CFR 1306.08.
Schedule II Controlled Substances Prescriptions
Comments. One commenter stated that, when a practitioner issues
multiple prescriptions for schedule II controlled substances pursuant
to 21 CFR 1306.12, the rule should allow one or all of those
prescriptions to be transferred for initial dispensing, if requested by
the patient.
DEA Response. Although issued at the same time, each prescription
for schedule II controlled substances issued pursuant to 21 CFR 1306.12
is a separate prescription. Therefore, if issued electronically, any of
these prescriptions may be transferred between pharmacies on a one-time
basis for initial dispensing under the conditions set forth in this
final rule.
Partial Fills
Comments. Two commenters noted that the proposed rule does not
address partial fills of EPCS. The commenters requested clarification
regarding the ability of a pharmacy to partially fill a controlled
substance prescription and then transfer the remainder to another
pharmacy for dispensing of the remaining portion. One of the commenters
specifically asked about partial filling of schedule II controlled
substance prescriptions while the other commenter asked about all
controlled substance prescriptions.
DEA Response. Current DEA regulations permit partial filling of
prescriptions for controlled substances in schedules III-V.\26\
Existing regulations also permit partial filling of a prescription for
a schedule II controlled substance if the pharmacy is unable to supply
the full quantity.\27\ In this case, the remaining portion of the
prescription may be filled within 72 hours of the first partial
filling; no additional quantity may be supplied after the 72-hour
period without a new prescription.\28\ In addition, DEA published a
final rule \29\ on July 21, 2023, which amends 21 CFR 1306.13 to allow
a pharmacist to partially fill a prescription for a schedule II
controlled substance at the request of the prescribing practitioner or
the patient, if permissible under State law.\30\ This rule becomes
effective on August 21, 2023.
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\26\ 21 CFR 1306.23.
\27\ 21 CFR 1306.13.
\28\ 21 CFR 1306.13(a).
\29\ Partial Filling of Prescriptions for Schedule II Controlled
Substances, 88 FR 46983 (July 21, 2023).
\30\ 21 CFR 1306.13(b).
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Regarding the transfer of prescriptions for controlled substances,
existing regulations permit the transfer of schedules III-V controlled
substance prescriptions for refill dispensing only.\31\ Further, under
this final rule, the regulations will permit the transfer of EPCS in
schedules II-V between DEA-registered retail pharmacies for initial
dispensing upon request from the patient. At this time, however, no DEA
regulation permits a partially-filled controlled substance prescription
to be transferred from one DEA-registered pharmacy to another for
dispensing of the remaining portion of the prescription. DEA did not
propose any revisions related to the partial filling of controlled
substances prescriptions in the proposed rule; thus, such a change
would be outside the scope of this final rule. Nonetheless, DEA
believes these regulations provide adequate options for patients to
obtain their medication without significant treatment disruptions or
delays when pharmacies are unable to fill controlled substances
prescriptions received electronically. DEA does not believe further
revisions to these regulations are warranted at this time.
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\31\ 21 CFR 1306.25.
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Economic Impact Analysis
Comments. Four commenters mentioned the economic impact analysis
that was included in the NPRM. One commenter, while supporting the
proposed rule, stated that the analysis focused only on monetary
benefits and did not include unquantifiable benefits such as the
reduced stress and improved productivity patients will experience as a
result of the rule. A practitioner organization agreed with DEA's
conclusion that the rule will result in net cost savings overall.
However, the commenter noted that the analysis assumed that a
practitioner's administrative staff would handle calls from patients
requesting new prescriptions, but some practitioners do not employ
administrative staff and must handle the calls themselves. Thus, the
commenter stated that the actual net cost savings of the rule will be
higher than DEA's estimate.
One pharmacists' association supports DEA's proposal to allow the
transfer of EPCS between pharmacies for initial filling from a patient
care perspective, but expressed concern about the economic impact of
the proposed rule on pharmacies. The association noted that although
DEA estimates the rule will result in overall health system cost
savings of $22 million annually, pharmacies will actually incur
significant costs of $91,625,000 annually, as estimated by DEA.\32\ The
association also noted that while DEA acknowledges that pharmacies will
incur additional expenses, including modifying software configurations,
updating business processes, and training personnel, these costs were
not included in DEA's analysis. Another commenter agreed that the
analysis did not include costs for software upgrades and further noted
that the analysis underestimated the time required to process
prescription transfers. The commenter stated that processing a
prescription transfer can take 15 minutes or more, depending on how
busy the pharmacies are at the time of the request. Moreover, the
commenter stated that the economic impact analysis did not include
additional time and expenses incurred by patients who may need to
travel farther to pick up medication from the pharmacy receiving the
transfer.
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\32\ The analysis has been updated since the NPRM using the most
recent data available. The updated estimated overall health system
cost savings is $29 million and the cost to pharmacies is
$50,005,000. See the Executive Order 12866 and Regulatory
Flexibility Act sections below under Regulatory Analyses for the
detailed analysis.
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DEA Response. DEA agrees that, in addition to saving time, as
indicated in the analysis below, this rule is likely to benefit
patients in many other ways, including reducing stress, as noted by the
commenter. In addition to minimizing opportunities for diversion, DEA's
chief reasons for this rulemaking are to provide patients with the
option of transferring EPCS for initial filling to prevent treatment
delays and reduce patient burden. However, this final rule does not
require a patient to request a transfer. DEA emphasizes that the
patient decides if, and to which pharmacy, a prescription is
transferred. Thus, this rule does not impose any additional travel
burden on patients.
[[Page 48370]]
DEA also agrees the cost savings per transfer would be higher for
prescribing practitioners who do not have administrative staff and
would have to handle calls from patients requesting new prescriptions
themselves under current regulations. According to Surescripts' ``2021
National Progress Report,'' the rate of electronic prescribing of
controlled substances was 73 percent in 2021.\33\ DEA believes it is
reasonable to assume that, on average, EPCS utilization will skew
toward practitioners with larger infrastructure and administrative
staff, while recognizing that there are some small and independent
offices without administrative staff that may experience greater cost
savings than estimated. This is because, under this final rule, the
prescribing practitioners at those small and independent offices
(versus administrative staff at larger practices), would no longer have
to handle calls from patients requesting new prescriptions be sent to
alternate pharmacies for initial dispensing.
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\33\ The numbers have been updated since the NPRM with 2021
data. See the Executive Order 12866 section below under Regulatory
Analyses for the detailed analysis.
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In regards to the estimated additional costs that pharmacies will
incur, DEA notes that, although the rule allows EPCS to be transferred
at the request of a patient, it does not require a pharmacy to transfer
EPCS if it is unable to do so (e.g., due to system limitations). In the
economic analysis, DEA estimated that there will be additional costs to
the transferring and receiving pharmacies. However, a pharmacy is
expected to participate in transfers of EPCS based on its own analysis
of benefits and costs. While only costs were quantified, benefits to
pharmacies may include customer retention, increased customer traffic,
increased customer loyalty, good will, etc., leading to increased sales
over time. DEA estimates each transfer of EPCS will cost $2.92 and
$4.38 for the transferring and receiving pharmacies, respectively.\34\
Since pharmacies are likely to transfer and receive, an average was
taken to determine the typical cost per EPCS transfer for a pharmacy.
The average cost is $3.65 per transfer.\35\ Applying this total to the
estimated maximum number of transfers of 13.7 million per year results
in a maximum total net cost, to all pharmacies combined, of $50,005,000
annually.\36\ As noted above, this $50 million estimate does not
reflect the costs that are mandated by this rule, as this rule by its
terms does not require pharmacies either to transfer EPCS or receive
EPCS, but it does reflect the estimated cost of doing business for
pharmacies that choose to transfer EPCS or receive EPCS under this
rule.
---------------------------------------------------------------------------
\34\ Id.
\35\ The numbers have been updated since the NPRM with 2021
data. See the Regulatory Flexibility Act section below under
Regulatory Analyses for the detailed analysis.
\36\ Id.
---------------------------------------------------------------------------
In the Regulatory Flexibility Act analysis below, DEA compared the
estimated cost of this rule to the annual revenues of the smallest of
small pharmacy firms, those with less than $100,000 in annual revenue.
The estimated cost of this rule is $9 annually for the 666 smallest of
small pharmacies.\37\ The average cost per firm of $9 equates to
0.01745 percent of average receipt per firm of $51,565.\38\ DEA
anticipates this rule will not have a significant economic impact for
the smallest of small pharmacies; and therefore, this rule will also
not have a significant economic impact for larger pharmacies.
Additionally, as noted in the analysis, DEA expects minor system and
implementation expenses, which consist of modifying software
configurations, updating business processes, and minimal personnel
training. DEA estimates the cost of these changes is minimal. As
discussed above, these costs are not being mandated by this rule, but
would be voluntarily borne by the various pharmacies in order to
improve or expand their abilities for transferring EPCS.
---------------------------------------------------------------------------
\37\ Id.
\38\ Id.
---------------------------------------------------------------------------
Other Comments
Comments. One commenter recommended that EPCS transmitted to one
pharmacy and dispensed at another pharmacy should not be considered
transferred prescriptions if the pharmacy that received the
prescription and the pharmacy that dispensed the prescription are both
owned by the same entity and share the same integrated information
technology (IT) system.
DEA Response. The CSA and DEA regulations require each registrant
to maintain complete and accurate records of controlled substances.\39\
Each pharmacy, not the entity who owns the pharmacy, is a DEA
registrant and is therefore, subject to DEA's recordkeeping
requirements. Consequently, a prescription that is received at one
pharmacy and dispensed at a different pharmacy is a transferred
prescription because the transaction is occurring between two different
DEA registrants, even if they are owned by the same entity and share an
integrated IT system.
---------------------------------------------------------------------------
\39\ 21 U.S.C. 827 and 21 CFR 1304.21(a).
---------------------------------------------------------------------------
Comments. One commenter recommended that DEA require a pharmacy
transferring EPCS to verify that the pharmacy receiving the transferred
prescription will be able to dispense the prescription's full quantity
prior to transferring the prescription to that receiving pharmacy.
DEA Response. This rule provides for transfers of EPCS at the
request of the patient. Although DEA suggests that the transferring
pharmacy or the patient verify, prior to the transfer, that the
receiving pharmacy is able to fill the transferred prescription, DEA is
not requiring pharmacies to do so.
Comments. One commenter stated that the prescribing practitioner
should receive an automatic notification when a controlled substance
prescription that they issued is transferred.
DEA Response. DEA does not believe that it is necessary to require
pharmacies to notify practitioners when an electronic controlled
substance prescription that they issued is transferred. DEA believes
this would be unnecessarily burdensome to pharmacies.
Comments. One commenter asked that DEA expand exceptions to the
definition of ``online pharmacy'' to clarify that using the internet to
transfer prescription information between pharmacies does not render a
pharmacy an ``online pharmacy.''
DEA Response. DEA does not believe further clarification is
necessary. The definition of an online pharmacy contains ten
exceptions, which include a DEA-registered pharmacy whose dispensing of
controlled substances via the internet consists solely of filling
prescriptions that were electronically prescribed in a manner otherwise
consistent with DEA regulations and the CSA.\40\
---------------------------------------------------------------------------
\40\ See 21 CFR 1300.04(h)(9).
---------------------------------------------------------------------------
Comments. One commenter recommended that DEA work with State
prescription drug monitoring programs (PDMPs) to require pharmacies
receiving transferred EPCS to report the transfers to the PDMP. The
commenter stated that prescribers should be able to easily identify
transferred prescriptions when searching a PDMP database.
DEA Response. PDMP reporting is beyond the scope of this rule and
DEA's authority, as PDMPs are regulated by the States.
Comments. One commenter suggested that DEA should preempt any State
requirements for transferring EPCS that exceed the requirements
established by DEA.
[[Page 48371]]
DEA Response. DEA generally will not preempt any State laws or
regulations related to dispensing controlled substances,\41\ including
the transfer of EPCS between pharmacies for initial dispensing.
---------------------------------------------------------------------------
\41\ See 21 U.S.C. 903.
---------------------------------------------------------------------------
Comments. One commenter recommended that DEA revise the language in
the proposed 21 CFR 1306.08(g), which states that EPCS transfers for
initial dispensing are permissible only if allowable under existing
State or other applicable law. The commenter stated that, as currently
written, a State would have to enact a law to expressly allow this
activity. The commenter recommended replacing ``only if allowable under
existing State or other applicable law'' with ``unless prohibited by
existing State or other applicable law.''
DEA Response. DEA understands the commenter's concern. However, DEA
is not amending this language at this time. The regulations for the
transfer of EPCS between pharmacies for initial dispensing were written
to parallel those for the transfer of prescription information for
refill dispensing, as well as those for prescriptions in general. DEA
notes that the phrase, ``only if allowable under existing State or
other applicable law,'' is included in several provisions in 21 CFR
part 1306.\42\
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\42\ See 21 CFR 1306.12(b)(1)(iv) and (v) and 1306.25(e).
---------------------------------------------------------------------------
Comments. One commenter recommended that DEA use the term
``forward'' instead of ``transfer'' when referring to the transfer of
prescription information for initial dispensing. The commenter was
concerned that the transfer of prescription information for initial
dispensing would be confused with the transfer of prescription
information for refill dispensing outlined in 21 CFR 1306.25. The
commenter noted that while schedule II controlled substance
prescriptions cannot be transferred for refill dispensing because
refills are not permitted, this rule, if promulgated, will allow the
transfer of schedule II controlled substance prescriptions between
pharmacies for initial dispensing.
DEA Response. DEA understands the commenter's concern and
preference for differentiating between prescriptions transferred for
initial dispensing and those transferred for refill dispensing.
However, DEA uses ``transfer'' to refer to the exchange of prescription
information between pharmacies for both initial and refill dispensing.
Therefore, this final rule continues to use the term ``transfer.''
Out of Scope
Five comments were outside the scope of this rule. Three commenters
asked DEA to also allow controlled substance prescriptions prescribed
orally and via facsimile to be transferred between pharmacies for
initial dispensing. This is beyond the scope of this rule which only
addresses the one-time transfer of EPCS between pharmacies for initial
dispensing. One commenter disagreed with health insurance entities
requiring prior authorization for medications currently being
prescribed and those prescribed to treat chronic illnesses. The
commenter also stated that after patients have been prescribed
medications to treat chronic illnesses for an extended period of time,
the prescriptions should be allowed to be refilled without requiring
patients to revisit the prescribing practitioner or requiring the
practitioner to issue new prescriptions. Additionally, the commenter
stated that practitioners should be allowed to prescribe stimulants for
less than a 30-day supply. One commenter wanted medications used to
treat attention-deficit/hyperactivity disorder removed from the
controlled substances lists. These comments are beyond the scope of
this rulemaking and therefore are not addressed.
Summary of Changes From the NPRM
DEA is finalizing the proposed regulatory text with modifications
to address concerns brought forth by commenters. The final rule adds
``upon request from the patient,'' to the proposed text in 21 CFR
1306.08(e) to clarify that prescription transfers must be requested by
the patient. Further, a new sentence is also added to 21 CFR 1306.08(e)
to clarify that, when a prescription for a schedule III, IV, or V
controlled substance issued with authorized refills is transferred, the
authorized refills are transferred with the original prescription.
Additionally, a new paragraph is added to 21 CFR 1306.08(f) to
state that a transferring or receiving pharmacy's prescription
processing software, if capable, is permitted to capture the
information required from the electronic prescription and automatically
populate the corresponding data fields to document the transfer of
prescriptions between pharmacies. The new paragraph also states that
the transferring or receiving pharmacist, as applicable, must ensure
that the populated information is complete and accurate.
Summary of the Final Rule
DEA is amending its regulations to allow, upon request from the
patient, the transfer of EPCS between registered retail pharmacies for
initial filling on a one-time basis only. The final rule explicitly
states that an electronic prescription for a controlled substance in
schedule II-V may be transferred between retail pharmacies for initial
filling on a one-time basis only, upon request from the patient, and
clarifies that any authorized refills included on a prescription for a
schedule III, IV, or V controlled substance are transferred with the
original prescription. The final rule specifies the following
requirements that must be met when EPCS are transferred between
pharmacies for initial dispensing. The prescription must be transferred
in its electronic form and may not be converted to another form (e.g.,
paper, facsimile) for transmission. The information required to be on a
controlled substance prescription pursuant to 21 CFR part 1306 must be
unaltered during the transmission. The transfer must be communicated
between two licensed pharmacists. The final rule also stipulates that
the transfer of EPCS for initial dispensing is permissible only if
allowable under existing State or other applicable law.
The final rule describes the documentation requirements for
pharmacies transferring EPCS for initial filling. A pharmacist
transferring an electronic controlled substance 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.
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, 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
[[Page 48372]]
populated information is complete and accurate. The final rule requires
the electronic records documenting EPCS transfers to be 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.\43\ The existing requirements for all
prescriptions, as outlined in 21 CFR part 1306, Prescriptions, and the
requirements for prescribing and pharmacy applications, as outlined in
21 CFR part 1311, Requirements for Electronic Orders and Prescriptions,
remain unchanged in this final rule.
---------------------------------------------------------------------------
\43\ 21 CFR 1304.06(g).
---------------------------------------------------------------------------
Regulatory Analyses
Executive Orders 12866 (Regulatory Planning and Review) and 13563
(Improving Regulation and Regulatory Review)
This final rule was developed in accordance with the principles of
Executive Orders (E.O.) 12866 and 13563. E.O. 12866 directs agencies to
assess all costs and benefits of available regulatory alternatives and,
if regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental,
public health, and safety effects; distributive impacts; and equity).
E.O. 13563 is supplemental to and reaffirms the principles, structures,
and definitions governing regulatory review as established in E.O.
12866. The Office of Management and Budget (OMB) has determined that
this rule is not a ``significant regulatory action'' under E.O. 12866,
section 3(f).
Analysis of Benefits and Costs
DEA is amending its regulations to allow the transfer of electronic
prescriptions for schedule II-V controlled substances between
registered retail pharmacies for initial dispensing, upon request from
the patient, on a one-time basis only. This amendment specifies the
procedure that must be followed and the information that must be
documented when transferring EPCS between DEA-registered retail
pharmacies. As described below, DEA estimates the annual cost savings
of this rule is $29 million.\44\
---------------------------------------------------------------------------
\44\ This analysis has been updated since the NPRM with the
latest available data.
---------------------------------------------------------------------------
The final rule specifies that: the transfer must be communicated
directly between two licensed pharmacists; the prescription must be
transferred in its electronic form and may not be converted to another
form (e.g., facsimile) for transmission; the required prescription
information must be unaltered during the transmission; and the transfer
of EPCS for initial dispensing is permissible only if allowable under
existing State or other applicable law. In addition to the above, the
pharmacist transferring the prescription must update the electronic
prescription record to note that the prescription was transferred. The
transferring pharmacist must also record 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.
Finally, the final rule requires that the electronic records
documenting the transfer be maintained for a period of two years from
the date of the transfer by both the pharmacy transferring the
electronic prescription and the pharmacy receiving the prescription.
As DEA regulations previously did not permit the transfer of
schedule II-V EPCS from one retail pharmacy to another retail pharmacy
for initial filling, DEA anticipates the ability to transfer EPCS under
this final rule will affect the following parties: the first
(transferring) pharmacy, patient, prescriber, and second (receiving)
pharmacy. To quantify the economic impact of this rule, DEA estimated
the average cost and cost savings for each transfer and applied this
cost or cost savings to the estimated number of transfers.\45\ DEA
notes, however, that nothing in this rule mandates that pharmacies must
transfer EPCS, or must receive EPCS; so, the economic analysis
addresses the estimated costs and cost savings in instances where the
transferring and receiving pharmacies agree to engage in such transfers
under the terms of this rule.
---------------------------------------------------------------------------
\45\ DEA expects minor system and implementation expenses, which
consist of modifying software configurations, updating business
processes, and minimal personnel training. DEA estimates the cost of
these changes is minimal.
---------------------------------------------------------------------------
Estimated Cost or Cost Savings per Transfer
To estimate the unit cost or cost savings, DEA compared the
anticipated activities for each of the affected parties when a pharmacy
receives EPCS it cannot fill under current practices (prior to the
final rule) versus the final rule. The term ``current'' is used in the
analysis to mean prior to the implementation of this final rule. The
anticipated activities for each of the affected parties under current
practices are described below. DEA understands there may be many
operational variations; however, DEA believes the scenarios described
below are good representations for the purposes of estimating costs.
The anticipated activities for each of the affected parties under
current practice are described below.
1. The first (transferring) pharmacy contacts the patient to inform
the patient that it is unable to fill the prescription.
2. The first pharmacy notes action taken, as needed.
3. The patient receives the call from the first pharmacy notifying
the patient that it is unable to fill the prescription.
4. The patient contacts the prescriber and requests a new
prescription.
5. The prescriber's secretary or administrative personnel receives
the phone call from the patient.
6. The prescriber cancels the EPCS at the first pharmacy and issues
a new EPCS at an alternate (receiving) pharmacy.
7. The alternate pharmacy receives and fills the EPCS.
8. The patient receives the filled prescription from the alternate
pharmacy.
By contrast, the anticipated activities for each of the affected
parties under the final rule and the economic impact are described
below.
1. The first (transferring) pharmacy contacts the patient to inform
them that it is unable to fill the prescription. DEA assumes the
duration of the call to the patient is the same under the current and
final rule scenarios, and therefore, there is no impact on the
transferring pharmacy.
2. The patient receives a call from the transferring pharmacy
notifying the patient that it is unable to fill the prescription; the
patient requests that the prescription be transferred to an alternate
(receiving) pharmacy. DEA assumes the duration of the call from the
transferring pharmacy is the same under current and final rule
scenarios. Therefore, there is no impact to the patient.
3. The patient (nor the transferring or receiving pharmacy) does
not need to contact the prescriber to request a new prescription under
the final rule. Therefore, there are cost savings for the patient from
not contacting the prescriber.
4. The prescriber does not receive a call from the patient.
Therefore, there are cost savings for the prescriber.
[[Page 48373]]
5. The prescriber does not need to issue a new EPCS. Therefore,
there are cost savings for the prescriber.
6. The transferring pharmacy transfers the prescription (including
contacting the receiving pharmacy, exchanging information, and
recording the required information regarding transfer). Transferring
the prescription will take longer than simply informing the patient
that the prescription cannot be filled. Therefore, there is an
additional cost to the transferring pharmacy to transfer a
prescription.
7. The alternate (receiving) pharmacy receives the transfer and
fills the transferred EPCS (including being contacted by the
transferring pharmacy, exchanging information, and recording the
required information regarding transfer). DEA anticipates there will be
additional costs related to being contacted by the transferring
pharmacy and exchanging information. Therefore, there is an additional
cost to the receiving pharmacy to transfer a prescription, but the
receiving pharmacy also obtains full reimbursement for the cost of
filling the prescription.
8. The patient receives the filled prescription from the alternate
(receiving) pharmacy. DEA assumes the burden is the same under the
current and final rule scenarios, and therefore, there is no impact on
the patient. Note that there may be a burden for the patient in needing
to travel to a different pharmacy, but that is a cost that arises in
every case where the patient must go to a different pharmacy than
expected because the first pharmacy is unable to fill the prescription.
There is no difference under this rule in the patient's burden in
traveling to a different pharmacy, whether the EPCS is transferred
under this rule, or the prescriber sends a new EPCS to the second
pharmacy, or the patient takes a paper prescription to the second
pharmacy.
Table 1 summarizes the activity scenarios under current practices
(prior to the final rule) and final rule and the anticipated economic
impact.
Table 1--Persons and Activities, Current vs. Final Rule
----------------------------------------------------------------------------------------------------------------
Change in activity
Persons -------------------------------------------------- Economic impact
Current Final Rule
----------------------------------------------------------------------------------------------------------------
First or Transferring Pharmacy....... First pharmacy contacts Transferring pharmacy Assume duration of call/
patient to inform that contacts patient to contact is same ==> no
they are unable to inform that it is impact.
fill the prescription. unable to fill the
prescription.
Note action taken Transfer prescription. Additional cost to
(i.e., void, cancel, ``Transfer'' includes: transfer vs. noting
etc.), as needed. contacting the action taken.
receiving pharmacy,
exchanging
information, and
recording the required
information regarding
transfer.
Patient.............................. Receive call from Receive call from Assume duration of call/
pharmacy that it is pharmacy that it is contact is same ==> no
unable to fill the unable to fill the impact.
prescription. prescription, request
transfer of the
prescription to an
alternate (receiving)
pharmacy.
Contact prescriber to N/A.................... Cost savings from not
request new having to contact
prescription. prescriber.
Receive filled Receive filled Assume same burden ==>
prescription from prescription from no impact.
second (receiving) receiving pharmacy.
pharmacy.
Prescriber........................... Receive call from N/A.................... Cost savings.
patient. (prescriber's
secretary).
Cancel prescription N/A.................... Cost savings.
sent to first pharmacy
and issue new
prescription at second
(receiving) pharmacy.
Second (Receiving) Pharmacy.......... Receive prescription Receive transfer and Additional cost to
and fill. fill. ``Transfer'' receive and record
includes: being transfer, but the
contacted by the receiving pharmacy
transferring pharmacy, gets full
exchanging reimbursement for
information, and filling prescription.
recording the required
information regarding
transfer.
----------------------------------------------------------------------------------------------------------------
Cost or cost savings is based on applying the loaded labor rate for
each of the affected persons to the estimated time to conduct the
activity. The Bureau of Labor Statistics (BLS) hourly wage data for
various occupation codes was used to estimate the labor rates for each
of the affected persons. Occupation codes 29-1051 Pharmacists, 00-0000
All Occupations, and 43-6013 Medical Secretaries and Administrative
Assistants are used as best representations of first (transferring) and
second (receiving) pharmacists, patient, and prescriber's secretary,
respectively. DEA estimates the best representation for prescribers are
the occupation codes 29-1215 Family Medicine Physicians, 29-1171 Nurse
Practitioners, and 29-1071 Physician Assistants for practitioner, nurse
practitioner, and physician assistant prescribers, respectively. The
occupation code 29-1215 Family Medicine Physicians was chosen to
represent practitioners as DEA estimates that it best represents the
typical prescribing practitioner.
DEA estimates the median hourly wages for the first (transferring)
and second (receiving) pharmacist, patient, prescriber's secretary, and
prescriber are $61.81, $22.00, $18.01, and $99.18,
respectively.46 47 Additionally, BLS reports that average
benefits for private industry is 29.5 percent of total compensation.
The 29.5 percent of total compensation equates to 41.8 percent (29.5
percent/70.5 percent) load on
[[Page 48374]]
wages and salaries.\48\ The load of 41.8 percent is added to each of
the hourly rates to estimate the loaded hourly rates. The loaded hourly
rates for the first (transferring) and second (receiving) pharmacy,
patient, prescriber's secretary, and weighted average prescriber are
$87.65, $31.20, $25.54, and $140.64, respectively. Table 2 summarizes
the calculation for the loaded hourly wages for each of the affected
persons.
---------------------------------------------------------------------------
\46\ BLS, May 2021 National Occupational Employment and Wage
Estimates United States. http://www.bls.gov/oes/current/oes_nat.htm.
\47\ The prescriber median hourly wage is a weighted average of
the hourly wages of the occupation codes 29-1215 Family Medicine
Physicians, 29-1171 Nurse Practitioners, and 29-1071 Physician
Assistants, with the weights based on 1,368,536 Practitioner,
331,410 Nurse Practitioner, and 143,725 Physician Assistant active
DEA registrations on 6/10/2022.
\48\ BLS, ``Employer Costs for Employee Compensation--December
2021'' (ECEC).
Table 2--Loaded Hourly Wages
----------------------------------------------------------------------------------------------------------------
Occupation Occupation code Median hourly Loaded hourly
Affected persons code description wage median wage
----------------------------------------------------------------------------------------------------------------
Patient............................... 00-0000 All Occupations......... $22.00 $31.20
Pharmacist............................ 29-1051 Pharmacists............. 61.81 87.65
Medical secretary..................... 43-6013 Medical Secretaries and 18.01 25.54
Administrative
Assistants.
Prescriber............................ .............. Prescriber (Weighted 99.18 140.64
Average).
----------------------------------------------------------------------------------------------------------------
The below sections describe the calculation conducted to quantify
the economic impact associated with the changes in activities under the
current and final rule scenarios described above.
1. Currently, the first pharmacy contacts the patient to inform the
patient that the pharmacy is unable fill the prescription. DEA
estimates that it takes three minutes for the first pharmacist to call
the patient. From Table 2, the estimated loaded hourly rate of a
pharmacist is $87.65. Multiplying the loaded hourly rate of $87.65 by
0.05 (3/60) hours results in a cost of $4.38. Under the final rule, the
first (transferring) pharmacist would also contact the patient
regarding the inability to fill the prescription. DEA estimates that it
would also take three minutes for the transferring pharmacist to call
the patient under the final rule, resulting in the same cost of $4.38.
Therefore, there is no economic impact to the transferring pharmacy
associated with this activity under the final rule.
2. Currently, the first pharmacist notes in the electronic
prescription record that the prescription was not filled. DEA estimates
that it takes one minute for the first pharmacist to make the entry in
the electronic prescription record. From Table 2, the estimated loaded
hourly rate of a pharmacist is $87.65. Multiplying the loaded hourly
rate of $87.65 by 0.0167 (1/60) hours results in a cost of $1.46. Under
the final rule, the transferring pharmacy may transfer the
prescription, upon request from the patient, to the receiving pharmacy.
Additionally, the transferring pharmacy must also contact the receiving
pharmacy and exchange and document information such as the transferring
pharmacy's name, address and DEA registration number, the name of the
transferring pharmacist, and the name of the pharmacist receiving the
transfer. DEA estimates that it takes three minutes for the
transferring pharmacist to transfer the prescription. From Table 2, the
estimated loaded hourly rate of a pharmacist is $87.65. Multiplying the
loaded hourly rate of $87.65 multiplied by 0.05 (3/60) hours results in
a cost of $4.38. Therefore, the net cost to the transferring pharmacy
under the final rule is $2.92 ($4.38-$1.46) per transfer.
3. Under current practices, the patient first receives a call from
the pharmacist who informs him/her that his/her prescription cannot be
filled. DEA estimates that the call between the pharmacist and the
patient lasts three minutes. From Table 2, the estimated loaded hourly
rate of a patient is $31.20. Multiplying the loaded hourly rate of
$31.20 multiplied by 0.05 (3/60) hours results in a cost of $1.56 to
the patient. Under the final rule, this activity does not change. With
transfers of EPCS, the pharmacist must still contact the patient. Thus,
under the final rule, the patient also receives a call from the
pharmacist. Estimating three minutes for the call, there is still a
cost of $1.56 to the patient. Therefore, there is no economic impact to
the patient associated with this activity under the final rule.
4. Under current practices, the patient must contact the prescriber
to request a new prescription. DEA estimates that it takes five minutes
for the patient to contact the prescriber. From Table 2, the estimated
loaded hourly rate of the patient is $31.20. Multiplying the loaded
hourly rate of $31.20 by 0.083 (5/60) hours results in a cost of $2.60.
Under the final rule, the patient no longer needs to contact the
prescriber; the patient requests an electronic transfer of the
prescription from the first (transferring) pharmacy to the second
(receiving) pharmacy; thus, there is zero cost to the patient.
Therefore, this activity under the final rule results in a cost savings
to the patient of $2.60 per transfer.
5. Under current practices, the patient has to contact the
prescriber asking for a new prescription. DEA estimates that it takes
five minutes for the prescriber's medical secretary to receive the call
from the patient. From Table 2, the estimated loaded hourly rate of a
medical secretary is $25.54. Multiplying the loaded hourly rate of
$25.54 by 0.083 (5/60) hours results in a cost of $2.13. Under the
final rule, the patient no longer needs to contact the prescriber;
thus, this interaction will not occur. Therefore, this activity under
the final rule results in a cost savings to the prescriber of $2.13 per
transfer.
6. Under current practices, after the medical secretary receives
the call from the patient and the information is relayed to the
prescriber, the prescriber issues a new prescription. DEA estimates the
prescriber takes two minutes to cancel the first prescription and issue
a new prescription. From Table 2, the estimated loaded hourly rate of a
prescriber is $140.64. Multiplying the loaded hourly rate of $140.64 by
0.03 (2/60) hours results in a cost of $4.69. Under the final rule, the
prescriber does not need to issue a new prescription; the original
prescription is simply transferred to the receiving pharmacy.
Therefore, this activity under the final rule results in a cost savings
to the prescriber of $4.69 per transfer.
7. Under current practices, the second (receiving) pharmacy
receives and fills the prescription. DEA estimates that it takes 15
minutes for the second (receiving) pharmacy to receive and fill the
prescription. From Table 2, the estimated loaded hourly rate of a
pharmacist is $87.65. Multiplying the loaded hourly rate of $87.65 by
0.25 (15/60) hours results in a cost of $21.91. Under the final rule,
DEA also estimates the receiving pharmacist still conducts this
activity at the same loaded labor
[[Page 48375]]
rate and time duration, resulting in a cost of $21.91. However, under
the final rule, the receiving pharmacist must also receive and record
transfer information from the transferring pharmacy. DEA estimates that
it takes three minutes for the receiving pharmacy to receive and record
transfer information. From Table 2, the estimated loaded hourly rate of
a pharmacist is $87.65. Multiplying the loaded hourly rate of $87.65 by
0.05 (3/60) hours results in a cost of $4.38. Therefore, this activity
under the final rule results in a cost to the receiving pharmacy of
$4.38 per transfer, but the receiving pharmacy would get the full
reimbursement for filling the prescription.
8. Under current practices, DEA assumes that the patient is
informed that the first pharmacy is unable to fill the prescription
prior to traveling to pick it up; thus, the patient only makes one trip
to the second pharmacy where the prescription was transferred. DEA
estimates that it takes 20 minutes for the patient to pick up the
filled prescription. From Table 2, the estimated loaded hourly rate of
a patient is $31.20. Multiplying the loaded hourly rate of $31.20 by
0.33 (20/60) hours results in a cost of $10.40. Under the final rule,
DEA also assumes that the patient is informed that the first pharmacy
is unable to fill the prescription prior to traveling to pick up the
prescription; thus, the patient only makes one trip. Estimating 20
minutes for the patient to pick up the filled prescription, under the
final rule, there is still a cost of $10.40 to the patient. Therefore,
there is no economic impact to the patient associated with this
activity under the final rule.
As shown by Table 3, the final rule results in a total cost of
$8.76 and a total cost savings of $10.88 per transfer. This results in
an overall net cost savings of $2.12 per transfer.
---------------------------------------------------------------------------
\49\ Due to the rapidly evolving industry and regulatory
conditions, the analysis period is five years.
Table 3--Cost/Cost Savings Calculation, Current vs. Final Rule
----------------------------------------------------------------------------------------------------------------
Current Final rule
---------------------------------------------------------------- Costs/(cost
Person/activity Estimated time Cost, current Estimated time Cost, final savings) ($)
(minutes) ($) (minutes) rule ($)
----------------------------------------------------------------------------------------------------------------
Transferring pharmacist:
1. Contact patient.......... 3 4.38 3 4.38 ..............
2.a. Void/transfer 1 1.46 .............. .............. (1.46)
prescription...............
2.b. Transfer prescription.. .............. .............. 3 4.38 4.38
Patient:
3. Receive call from 3 1.56 3 1.56 ..............
pharmacist.................
4. Contact prescriber....... 5 2.60 .............. .............. (2.60)
5. Received filled 20 10.40 20 10.40 ..............
prescription...............
Prescriber:
6. Receive call from patient 5 2.13 .............. .............. (2.13)
(secretary)................
7. Issue new prescription 2 4.69 .............. .............. (4.69)
(prescriber)...............
Receiving pharmacist:
8.a. Receive prescription 15 21.91 15 21.91 ..............
and fill...................
8.b. Receive and record .............. .............. 3 4.38 4.38
transfer info..............
-------------------------------------------------------------------------------
Total Costs............. .............. .............. .............. .............. 8.76
Total Cost Savings...... .............. .............. .............. .............. (10.88)
Net Cost Savings........ .............. .............. .............. .............. (2.12)
----------------------------------------------------------------------------------------------------------------
Estimated Number of Transfers
As mentioned earlier, in order to calculate the total cost savings,
DEA applied the $2.12 net cost savings per transaction, from above, to
the estimated number of total transfers. DEA estimated the number of
total transfers by estimating the number of EPCS for the analysis
period, the first five years after the rule goes into effect, and
applying an estimated percentage of EPCS that will be transferred.\49\
Surescripts' National Progress Reports for 2019, 2020, and 2021
form the basis for estimating the number of EPCS for the five-year
analysis period.\50\ The reports indicate that the rate of electronic
prescribing for non-controlled substances (E-RX) was 76, 83, 86, 89,
and 97 percent in 2017, 2018, 2019, 2020, and 2021, respectively.\51\
Additionally, the reports indicate that the rate of EPCS is rising
rapidly; the rate was 17, 26, 38, 58, and 73 percent in 2017, 2018,
2019, 2020, and 2021, respectively.\52\ Furthermore, there were 65,
96.8, 134.2, 203.6, and 256.9 million EPCS filled in 2017, 2018, 2019,
2020, and 2021, respectively.\53\ Dividing the total EPCS by the rate
of EPCS, DEA estimates the total controlled substances prescriptions,
electronic and non-electronic, were 382.4, 372.3, 353.2, 351.0, and
351.9 million in 2017, 2018, 2019, 2020, and 2021, respectively. Table
4 summarizes the data provided by the reports and the estimated total
prescriptions for controlled substances for years 2017-2021.
---------------------------------------------------------------------------
\50\ Surescripts, ``2019 National Progress Report'' for 2017
data, ``2020 National Progress Report'' for 2018-2020 data, and
``2021 National Progress Report'' for 2018-2021 data.
\51\ Ibid.
\52\ Ibid.
\53\ Ibid.
[[Page 48376]]
Table 4--Estimated Total Prescriptions for Controlled Substances
[2017-2021]
----------------------------------------------------------------------------------------------------------------
2017 2018 2019 2020 2021
----------------------------------------------------------------------------------------------------------------
Non-Controlled Substances:
Rate of E-Rx (%)............ 76 83 86 89 97
Controlled Substances:
Total Rx, E and non-E 382.4 372.3 353.2 351.0 351.9
(millions of Rx)...........
Rate of EPCS (%)............ 17 26 38 58 73
Total EPCS (millions of Rx). 65.0 96.8 134.2 203.6 256.9
----------------------------------------------------------------------------------------------------------------
As shown in Table 4, the estimated total prescriptions for
controlled substances decreased from 382.4 million in 2017 to 351.9
million in 2021. For the purposes of this analysis, DEA estimates the
total number of controlled substances prescriptions will stay constant
at 351.9 million per year for the five-year analysis period.
Also, from Table 4, the rate of electronic prescribing for non-
controlled substances is higher than that of controlled substances.
However, DEA estimates the rate of electronic prescribing for
controlled substances will match that of non-controlled substances in
year one due to a CMS December 2020 rule, which requires electronic
prescribing for all controlled substances (with some exceptions)
covered under Medicare Part D.\54\ The 2021 rate of electronic
prescriptions for non-controlled substances was 97 percent. While it is
possible that this rate could continue to increase in the future, DEA
has no basis to estimate how much higher the rate would go. As the rate
of increase has been slowing over the past several years, DEA
conservatively estimates that the rate of electronic prescribing for
non-controlled substances has peaked at 97 percent and the rate of
electronic prescribing for controlled substances will be 97 percent for
the analysis period. Multiplying the estimated total number of
controlled substance prescriptions, 351.9 million per year, by the
estimated rate of EPCS of 97 percent, the estimated total EPCS is 341.3
million per year for the analysis period, the first five years after
the rule goes into effect.
---------------------------------------------------------------------------
\54\ 85 FR 84472 (Dec. 28, 2020).
---------------------------------------------------------------------------
CMS estimates that as much as four percent of electronic
prescriptions for non-controlled substances in 2019 were transfers.\55\
Applying the four percent transfer rate to the total EPCS
prescriptions, DEA estimates the number of transfers is 13.7 million
per year for each of the first five years.
---------------------------------------------------------------------------
\55\ Conference call between CMS and DEA, January 2021. CMS's
estimate is a ``high'' estimate and ``four percent'' is considered
the maximum percent of electronic prescriptions that are transfers.
---------------------------------------------------------------------------
Total Cost Savings
In order to calculate the total cost savings, DEA applied the $2.12
net cost savings per transaction to the estimated 13.7 million
transfers, resulting in a total annual net cost savings of $29.0
million over the five-year analysis period. The net present value (NPV)
of the cost savings is $132.8 million at three percent discount rate
and $118.9 million at seven percent discount rate. The annualized cost
savings from year one to year five is $29.0 million at three percent
and seven percent. Table 5 summarizes the NPV and annualized cost
savings calculation.
Table 5--NPV and Annualized Cost Savings
------------------------------------------------------------------------
3 Percent 7 Percent
------------------------------------------------------------------------
NPV of Cost Savings............................. $132.8 $118.9
Annualized Cost Savings......................... 29.0 29.0
------------------------------------------------------------------------
Executive Order 12988, Civil Justice Reform
This final rule meets the applicable standards set forth in
sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors
and ambiguity, minimize litigation, provide a clear legal standard for
affected conduct, and promote simplification and burden reduction.
Executive Order 13132, Federalism
This final rule does not have federalism implications warranting
the application of E.O. 13132. The final rule does not have substantial
direct effects on the States, on the relationship between the National
Government and the States, or the distribution of power and
responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This final rule does not have tribal implications warranting the
application of E.O. 13175. It does not have substantial direct effects
on one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.
Regulatory Flexibility Act
In accordance with the Regulatory Flexibility Act (RFA), DEA
evaluated the impact of this rule on small entities. DEA's evaluation
of economic impact by size category indicates that the rule will not
have a significant economic impact on a substantial number of these
small entities.
The RFA requires an agency to analyze options for regulatory relief
of small entities unless it can certify that the rule will not have a
significant impact on a substantial number of small entities. DEA has
analyzed the economic impact of each provision of this final rule and
estimates that it will have minimal economic impact on affected
entities, including small businesses, nonprofit organizations, and
small governmental jurisdictions.
DEA is amending its regulations to allow the transfer of electronic
prescriptions for schedules II-V controlled substances between
registered retail pharmacies for initial dispensing, upon request from
the patient, on a one-time basis only. This amendment specifies the
procedure that must be followed and the information that must be
documented when transferring EPCS between DEA-registered retail
pharmacies.
The final rule specifies that: the transfer must be communicated
directly between two licensed pharmacists; the prescription must be
transferred in its electronic form and may not be converted to another
form (e.g., facsimile) for transmission; the required prescription
information must be unaltered during the transmission; and the transfer
of EPCS for initial dispensing is permissible only if allowable under
existing State or other applicable law. In addition to the above, the
pharmacist transferring the prescription must update the electronic
prescription record to note that the prescription was transferred. The
transferring pharmacist must also record
[[Page 48377]]
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. Finally, the final rule requires that the electronic records
documenting the transfer be maintained for a period of two years from
the date of the transfer by both the pharmacy transferring the
electronic prescription and the pharmacy receiving the prescription.
DEA anticipates this final rule will affect pharmacies, offices of
physicians, and hospitals, as the majority of prescribers are employed
by offices of physicians or hospitals. Table 6 indicates the sectors,
as defined by the North American Industry Classification System
(NAICS), affected by this final rule. There may be other small entities
under Small Business Administration size standards in other NAICS code
industries affected by this final rule. However, DEA believes the list
in Table 6 is a good general representation of affected small entities
and their industries as defined by NAICS.
Table 6--Affected Industrial Sectors
------------------------------------------------------------------------
NAICS Code
Business activity NAICS code description
------------------------------------------------------------------------
Pharmacy.......................... 446110 Pharmacies and Drug
Stores.
Prescriber........................ 621111 Offices of
622110 Physicians (except
Mental Health
Specialists).
General Medical and
Surgical Hospitals.
------------------------------------------------------------------------
CMS estimates that as much as four percent of electronic
prescriptions for non-controlled substances in 2019 were transfers.\56\
DEA assumes, for the purposes of this analysis, that such transfers of
EPCS are distributed proportionally across all prescribers and
pharmacies. Therefore, DEA estimates a substantial number of small
entities in the affected industries will be affected by this final
rule.
---------------------------------------------------------------------------
\56\ Conference call between CMS and DEA, January 2021. CMS's
estimate is a ``high'' estimate and ``four percent'' is considered
the maximum percent of electronic prescriptions that are transfers.
---------------------------------------------------------------------------
In order to determine whether the final rule will result in a
significant impact on the affected small entities, the following steps
were taken:
1. Estimate the cost or cost savings per transfer.
2. Estimate the total cost or cost savings of transfers.
3. Allocate the total cost or cost savings across all affected
entities in proportion to their revenue to estimate the cost or cost
savings per entity.
4. Compare the cost or cost savings to the annual revenue for the
smallest of small entities. If the impact is not significant for the
smallest of small entities, then the impact is not significant for the
larger small entities.
Table 3 summarizes the cost or cost savings on a per-transfer
basis. The net cost to the transferring pharmacy is $2.92 (the cost of
transferring the prescription, $4.38 (2.b.), minus the cost of updating
the prescription record to note that the prescription was not filled,
$1.46 (2.a.)). The cost to the receiving pharmacy is $4.38 (8.b.) per
transfer. Each transfer affects two different pharmacies, the
transferring and receiving pharmacies. Since pharmacies are likely to
transfer and receive, an average was taken to determine the typical
cost per transfer for a pharmacy. The average cost is $3.65 (($2.92 +
$4.38)/2) per transfer. Also, from Table 3, the total cost savings to a
prescriber (office of physician or hospital) is $6.82, the sum of the
cost savings from not receiving a call from the patient $2.13 (6.) and
the cost savings from not issuing a new prescription $4.69 (7.).
To calculate the total cost to pharmacies and total cost savings to
prescribers, the unit cost and cost savings are multiplied by the
estimated total annual transfers. From above, the estimated number of
transfers is 13.7 million per year. Multiplying the average net cost of
$3.65 per transfer for pharmacies by 13.7 million transfers, the
estimated total cost of transfers to all pharmacies is $50,005,000 per
year. Multiplying the cost saving of $6.82 per transfer for prescribers
(office of physician or hospital) by 13.7 million transfers, the
estimated total cost saving to all prescribers is $93,434,000 per year.
The U.S. Census Bureau's Statistics of U.S. Businesses (SUSB) is an
annual series that provides national and subnational data on the
distribution of economic data by enterprise size and industry. SUSB
data includes the number of firms at various size ranges. For the
purposes of this analysis, the term ``firm'' as defined in the SUSB is
used interchangeably with ``entity'' as defined in the RFA. Based on
SUSB data, there are 19,234, 161,286, and 2,560 firms in 446110--
Pharmacies and Drugs Stores, 621111--Offices of Physicians (except
Mental Health Specialists), and 622110--General Medical and Surgical
Hospitals industry sectors, respectively.\57\ Furthermore, the total
receipts for all firms, including all size ranges, are $282 billion,
$474 billion, and $997 billion (rounded) for 446110--Pharmacies and
Drugs Stores, 621111--Offices of Physicians (except Mental Health
Specialists), and 622110--General Medical and Surgical Hospitals
industry sectors, respectively.\58\ Table 7 summarizes the SUSB data
and provides receipt values without rounding.
---------------------------------------------------------------------------
\57\ SUSB, 2017 SUSB Annual Data Tables by Establishment
Industry, Data by Enterprise Receipt Size, U.S., 6-digit NAICS,
https://www.census.gov/data/tables/2017/econ/susb/2017-susb-annual.html (https://www2.census.gov/programs-surveys/susb/tables/2017/us_6digitnaics_rcptsize_2017.xlsx). (Accessed June 8, 2022.)
2017 data by enterprise receipt size is the latest available.
\58\ Ibid.
Table 7--Number of Firms and Total Receipts
----------------------------------------------------------------------------------------------------------------
Number of Receipts
NAICS Code NAICS Code description Receipt size ($) firms ($000)
----------------------------------------------------------------------------------------------------------------
446110........................... Pharmacies and Drug All size ranges.... 19,234 281,653,229
Stores.
621111........................... Offices of Physicians All size ranges.... 161,286 473,954,346
(except Mental Health
Specialists).
622110........................... General Medical and All size ranges.... 2,560 997,368,727
Surgical Hospitals.
----------------------------------------------------------------------------------------------------------------
[[Page 48378]]
SUSB data also includes the number of firms and receipts for
various receipt-size ranges. The smallest size range is firms with
annual revenue less than $100,000. The average receipt per firm was
calculated based on the number of firms and for the receipts for the
firms in the size range. For example, in the 446110--Pharmacies and
Drug Stores industry sector, there are 666 firms with receipts under
$100,000, and their combined receipts is $34,342,000. Dividing
$34,342,000 by 666 results in an average receipt of $51,565 per firm.
Performing the same calculation for all three industries, the average
receipt per firm is $51,565, $50,554, and $259,478 for the smallest
size category in 446110--Pharmacies and Drugs Stores, 621111--Offices
of Physicians (except Mental Health Specialists), and 622110--General
Medical and Surgical Hospitals industry sectors, respectively. Table 8
summarizes the calculation for the average receipt per firm.
Table 8--Average Receipt per Firm
----------------------------------------------------------------------------------------------------------------
Average
NAICS Code NAICS Code description Receipt size ($) Number of Receipts receipt per
firms ($000) firm ($)
----------------------------------------------------------------------------------------------------------------
446110........................ Pharmacies and Drug <100,000 666 34,342 51,565
Stores.
621111........................ Offices of Physicians <100,000 14,302 723,029 50,554
(except Mental Health
Specialists).
622110........................ General Medical and 100,000-* 499,999 23 5,968 259,478
Surgical Hospitals.
----------------------------------------------------------------------------------------------------------------
* ``Receipts'' not available for the smallest size range of ``<100,000; therefore, used next size range of
``100,000-499,000'' for comparison.
To compare the average cost per firm with the average receipt per
firm, DEA allocated the cost and cost savings proportionally by
revenue, divided by the number of firms to calculate the average cost
per firm, and compared the average cost per firm as a percent of
receipt per firm. For example, the receipts for the 666 firms with
receipts under $100,000 in 446110--Pharmacies and Drug Stores industry
sector is $34,342,000. This is 0.0121930 percent of total receipt of
$281,653,229,000 for all size ranges. Allocating 0.0121930 percent of
total cost to pharmacies of $50,005,000 to the 666 firms, the average
cost per firm is $9.\59\ Dividing the average cost per firm of $9 by
the average receipt per firm of $51,565, the average cost per firm is
0.01745 percent of average receipt per firm.
---------------------------------------------------------------------------
\59\ ($50,005,000 x 0.0121930 percent)/666 = $9.
---------------------------------------------------------------------------
This calculation is repeated for 621111--Offices of Physicians
(except Mental Health Specialists) and 622110--General Medical and
Surgical Hospitals industry sectors. However, the economic impact for
621111--Offices of Physicians (except Mental Health Specialists) and
622110--General Medical and Surgical Hospitals industry sectors is a
cost savings, rather than a cost. Although employment of prescribers is
expected to be split between these two industries, to be conservative,
the total cost savings (rather than estimating a split between the two
industries) is compared to the average receipt per firm. In summary,
the average cost or cost savings per firm as percent of receipt is
0.01745 percent, 0.01978 percent, and 0.00925 percent for 446110--
Pharmacies and Drugs Stores, 621111--Offices of Physicians (except
Mental Health Specialists), and 622110--General Medical and Surgical
Hospitals industry sectors, respectively. Table 9 summarizes the
calculation and results.
Table 9--Cost or Cost Savings per Firm as Percentage of Receipts
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average cost/
Receipt as cost savings
NAICS Code Number of percent of Allocated cost Average cost per firm as
NAICS Code description Receipt size ($) firms total to firms in per firm ($) percent of
(percent) size range ($) receipt
(percent)
--------------------------------------------------------------------------------------------------------------------------------------------------------
446110............................ Pharmacies and Drug <100,000 666 0.012193 6,097 9 0.01745
Stores.
621111............................ Offices of <100,000 14,302 0.152552 142,536 10 * (0.01978)
Physicians (except
Mental Health
Specialists).
622110............................ General Medical and 100,000-499,999 23 0.000598 559 24 * (0.00925)
Surgical Hospitals.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Cost savings.
In conclusion, the average cost or cost savings per firm as percent
of receipt of 0.01745 percent, 0.01978 percent, and 0.00925 percent are
not significant economic impacts. Therefore, DEA concludes this final
rule will not have a significant economic impact on a substantial
number of small entities.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995,
2 U.S.C. 1501 et seq., DEA has determined and certifies that this final
rule will not result in any Federal mandate that may result ``in the
expenditure by State, local, and tribal governments, in the aggregate,
or by the private sector, of $100,000,000 or more (adjusted annually
for inflation) in any 1 year.'' Therefore, neither a Small Government
Agency Plan nor any other action is required under UMRA of 1995.
Paperwork Reduction Act of 1995
Pursuant to section 3507(d) of the Paperwork Reduction Act of 1995
(PRA), DEA has identified the following collection of information
related to this rule and has submitted this collection request to the
Office of Management and Budget (OMB) for review and approval.\60\ This
final rule establishes the recordkeeping requirements for pharmacies
electronically transferring of schedules II-V EPCS for initial
dispensing. A person is not required to respond to a collection of
information unless it displays a valid OMB control number. Copies of
existing information collections approved by OMB may be
[[Page 48379]]
obtained at https://www.reginfo.gov/public/do/PRAMain.
---------------------------------------------------------------------------
\60\ 44 U.S.C. 3501 et seq.
---------------------------------------------------------------------------
A. Collections of Information Associated With the Rule
Title: Recordkeeping Requirements for the electronic transfer of
electronic prescriptions for schedules II-V controlled substances
between pharmacies for initial filling.
OMB Control Number: 1117-0061.
DEA Form Number: N/A.
DEA is creating a new collection of information by requiring
pharmacies to create and maintain certain records relating to the
transfer of unfilled EPCS between pharmacies for initial filling. The
rule requires the transferring pharmacy to note in the electronic
prescription record that the prescription was transferred. The
transferring pharmacy is also required to add to the prescription
record the name, address, and DEA registration number of the pharmacy
to which the prescription was transferred, as well as the name of the
pharmacist receiving the transfer, the name of the transferring
pharmacist, and the date of the transfer. Similarly, the rule requires
the pharmacy receiving the transfer to record the name, address, and
DEA registration number of the transferring pharmacy, the name of the
transferring pharmacist, the name of the pharmacist receiving the
transfer, and the date of the transfer. In addition, the rule required
the records to be maintained by both pharmacies for at least two years
from the date of the transfer. DEA estimates the following number of
respondents and burden associated with this collection of information:
Number of respondents: 70,567.
Frequency of response: 354.273244 (calculated average).
Number of responses: 25,000,000.
Burden per response: 0.05 hour.
Total annual hour burden: 1,250,000.
The activities described in this information collection are usual
and ordinary business activities and no additional cost is anticipated.
If you need additional information, please contact the Regulatory
Drafting and Policy Support Section (DPW), Diversion Control Division,
Drug Enforcement Administration; Mailing Address: 8701 Morrissette
Drive, Springfield, Virginia 22152; Telephone: (571) 776-2265.
Any additional comments on this collection of information may be
sent in writing to the Office of Information and Regulatory Affairs,
OMB, Attention: Desk Officer for DOJ, Washington, DC 20503. Please
state that your comments refer to RIN 1117-AB64/Docket No. DEA-637.
Congressional Review Act
This final rule is not a major rule as defined by the Congressional
Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, DEA is
submitting a copy of this final rule to both Houses of Congress and to
the Comptroller General.
Signing Authority
This document of the Drug Enforcement Administration was signed on
July 20, 2023, by Administrator Anne Milgram. That document with the
original signature and date is maintained by DEA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned DEA Federal Register Liaison Officer
has been authorized to sign and submit the document in electronic
format for publication, as an official document of DEA. This
administrative process in no way alters the legal effect of this
document upon publication in the Federal Register.
List of Subjects 21 CFR Part 1306
Drug traffic control, Prescription drugs.
For the reasons stated in the preamble, DEA amends 21 CFR part 1306
as follows:
PART 1306--PRESCRIPTIONS
0
1. The authority citation for part 1306 continues to read as follows:
Authority: 21 U.S.C. 821, 823, 829, 829a, 831, 871(b) unless
otherwise noted.
0
2. Amend Sec. 1306.08 by adding paragraphs (e) through (i) to read as
follows:
Sec. 1306.08 Electronic prescriptions.
* * * * *
(e) The transfer for initial dispensing of an electronic
prescription for a controlled substance in Schedule II-V is permissible
between retail pharmacies, upon request from the patient, on a one-time
basis only. If the transferred prescription is for a controlled
substance in Schedule III, IV, or V and includes authorized refills,
the refills are transferred with the initial prescription to the
pharmacy receiving the transfer.
(f) The transfer of an electronic prescription for a controlled
substance in Schedule II-V between retail pharmacies for the purpose of
initial dispensing is subject to the following requirements:
(1) The prescription must be transferred from one retail pharmacy
to another retail pharmacy in its electronic form. At no time may an
intermediary convert an electronic prescription to another form (e.g.,
facsimile) for transmission.
(2) The contents of the prescription required by this part must not
be altered during transfer between retail pharmacies. Any change to the
content during transfer, including truncation or removal of data, will
render the electronic prescription invalid.
(3) The transfer must be communicated directly between two licensed
pharmacists.
(4) The transferring pharmacist must add the following to the
electronic prescription record:
(i) Information that the prescription has been transferred.
(ii) The name, address, and DEA registration number of the pharmacy
to which the prescription was transferred and the name of the
pharmacist receiving the prescription information.
(iii) The date of the transfer and the name of the pharmacist
transferring the prescription information.
(5) The receiving pharmacist must do the following:
(i) Add the word ``transfer'' to the electronic prescription record
at the receiving pharmacy.
(ii) Annotate the prescription record with the name, address, and
DEA registration number of the pharmacy from which the prescription was
transferred and the name of the pharmacist who transferred the
prescription.
(iii) Record the date of the transfer and the name of the
pharmacist receiving the prescription information.
(6) In lieu of manual data entry, the transferring or receiving
pharmacy's prescription processing software may, if capable, capture
the information required, as outlined in this paragraph (f), from the
electronic prescription and automatically populate the corresponding
data fields to document the transfer of an electronic controlled
substance prescription between pharmacies. The transferring or
receiving pharmacist, as applicable, must ensure that the populated
information is complete and accurate.
(g) The transfer of an electronic prescription for a controlled
substance in Schedule II-V for the purpose of initial dispensing is
permissible only if allowable under existing State or other applicable
law.
(h) The electronic records documenting the transfer of the
electronic prescription must be maintained for a period of two years
[[Page 48380]]
from the date of the transfer by both the pharmacy transferring the
electronic prescription and the pharmacy receiving the electronic
prescription.
(i) A pharmacy may transfer electronic prescription information for
a controlled substance in Schedule III, IV, and V to another pharmacy
for the purpose of refill dispensing pursuant to Sec. 1306.25.
Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2023-15847 Filed 7-26-23; 8:45 am]
BILLING CODE 4410-09-P