Transfer of Electronic Prescriptions for Schedules II-V Controlled Substances Between Pharmacies for Initial Filling, 48365-48380 [2023-15847]

Agencies

• Drug Enforcement Administration
• Department of Justice

[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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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. https://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