[Federal Register Volume 86, Number 221 (Friday, November 19, 2021)]
[Proposed Rules]
[Pages 64881-64892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-24981]


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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: Notice of proposed rulemaking.

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SUMMARY: The Drug Enforcement Administration (DEA) is proposing to 
amend its regulations to allow the transfer of electronic prescriptions 
for schedule II-V controlled substances between registered retail 
pharmacies for initial filling on a one-time basis. This amendment will 
specify the procedure that must be followed and the information that 
must be documented when transferring an electronic controlled substance 
prescription between DEA-registered retail pharmacies.

DATES: Electronic comments must be submitted, and written comments must 
be postmarked, on or before January 18, 2022. Commenters should be 
aware that the electronic Federal Docket Management System will not 
accept comments after 11:59 p.m. Eastern Time on the last day of the 
comment period.
    All comments concerning collections of information under the 
Paperwork Reduction Act must be submitted to the Office of Management 
and Budget (OMB) on or before January 18, 2022

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-637'' on all correspondence, including any 
attachments.
    DEA encourages all comments be submitted electronically through the 
Federal eRulemaking Portal, which provides the ability to type short 
comments directly into the comment field on the web page or attach a 
file for lengthier comments. Please go to http://www.regulations.gov 
and follow the online instructions at that site for submitting 
comments. Upon completion of your submission, you will receive a 
Comment Tracking Number. Please be aware that submitted comments are 
not instantaneously available for public view on Regulations.gov. If 
you have received a Comment Tracking Number, your comment has been 
successfully submitted, and there is no need to resubmit the same 
comment. Paper comments that duplicate the electronic submission are 
not necessary and are discouraged. Should you wish to mail a paper 
comment in lieu of an electronic comment, it should be sent via regular 
or express mail to: DEA Federal Register Representative/DPW, 8701 
Morrissette Drive, Springfield, VA 22152.
    All comments concerning collections of information under the 
Paperwork Reduction Act must be submitted to the Office of Information 
and Regulatory Affairs, OMB, Attention: Desk Officer for DOJ, 
Washington, DC 20503. Please state that your comment refers to RIN 
1117-AB64/Docket No. DEA-637.

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) 776-2265.

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

    Please note that all comments received are considered part of the 
public record. They will, unless reasonable cause is given, be made 
available by DEA for public inspection online at http://www.regulations.gov. Such information includes personal identifying 
information (such as your name, address, etc.) voluntarily submitted by 
the commenter. The Freedom of Information Act applies to all comments 
received. If you want to submit personal identifying information (such 
as your name, address, etc.) as part of your comment, but do not want 
it to be made publicly available, you must include the phrase 
``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of your 
comment. You must also place all of the personal identifying 
information you do not want made publicly available in the first 
paragraph of your comment and identify what information you want 
redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be made publicly available, you 
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the 
first paragraph of your comment. You must also prominently identify the 
confidential business information to be redacted within the comment.
    Comments containing personal identifying information and 
confidential business information identified as directed above will 
generally be made publicly available in redacted form. If a comment has 
so much confidential business information or personal identifying 
information that it cannot be effectively redacted, all or part of that 
comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information 
(such as name, address, and phone number) included in the text of your 
electronic submission that is not identified as directed above as 
confidential.
    An electronic copy of this document and supplemental information to 
this proposed rule are available at http://www.regulations.gov for easy 
reference.

Legal Authority

    The Controlled Substances Act (CSA or Act) 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.\1\ The Attorney General has delegated this 
authority to the Administrator of the Drug Enforcement Administration 
(DEA).\2\
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    \1\ 21 U.S.C. 871(b).
    \2\ 28 CFR 0.100(b).

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[[Page 64882]]

Purpose of the Proposed Rule

    Currently, DEA regulations do not address the transfer of 
controlled substance prescriptions (paper or electronic) between 
pharmacies for initial filling.\3\ 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. Although the transfer of paper 
prescriptions between pharmacies for initial dispensing is not 
addressed in the regulations, these prescriptions are inherently 
portable due to the format of the prescription itself.
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    \3\ In contrast, as discussed below, 21 CFR 1360.25 already 
addresses the transfer of controlled substance prescriptions between 
pharmacies for refill purposes.
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    However, electronic prescriptions are generated using an electronic 
application and are transmitted directly from the practitioner to the 
pharmacy in the form of an electronic data file. Consequently, if a 
pharmacy receives an electronic prescription for a controlled substance 
(EPCS) that it is unable to fill, the pharmacy cannot give the 
prescription (i.e., electronic data file) to the patient to take to 
another pharmacy. Further, DEA regulations do not include provisions 
for a pharmacy to transfer an EPCS to another pharmacy; the regulations 
also do not describe how a pharmacy should handle an EPCS that it 
receives but cannot fill. At present, a pharmacy that receives an EPCS 
that it is unable to fill can only notify the patient that the 
prescription cannot be filled. In this scenario, the patient could then 
call the prescribing practitioner to request that a new EPCS be sent to 
a different pharmacy. DEA realizes that this scenario creates the 
potential for duplication of prescriptions if the practitioner 
transmits a new EPCS to a different pharmacy and does not cancel or 
void the original EPCS 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 original prescribing doctor and 
request a new prescription.
    Therefore, DEA is proposing to revise its regulations to state 
that, upon request, a registered retail pharmacy may transfer an EPCS 
to another registered retail pharmacy for initial filling. This 
proposed rule will also specify the procedures that retail pharmacies 
must follow and the information that must be documented when 
transferring electronic prescriptions for controlled substances in 
schedules II-V. 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 in 
schedule II only pursuant to a written prescription (including an 
EPCS), 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 paper prescription, a facsimile of a 
signed paper prescription, an EPCS, or an oral prescription made by an 
individual practitioner and promptly reduced to writing by the 
pharmacist.\6\ Prescriptions for schedule III and IV substances may not 
be filled or refilled more than six months after the date of issuance 
or be refilled more than five times.\7\ The CSA does not address the 
transfer of controlled substance prescriptions between pharmacies for 
initial filling. DEA regulations address the transfer of controlled 
substances prescriptions between pharmacies for refills, but not for 
initial filling.\8\ Hence, DEA is proposing to revise its regulations 
to state that the transfer of EPCS is permissible between registered 
retail pharmacies for initial filling on a one-time basis.
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    \4\ 21 CFR 1306.11(a) and (d).
    \5\ 21 U.S.C. 829(a).
    \6\ 21 CFR 1306.21(a).
    \7\ 21 CFR 1306.22(a).
    \8\ 21 CFR 1306.25.
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Why the Proposed Rule Is Necessary

    On March 31, 2010, DEA published an interim final rule, Electronic 
Prescriptions for Controlled Substances (EPCS IFR), which provides 
practitioners with the option of issuing, and pharmacies with the 
option of receiving, dispensing, and archiving electronic prescriptions 
for schedule II-V controlled substances.\9\ The EPCS IFR provides the 
regulations governing the electronic creation, signature, transmission, 
and processing of schedule II-V controlled substance prescriptions. The 
regulations, codified at 21 CFR parts 1300, 1304, 1306, and 1311, 
specifically define an electronic prescription as ``a prescription that 
is generated on an electronic application and transmitted as an 
electronic data file.'' \10\ The regulations also provide the security 
and recordkeeping requirements imposed on prescription and pharmacy 
applications that create, process, and archive electronic controlled 
substance prescriptions.
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    \9\ 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).
    \10\ 21 CFR 1300.03.
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    Although DEA regulations permit the transfer of prescription 
information between pharmacies for refill dispensing of schedules III-V 
controlled substance prescriptions on a one-time basis, the regulations 
do not address the transfer of controlled substance prescriptions 
(paper or electronic) for initial dispensing.\11\ As previously 
discussed, a patient can choose to take a paper prescription to another 
pharmacy if the first pharmacy is unable to fill it. However, because 
patients do not have a physical copy of an electronic prescription, the 
patient cannot take the prescription to another pharmacy if it cannot 
be filled by the first pharmacy.
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    \11\ 21 CFR 1306.25.
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    DEA emphasized in the EPCS IFR that the option for EPCS is in 
addition to, not a replacement of, the requirements and provisions that 
exist for paper prescriptions for controlled substances.\12\ Thus, the 
same rules and regulations applicable to paper prescriptions, as well 
as the same permissions, were also intended to apply to electronic 
prescriptions for controlled substances. Patients prescribed controlled 
substances electronically should have the same ability as patients 
issued paper controlled substance prescriptions to choose an alternate 
pharmacy if the first pharmacy is unable to fill a prescription. As 
more practitioners begin to issue controlled substance prescriptions 
electronically, as discussed below, there is an increasing need to 
address this issue.
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    \12\ 75 FR 16244.

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[[Page 64883]]

    In a recently published request for information, 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 the EPCS IFR was published in 2010.\13\ Further, 
the Substance Use-Disorder Prevention that Promotes Opioid Recovery and 
Treatment for Patients and Communities Act (SUPPORT Act) was signed 
into law on October 24, 2018.\14\ Section 2003 of the SUPPORT Act 
mandates the electronic prescribing of schedule II-V controlled 
substances (with some exceptions) covered under Medicare Part D, 
beginning on or after January 1, 2021.\15\ In addition, in its 2019 
National Progress Report, Surescripts, a health information network and 
electronic prescribing intermediary, noted that more than half of all 
States now require electronic prescribing of opioids, all controlled 
substances, or all prescriptions.\16\ Thus, it is essential that 
procedures for transferring an EPCS are established as electronic 
prescribing of controlled substances becomes more prevalent. This 
rulemaking is being proposed to address this issue.
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    \13\ Medicare Program: Electronic Prescribing of Controlled 
Substances; RFI, 85 FR 47151 (August 4, 2020).
    \14\ Substance Use-Disorder Prevention that Promotes Opioid 
Recovery and Treatment for Patients and Communities Act (SUPPORT 
Act), Public Law 115-271, 132 Stat. 3894 (2018).
    \15\ SUPPORT Act, sec. 2003(a)(b). This requirement is codified 
at 21 U.S.C. 1395w-104(e)(7).
    \16\ Surescripts, National Progress Report 2019 https://surescripts.com/news-center/national-progress-report-2019/ (Accessed 
March 31, 2021).
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    If finalized, this proposed rule would allow for the transfer of 
electronic prescriptions for schedules II-V controlled substances 
between DEA-registered retail pharmacies for initial filling. This 
proposed rule would also establish the procedures that must be followed 
and the information that must be documented when transferring an EPCS. 
For reasons discussed previously, this proposed rule focuses only on 
electronic prescriptions for controlled substances for initial 
dispensing and does not propose to amend 21 CFR 1306.25 which permits 
the transfer of paper, oral, or electronic prescriptions in schedules 
III, IV, and V for refill dispensing. A cross-reference to Sec.  
1306.25 is included in Sec.  1306.08(i) to provide an easy reference to 
the regulations regarding the transfer of electronic prescriptions for 
refill purposes. DEA believes this proposed rule, if finalized, will 
reduce the potential for duplicate prescriptions, as well as the 
opportunity for diversion.

Summary of Proposed Changes

    DEA proposes to amend its regulations to allow the transfer of EPCS 
between registered retail pharmacies for initial filling on a one-time 
basis only. The proposed amendment would explicitly state that a DEA-
registered retail pharmacy may transfer schedules II-V EPCS to another 
DEA-registered retail pharmacy for initial dispensing. The proposed 
amendment would stipulate 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 part 1306 must be unaltered during the transmission. This proposed 
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 proposed amendment would also describe the 
documentation requirements for pharmacies transferring an EPCS for 
initial dispensing. Specifically, the pharmacist transferring the EPCS 
must update the electronic prescription record to note that the 
prescription was transferred. The transferring pharmacist must also 
update the prescription record with the following information: The 
name, address, and DEA registration number of the pharmacy to which the 
prescription was transferred; the name of the pharmacist receiving the 
transfer; the name of the transferring pharmacist; and the date of the 
transfer. Likewise, the pharmacist receiving the transferred EPCS 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, under the proposed amendment, the electronic records 
documenting the transfer must be maintained for a period of two years 
from the date of the transfer by both the pharmacy transferring the 
EPCS and the pharmacy receiving the EPCS. This proposed rule does not 
change the existing requirements for all prescriptions, as outlined in 
21 CFR part 1306, Prescriptions, or the requirements for prescribing 
and pharmacy applications, as outlined in 21 CFR part 1311, 
Requirements for Electronic Orders and Prescriptions.

Regulatory Analyses

Executive Orders 12866 (Regulatory Planning and Review) and 13563 
(Improving Regulation and Regulatory Review)

    This proposed 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. DEA has determined that this proposed rule is not a 
``significant regulatory action'' under E.O. 12866, section 3(f).

Analysis of Benefits and Costs

    DEA is proposing to amend its regulations to allow the transfer of 
electronic prescriptions for schedule II-V controlled substances 
between registered retail pharmacies for initial dispensing on a one-
time basis only. This amendment will specify the procedure that must be 
followed and the information that must be documented when transferring 
an EPCS between registered retail pharmacies. As described below, DEA 
estimates the annual cost savings of this proposed rule is $22.0 
million.
    The proposed amendment would stipulate that: The transfer must be 
communicated directly between two licensed pharmacists; the 
prescription must remain in its electronic form and the required 
prescription information must be unaltered during the transmission. 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 is being electronically transferred, the name 
of the pharmacist receiving the transfer, the name of the transferring 
pharmacist, and the date of the transfer. Likewise, the pharmacist 
receiving the transferred prescription must record 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. Finally, under the proposed amendment, the electronic records 
documenting the transfer must 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 current DEA regulations do not address the transfer of schedule 
II-V controlled substance prescriptions in

[[Page 64884]]

any form (paper or electronic) from one retail pharmacy to another 
retail pharmacy for initial filling, DEA anticipates the proposed rule 
will affect the following parties: The first (transferring) pharmacy, 
patient, prescriber, and second (receiving) pharmacy. To quantify the 
economic impact of this proposed 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.\17\
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    \17\ 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.
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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 an EPCS it cannot fill under current practices versus the 
proposed regulations. 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 pharmacy contacts the patient to inform the patient 
that they are unable to fill the prescription.
    2. The first pharmacy notes action taken, as needed.
    3. Patient receives call from the first pharmacy that they are 
unable to fill the prescription.
    4. Patient contacts prescriber and requests new prescription.
    5. Prescriber's secretary or administrative personnel receives 
phone call from the patient (likely by an administrative personnel at 
the prescriber's office).
    6. Prescriber cancels the EPCS at the first pharmacy and issues a 
new EPCS at an alternate (receiving) pharmacy.
    7. Receiving pharmacy receives and fills EPCS.
    8. Patient receives filled prescription from the alternate 
pharmacy.
    The anticipated activities for each of the affected parties under 
the proposed regulations and the economic impact are described below.
    1. Transferring pharmacy contacts patient to inform that they are 
unable to fill the prescription. Assume duration of the call to the 
patient is same under current and proposed scenarios. Therefore, no 
impact.
    2. The patient receives a call from the transferring pharmacy that 
they are unable to fill the prescription; the patient requests the 
prescription be transferred to an alternate (receiving) pharmacy. 
Assume duration of the call from the transferring pharmacy is same 
under current and proposed scenarios. Therefore, no impact.
    3. Transferring pharmacy transfers prescription (including 
contacting the receiving pharmacy, exchanging information, and 
recording the required information regarding transfer). Transferring 
will take longer than simply informing the patient that the 
prescription cannot be filled. Therefore, additional cost to transfer.
    4. Patient does not need to contact prescriber to request a new 
prescription under proposed regulations. Therefore, cost savings from 
not needing to contact prescriber.
    5. Patient receives filled prescription from receiving pharmacy. 
Assume same burden, no impact.
    6. Prescriber does not receive a call from the patient. Therefore, 
cost savings.
    7. Prescriber does not need to issue a new EPCS. Therefore, cost 
savings.
    8. Receiving pharmacy receives transfer and fills transferred EPCS 
(including being contacted by the transferring pharmacy, exchanging 
information, and recording the required information regarding 
transfer). Anticipate additional costs related to being contacted by 
the transferring pharmacy and exchanging information.
    Table 1 summarizes the activity scenarios under current practices 
and proposed regulations and the anticipated economic impact.

[[Page 64885]]

[GRAPHIC] [TIFF OMITTED] TP19NO21.577

    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. Using the occupation codes 29-1051 
Pharmacists, 00-0000 All Occupations, 43-6013 Medical Secretaries and 
Administrative Assistants, and 29-1215 Family Medicine Physicians as 
best representations of first (transferring) and second (receiving) 
pharmacists, patient, prescriber's secretary, and prescriber, 
respectively, DEA estimates the median hourly wages for the first 
(transferring) and second (receiving) pharmacy, patient, prescriber's 
secretary, and prescriber are $61.58, $19.14, $17.59, and $98.84, 
respectively.\18\ Additionally, BLS reports that average benefits for 
private industry is 30.0 percent of total compensation. The 30.0 
percent of total compensation equates to 42.9 percent (30.0 percent/
70.0 percent) load on wages and salaries.\19\ The load of 42.9 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 prescriber 
are $88.00, $27.35, $25.14, and $141.24, respectively. Table 2 
summarizes the calculation for the loaded hourly wages for each of the 
affected persons.
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    \18\ BLS, May 2019 National Occupational Employment and Wage 
Estimates United States. http://www.bls.gov/oes/current/oes_nat.htm.
    \19\ BLS, ``Employer Costs for Employee Compensation--September 
2020'' (ECEC).

[[Page 64886]]



                                          Table 2--Loaded Hourly Wages
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                                         Occupation         Occupation code       Median hourly   Loaded hourly
           Affected persons                 code              description             wage         median wage
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Patient..............................         00-0000  All Occupations.........          $19.14           $27.35
Pharmacist...........................         29-1051  Pharmacists.............           61.58            88.00
Medical secretary....................         43-6013  Medical Secretaries and            17.59            25.14
                                                        Administrative
                                                        Assistants.
Prescriber...........................         29-1215  Family Medicine                    98.84           141.24
                                                        Physicians.
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    The below sections describe the calculation conducted to quantify 
the economic impact associated with the changes in activities under the 
current and proposed 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 $88.00. Multiplying the loaded hourly rate of $88.00 by 
0.05 (3/60) hours results in a cost of $4.40. Under the proposed 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 proposed rule, resulting in the same cost of 
$4.40. Therefore, there is no economic impact associated with this 
activity under the proposed 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 $88.00. Multiplying the loaded hourly 
rate of $88.00 by 0.0167 (1/60) hours results in a cost of $1.47. Under 
the proposed 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 $88.00. Multiplying the 
loaded hourly rate of $88.00 multiplied by 0.05 (3/60) hours results in 
a cost of $4.40. Therefore, the net cost to the transferring pharmacy 
under the proposed rule is $2.93 ($4.40-$1.47) per transfer.
    3. Under current practices, the patient first receives a call from 
the pharmacist who informs them that their 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 $27.35. Multiplying the loaded hourly rate of 
$27.35 multiplied by 0.05 (3/60) hours results in a cost of $1.37 to 
the patient. Under the proposed rule, this activity does not change. 
With transfers of an EPCS, the pharmacist must still contact the 
patient. Thus, under the proposed rule, the patient also receives a 
call from the pharmacist. Estimating three minutes for the call, there 
is still a cost of $1.37 to the patient. Therefore, there is no 
economic impact associated with this activity under the proposed 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 $27.35. Multiplying the loaded 
hourly rate of $27.35 by 0.083 (5/60) hours results in a cost of $2.28. 
Under the proposed 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 proposed rule results in a cost 
savings of $2.28 per transfer.
    5. Under current practices, DEA assumes that the patient is 
informed that the first pharmacy is unable to fill the prescription 
prior to travelling 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 $27.35. Multiplying the loaded hourly rate of $27.35 by 
0.33 (20/60) hours results in a cost of $9.12. Under the proposed rule, 
DEA also assumes that the patient is informed about the pending 
transfer of the prescription prior to travelling 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 
proposed rule, there is still a cost of $9.12 to the patient. 
Therefore, there is no economic impact associated with this activity 
under the proposed rule.
    6. 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 $25.14. Multiplying the loaded hourly rate of 
$25.14 by 0.083 (5/60) hours results in a cost of $2.10. Under the 
proposed rule, the patient no longer needs to contact the prescriber; 
thus, this interaction will not occur. Therefore, this activity under 
the proposed rule results in a cost savings of $2.10 per transfer.
    7. 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 $141.24. Multiplying the loaded hourly rate of $141.24 by 
0.03 (2/60) hours results in a cost of $4.71. Under the proposed rule, 
the prescriber does not need to issue a new prescription. The original 
prescription is simply transferred to the receiving pharmacy; thus, 
this activity will not occur. Therefore, this activity under the 
proposed rule results in a cost savings of $4.71 per transfer.
    8. 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 $88.00. Multiplying the loaded hourly rate of $88.00 by 
0.25 (15/60) hours results in a cost of $22.00. Under the proposed 
rule, DEA also estimates the receiving pharmacist still conducts this 
activity at the same

[[Page 64887]]

loaded labor rate and time duration, resulting in a cost of $22.00. 
However, under the proposed 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 $88.00. Multiplying the loaded 
hourly rate of $88.00 by 0.05 (3/60) hours results in a cost of $4.40. 
Therefore, this activity under the proposed rule results in a cost of 
$4.40 per transfer.
    As shown by Table 3, the proposed rule results in a total cost of 
$8.80 and a total cost savings of $10.56 per transfer. This results in 
an overall net cost savings of $1.76 per transfer.
[GRAPHIC] [TIFF OMITTED] TP19NO21.578

Estimated Number of Transfers
    As mentioned earlier, in order to calculate the total cost savings, 
DEA applied the $1.76 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 from 2022 to 2026, the 
analysis period, and applying an estimated percentage of EPCS that will 
be transferred.\20\
---------------------------------------------------------------------------

    \20\ Due to the rapidly evolving industry and regulatory 
conditions, the analysis period is from 2022 to 2026.
---------------------------------------------------------------------------

    Surescripts' reports, ``2019 National Progress Report'' and ``2020 
National Progress Report'' form the basis for estimating the number of 
EPCS from 2022 to 2026.\21\ The reports indicate that the rate of 
electronic prescribing for non-controlled substances (E-RX) was 76, 83, 
and 86, and 89 percent in 2017, 2018, 2019, and 2020, respectively.\22\ 
Additionally, the reports indicate that the rate of electronic 
prescribing for controlled substances (EPCS) is rising rapidly; the 
rate was 17, 26, 38, and 58 percent in 2017, 2018, 2019, and 2020, 
respectively.\23\ Furthermore, there were 65.0, 96.8, 134.2, and 203.6 
million EPCS filled in 2017, 2018, 2019, and 2020 respectively.\24\ 
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, and 351.0 million in 2017, 2018, 2019, and 
2020, respectively. Table 4 summarizes the data provided by the report 
and the

[[Page 64888]]

estimated total prescriptions for controlled substances for years 2017-
2020.
---------------------------------------------------------------------------

    \21\ Surescripts, ``2019 National Progress Report'' for 2017 
data and ``2020 National Progress Report'' for 2018-2020 data.
    \22\ Ibid.
    \23\ Ibid.
    \24\ Ibid.

                   Table 4--Estimated Total Prescriptions for Controlled Substances, 2017-2020
----------------------------------------------------------------------------------------------------------------
                                                                  2017         2018         2019         2020
----------------------------------------------------------------------------------------------------------------
Non-Controlled Substances:
    Rate of E-Rx (%)........................................           76           83           86           89
Controlled Substances:
    Total Rx, E and non-E (millions of Rx)..................        382.4        372.3        353.2        351.0
    Rate of EPCS (%)........................................           17           26           38           58
    Total EPCS (millions of Rx).............................         65.0         96.8        134.2        203.6
----------------------------------------------------------------------------------------------------------------

    As shown in Table 4, the estimated total prescriptions for 
controlled substances decreased from 382.4 million in 2017 to 351.0 
million in 2020. For the purposes of this analysis, DEA estimates the 
total number of controlled substances prescriptions will stay constant 
at 351.0 million from 2022 to 2026.
    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 
2022 due to a recently published CMS rule, which requires electronic 
prescribing for all controlled substances (with some exceptions) 
covered under Medicare Part D.\25\ The 2020 rate of electronic 
prescriptions for non-controlled substances was 89 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 89 percent and the rate of 
electronic prescribing for controlled substances will be 89 percent for 
the analysis period of 2022-2026. Multiplying the estimated total 
number of controlled substance prescriptions, 351.0 million per year, 
by the estimated rate of EPCS of 89 percent, the estimated total EPCS 
is 312.4 million per year for the analysis period 2022-2026.
---------------------------------------------------------------------------

    \25\ 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.\26\ 
Applying the four percent transfer rate to the total EPCS 
prescriptions, DEA estimates the number of transfers are 12.5 million 
per year from 2022-2026.
---------------------------------------------------------------------------

    \26\ Conference call between CMS and DEA, January 2021. CMS's 
estimate is a ``high'' estimate and ``4 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 $1.76 
net cost savings per transaction to the estimated 12.5 million 
transfers, resulting in a total annual net cost savings of $22.0 
million over the analysis period, 2022-2026. The net present value 
(NPV) of the cost savings is $100.8 million at three percent discount 
rate and 90.2 million at seven percent discount rate. The annualized 
cost savings from 2022 to 2026 is $22.0 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         7
                                                       percent   percent
------------------------------------------------------------------------
NPV of Cost Savings.................................    $100.8     $90.2
Annualized Cost Savings.............................      22.0      22.0
------------------------------------------------------------------------

Executive Order 12988, Civil Justice Reform

    This proposed 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 proposed rule does not have federalism implications warranting 
the application of E.O. 13132. The proposed 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 proposed 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 proposed rule on small entities. DEA's 
evaluation of economic impact by size category indicates that the 
proposed rule will not, if promulgated, 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 proposed rule 
and estimates that it will have minimal economic impact on affected 
entities, including small businesses, nonprofit organizations, and 
small governmental jurisdictions.
    DEA is proposing to amend its regulations to allow the electronic 
transfer of schedule II-V controlled substance prescriptions between 
registered retail pharmacies for initial filling on a one-time basis 
only. This amendment will specify the procedure that must be followed 
and the information that must be documented when electronically 
transferring an EPCS between pharmacies. The proposed amendment would 
stipulate that the transfer must be communicated directly between two 
licensed pharmacists, the prescription must remain in its electronic 
form, and the required prescription information must be unaltered 
during the transmission.

[[Page 64889]]

Nothing in this proposed rule alters the existing pharmacy application 
requirements as specified in 21 CFR 1311.205.
    In addition to the above, the pharmacist transferring the 
prescription must update the electronic prescription record to include 
information noting 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 is being 
transferred, the name of the pharmacist receiving the transfer, the 
name of the transferring pharmacist, and the date of the transfer. 
Likewise, the pharmacist receiving the transferred prescription must 
record 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. Finally, under the proposed 
amendment, the electronic records documenting the transfer must 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 transfer.
    DEA anticipates the proposed 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 the proposed rule. There may be other small 
entities under Small Business Administration size standards in other 
NAICS code industries affected by this proposed 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
------------------------------------------------------------------------
       Business activity           NAICS code     NAICS code description
------------------------------------------------------------------------
Pharmacy.......................          446110  Pharmacies and Drug
                                                  Stores.
Prescriber.....................          621111  Offices of Physicians
                                                  (except Mental Health
                                                  Specialists).
                                         622110  General Medical and
                                                  Surgical Hospitals.
------------------------------------------------------------------------

    Although transfers of EPCS may not be common, as much as four 
percent of prescriptions, DEA estimates, for the purposes of this 
analysis, 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 would be affected 
by this proposed rule.
    In order to determine if the proposed rule will result in a 
significant impact on 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 $2.93 (the cost of 
transferring the prescription, $4.40 (2.b.), minus the cost of updating 
the prescription record to note that the prescription was not filled, 
$1.47 (2.a.)). The cost to the receiving pharmacy is $4.40 (8.b.) per 
transfer, resulting in a combined net cost of $7.33. Each transfer 
affects two different pharmacies, transferring and receiving 
pharmacies. However, to be conservative, the estimated cost per 
transfer to a pharmacy is $7.33 because the transferring and receiving 
pharmacies may be different establishments of the same parent entity. 
Also from Table 3, the total cost savings to a prescriber (office of 
physician or hospital) is $6.81, sum of the cost savings from not 
receiving a call from the patient $2.10 (6.) and the cost savings from 
not issuing a new prescription $4.71 (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 12.5 million per year. Multiplying the net cost of $7.33 
per transfer for pharmacies by 12.5 million transfers, the estimated 
total cost of transfers to all pharmacies is $91,625,000 per year. 
Multiplying the cost saving of $6.81 per transfer for prescribers 
(office of physician or hospital) by 12.5 million transfers, the 
estimated total cost saving to all prescribers is $85,125,000 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 18,852, 174,901, and 2,904 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.\27\ Furthermore, the total 
receipts for all firms, including all size ranges, are $236 billion, 
$402 billion, and $827 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.\28\ Table 7 summarizes the SUSB data 
and provides receipt values without rounding.
---------------------------------------------------------------------------

    \27\ SUSB, 2012 SUSB Annual Data Tables by Establishment 
Industry, Data by Enterprise Receipt Size, U.S., 6-digit NAICS, 
https://www.census.gov/data/tables/2012/econ/susb/2012-susb-annual.html (https://www2.census.gov/programs-surveys/susb/tables/2012/us_6digitnaics_r_2012.xlsx). (Accessed February 25, 2021.) 2012 
data by enterprise receipt size is the latest available.
    \28\ Ibid.

[[Page 64890]]



                                   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...............          18,852     236,277,373
                          Stores.
621111.................  Offices of Physicians    All size ranges...............         174,901     402,159,295
                          (except Mental Health
                          Specialists).
622110.................  General Medical and      All size ranges...............           2,904     826,654,913
                          Surgical Hospitals.
----------------------------------------------------------------------------------------------------------------

    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 751 firms with receipts under 
$100,000, and their combined receipts is $36,066,000. Dividing 
$36,066,000 by 751 results in an average receipt of $48,024 per firm. 
Performing the same calculation for all three industries, the average 
receipt per firm is $48,024, $50,493, and $272,286 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          751       36,066       48,024
                            Stores.
621111...................  Offices of Physicians                 <100,000       15,275      771,280       50,493
                            (except Mental Health
                            Specialists).
622110...................  General Medical and          * 100,000-499,999           14        3,812      272,286
                            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 751 firms with 
receipts under $100,000 in 446110--Pharmacies and Drug Stores industry 
sector is $36,066,000. This is 0.015264 percent of total receipt of 
$236,277,373,000 for all size ranges. Allocating 0.015264 percent of 
total cost to pharmacies of $91,625,000 to the 751 firms, the average 
cost per firm is $19.\29\ Dividing the average cost per firm of $19 by 
the average receipt per firm of $48,024, the average cost per firm is 
0.03956 percent of average receipt per firm.
---------------------------------------------------------------------------

    \29\ ($91,625,000 x 0.015264 percent)/751 = $19.
---------------------------------------------------------------------------

    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 
are 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 0.03956 percent, 0.02179 percent, and 0.01028 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   Allocated                cost savings
                                                                                          Number of   percent of    cost to      Average     per firm as
             NAICS code                   NAICS code description       Receipt size ($)     firms       total       firms in     cost per    percent of
                                                                                                      (percent)    size range    firm ($)      receipt
                                                                                                                      ($)                     (percent)
--------------------------------------------------------------------------------------------------------------------------------------------------------
446110..............................  Pharmacies and Drug Stores....           <100,000         751     0.015264       13,762           19      0. 03956
621111..............................  Offices of Physicians (except            <100,000      15,275     0.191785      160,645           11   * (0.02179)
                                       Mental Health Specialists).
622110..............................  General Medical and Surgical      100,000-499,999          14     0.000461          386           28   * (0.01028)
                                       Hospitals.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Cost savings.

    In conclusion, the average cost or cost savings per firm as percent 
of receipt of 0.03956 percent, 0.02179 percent, and 0.01028 percent are 
not significant economic impacts. Therefore, DEA concludes this 
proposed rule will not, if promulgated, have a significant economic 
impact on a substantial number of small entities.

[[Page 64891]]

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 
proposed rule would 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 proposed rule.\30\ If adopted, this proposed rule would 
create additional 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 obtained at 
http://www.reginfo.gov/public/do/PRAMain.
---------------------------------------------------------------------------

    \30\ 44 U.S.C. 3501 et seq.
---------------------------------------------------------------------------

A. Collections of Information Associated With the Proposed 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-NEW.
    DEA Form Number: N/A.
    DEA is proposing to require pharmacies to create and maintain 
certain records relating to the transfer of unfilled EPCS between 
pharmacies for initial filling. The rulemaking proposes to require the 
transferring pharmacy to note in the electronic prescription record 
that the prescription was transferred. The transferring pharmacy would 
also be 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 proposed rule would require 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 proposed rule 
would require 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.
B. Request for Comments Regarding the Proposed Collections of 
Information
     Written comments and suggestions from the public and 
affected entities concerning the proposed collections of information 
are encouraged. Under the PRA, the DEA is required to provide a notice 
regarding the proposed collections of information in the Federal 
Register with the notice of proposed rulemaking and solicit public 
comment. Pursuant to section 3506(c)(2) of the PRA, the DEA solicits 
comment on the following issues: The need for the information 
collection and its usefulness in carrying out the proper functions of 
DEA.
     The accuracy of DEA's estimate of the burden the proposed 
collection of information, including the validity of the methodology 
and assumptions used.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    Please send written comments 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. All comments must be submitted to OMB on or before January 
18, 2022. The final rule will respond to any OMB or public comments on 
the information collection requirements contained in this proposal.

List of Subjects 21 CFR Part 1306

    Drug traffic control, Prescription drugs.

    For the reasons stated in the preamble, DEA proposes to amend 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, 829(a), 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 on a one-time basis only.
    (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 part 1306 of this 
chapter 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.
    (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

[[Page 64892]]

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 
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.

Anne Milgram,
Administrator.
[FR Doc. 2021-24981 Filed 11-18-21; 8:45 am]
BILLING CODE 4410-09-P