Proposed Rule2021-24981
Transfer of Electronic Prescriptions for Schedules II-V Controlled Substances Between Pharmacies for Initial Filling
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Published
November 19, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 221 (Friday, November 19, 2021)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>
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 <a href="http://Regulations.gov">Regulations.gov</a>. 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a> 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a> 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 <a href="https://surescripts.com/news-center/national-progress-report-2019/">https://surescripts.com/news-center/national-progress-report-2019/</a> (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. <a href="http://www.bls.gov/oes/current/oes_nat.htm">http://www.bls.gov/oes/current/oes_nat.htm</a>.
\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 $827 billion (rounded) for 446110--Pharmacies and
Drugs Stores, 621111--Offices of Physicians (except Mental Health
Specialists), and 622110--General Medical and Surgical Hospitals
industry sectors, respectively.\28\ Table 7 summarizes the SUSB data
and provides receipt values without rounding.
---------------------------------------------------------------------------
\27\ SUSB, 2012 SUSB Annual Data Tables by Establishment
Industry, Data by Enterprise Receipt Size, U.S., 6-digit NAICS,
<a href="https://www.census.gov/data/tables/2012/econ/susb/2012-susb-annual.html">https://www.census.gov/data/tables/2012/econ/susb/2012-susb-annual.html</a> (<a href="https://www2.census.gov/programs-surveys/susb/tables/2012/us_6digitnaics_r_2012.xlsx">https://www2.census.gov/programs-surveys/susb/tables/2012/us_6digitnaics_r_2012.xlsx</a>). (Accessed February 25, 2021.) 2012
data by enterprise receipt size is the latest available.
\28\ Ibid.
[[Page 64890]]
Table 7--Number of Firms and Total Receipts
----------------------------------------------------------------------------------------------------------------
Number of Receipts
NAICS code NAICS code description Receipt size ($) 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
<a href="http://www.reginfo.gov/public/do/PRAMain">http://www.reginfo.gov/public/do/PRAMain</a>.
---------------------------------------------------------------------------
\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:
<bullet> Number of respondents: 70,567.
<bullet> Frequency of response: 354.273244 (calculated average).
<bullet> Number of responses: 25,000,000.
<bullet> Burden per response: 0.05 hour.
<bullet> 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
<bullet> 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.
<bullet> The accuracy of DEA's estimate of the burden the proposed
collection of information, including the validity of the methodology
and assumptions used.
<bullet> The quality, utility, and clarity of the information to be
collected.
<bullet> 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
</pre></body>
</html>Indexed from Federal Register on November 19, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.