Rule2026-11526
Implementation of the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018: Dispensing and Administering Controlled Substances for Medication-Assisted Treatment
Primary source
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Published
June 9, 2026
Effective
July 9, 2026
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The "Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018 (the SUPPORT Act)," which became law on October 24, 2018, amended the Controlled Substances Act to expand the conditions a practitioner must meet to provide medication-assisted treatment for opioid use disorder and expand the options available for a physician to be considered a qualifying physician. The SUPPORT Act also allowed a pharmacy to deliver prescribed controlled substances to a practitioner's registered location for the purpose of maintenance or detoxification treatment to be administered under certain conditions by a practitioner. The Drug Enforcement Administration promulgated an interim final rule with request for comments in November 2020 to amend its regulations to make them consistent with the SUPPORT Act and implement its requirements. On December 29, 2022, the Restoring Hope for Mental Health and Well-Being Act of 2022 removed many of the statutory provisions of the SUPPORT Act. This final rule adopts the provisions of the interim final rule that are still applicable as final, with minor changes. In addition, this final rule implements the related provisions of the Restoring Hope for Mental Health and Well-Being Act of 2022.
Full Text
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<title>Federal Register, Volume 91 Issue 110 (Tuesday, June 9, 2026)</title>
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[Federal Register Volume 91, Number 110 (Tuesday, June 9, 2026)]
[Rules and Regulations]
[Pages 34754-34768]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-11526]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1300, 1301, and 1306
[Docket No. DEA-499]
RIN 1117-AB55
Implementation of the Substance Use-Disorder Prevention That
Promotes Opioid Recovery and Treatment for Patients and Communities Act
of 2018: Dispensing and Administering Controlled Substances for
Medication-Assisted Treatment
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
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SUMMARY: The ``Substance Use-Disorder Prevention that Promotes Opioid
Recovery and Treatment for Patients and Communities Act of 2018 (the
SUPPORT Act),'' which became law on October 24, 2018, amended the
Controlled Substances Act to expand the conditions a practitioner must
meet to provide medication-assisted treatment for opioid use disorder
and expand the options available for a physician to be considered a
qualifying physician. The SUPPORT Act also allowed a pharmacy to
deliver prescribed controlled substances to a practitioner's registered
location for the purpose of maintenance or detoxification treatment to
be administered under certain conditions by a practitioner. The Drug
Enforcement Administration promulgated an interim final rule with
request for comments in November 2020 to amend its regulations to make
them consistent with the SUPPORT Act and implement its requirements. On
December 29, 2022, the Restoring Hope for Mental Health and Well-Being
Act of 2022 removed many of the statutory provisions of the SUPPORT
Act. This final rule adopts the provisions of the interim final rule
that are still applicable as final, with minor changes. In addition,
this final rule implements the related provisions of the Restoring Hope
for Mental Health and Well-Being Act of 2022.
DATES: This final rule is effective July 9, 2026.
FOR FURTHER INFORMATION CONTACT: Heather E. Achbach, Regulatory
Drafting and Policy Support Section (DPW) Diversion Control Division,
Drug Enforcement Administration; Mailing Address: 8701 Morrissette
Drive, Springfield, Virginia 22152; Telephone: (571) 776-3882.
SUPPLEMENTARY INFORMATION:
Legal Authority
Pertinent Provisions of the SUPPORT Act
The Controlled Substances Act (CSA), in 21 U.S.C 823(h),\1\ has
long mandated that practitioners who dispense narcotic drugs for
maintenance or detoxification treatment must obtain an annual separate
registration for that purpose \2\ and has also provided exceptions to
that requirement in a previous iteration. Congress has revised, and
then removed, the exceptions over time. Previously, 21 U.S.C. 823(h)(2)
set forth the conditions under which a practitioner could, without
being separately registered as a Narcotic Treatment Program (NTP),
dispense a narcotic drug in Schedule III, IV, or V for the purpose of
maintenance treatment \3\ or detoxification treatment.\4\ On October
24, 2018, the President signed the SUPPORT Act into law as Public Law
115-271. Sections 3201 and 3202 of the SUPPORT Act amended certain
provisions of 21 U.S.C. 823(g)(2) [now 823(h)(2)].\5\ Section 3204 of
the SUPPORT Act amended the Controlled Substances Act (CSA) by adding
section 309A (21 U.S.C. 829a), which sets forth the conditions under
which a pharmacy may deliver certain controlled substances to the
prescribing practitioner or the practitioner administering the
controlled substance (administering practitioner) for the purpose of
maintenance or detoxification treatment. All of the changes to the CSA,
from these sections of the SUPPORT Act, will be fully described below.
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\1\ The language being discussed originally was codified at 21
U.S.C. 823(g). It was redesignated as 21 U.S.C. 823(h) by the
Medical Marijuana and Cannabidiol Research Expansion Act, 117 Public
Law 215 Sec. 103 (2022).
\2\ This requirement was incorporated into the CSA by the
Narcotic Treatment Act of 1974 (NATA), 93 P.L. 281 Sec. 3 (1974).
\3\ 21 U.S.C. 802(29) defines maintenance treatment as the
dispensing, for a period in excess of twenty-one days, of a narcotic
drug in the treatment of an individual for dependence upon heroin or
other morphine-like drugs.
\4\ 21 U.S.C. 802(30) defines detoxification treatment as the
dispensing, for a period not in excess of one hundred and eighty
days, of a narcotic drug in decreasing doses to an individual in
order to alleviate adverse physiological or psychological effects
incident to withdrawal from the continuous or sustained use of a
narcotic drug and as a method of bringing the individual to a
narcotic drug-free state within such period.
\5\ DEA notes that the SUPPORT for Patients and Communities
Reauthorization Act of 2025 (Pub. L. 119-44) became law on December
1, 2025, which includes an additional flexibility to allow delivery
of a controlled substance by a pharmacy to a practitioner. This
provision will be implemented in a future rulemaking.
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Restoring Hope for Mental Health and Well-Being Act of 2022
On December 29, 2022, the President signed the Restoring Hope for
Mental Health and Well-Being Act of 2022 into law by way of the
Consolidated Appropriations Act, 2023 (hereinafter Omnibus), as title I
of Division FF of Public Law 117-328. Section 1262 of the Omnibus
amended the CSA by striking section 303(h)(2) (21 U.S.C. 823(h)(2)) in
its entirety and striking parts of 303(h)(1) (21 U.S.C. 823(h)(1)),
eliminating the DATA-waiver program.\6\ Additionally, Section 1263 of
the Omnibus added paragraph (m) to section 303 (21 U.S.C. 823),
implementing a one-time training requirement for prescribers of
controlled
[[Page 34755]]
substances.\7\ Section 1264 amended section 309A(a)(5) (21 U.S.C.
829a(a)(5)) by increasing the number of days within which certain
controlled substances must be administered. All of the changes to the
CSA from these sections of the Omnibus will be fully described below.
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\6\ On October 17, 2000, Congress passed the Drug Addiction
Treatment Act of 2000 (DATA), amending the CSA to establish ``waiver
authority for physicians who dispense or prescribe certain narcotic
drugs for maintenance treatment or detoxification treatment.''
Public Law 106-310, title XXXV; 114 Stat. 1222. Prior to DATA, the
CSA and DEA regulations required practitioners who wanted to conduct
maintenance or detoxification treatment using any narcotic
controlled drugs to be registered as a Narcotic Treatment Program
(NTP) in addition to the practitioner's personal registration.
Hence, the term ``DATA-waiver program'' is used to describe the
process by which individual practitioners (physicians, nurse
practitioners, physician assistants, clinical nurse specialists,
certified registered nurse anesthetists, and certified nurse
midwives) would receive an identification number from DEA, and be
exempt from the requirement for separate registration to dispense or
prescribe schedule III, IV, or V narcotic controlled drugs approved
by the Food and Drug Administration specifically for use in
maintenance or detoxification treatment.
\7\ In the Omnibus, this provision was designated as subsection
(l). In the Halt All Lethal Trafficking of Fentanyl Act, Public Law
119-26 Sec. 3(a) (2025), Congress redesignated this provision as
subsection (m) because 21 U.S.C. 823 already contained a subsection
(l).
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Background
Opioid Use Disorder and Treatment Need
Opioid use disorder in the United States continue to impact
disparate communities and populations. According to the report ``Key
Substance Use and Mental Health Indicators in the United States:
Results from the 2019 National Survey on Drug Use and Health'' released
by the Substance Abuse and Mental Health Services Administration
(SAMHSA), an estimated 1.6 million people (0.6 percent of this
population) aged 12 or older had an opioid use disorder (OUD) in
2019.\8\ The share of the population 12 and older estimated to have had
an OUD in 2015, 2016, 2017, and 2018 was 0.9 percent, 0.8 percent, 0.8
percent, and 0.7 percent respectively. Among people aged 12 or older
with an OUD in 2019, about 294,000 received medication-assisted
treatment (MAT) for OUD at a specialty facility \9\ in the past year,
or 18.1 percent of all those with an OUD. The percentage of those with
an OUD that received treatment at a specialty facility in 2015, 2016,
2017, and 2018 was estimated to be 21.7 percent, 21.1 percent, 28.6
percent, and 19.7 percent respectively.
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\8\ U.S. Department of Health and Human Services. SAMHSA. Key
Substance Use and Mental Health Indicators in the United States:
Results from the 2019 National Survey on Drug Use and Health. 2020.
In this final rule, the Drug Enforcement Administration (DEA) used
results from the 2019 National Survey on Drug Use and Health, the
most recent data available at the time of the initial drafting of
this final rule. In its November 2, 2020, interim final rule, the
DEA used results from the 2018 National Survey on Drug Use and
Health, the most recent data available at that time. See 85 FR
69153, 69154.
\9\ According to the 2019 National Survey on Drug Use and
Health, substance use treatment at a specialty facility refers to
substance use treatment at a hospital (only as an inpatient), a drug
or alcohol rehabilitation facility (as an inpatient or outpatient),
or a mental health center. This definition historically has not
considered emergency rooms, private doctors' offices, prisons or
jails, and self-help groups to be specialty facilities for the
receipt of substance use treatment.
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Interim Final Rule
DEA published an Interim Final Rule (IFR) with request for comments
in the Federal Register on November 2, 2020. 85 FR 69153. The
regulations went into effect on October 30, 2020; however, comments
could be submitted through January 4, 2021.
Additional Flexibility Regarding the DATA-Waiver Patient Limit
In the IFR, in accordance with Sec. 3201(a) of the SUPPORT Act
(formerly codified at 21 U.S.C. 823(h)(2)), DEA revised 21 CFR
1301.28(b)(1)(iii)(B)(2) to provide flexibility to practitioners
regarding the number of patients they may treat under a DATA-waiver,
without being separately registered as an NTP. In addition to the
options that were available before the SUPPORT Act, DEA added more
opportunities to increase the applicable number of patients that may be
treated under a DATA-waiver from 30 to 100. DEA also revised 21 CFR
1301.28(b)(1)(iii)(B) in the IFR to clarify that a practitioner
treating up to 275 patients must meet the requirements set forth in 42
CFR 8.610 to 8.655.\10\
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\10\ DEA added the 275 limit in a 2018 final rule (83 FR 3071,
January 23, 2018) to reflect limits set by the Department of Health
and Human Services (81 FR 44712, July 8, 2016).
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Elimination of Time Limit for Certain Qualifying Practitioners and
Expanding the Definition of Qualifying Other Practitioner
Prior to passage of the Omnibus, the CSA mandated that a
practitioner who dispensed narcotic drugs for maintenance treatment or
detoxification treatment under a DATA-waiver be a qualifying
practitioner, which included ``qualifying physicians'' and ``qualifying
other practitioners.'' 21 U.S.C. 823(h)(2)(B)(i). Pursuant to
Sec. Sec. 3201(b)-(d) of the SUPPORT Act, the IFR revised 21 CFR
1301.28(b)(1)(i) to permanently allow a nurse practitioner or a
physician assistant to be considered a ``qualifying other
practitioner,'' and temporarily (until October 1, 2023) expanded the
definition of a ``qualifying practitioner'' to also include a clinical
nurse specialist (CNS), certified registered nurse anesthetist (CRNA),
or a certified nurse midwife (CNM) who meets the qualifications set
forth in 21 U.S.C. 823(h)(2)(G)(iv), allowing more flexibility.
Additional Option To Allow a Physician To Become a Qualifying Physician
Section 3202(a) of the SUPPORT Act added an eighth option for a
physician to be considered a ``qualifying physician'' for purposes of
the DATA waiver. In the IFR, DEA revised 21 CFR 1306.04 by adding
paragraph (d) to implement this new option. Specifically, paragraph (d)
allows a physician to be considered a qualifying physician if they
graduated in good standing from an accredited school of allopathic
medicine or osteopathic medicine in the United States within the five-
year period immediately preceding the date that the physician notified
the Secretary of the Department of Health and Human Services (HHS)
(Secretary of HHS or Secretary) of their intent to dispense narcotic
drugs for maintenance or detoxification treatment, and successfully
completed a comprehensive allopathic or osteopathic medicine curriculum
or accredited medical residency that included training as further
specified in the statute.
Dispensing Controlled Substances for Maintenance or Detoxification
Treatment
Section 3204(a) of the SUPPORT Act amended the CSA by adding
section 309A (21 U.S.C. 829a), which sets forth the conditions in which
a pharmacy may deliver certain prescribed controlled substances to an
administering practitioner, where previously a pharmacy could only
deliver such prescribed controlled substance to an ultimate user or
research subject. The preamble of the IFR explained, at length, the
conditions stipulated in 21 U.S.C. 829a for a pharmacy to deliver
certain prescribed controlled substances to the prescribing
practitioner's or administering practitioner's registered location for
the purpose of maintenance or detoxification treatment to be
administered to a patient. See 85 FR 69153, 69155. Briefly, 21 U.S.C.
829a allowed a pharmacy to deliver narcotic drugs in schedule III, IV,
or V, or combinations of such drugs, approved by FDA for use in
maintenance or detoxification treatment, in accordance with a
prescription, to a practitioner for the purpose of administration by
injection or implantation. Under the SUPPORT Act, the prescription was
required to be issued by a qualifying practitioner and the prescription
could not be used to supply any practitioner with a stock of controlled
substances for the purpose of general dispensing to patients. In the
IFR, DEA implemented these conditions by adding Sec. 1306.07(f).
In addition, at the time, 21 U.S.C. 829a stipulated that the
practitioner must administer the controlled substance (by implantation
or injection) to the patient named on the prescription
[[Page 34756]]
not later than 14 days after the date of receipt by the practitioner.
DEA implemented this requirement in Sec. 1306.07(f)(5).
Finally, 21 U.S.C. 829a stipulates that the practitioner and
pharmacy need to be authorized to conduct these activities in the State
in which such activities take place. The prescribing practitioner and
administering practitioner must maintain complete and accurate records
of all controlled substances delivered, received, administered, or
otherwise disposed of, including the persons to whom controlled
substances were delivered and such other information that the Attorney
General may require by regulations. DEA implemented these specific
conditions in the IFR, again in Sec. 1306.07(f).
Changes After Publication of the Interim Final Rule
Following passage of the Omnibus, the separate registration
requirement in 21 U.S.C. 823(h) is only applicable to practitioners
dispensing narcotic drugs in schedule II for the purpose of maintenance
or detoxification treatment. Any practitioner wishing to dispense
narcotic drugs in schedule II for the purpose of maintenance or
detoxification treatment must obtain a separate registration as an NTP
pursuant to that section.
By limiting the applicability of 21 U.S.C. 823(h) to only narcotic
drugs in schedule II, Congress eliminated the need for practitioners to
obtain a waiver of the requirement for a separate registration to
dispense narcotic drugs in schedules III, IV, and V for maintenance or
detoxification treatment. As such, Congress eliminated the waiver
described in 21 U.S.C. 823(h)(2) and all conditions for such waiver,
including the requirement to notify the Secretary of HHS, the
applicable number, and the requirement to be a ``qualifying
practitioner'' and associated definition. These amendments require DEA
to remove 21 CFR 1301.28. DEA also must eliminate 21 CFR 1306.05(b) and
make conforming changes to 21 CFR 1306.04(c) and (d), and 1306.07(a),
(d) and (f)(2). In so doing, DEA is revising 21 CFR 1306.04(c) to state
in an affirmative manner the prescribing authorities that exist after
the passage of the Omnibus.
In Section 1263 of the Omnibus, Congress added training
requirements to 21 U.S.C. 823(m) as a condition of receiving a DEA
registration for any qualified practitioner to dispense controlled
substances in schedules II--V. These requirements are similar to those
previously applicable to DATA-waiver practitioners under the repealed
21 U.S.C. 823(h)(2), although the new 21 U.S.C. 823(m) includes more
provisions. Section 1263 defined the term ``qualified practitioner'' as
a practitioner who is licensed under State law to prescribe controlled
substances and is not solely a veterinarian.
Prior to the Omnibus, training was only required for qualifying
practitioners who wished to obtain a waiver of the requirement for a
separate registration to dispense controlled substances in schedule
III, IV, or V for maintenance treatment or detoxification treatment.
Now, all practitioners (except those who are practicing solely as a
veterinarian) seeking a DEA registration or registration renewal to
dispense controlled substances in schedule II, III, IV, or V are
required to satisfy a one-time training requirement. This new
requirement applies to any registration or renewal application
submitted on or after June 27, 2023. These amendments require a
modification to 21 CFR 1301.11 and to the definitions in 21 CFR
1300.01.
Last, Section 1264 of the Omnibus amended 21 U.S.C 829a(a)(5) by
changing the number of days before which a controlled substance that
was delivered by a pharmacy to an administering practitioner must be
administered (by implantation or injection) to the named patient. As
stated above, 21 U.S.C. 829a(a)(5) initially mandated 14 days however
the Omnibus has amended the statutory requirement to be 45 days. This
requires a modification to Sec. 1306.07(f)(5).
Discussion of Comments
DEA received 55 comments from the public, companies, associations,
and state representatives; however, a few of these comments were
duplicates. Each issue is summarized below, along with DEA's responses.
Increase in Number of Patients Who May Be Treated Under a DATA Waiver
Issue: Overall, many commenters praised the IFR's increase in the
number of patients that a practitioner may treat for maintenance
treatment or detoxification treatment, without separately being
registered as an NTP. However, there were some who expressed concern
with the increase saying that it could lead to harmful and undesirable
outcomes. Commenters expressed concern that while there aren't enough
providers to treat addiction, simply allowing providers to treat more
patients will not address the shortage. It was stated that treatments
need to be carefully monitored by providers and stated that many
providers, even those who have undergone training, do not understand
that it takes a minimum of six months to address opioid use disorders.
Commenters also asserted that the number of patients should be
reflective of the administrative support, expertise, and experience of
each individual physician.
Commenters also mentioned that with the increase, there is the
potential for patients to fall through the safety net of their provider
so DEA should make sure that physicians aren't pressured to take on
more patients than they can handle. It was further suggested that DEA
should set clear guidelines for legal ramifications of mistreatment,
and add a requirement to this rule that will force practitioners to
follow their patients more closely, along with some incentive for
patients to return to their providers more regularly.
The commenters also discussed the two additional circumstances
under which a DATA-waived practitioner may treat up to 100 patients
(i.e., if the practitioner holds additional credentialing or if a
practitioner provides MAT within a qualified practice setting \11\),
saying that the circumstances may stunt the positive impact. Many
commenters brought up the socioeconomic factors, stating that in the
areas most affected, the practitioners that are most likely to benefit
are primary care physicians and they would lack the additional
credentialing required to take advantage of the increase in patients.
It was suggested that there be a requirement for a provider to register
if they are providing treatment with the expanded flexibilities but not
condition the ability to treat more patients upon being able to meet
these two ``proposed'' circumstances. One commenter stated that a
provider should be required to inform DEA if they are treating an
expanded number of patients or if they are providing treatment in an
unqualified practice setting. This commenter also suggested that DEA
redefine ``additional credentialing'' by allowing the credentials to be
a provider's unrestricted license to provide MAT within their scope of
practice.
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\11\ DEA notes that a ``qualified practice setting'' is defined
in the SAMHSA regulations at 42 CFR 8.615.
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DEA also received comments supporting the increase implemented in
the IFR, stating the increase will allow practitioners to treat more
people and improve the lives of those who suffer from opioid use
disorders. The commenters also mentioned that
[[Page 34757]]
allowing practitioners to treat more patients will benefit rural and
underserved areas that are suffering from increased rates of opioid
addiction by removing barriers for treatment in underserved regions.
DEA Response: DEA acknowledges the concerns for potential harm
expressed by commenters, however the Omnibus has removed the DATA-
waiver provisions in 21 U.S.C. 823(h)(2) and all conditions on those
waivers. As such, there is no longer a federal limit on the number of
patients that a practitioner may treat for maintenance treatment or
detoxification treatment, without separately being registered as NTP.
Accordingly, DEA is removing the applicable number of patients in this
final rule.
Elimination of Time Limit for Certain Qualifying Practitioners and
Temporary Expansion of the Definition of Qualifying Other Practitioner
Issue: Prior to the SUPPORT Act, the CSA defined a ``qualifying
practitioner'' under 21 U.S.C. 823(h)(2)(G)(iii), for purposes of the
DATA waiver, to include a ``qualifying other practitioner'' which
temporarily (until October 21, 2021) included NPs and PAs who met
certain conditions. The SUPPORT Act made the inclusion of NPs and PAs
permanent. Some commenters supported the permanent inclusion of NPs and
PAs as qualifying other practitioners for purposes of the DATA-waiver,
with one commenter noting that this elimination of the temporary time
limit was one of the most important amendments of the SUPPORT Act.
Commenters stated that this elimination and the expansion of the
definition of ``qualifying other practitioner'' (temporarily until
October 1, 2023, to include a CNS, a CRNA, or a CNM who meets certain
conditions) increases the number of providers qualified to prescribe
drugs used in MAT for OUD. Commenters also mentioned that the
bottleneck of patients waiting to be seen in a detoxification or
maintenance treatment center existing at the time of the IFR will be
reduced or eliminated and patients will be treated more quickly;
however, DEA should ensure that prescribers have an understanding of
MAT, as the mismanagement of MAT by physicians could decrease the
effectiveness and even be harmful. A commenter suggested that DEA,
SAMHSA, and other relevant stakeholders provide additional education
and support for MAT.
Commenters supported the elimination of the time limit for NPs and
PAs, stating that this expands the number of quality practitioners
available and the amount of patients that can receive care. Commenters
explained that NPs and PAs are qualified to address addiction since
they can specialize their course of study and they can write
prescriptions for narcotics. Commenters added that this elimination
will be a benefit because it will help lessen the workload of
physicians. Commenters said that this allows NPs and PAs to continue
their relationships with their patients, encouraging steady,
uninterrupted treatment and increasing affordability and patient-
provider trust.
In addition, commenters supported the SUPPORT Act's temporary
inclusion of CNSs, CRNAs, and CNMs as qualifying other practitioners,
stating that the expansion will allow for flexibilities in underserved
regions that may not have physician coverage. One commenter also
mentioned that the expansion would allow for an expanded ``team based''
coverage at facilities, but suggested that DEA should further explain
the flexibilities and ensure that qualifying other practitioners and
qualifying practitioners \12\ are sufficiently trained to identify
patients with opioid addiction and administer narcotics for maintenance
and/or detoxification treatments due to the immense risks and
challenges to healthcare organizations and the patients.
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\12\ The comment being discussed originally used the term
``qualified'' other practitioners and ``qualified'' practitioners.
The accurate term at the time of the comment's submission was
``qualifying'' practitioners. However, after the passage of the
Omnibus, the designation of ``qualifying'' practitioner no longer
exists and the current defined term is ``qualified'' practitioner.
The text here uses ``qualifying'' practitioner for clarity and
consistency.
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DEA received comments disapproving of the time limit elimination
for NPs and PAs, stating that care for opioid use disorders should be
led by a physician. One commenter expressed that while health
professionals should collaborate, regulations shouldn't be implemented
which undermine the physician-led team-based care models that have
proven to be effective. Commenters also stated that the skillset of an
NP and a PA is not interchangeable with that of a fully trained
physician.
Some commenters did not support the temporary expansion to include
CNSs, CRNAs, and CNMs, stating that this could endanger patients by
allowing the nursing specialties to prescribe buprenorphine when it is
not their typical scope of practice. Commenters suggested that CRNAs
and CNMs do not possess qualifications that guide them in caring for
patients with opioid addiction.
Commenters also expressed socioeconomic concerns that, while the
expansion of the definition of qualifying other practitioners may help
improve access in low-income and rural communities, it may lead to more
practitioners in suburban and higher-income communities. A commenter
suggested that there needs to be specific legislative efforts that
prioritize expanding access to low income and rural communities so that
they are granted access to these opportunities.
DEA Response: The amendments made in the IFR are no longer
applicable due to the implementation of the Omnibus. With the removal
of paragraph (2) of 21 U.S.C. 823(h), the CSA no longer uses the
classifications of qualifying practitioner and qualifying other
practitioner. DEA recognizes that there are socioeconomic factors that
come into play with the additions to the regulations that have already
been implemented by the IFR. The elimination of the time limit for NPs
and PAs along with the expansion of the definition of ``qualifying
other practitioner'' opens up possibilities for those in low income and
rural areas to have greater access to more providers.
DEA notes that many commenters were concerned about the educational
qualifications for NPs, PAs, CNSs, CRNAs, and CNMs. In the Omnibus,
Congress added training requirements for all qualified practitioners
who wish to register to dispense controlled substances in schedule II-
V. The CSA no longer explicitly states that CNSs, CRNAs, and CNMs can
qualify to dispense. To obtain a DEA registration, all non-physician
practitioners must be legally authorized by the State to dispense
controlled substances in schedule II-V and, if they do not practice
solely as a veterinarian, must satisfy one of the training conditions
set forth in 21 U.S.C. 823(m)(1)(B). DEA is making changes in this
final rule from the provisions that had previously been adopted in the
IFR to implement the Omnibus training requirements.
Additional Option to Allow a Physician to Become a Qualifying
Physician Issue: As noted above, the SUPPORT Act added an eighth method
by which physicians could be considered qualifying practitioners for
purposes of the DATA waiver. Multiple commenters did not support the
requirement in this eighth option that the medical school, from which
the physician graduated in good standing, be located within the United
States. The commenters said that all physicians must pass the same
licensing exams to enter residency, regardless of their school's
location, and residency is a
[[Page 34758]]
requirement to practice medicine in the United States. A commenter also
expressed concern that this will marginalize the skill and expertise of
a pool of potential providers, as 25 percent of the physicians in the
U.S. are international medical graduates. The commenter further stated
that these graduates tend to specialize in primary care and practice in
underserved areas. Commenters also opposed the SUPPORT Act limitation
that no more than five years may have elapsed between the physician's
successful completion of a particular medical school curriculum or
residency and the physician's notification to HHS that they intend to
begin dispensing certain narcotic drugs to patients for maintenance or
detoxification treatment under 21 U.S.C. 823(h)(2)(B)), noting that it
neglects to consider the physicians that have been practicing medicine
for more than five years.
Another commenter was concerned about this SUPPORT Act option
because it only requires graduating in good standing from an accredited
institution and only eight hours of training, stating that this frames
opioid dependence as something that is simple. This commenter added
that this option does not take into account that this disorder is a
complex condition that requires a level of expertise.
Other commenters supported the additional option saying that
requiring the additional training allows clinicians to make
improvements to deal with the opioid epidemic. Various commenters also
said this will enable physicians to educate their patients on opioid
medication and offer alternatives. Commenters spoke to the training
requirement having a positive impact, as practitioners will be more
likely to review patients' history in order to ensure they do not have
an opioid use disorder.
DEA Response: DEA appreciates the numerous commenters' views
regarding the additional training option for a physician to be
considered a ``qualifying physician'' eligible for a DATA-waiver.
Section 3202(a) of the SUPPORT Act amended the CSA to add this option
and the IFR merely implemented Federal legislation. DEA does not have
the authority to change the statutory provisions set forth by Congress.
Due to the amendments made in the Omnibus, DEA is omitting these
provisions related to the DATA-waiver from this final rule by removing
the corresponding provision in 21 CFR 1306.04(d) and as such, this
option is no longer relevant. However, Congress enacted a similar, but
not identical, provision in the new training requirements for
dispensers of controlled substances in schedules II, III, IV, and V.
Because the new training requirements in 21 U.S.C. 823(m)(1)(A)
discusses the condition of graduation from an accredited institution
within the 5-year period immediately preceding the date on which the
physician first registers with DEA,\13\ DEA wants to clarify that
additional options are available for those physicians who have been
practicing longer than five years. DEA notes that a designation of
``qualifying practitioner'' no longer exists. Instead, relevant
practitioners would be considered ``qualified practitioners.''
Physicians that have been practicing longer than five years can use one
of the alternative options for meeting the training requirements,
including the option applicable to physicians that are already board
certified or trained in addiction medicine or addiction psychiatry.
Alternatively, 21 U.S.C. 823(m)(1)(A) allows physicians to meet the
training requirements by completing not less than 8 hours of training
on the specified topics provided by the types of organizations
mentioned in the law. However, a newer graduate would be less likely to
be board certified and will have likely gone through a curriculum
similar to the additional training. As such, this provision allows a
practitioner who is a physician to meet the training requirements if
they have recently (within the previous five years) graduated from an
accredited allopathic or osteopathic medical school or dental surgery
or dental medicine curriculum in the United States and completed a
curriculum or an accredited medical residency which included not less
than eight hours of training on treating and managing patients with
opioid or other substance use disorders, or the other topics now
mentioned in 21 U.S.C. 823(m)(1)(A)(v). As stated above, the
requirement that the medical school be in the United States is a
statutory mandate and cannot be changed.
---------------------------------------------------------------------------
\13\ 21 U.S.C. 823(m)(1)(A)(v).
---------------------------------------------------------------------------
Dispensing Controlled Substances for Maintenance or Detoxification
Treatment
Issue 1: The IFR implemented section 3204(a) of the SUPPORT Act to
allow a pharmacy to deliver a controlled substance to the prescribing
practitioner's or administering practitioner's registered location,
rather than only to the ultimate user or research subject, pursuant to
a valid prescription for administration to the patient for purposes of
maintenance or detoxification treatment within 14 days from when the
practitioner receives the controlled substance (14-day limit). DEA
received many comments stating that allowing a pharmacy to deliver a
controlled substance in this manner will help to ensure that patients
are receiving the treatment they need and complying with drug treatment
plans, and that opioids are ending up with the correct person.
Commenters also opined that this is a good step in ensuring that
opioids are properly distributed while still increasing access.
Commenters suggested that this will streamline service to patients, can
decrease costs along the line of care, and will allow patients to
access treatment directly within facilities under the direct
supervision of their providers, hopefully increasing the level of care
received.
While many commenters believe this delivery method to the
practitioner will further allow for the ability to successfully treat
patients in underserved regions, other commenters said this provision
does not take into account low-income communities, where care would be
inaccessible due to the lack of insurance and shortage of treatment
options. The commenters said MAT centers and health care facilities are
often far from rural and low-income communities and transportation is
often an issue. One commenter said ``clear and specific legislative
efforts'' are needed that prioritize the expansion of access to low
income and rural communities. They also mentioned that while
transportation is not the fault of DEA, DEA can work towards filling
the gap of health care access ``by focusing on equaling the
distribution of MAT, through waived and qualified practitioners, across
the nation.'' Another commenter also stated that DEA is not considering
patients who are being released from jail/prison. The commenter
mentioned that upon release from jail, care coordinators need time to
find appropriate medical care and practitioners to support the
patient's recovery, which can take weeks.
DEA Response 1: DEA agrees with the many commenters' assertions
that Congress's decision to allow pharmacies to deliver these
medications to the prescribing or administering practitioner's location
will be helpful for patients receiving treatment. While the IFR, as
well as this rule, are not focused solely on rural and low-income
areas, DEA is committed to creating regulations that allow access to
care regardless of the socioeconomic status or location of the patient.
For example, DEA has incorporated alternative methods to bring
treatment to those in rural or other areas (see 85 FR 11008, Feb. 26,
2020) and patients can reach
[[Page 34759]]
out to state opioid treatment authorities, which provide oversight and
support to opioid treatment programs, for other alternatives for
treatment. DEA acknowledges the commenters' wants for clear and
specific legislative efforts addressing low income and rural
communities, however DEA is only responsible for the implementation of
legislation created and mandated by Congress, but does not actually
create the legislation.
DEA believes that the delivery method defined in 21 U.S.C. 829a and
21 CFR 1306.07(f) increases provider options, helps to address the
socioeconomic issues that commenters have expressed, and helps increase
access to treatment in low-income and rural communities. As mentioned
by commenters, the IFR did not address issues created by patients' lack
of insurance, as insurance was outside the scope of the rule and the
legislation on which the IFR was based. However, DEA believes that
allowing a pharmacy to deliver these medications to the prescribing or
administering practitioner may reduce burdens on patients by reducing
other costs to access the medication, including the cost of
transportation to the pharmacy. This delivery provision coupled with
the provision discussed below where an administering practitioner does
not have to be DATA-waived are steps toward filling the gap of MAT
access.
In addition, the increase in provider options for administering
should ease some concerns relating to the time needed to find care for
patients being released from jail. While care coordinators are finding
the appropriate medical care to support the patient's recovery,
patients will be able to find an initial practitioner to whom the
prescription can be sent for administration temporarily.
In this final rule, DEA is making no changes from the provisions
that had previously been adopted in the IFR regarding to whom the
prescription can be delivered.
Issue 2: Many companies, associations, and organizations requested
that DEA clarify whether practitioners who are not DATA-waived can
administer long-acting injectable (LAI) and implantable buprenorphine
pursuant to a lawful prescription by a DATA-waived practitioner.
According to these commenters, DATA-waived practitioners may not have
the facility to administer the injections, so non-DATA waived
practitioners should be permitted to administer injections ordered by a
DATA-waived provider.
DEA Response 2: Since the DATA-waiver program no longer exists, DEA
is not making any clarification. Instead, DEA is amending 21 CFR
1306.07(f)(2) to align with the amendments made by the Omnibus.
Issue 3: Companies, associations, organizations, and other
commenters requested that DEA clarify that pharmacists are
administering practitioners under 21 U.S.C. 829a, and are allowed to
administer controlled substances pursuant to a valid prescription from
a DATA-waived practitioner and to the extent authorized by state law.
Three of these commenters provided a detailed rationale for why a
pharmacist who is employed by a DEA-registered pharmacy and is
authorized by state law to dispense controlled substances should be
included in the CSA's definition of ``practitioner,'' which is found at
21 U.S.C. 802(21),\14\ and therefore, should be able to administer such
substances. Commenters also noted that Congress did not expressly
require that the administering practitioner be a ``qualifying
practitioner.'' Commenters also said that pharmacists have been
appropriately trained and therefore, DEA should treat pharmacists as
practitioners who may administer LAI buprenorphine to the extent
authorized by state law.
---------------------------------------------------------------------------
\14\ The commenters noted that the CSA definition for
``practitioner'' includes, among others, a ``pharmacy'' or ``other
person licensed, registered, or otherwise permitted, by the United
States or the jurisdiction in which he practices . . . , to
distribute, dispense, . . . administer . . . a controlled substance
in the course of professional practice or research.''
---------------------------------------------------------------------------
Commenters suggested various limitations for the pharmacists to be
considered an administering practitioner. Some stated that the
pharmacist must be employed at a pharmacy while others specified that
such pharmacy must hold a DEA registration. Still others noted that
certain states allow a pharmacist to administer LAI buprenorphine under
specified conditions and thus such administration would be within the
scope of the pharmacist's practice. In addition, one commenter noted
that DEA itself recognizes pharmacists in certain states as registered
mid-level practitioners (MLPs) with specified controlled substance
authority including administration.\15\ Most commenters suggested that
pharmacists be permitted to administer both LAI and implantable
controlled substances; however, one commenter stipulated that the
pharmacist's administration should only include injectables, not
implantables.
---------------------------------------------------------------------------
\15\ See DEA's guidance, MID LEVEL PRACTITIONERS--Controlled
Substance Authority by Discipline within State, available at <a href="https://www.deadiversion.usdoj.gov/drugreg/practioners/mlp_by_state.pdf">https://www.deadiversion.usdoj.gov/drugreg/practioners/mlp_by_state.pdf</a>,
last updated on December 2, 2022, last accessed January 18, 2024.
---------------------------------------------------------------------------
Commenters stated that the clarification that pharmacists can be
administering practitioners is necessary to avoid delays or disruptions
in care when a DATA-waived practitioner is unavailable to administer
the substance. The commenters maintained that this clarification will
have a positive effect on patients in rural areas and in residential
care facilities, and those receiving regular treatment via
telemedicine, during natural disasters and during pandemics.
DEA Response 3: As noted by three commenters, the CSA's definition
of ``practitioner'' includes a ``pharmacy . . . or other person
licensed, registered, or otherwise permitted, by the United States or
the jurisdiction in which he practices . . . , to distribute, dispense,
. . . administer . . . a controlled substance in the course of
professional practice or research.'' Section 3204(a) of the SUPPORT Act
required only that the prescribing practitioner be a ``qualifying
practitioner'' and placed no such limitations on the administering
practitioner. DEA has considered the commenters' positions on
pharmacists being considered an administering practitioner.
However, DEA declines to specifically list pharmacists as an
administering practitioner in this final rule. DEA believes that
Congress intended 21 U.S.C. 829a to allow a pharmacy to deliver a
controlled substance to a different location from the pharmacy (i.e.,
to the location listed on the certificate of registration of the
prescribing practitioner or to the location listed on the certificate
of registration of the administering practitioner). In furtherance of
that intent, DEA is requiring the administering practitioner be
individually registered under 21 U.S.C. 823(g) (pursuant to which DEA
issues registrations) to dispense, and acting within the scope of such
registration. While states also regulate pharmacists and decide what a
pharmacist licensed in their state is authorized to do, currently, only
a limited number of states allow MLPs individually registered with DEA
as Registered Pharmacists to administer controlled substances.
Note, in this final rule, that DEA does not need to clarify that an
administering practitioner is not required to be DATA-waived because
the DATA-waiver program no longer exists.
Issue 4: Many commenters suggested that DEA use the authority
granted by Congress under section 3204 of the
[[Page 34760]]
SUPPORT Act (codified at 21 U.S.C. 829a) to modify the 14-day limit for
administering such controlled substances to the patient named on the
prescription. Commenters requested that DEA increase the 14-day limit
to 30 or 60 days. Specifically, these commenters noted that section
3204 expressly allows DEA (under authority delegated by the Attorney
General), in coordination with HHS, to change the time limit after the
publication of a required report by the U.S. Government Accountability
Office (GAO) on ``access to and potential diversion of controlled
substances administered by injection or implantation.'' Some of the
commenters also mentioned that the required GAO report, issued in
August 2020, concluded that there is low use of implantable and
injectable buprenorphine and the risk of diversion of implantable and
injectable buprenorphine has been reduced.
Commenters had many concerns with the 14-day limit and expressed
that this provision discourages providers from treating these patients.
A commenter expressed concern that the 14-day limit could lead to
overdose due to patients not being able to access the medication the
remaining 16 days of the month. Commenters mentioned that patients have
difficulty keeping appointments for reasons such as patient needs,
insecure housing, transportation issues, problems with insurance, and
holidays. They stated that the 14-day restriction puts an undue burden
on the use of the valuable product because often times a patient is
unable to schedule or reschedule within 14 days, and that after that
time the provider would have to send the medication back and absorb the
costs. Commenters also mentioned that when a patient requests a change
in dosage strength after a medication has been delivered, the doctor
would have to absorb the cost of the delivered patient-specific
medication if the doctor cannot retain the medication in their
inventory longer than 14 days. Commenters said that starting the
process again after 14 days is taxing on staff and slows down the
effort to help patients suffering from the opioid epidemic.
Companies, associations, and other DEA registrants mentioned that
the alternative, non-patient-specific method by which practitioners can
obtain these medications, ``buy and bill,'' is costly and many
practitioners cannot bear the financial risks, especially when
considering the uncertainty over whether a patient's insurance will
reimburse, and if so, how much. These commenters also noted that non-
patient-specific medication obtained by ``buy and bill'' is permitted
to be stored until the medication expires.
Multiple commenters stated that 14 days is impracticable, as
administering within this timeframe involves coordination of many
components, including the pharmacy, practitioner, and patient.
Commenters also informed DEA that there is a forthcoming product that
will be shipped with four separate weekly injections at a time.
Commenters said that the 14-day limit does not consider delays in
shipping from retail and specialty pharmacies and is proving unworkable
for providers and patients.
Commenters also said the requirement to destroy the received
controlled substance after 14 days creates a large potential for waste.
They opined that providers will be deterred from using this option due
to fears that they may have to destroy it and incur significant costs
in doing so.
DEA Response 4: DEA acknowledges the concerns regarding the 14-day
limit. With the enactment of the Omnibus, Congress increased the 14-day
limit to 45 days in section 309A(a)(5) of the CSA (21 U.S.C.
829a(a)(5)). Because 45 days is the new baseline requirement, which DEA
may modify in coordination with the Secretary of HHS pursuant to
section 309A(b)(2) (21 U.S.C. 829a(b)(2)), DEA is implementing the
increase to 45 days in this final rule. DEA will consider whether it is
necessary to modify the 45-day limit, in consultation with the
Secretary, in the future.
Finally, DEA notes that the time expended in obtaining insurance
authorizations or during shipping does not affect the 45-day limit. The
45-day timeframe established by 21 U.S.C. 829a(a)(5) and 21 CFR
1306.07(f)(5) runs from the date the controlled substance is received
by the practitioner. Additionally, DEA notes that neither the CSA nor
DEA regulations require the destruction of the dispensed controlled
substance after the 45-day period elapses. To the extent that
destruction is required by state authorities, commenters may wish to
engage with those state authorities.
Economic Impact
Issue: One commenter expressed skepticism regarding DEA's analysis
of the anticipated economic impact of the IFR. This commenter took
issue with DEA's estimates regarding the number of qualifying
providers, the number of patients receiving treatment, the treatment
success rate of 29 percent, societal cost savings, and, as a result,
the economic burden reduction derived from these estimates. In fact,
the commenter believed the effect might instead add another cost burden
on local, State, and Federal governments, and urged DEA to do further
evaluations before finalizing the IFR.
More specifically, the commenter believed the projected number of
NPs, PAs, CNSs, CRNAs, and CNMs providers is too high, the estimated
number of two million patients with OUD is not accurate, estimated
``cost reduction'' by twenty-nine percent is too high, and the lost
productivity savings and criminal justice cost savings are too high.
DEA Response: While this commenter questioned the underlying
assumptions of DEA's economic analysis, the commenter did not provide
any studies, data sources, or alternative calculations that would
assist DEA in refining its analysis. DEA's analysis is based firmly
upon many academic studies, its own provider data, and making
reasonable assumptions where specific data is not available. Data
sources are clearly cited in the IFR. The projection for providers is
based on DEA's registration data. The number of patients with opioid
use disorder is based on published research (noted in the IFR) which
includes the number of patients with opioid use disorder reported by
SAMHSA's National Survey on Drug Use and Health as meeting the American
Psychiatric Association's Diagnostic and Statistical Manual of Mental
Disorders (DSM-IV) criteria for abuse or dependence.\16\ Furthermore,
DEA believes the commenter misunderstood the use of ``twenty-nine
percent'' in the analysis. The commenter believed the ``twenty-nine
percent'' represented cost reduction; however, it represents the
treatment success rate in the analysis. Therefore, DEA does not have
enough additional information to alter the conclusions of the analysis,
or to warrant further evaluations. The economic analysis in the
Regulatory Analysis section below focuses on the impact of the limited
changes from the IFR to the Final Rule.
---------------------------------------------------------------------------
\16\ In this final rule, the DEA used results from the 2019
National Survey on Drug Use and Health, which used criteria
specified in the Diagnostic and Statistical Manual for Mental
Disorders, 4th edition (DSM-IV).
---------------------------------------------------------------------------
Provisions of This Final Rule
While DEA considered the public comments submitted on the IFR, the
Omnibus repealed many of the statutory provisions on which the IFR is
based. Through this final rule, DEA is finalizing the IFR with
modifications pursuant to the Omnibus. As such, DEA is removing many of
the provisions that had been implemented by the IFR on the basis of
now-repealed laws. DEA is
[[Page 34761]]
implementing minor changes to some regulations to conform to the new
statutory language adopted through the Omnibus. Additionally, DEA is
implementing in this rulemaking the separate registration requirement
for NTPs that was implemented in the CSA by the NATA. Through this
rule, DEA is also making modifications where necessary to clarify
issues presented by commenters.
Definition of ``Qualified Practitioner''
First, DEA is including the definition of ``qualified
practitioner'' in the regulations pursuant to the definition set forth
in 21 U.S.C. 823(m)(4)(B). A qualified practitioner is a practitioner
who is licensed under State law to prescribe controlled substances and
who is not solely a veterinarian. This definition is found in 21 CFR
1300.01.
Registration
Second, in 21 CFR 1301.11, DEA is setting forth the requirement
that NTPs obtain a separate registration for that purpose, annually.
This will be found in the new paragraph (b), with the current paragraph
(b) being moved to paragraph (d). This corresponds to the requirement
in 21 U.S.C. 823(h).
Training Requirements
In the newly added paragraph (c) of 1301.11, DEA is including the
training requirement for ``qualified practitioners'' who wish to obtain
a registration from DEA to dispense controlled substances, as found in
21 U.S.C. 823(m). The 21 U.S.C. 823(m) training requirements are
determined by whether the qualified practitioner is or is not a
physician, as defined by 42 U.S.C. 1395x(r). In accordance with moving
the current paragraph (b) to paragraph (d), DEA is also revising
paragraph (a) to update the reference to paragraph (b).
In accordance with these new training requirements for qualified
practitioners, DEA has modified its forms 224 and 224a to require
practitioners to self-attest to training when applying for registration
and renewing their registration. The Omnibus requires the practitioners
to meet the training requirement starting with the first applicable
registration. The first applicable registration is defined in 21 U.S.C.
823(m)(4)(A) as the first registration or renewal of registration by a
qualified practitioner that occurs on or after 180 days of the date of
enactment of the Omnibus. That date is June 27, 2023.
Elimination of the DATA-Waiver Program and Provisions
Third, DEA is removing 21 CFR 1301.28 in its entirety and will be
reserving that section for future use. This regulation implemented 21
U.S.C. 823(h)(2) by describing the DATA-waiver program, which has now
been removed from the CSA by the Omnibus. There is no longer the
opportunity or requirement to receive a waiver from the separate NTP
registration requirement to dispense controlled substances in schedule
III-V for maintenance or detoxification. There is no longer a
definition for ``qualifying physician,'' ``qualifying practitioner,''
and ``qualifying other practitioner.'' In addition, there is no longer
an applicable number to limit how many patients can be treated by a
practitioner.
Next, DEA is modifying 21 CFR 1306.04(c) to remove the reference to
21 CFR 1301.28 since it will be deleted. Also, DEA is revising 21 CFR
1306.04(d) by removing references to ``qualifying'' throughout the
paragraph and the applicable references to conform to the CSA.
DEA is also modifying 21 CFR 1306.05 by removing and reserving
paragraph (b). Paragraph (b) required a prescription issued under the
DATA-waiver program to include the identification number issued by DEA
when registering for the program. However, now that the DATA-waiver
program no longer exists, this regulation is no longer valid. In
addition, DEA is revising 21 CFR 1306.07(d) by removing the citation
reference to 21 CFR 1301.28 and adding a corresponding clarification in
21 CFR 1306.07(a). Again, 21 CFR 1301.28 is being removed and the new
training requirements can now be found in 21 CFR 1301.11, which now
applies to all qualified practitioners.
DEA is also revising 21 CFR 1306.07(f)(2) to align with the
amendments to the CSA. Specifically, DEA is removing the citation to
the now-revoked DATA-waiver program in the CSA, as well as the
requirement that a prescribing practitioner be a qualifying
practitioner, and is repeating in the regulatory text the language of
21 U.S.C. 829a(a)(2) as enacted by the Omnibus. DEA is also amending 21
CFR 1306.07(f)(5) to modify the current 14-day limit (the time for the
practitioner to administer the controlled substance to a patient from
when the practitioner receives the controlled substance) to 45 days, as
now set forth in the CSA.\17\ In response to commenters of the IFR, DEA
is also revising 21 CFR 1306.07(f)(1) to use abbreviated language for
clarity. Specifically, rather than repeating ``the practitioner
administering the controlled substance'' in several paragraphs of this
subsection, DEA is adding the parenthetical ``(in this paragraph
referred to as the `administering practitioner')'' in 1306.07(f)(1) and
then making the relevant textual replacements in 1306.07(f)(3) and
(f)(6).
---------------------------------------------------------------------------
\17\ 21 U.S.C. 829a(a)(5).
---------------------------------------------------------------------------
This final rule also revises the existing language in 21 CFR
1306.07(f)(3) for clarity and consistency. While the current text
exactly reflects the language of 21 U.S.C. 829a(a)(3), DEA is revising
the term ``practitioner'' to read ``the prescribing practitioner, and
the administering practitioner'' to be consistent with the remainder of
paragraph (f). This change is non-substantive, as this is the only
possible reading of the statutory text, and does not change the meaning
of the existing regulatory text.
Recordkeeping Requirements
Last, DEA is making a minor, non-substantive change to include a
cross-reference in 21 CFR 1306.07(f)(6). DEA's regulations in 21 CFR
1304.03(c) and 1304.06 define recordkeeping requirements relating to
controlled substances that are prescribed. Under 21 CFR 1304.03(c),
prescribers must maintain records of all substances that are prescribed
in the course of maintenance or detoxification treatment of an
individual, which would include controlled substances prescribed in the
course of maintenance or detoxification treatment pursuant to 21 U.S.C.
829a. DEA notes that under 21 U.S.C. 827(a)(3), DEA-registered
pharmacies must maintain complete and accurate records of all
controlled substances delivered, which would include deliveries of
controlled substances to the prescribing or administering practitioner
under 21 U.S.C. 829a.
Regulatory Analysis
Administrative Procedure Act
An agency may find good cause to exempt a rule from provisions of
the Administrative Procedure Act (APA) requiring public notice and
comment prior to implementation (5 U.S.C. 553(b)(B)), if it is
determined to be unnecessary, impracticable, or contrary to the public
interest. Portions of this rule were originally introduced as an IFR,
with an opportunity for comment; however, after passage of the Omnibus,
the legal provisions underlying much of the already implemented
provisions of the rule were eliminated.
[[Page 34762]]
Along with the elimination of old provisions, Congress also created
new provisions in the Omnibus, and DEA identified another existing
statutory provision that had never been incorporated into DEA's
regulations. Specifically, DEA is adding a new provision in 21 CFR
1301.11(b) based on the NATA, which was previously incorporated into
the CSA. This rule merely incorporates the existing statutory provision
into DEA regulations without any changes. Additionally, while this rule
does implement Congress's new requirement that certain practitioners
complete training to receive a DEA registration number, DEA is not
adding any additional requirements beyond those mandated by Congress.
DEA is adding a cross-reference to recordkeeping requirements currently
contained in other sections of DEA's regulations, without expanding the
existing requirements. As such, DEA concludes that it is unnecessary to
accept comment on provisions that implement the Omnibus or other
Federal laws, that cross-reference existing regulatory provisions for
clarity without changing or expanding their applicability, or that
standardize language without making any new interpretation.
Executive Orders 12866, 13563, and 14192 (Regulatory Review)
DEA has determined that this rulemaking is a ``significant
regulatory action'' under section 3(f)(1) of Executive Order (E.O.)
12866, Regulatory Planning and Review. Accordingly, this final rule has
been submitted to the Office of Management and Budget (OMB) for review.
This final rule has been drafted and reviewed in accordance with E.O.
12866, ``Regulatory Planning and Review,'' section 1(b), Principles of
Regulation; E.O. 13563, ``Improving Regulation and Regulatory Review,''
section 1(b), General Principles of Regulation; and E.O. 14192,
``Unleashing Prosperity Through Deregulation.''
The interim final rule was determined to be a significant
regulatory action under E.O. 12866 with a net annualized benefit of
$543 million over five years, and accordingly, the interim final rule
was reviewed by OMB.
The interim final rule was estimated to have a net present value of
benefits (in form of cost savings) of $2,627 million and $2,226 million
at 3 percent and 7 percent discount rates, respectively, and an
annualized net benefit of $574 million and $543 million at 3 percent
and 7 percent, respectively.\18\ The net present value of the estimated
maximum cost is $3,141 million and $2,725 million at 3 percent and 7
percent discount rates, respectively. Applying a factor of 1.23 to
adjust IFR figures to 2024 dollars, the IFR net present value of
benefits (cost savings) is $3,231 million and $2,738 million at 3
percent and 7 percent discount rates, respectively.\19\ The combined
effect of the IFR and final rule is the sum of net present value of
benefits (cost savings) of the IFR and the net present value of costs
of this final rule. At 3 percent discount rate, the combined effect is
$90 million ($3,231 million-$3,134 million) in cost savings. At 7
percent discount rate, the combined effect is $13 million ($2,738
million-$2,725 million) in cost savings. These net cost savings do not
include expected, but not quantified, cost savings from treatment of
OUD anticipated in this final rule.
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\18\ 85 FR 69153; November 2, 2020.
\19\ U.S. Department of Commerce, Bureau of Economic Analysis,
National Income and Product Accounts, Table 1.1.9 Implicit Price
Deflators for Gross Domestic Product. (Accessed 5/12/2026). Line 1
Gross domestic product: 2018 = 102.291; 2024 = 125.428. 125.428/
102.291 = 1.23.
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The following discussion analyzes the economic impact of the
changes from the interim final rule to this final rule.
DEA has examined the benefits and costs of this final rule and
believes this rule will be of net economic benefit. DEA does not have a
good measure of the number of impacted practitioners or the number of
additional patients that will be treated as a result of this rule.
However, based on an estimated maximum number of impacted
practitioners, DEA has estimated a maximum annualized cost of
$368,278,282 and $387,997,558 at 3 percent and 7 percent, respectively.
However, due to potentially high societal cost savings from the
expected increase in the number of patients treated for OUD, the break-
even is low. For example, in the first year of the analysis period, the
break-even is 3,047 patients treated for OUD by the 639,821
practitioners who would be newly authorized to provide MAT. This is a
ratio of 210 practitioners to one patient. DEA believes this rule has a
low break-even point and the economic impact of this rule will be a net
cost savings. The analysis below details the aforementioned figures and
other benefits/cost savings.
This final rule adopts the provisions of the interim final rule
that are still applicable as final, with minor changes. In addition,
this final rule implements the provisions of the Restoring Hope for
Mental Health and Well-Being Act of 2022 that relate to this rule by
way of the Consolidated Appropriations Act, 2023 (Omnibus). This final
rule makes the following changes to the interim final rule. First, DEA
is removing the DATA-waiver program and is including new training
requirements for a qualified practitioner's registration. Second, DEA
is setting forth the requirement that NTPs obtain a separate
registration for that purpose, annually. Third, DEA is modifying the
current 14-day limit (the time for the practitioner to administer the
controlled substance to a patient from when the practitioner receives
the controlled substance) to 45 days, as now set forth in 21 U.S.C.
829a. Finally, DEA is making a minor, non-substantive change to
recordkeeping requirements for clarity. The analysis of these changes
is below.
Alternative Approaches
This final rule amends the DEA regulations only to the extent
necessary to implement the provisions of the Omnibus and NATA.\20\ The
Omnibus amended the CSA to remove the DATA-waiver program and added new
training requirements for registration. Additionally, the Omnibus
amended the CSA by changing the number of days before which a
controlled substance that was delivered by a pharmacy to an
administering practitioner is to be administered (by implantation or
injection) to the named patient from 14 days to 45 days. NATA amended
the CSA to require separate registrations for NTPs, which DEA is now
including in 21 CFR 1301.11(b). DEA is obligated to implement these
amendments to the CSA. As a result, DEA has no discretion not to amend
its regulations as is being done in this final rule. This final rule
simply updates the DEA regulations to reflect these new provisions;
thus, no alternative approaches are possible.
---------------------------------------------------------------------------
\20\ This final rule also changes 21 CFR 1306.07(f)(6), which is
not part of the Omnibus. This is a minor, non-substantive change to
clarify that, the prescribing practitioners must keep complete and
records of all controlled substances for which a prescription was
issued. Therefore, alternatives to this clarification are not
considered.
---------------------------------------------------------------------------
Analysis of Changes
Change 1: DATA-Waiver Removal and New Training Requirement
The Omnibus removed the DATA-waiver program and sets new
requirements for qualified practitioners. ``Qualified practitioner''
means a practitioner who is licensed under State law to prescribe
controlled substances; and is not solely a veterinarian. [21 U.S.C.
823(m)(4)(B)].
As a condition on registration under this section to dispense
controlled
[[Page 34763]]
substances in schedule II, III, IV, or V, the Attorney General shall
require any qualified practitioner, beginning with the first applicable
registration for the practitioner, to meet the following:
If the practitioner is a physician, the practitioner must meet one
or more of the following conditions:
1. Hold a board certification as specified in 21 U.S.C.
823(m)(1)(A)(i)-(iii),
2. Completed not less than eight hours of training as specified in
21 U.S.C. 823(m)(1)(A)(iv), or
3. Graduated in good standing as specified in 21 U.S.C.
823(m)(1)(A)(v).
If the practitioner is not a physician, the practitioner must be
legally authorized by the State to dispense controlled substances under
schedule II, III, IV, or V, dispense such substances within such State
in accordance with all applicable State laws, and meet one or more of
the following conditions:
1. Completed not less than eight hours of training as specified in
21 U.S.C. 823(m)(1)(B)(i), or
2. Graduated in good standing as specified in 21 U.S.C.
823(m)(1)(B)(ii).
The CSA no longer explicitly states that CNSs, CRNAs, and CNMs can
qualify to dispense. Therefore, beginning June 27, 2023, to obtain a
DEA registration, all non-physician practitioners must be legally
authorized by the State to dispense controlled substances in the
schedules for which they are seeking registration and, if they do not
practice solely as a veterinarian, must satisfy one of the training
conditions set forth in 21 U.S.C. 823(m)(1)(B).
The Omnibus requires all qualified practitioners to meet the
condition above starting with the first applicable registration that
occurs on or after the date that is 180 days after December 29, 2022.
A. Benefits/Cost Savings
This change, removing the DATA-waiver program, greatly expands the
number of practitioners who will be authorized to dispense narcotic
drugs in schedules III, IV, and V for maintenance or detoxification
treatment. With this change, all DEA-registered practitioners are
authorized under the CSA to dispense narcotic drugs in schedules III,
IV, and V for maintenance or detoxification treatment, greatly
expanding the number of practitioners authorized to provide treatment.
Additionally, treatment providers will not be subject to any
patient limits. The expansion in the number of practitioners authorized
to dispense narcotic drugs in schedules III, IV, and V for maintenance
or detoxification treatment is expected to lead to more patients being
treated for OUD and the increase in the number of patients treated is
expected to result in better patient outcomes and societal benefits.
While DEA is unable to quantify the number of additional patients
that will be treated as a result of this final rule, DEA anticipates
there will be an increase. DEA anticipates the increase in the number
of patients receiving treatment authorized by this final rule will
generate a substantial benefit in the form of societal cost savings. In
a 2015 study of the efficacy of various interventions for opioid
dependence, the study concluded that among opioid-dependent patients,
practitioner-initiated buprenorphine treatment ``significantly
increased engagement in addiction treatment, reduced self-reported
illicit opioid use, and decreased use of inpatient addiction treatment
services.'' \21\
---------------------------------------------------------------------------
\21\ D'Onofrio G, O'Connor P, Pantalon M, Chawarski M, Et al.
Emergency Department-Initiated Buprenorphine/Naloxone Treatment for
Opioid Dependence: A Randomized Clinical Trial. JAMA. 2015 April 28;
313(16): 1636-1644.
---------------------------------------------------------------------------
A study published in 2021 of the societal costs for OUD found that
the ``Costs for opioid use disorder and fatal opioid overdose in 2017
were estimated to be $1.02 trillion. The majority of the economic
burden is due to reduced quality of life from opioid use disorder and
the value of life lost due to fatal opioid overdose.'' \22\ According
to the report, in 2017 total non-fatal costs are $471 billion and total
fatal costs are $550 billion, there were 2.1 million persons ages 12
years and older with an OUD, and 47,600 fatal opioid overdoses. The
$471 billion in non-fatal costs include costs associated with health
care ($31 billion), substance use disorder treatment ($4 billion),
criminal justice ($15 billion), lost productivity ($31 billion), and
the value of reduced quality of life ($390 billion). The $550 billion
in fatal costs include costs associated with lost productivity ($69
billion), health care ($0 billion),\23\ and value of statistical life
lost ($481 billion).\24\ Dividing the total non-fatal costs of $471
billion by the number of persons ages 12 and older with an OUD, 2.1
million, the societal cost of non-fatal OUD is approximately $224,000
($471 billion/2.1 million) per person per year. Dividing the total
fatal costs of $550 billion by the number of fatal opioid overdoses,
47,600, the societal cost of fatal overdoses is approximately $11.6
million ($550 billion/47,600) per person. While DEA is unable to
quantify how many of the affected patients will be successfully treated
for OUD or how many fatal opioid overdoses will be avoided as a result
of this final rule, the potential cost savings are disproportionally
large compared to any cost associated with this rule.
---------------------------------------------------------------------------
\22\ Florence C, Luo F, Rice K. The economic burden of opioid
use disorder and fatal opioid overdose in the United States, 2017.
Drug Alcohol Depend. 2021; 218:108350. doi: 10.1016/
j.drugalcdep.2020.108350.
\23\ $260 million in report, rounded to $0 billion.
\24\ As stated in the report, the authors followed issued
guidelines for regulatory impact analysis by the U.S. Department of
Health and Human Services (HHS) (Office of the Assistant Secretary
for Planning and Evaluation, 2016), adjusted to 2017 dollars. ``The
value of life lost due to opioid overdose was determined by
multiplying the number of overdose cases by the consensus VSL
estimates for 2017 (VSL=$10.1 million).''
---------------------------------------------------------------------------
B. Costs
DEA first calculated the unit cost for a practitioner that may need
to obtain training, then applied that unit cost to the estimated number
of practitioners that will need to obtain training.
Unit Cost
With the Omnibus implemented, in order to obtain a DEA registration
to dispense controlled substances in schedule II, III, IV, or V, all
practitioners who are not solely a veterinarian will need to meet the
training requirements in 21 U.S.C. 823(m). DEA estimates some
practitioners already meet the requirements, resulting in no cost, and
others will need to obtain eight hours of training at a cost.
<bullet> Scenario 1: the practitioner already meets training
requirement, there is no additional cost as a result of this change.
<bullet> Scenario 2: the practitioner does not meet training
requirement and the practitioner will need to obtain eight hours of
training.
In both scenarios, the practitioner, or prospective practitioner,
will need to self-attest on the registration application to meeting
training requirements. The cost of self-attestation is expected to be
minimal.
For scenario 2, the eight-hour training course for physicians and
non-physicians is available online, free of charge.\25\ As the eight-
hour training is online and free, cost of this requirement is limited
to the practitioners' opportunity cost associated with obtaining the
training.
---------------------------------------------------------------------------
\25\ Providers Clinical Support System (PCSS), Medications for
Opioid Use Disorder (MOUD), <a href="https://pcssnow.org/medications-for-opioid-use-disorder/">https://pcssnow.org/medications-for-opioid-use-disorder/</a>. (Accessed 1/3/2024.)
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[[Page 34764]]
DEA estimates a total time of eight hours and 10 minutes (8.17
hours) to complete the training requirement, eight hours to complete
the training and an additional 10 minutes for logging in or creating an
account. To estimate the training opportunity cost, DEA applied the
required hours to the estimated loaded hourly wage for physicians and
non-physicians. DEA used the physician median wage to estimate the wage
of a practitioner who is a physician; and as physician assistants and
nurse practitioners are the majority of practitioners who are not
physicians, DEA used the average wages of physician assistants and
nurse practitioners to estimate the wages of a practitioner who is not
a physician. The U.S. Bureau of Labor Statistics (BLS) data indicates
that median hourly wage for physicians, physician assistants, and nurse
practitioners are $107.41, $60.58, and $58.47, respectively.\26\ The
average wage of physician assistants and nurse practitioners is $59.53
(($60.58 + $58.47)/2). According to the BLS Employer Costs for Employee
Compensation (ECEC), for private industry workers, average total
benefits are 29.5 percent and wages and salaries are 70.5 percent of
total compensation.\27\ The total benefits of 29.5 percent equate to a
41.8 (29.5/70.5) percent load on wages and salaries. Adding the 41.8
percent load on the median salaries, the loaded median hourly wage for
a physician and a non-physician practitioner are $152.31 ($107.41 x
1.418) and $84.41 ($59.53 x 1.418), respectively. Applying eight hours
of training (8.17 hours) to each of the estimated loaded hourly wages,
the labor cost of obtaining training for a physician practitioner and a
non-physician practitioner, under Scenario 2, are $1,244 ($152.31 x
8.17) and $690 ($84.41 x 8.17) per person.
---------------------------------------------------------------------------
\26\ BLS, May 2022 National Occupational Employment and Wage
Estimates, United States. Occupation code 29-1229 Physicians, All
Other; 29-1071 Physician Assistants; 29-1171 Nurse Practitioners.
<a href="https://www.bls.gov/oes/current/oes_nat.htm">https://www.bls.gov/oes/current/oes_nat.htm</a>. (Accessed 09/15/2023)
\27\ BLS, Employer Cost for Employee Compensation-June 2023
(ECEC) <a href="https://www.bls.gov/news.release/pdf/ecec.pdf">https://www.bls.gov/news.release/pdf/ecec.pdf</a> (Accessed 09/
15/2023)
---------------------------------------------------------------------------
Number of Registrations Under Scenario 2
DEA estimated the number of practitioners under Scenario 2 based on
DEA's registration records. There are two categories of registrants
that fall under Scenario 2: (1) applicants for renewal registration for
existing registrants, and (2) applicants for new registrations.
Although the new 21 U.S.C. 823(m) includes more provisions, the
training requirements are similar to those previously applicable to
DATA-waiver practitioners under the repealed 21 U.S.C. 823(h)(2).
Therefore, previously DATA-waived practitioners are presumed to already
meet the training requirements.
DEA is unable to precisely estimate the number of renewal
applicants who will need to obtain training because many registrants
may already meet the training requirements and DEA does not track a
practitioner's board certification or education curriculum. However,
based on the number of DATA-waived practitioners (as of December 2022),
who had met prior similar training requirements, DEA is able to
estimate the maximum number of practitioners who will need to obtain
training.
Based on DEA's registration data, DEA estimated the maximum number
of practitioners, physician and non-physician, who will need to obtain
training. Because practitioner registrations are three-year
registrations, renewal applicants who may need to obtain training would
only exist for three years for those already registered prior to June
27, 2023. Any new applicant on or after this date are required to meet
the training requirement in order to register. Therefore, based on the
number of practitioner and mid-level practitioner registrations as of
June 2023,\28\ adjusting for the estimated number of practitioners who
are not solely veterinarians \29\ and adjusting for the number of
previously DATA-waived practitioners,\30\ on Table 1, DEA summarizes
the maximum number of renewal applicants who will need to obtain
training.
---------------------------------------------------------------------------
\28\ DEA, Registrant Population-Summary, <a href="https://apps.deadiversion.usdoj.gov/RAPR/raprRegistrantPopulationSummary.xhtml#no-back-button">https://apps.deadiversion.usdoj.gov/RAPR/raprRegistrantPopulationSummary.xhtml#no-back-button</a>.
\29\ DEA's registration system.
\30\ DEA, Qualifying Practitioners by State, <a href="https://apps.deadiversion.usdoj.gov/RAPR/raprQualifyingPractitionersByState.xhtml#no-back-button">https://apps.deadiversion.usdoj.gov/RAPR/raprQualifyingPractitionersByState.xhtml#no-back-button</a>.
Table 1--Maximum Renewal Applicant Practitioners Who Will Need To Obtain
Training
------------------------------------------------------------------------
Year \31\ Physician Non-physician
------------------------------------------------------------------------
1....................................... 348,067 139,937
2....................................... 347,628 149,226
3....................................... 354,017 163,297
4....................................... .............. ..............
5....................................... .............. ..............
6....................................... .............. ..............
7....................................... .............. ..............
8....................................... .............. ..............
9....................................... .............. ..............
10...................................... .............. ..............
------------------------------------------------------------------------
Source: DEA.
Similarly, DEA is unable to precisely estimate the number of new
applicants who may need to obtain training to meet the training
requirements of the rule. As mentioned earlier, DEA does not track a
practitioner's board certification or education curriculum.
Additionally, education institutions may include the requisite
curriculum without additional cost to the prospective new applicant.
However, DEA is able estimate the maximum number of new applicants who
will need training.
---------------------------------------------------------------------------
\31\ ``Year 1'' corresponds to the period 6/27/2023-6/26/2024;
``year 2'' corresponds to the period 6/27/2024-6/26/2025; ``year 3''
corresponds to the period 6/27/2025-6/26/2026, etc.
---------------------------------------------------------------------------
Based on historical number of new applicants, DEA estimated the
number of new applicants for a ten-year period; then adjusted for the
estimated baseline number of practitioners who are veterinarians; then
adjusted for the estimated baseline number of DATA-waived
practitioners. Table 2 summarizes the resulting maximum number of new
practitioners who will need to obtain required training at an
additional cost.
[[Page 34765]]
Table 2--Maximum New Applicant Practitioners Who Will Need To Obtain
Training
------------------------------------------------------------------------
Year Physician Non-physician
------------------------------------------------------------------------
1....................................... 86,970 64,847
2....................................... 90,812 68,815
3....................................... 94,823 73,026
4....................................... 99,012 77,495
5....................................... 103,385 82,238
6....................................... 107,952 87,270
7....................................... 112,721 92,611
8....................................... 117,699 98,278
9....................................... 122,898 104,293
10...................................... 128,327 110,676
-------------------------------
Total............................... 1,064,599 859,549
------------------------------------------------------------------------
Source: DEA.
Combining the figures in Table 1 and Table 2, the maximum number of
practitioners who will need training as a result of this rule is
presented in Table 3.
Table 3--Maximum Combined, Renewal and New Applicant Practitioners Who Will Need To Obtain Training
----------------------------------------------------------------------------------------------------------------
Year Physician Non-physician Total
----------------------------------------------------------------------------------------------------------------
1............................................................... 435,037 204,784 639,821
2............................................................... 438,440 218,041 656,481
3............................................................... 448,840 236,323 685,163
4............................................................... 99,012 77,495 176,507
5............................................................... 103,385 82,238 185,623
6............................................................... 107,952 87,270 195,222
7............................................................... 112,721 92,611 205,332
8............................................................... 117,699 98,278 215,977
9............................................................... 122,898 104,293 227,191
10.............................................................. 128,327 110,676 239,003
-----------------------------------------------
Total....................................................... 2,114,311 1,312,009 3,426,320
----------------------------------------------------------------------------------------------------------------
Applying the unit opportunity cost, estimated earlier, of $1,244
and $690 for physicians and non-physicians, respectively, Table 4 lists
the estimated maximum cost of this rule.
Table 4--Maximum Opportunity Costs of This Rule
----------------------------------------------------------------------------------------------------------------
Non-physician
Year Physician ($) ($) Total ($)
----------------------------------------------------------------------------------------------------------------
1............................................................... 541,186,028 141,300,960 682,486,988
2............................................................... 545,419,360 150,448,290 695,867,650
3............................................................... 558,356,960 163,062,870 721,419,830
4............................................................... 123,170,928 53,471,550 176,642,478
5............................................................... 128,610,940 56,744,220 185,355,160
6............................................................... 134,292,288 60,216,300 194,508,588
7............................................................... 140,224,924 63,901,590 204,126,514
8............................................................... 146,417,556 67,811,820 214,229,376
9............................................................... 152,885,112 71,962,170 224,847,282
10.............................................................. 159,638,788 76,366,440 236,005,228
-----------------------------------------------
Total....................................................... 2,630,202,884 905,286,210 3,535,489,094
----------------------------------------------------------------------------------------------------------------
The net present value of the estimated maximum cost is
$3,141,488,447 and $2,725,132,486 at 3 percent and 7 percent discount
rates, respectively. Additionally, the annualized maximum cost is
$368,278,282 and $387,997,558 at 3 percent and 7 percent, respectively.
While the maximum costs seem large, the potential cost savings per
treated patient is also large--resulting in a low break-even point. For
example, from Tables 3 and 4, in Year 1, the maximum number of
registrants that will need to obtain training is 639,821 at a cost of
$682,486,988. As stated earlier, the societal cost of non-fatal OUD is
approximately $224,000 per person per year. The resulting break-even is
3,047 ($682,486,988/$224,000) patients treated by the 639,821
practitioners who are able to provide MAT as a result of this rule.
Therefore, this rule `breaks even' if 639,821 practitioners,
[[Page 34766]]
authorized to provide MAT as a result of this rule in Year 1,
successfully treat the OUD of 3,047 patients for one year in Year 1 or
if the practitioners are able to avoid 59 deaths ($682 million/$11.6
million). This is a ratio of 210 practitioners to one case of non-fatal
OUD avoided or successfully treated. DEA believes this is a low break-
even point and the economic impact of this provision will be a net cost
savings.
Change 2: NTP Registration
Following passage of the Omnibus, the separate registration
requirement in 21 U.S.C. 823(h) is only applicable to practitioners
dispensing narcotic drugs in schedule II for the purpose of maintenance
or detoxification treatment. Any practitioner wishing to dispense
narcotic drugs in schedule II for the purpose of maintenance or
detoxification treatment must obtain annually a separate registration
as an NTP pursuant to that section.
While this provision is a change to the regulations based on
statute, this change continues the current requirements for
practitioners dispensing narcotic drugs in schedule II for maintenance
treatment or detoxification treatment. Prior to Omnibus, to dispense a
narcotic drug in schedule II for maintenance or detoxification
treatment, a practitioner was required to obtain a separate
registration annually, as DATA-waiver only applied to the dispensing of
schedule III-V narcotic approved by the FDA for maintenance or
detoxification treatment. Therefore, any economic impact of this change
is minimal.
Furthermore, 85 of 2,235 currently registered NTPs are authorized
to dispense only narcotic drugs in schedule III.\32\ It is plausible
some of the 85 NTPs may find an NTP registration unnecessary and decide
to not renew its registration. The annual registration fee is $296 per
year. If all 85 NTPs did not renew its registration, there would be a
decrease of $25,160 ($296 x 85) in fees paid to DEA. However, since all
of the 85 NTPs obtained their registration after 180 days of the
enactment of the Omnibus (June 27, 2023), DEA believes registered NTPs
that are authorized to dispense only narcotic drugs in schedule III
have other reasons for maintaining a DEA registration. Therefore, DEA
estimates any impact associated with this change is minimal.
---------------------------------------------------------------------------
\32\ Source: DEA, as of 9/12/2024.
---------------------------------------------------------------------------
Change 3: Day Limit Increased
DEA is modifying the current 14-day limit (the time for the
practitioner to administer the controlled substance to a patient from
when the practitioner receives the controlled substance from pharmacy)
to 45 days, as now set forth in 21 U.S.C. 829a.
Increasing the number of days to administer treatments from 14 days
to 45 days will increase flexibility in scheduling, increase the number
of patients receiving needed medication and improve patient care
outcomes. The added flexibility is expected to reduce returns and
wastage. DEA has no basis to estimate the cost savings due to reduced
returns and wastage or improvements to patient care; however, it cannot
be dismissed as negligible.
Change 4: Recordkeeping
Finally, DEA is making a minor, non-substantive change to include a
cross-reference to existing regulations describing practitioners'
recordkeeping requirements relevant to prescriptions. This cross-
reference will increase clarity in regulations while imposing no
additional cost to prescribing practitioners, as it effects no change
in regulatory requirements.
Summary of Benefits/Cost Savings and Costs
In summary, DEA is making the following changes in this final rule:
1) DATA-waiver removal and new training requirement, 2) NTP
registration requirement, 3) day limit increase (from 14 to 45 days),
and 4) recordkeeping. The DATA-waiver removal and new training
requirement is expected to have a potentially large cost, with the
annualized maximum cost of $368,278,282 and $387,997,558 at 3 percent
and 7 percent, respectively. However, due to the potentially high
societal cost savings, the break-even is low. For example, in Year 1,
the break-even is the successful treatment for one year of non-fatal
OUD for 3,047 patients treated by the 639,821 practitioners at a ratio
of 210 practitioners to one case of OUD. If the training requirement
allows for the abatement of fatal OUD cases, the break-even point is
even lower. DEA believes this is a low break-even point and the
economic impact of this provision will be a net cost savings. The NTP
registration requirement continues the pre-existing requirement to
dispense narcotic drugs in schedule II for maintenance or
detoxification treatment. Increasing the day limit from 14 to 45 days
is expected to reduce returns and wastage and improve patient care.
While this cost savings cannot be quantified, it cannot be dismissed as
minimal. Finally, the recordkeeping requirement is expected to increase
clarity while imposing no additional costs.
This final rule is an E.O. 14192 deregulatory action because this
is an enabling rule that expands consumption and/or production options.
This final rule implements the Omnibus that allows all practitioners to
dispense narcotic drugs in schedules III, IV, and V for maintenance or
detoxification treatment without obtaining a waiver of the requirement
for a separate registration.
Executive Order 14294, Overcriminalization of Federal Regulations
Executive Order 14294 requires agencies promulgating regulations
with criminal regulatory offenses potentially subject to criminal
enforcement to explicitly describe the conduct subject to criminal
enforcement, the authorizing statutes, and the mens rea standard
applicable to each element of those offenses. This final rule does not
impose a criminal regulatory penalty and is thus exempt from E.O. 14294
requirements.
Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to
rules that are subject to notice and comment under section 553(b) of
the APA. As explained above, DEA determined that there is good cause to
exempt this final rule from notice and comment.
Consequently, DEA is not required to conduct a Final Regulatory
Flexibility Analysis for this final rule. 5 U.S.C. 605.
Executive Order 12988, Civil Justice Reform
This final rule meets the applicable standards set forth in
sections 3(a) and 3(b)(2) of E.O. 12988, Civil Justice Reform to
eliminate ambiguity, minimize litigation, establish clear legal
standards, and reduce burden.
Executive Order 13132, Federalism
This rulemaking does not have federalism implications warranting
the application of E.O. 13132. The final rule does not have substantial
direct effects on the States, on the relationship between the National
government and the States, or the distribution of power and
responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This final rule does not have substantial direct effects on the
States, on the relationship between the National government and the
States, or the distribution of power and responsibilities between the
Federal government and Indian tribes.
[[Page 34767]]
Unfunded Mandates Reform Act of 1995
This final rule will not result in the expenditure by state, local,
and tribal governments, in the aggregate, or by the private sector, of
$100 million or more (adjusted annually for inflation) in any one year,
and will not significantly or uniquely affect small governments.
Therefore, no actions were deemed under the provisions of the Unfunded
Mandates Reform Act of 1995, 2 U.S.C. 1532.
Congressional Review Act
The Office of Information and Regulatory Affairs has determined
that this final rule is a major rule as defined by the Congressional
Review Act. 5 U.S.C. 804. This rule is not subject to the 60-day
delayed effective date requirement at 5 U.S.C. 801(a)(3)(A) because the
DEA has found, as described above, that prior notice and comment is
unnecessary for this rule. 5 U.S.C. 808(2). DEA is submitting the
required report under the CRA, together with a copy of this final rule,
to both Houses of Congress and to the Comptroller General.
Paperwork Reduction Act of 1995
This final rule involves existing collection 1117-0014 but does not
impose a new collection or modify an existing collection of information
under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. The
modification mentioned in the rule has already been submitted to the
Office of Management and Budget (OMB) and approved through a separate
information collection process. A 60-day Federal Register Notice \33\
and a 30-day Federal Register Notice \34\ were published and no
comments were received. Also, this final rule does not impose new or
modify existing recordkeeping or reporting requirements on State or
local governments, individuals, businesses, or other organizations. An
agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a valid OMB
control number. Copies of the approved existing information collection
may be obtained at <a href="http://www.reginfo.gov/public/do/PRAMain">http://www.reginfo.gov/public/do/PRAMain</a>.
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\33\ The 60-day Federal Register Notice was published on March
3, 2023 and can be found at 88 FR 13469. The comment period closed
May 2, 2023.
\34\ The 30-day Federal Register Notice was published on May 26,
2023 and can be found at 88 FR 34185. The comment period closed June
26, 2023.
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List of Subjects
21 CFR Part 1300
Chemicals, Drug traffic control.
21 CFR Part 1301
Administrative practice and procedure, Drug traffic control,
Security measures.
21 CFR Part 1306
Drug traffic control, Prescription drugs.
For the reasons set out above, the interim final rule amending 21
CFR parts 1301 and 1306, which published on November 2, 2020 (85 FR
69153) is adopted as a final rule, with the following amendments in
parts 1300, 1301, and 1306:
PART 1300--DEFINITIONS
0
1. The authority citation for part 1300 is revised to read as follows:
Authority: 21 U.S.C. 802, 821, 822, 823, 829, 871(b), 951,
958(f).
0
2. In Sec. 1300.01, amend paragraph (b) by adding, in alphabetical
order, the definition for ``Qualified practitioner'' to read as
follows:
Sec. 1300.01 Definitions relating to controlled substances.
* * * * *
(b) * * *
Qualified practitioner means a practitioner who:
(1) Is licensed under State law to prescribe controlled substances;
and
(2) Is not solely a veterinarian.
* * * * *
PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND
DISPENSERS OF CONTROLLED SUBSTANCES
0
3. The authority citation for part 1301 continues to read as follows:
Authority: 21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877,
886a, 951, 952, 956, 957, 958, 965 unless otherwise noted.
0
4. Revise and republish Sec. 1301.11 to read as follows:
Sec. 1301.11 Persons required to register; requirement of
modification of registration authorizing activity as an online
pharmacy.
(a) Every person who manufactures, distributes, dispenses, imports,
or exports any controlled substance or who proposes to engage in the
manufacture, distribution, dispensing, importation or exportation of
any controlled substance shall obtain a registration unless exempted by
law or pursuant to Sec. Sec. 1301.22 through 1301.26. Except as
provided in paragraph (d) of this section, only persons actually
engaged in such activities are required to obtain a registration;
related or affiliated persons who are not engaged in such activities
are not required to be registered. (For example, a stockholder or
parent corporation of a corporation manufacturing controlled substances
is not required to obtain a registration.)
(b) Practitioners who dispense narcotic drugs (other than narcotic
drugs in schedule III, IV, or V) to individuals for maintenance
treatment or detoxification treatment shall obtain annually a separate
registration for that purpose.
(c) As a condition on registration under this part and section 303
of the Act (21 U.S.C. 823) to dispense controlled substances in
schedule II, III, IV, or V, qualified practitioners, as defined in
Sec. 1300.01 of this chapter, must meet the training requirements set
forth in section 303(m) of the Act (21 U.S.C. 823(m)). No qualified
practitioner is required to complete the training more than once. This
requirement applies from the first registration or renewal of
registration by a qualified practitioner that occurs on or after June
27, 2023.
(d) As provided in sections 303(f) and 401(h) of the Act (21 U.S.C.
823(f) and 841(h)), it is unlawful for any person who falls within the
definition of ``online pharmacy'' (as set forth in section 102(52) of
the Act (21 U.S.C. 802(52)) and Sec. 1300.04(h) of this chapter) to
deliver, distribute, or dispense a controlled substance by means of the
internet if such person is not validly registered with a modification
of such registration authorizing such activity (unless such person is
exempt from such modified registration requirement under the Act or
this chapter). The Act further provides that the Administrator may only
issue such modification of registration to a person who is registered
as a pharmacy under section 303(f) of the Act (21 U.S.C. 823(f)).
Accordingly, any pharmacy registered pursuant to Sec. 1301.13 that
falls within the definition of an online pharmacy and proposes to
dispense controlled substances by means of the internet must obtain a
modification of its registration authorizing such activity following
the submission of an application in accordance with Sec. 1301.19. This
requirement does not apply to a registered pharmacy that does not fall
within the definition of an online pharmacy set forth in Sec.
1300.04(h) of this chapter. Under the Act, persons other than
registered pharmacies are not eligible to obtain such a modification of
registration but remain liable under section 401(h) of the Act (21
U.S.C. 841(h)) if they deliver, distribute, or dispense a controlled
substance while acting as an online pharmacy without
[[Page 34768]]
being validly registered with a modification authorizing such activity.
* * * * *
Sec. 1301.28 [Removed and Reserved]
0
5. Remove and reserve Sec. 1301.28.
PART 1306--PRESCRIPTIONS
0
6. The authority citation for part 1306 continues to read as follows:
Authority: 21 U.S.C. 821, 823, 829, 829a, 831, 871(b) unless
otherwise noted.
0
7. In Sec. 1306.04, revise paragraphs (c) and (d) to read as follows:
Sec. 1306.04 Purpose of issue of prescription.
* * * * *
(c) A prescription may be issued by a practitioner for a controlled
substance in Schedule III, IV, or V for use in detoxification treatment
or maintenance treatment.
(d) A prescription may be issued by a practitioner in accordance
with Sec. 1306.05 for a Schedule III, IV, or V controlled substance
for the purpose of maintenance or detoxification treatment for the
purposes of administration in accordance with section 309A of the Act
(21 U.S.C. 829a) and Sec. 1306.07(f). Such prescription shall not be
used to supply any practitioner with a stock of controlled substances
for the purpose of general dispensing to patients.
Sec. 1306.05 [Amended]
0
8. In Sec. 1306.05, remove and reserve paragraph (b).
0
9. In Sec. 1306.07, revise paragraphs (a) introductory text, (d),
(f)(1) through (3), (5), and (6) to read as follows:
Sec. 1306.07 Administering or dispensing of narcotic drugs.
(a) A practitioner may administer or dispense directly (but not
prescribe) a narcotic drug in Schedule II to a narcotic dependent
person for the purpose of maintenance or detoxification treatment if
the practitioner meets both of the following conditions:
* * * * *
(d) A practitioner may administer or dispense (including prescribe)
any Schedule III, IV, or V narcotic drug for use in maintenance or
detoxification treatment to a narcotic dependent person.
* * * * *
(f) * * *
(1) The controlled substance is delivered by the pharmacy to the
prescribing practitioner or the practitioner administering the
controlled substance (in this paragraph (f) referred to as the
``administering practitioner''), as applicable, at the location listed
on the practitioner's DEA certificate of registration;
(2) The controlled substance is a narcotic drug in schedule III,
IV, or V to be administered for the purpose of maintenance or
detoxification treatment and is to be administered by injection or
implantation;
(3) The pharmacy, the prescribing practitioner, and the
administering practitioner (as applicable) are authorized to conduct
such activities specified in this paragraph (f) under the law of the
State in which such activities take place;
* * * * *
(5) The controlled substance is to be administered only to the
patient named on the prescription not later than 45 days after the date
of receipt of the controlled substance by the practitioner; and
(6) Notwithstanding any exceptions under section 307 of the Act (21
U.S.C. 827), the prescribing practitioner and the administering
practitioner, as applicable, shall maintain complete and accurate
records of all controlled substances delivered, received, administered,
or otherwise disposed of under this paragraph (f), including the
persons to whom the controlled substances were delivered and such other
information as may be required under this chapter. Recordkeeping
requirements for prescriptions are addressed in Sec. Sec. 1304.03(c)
and 1304.06 of this chapter.
* * * * *
Signing Authority
This document of the Drug Enforcement Administration was signed on
June 3, 2026, by DEA Administrator Terrance C. Cole. That document with
the original signature and date is maintained by DEA. For
administrative purposes only, and in compliance with requirements of
the Office of the Federal Register, the undersigned DEA Federal
Register Liaison Officer has been authorized to sign and submit the
document in electronic format for publication, as an official document
of DEA. This administrative process in no way alters the legal effect
of this document upon publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2026-11526 Filed 6-8-26; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on June 9, 2026.
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.