Rule2026-02288
Registering Emergency Medical Services Agencies Under the Protecting Patient Access to Emergency Medications Act of 2017
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 5, 2026
Effective
March 9, 2026
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The "Protecting Patient Access to Emergency Medications Act of 2017," (the Act) which became law on November 17, 2017, amended the Controlled Substances Act (CSA) to allow for a new registration category for emergency medical services agencies that handle controlled substances. It also established standards for registering emergency medical services agencies, and set forth new requirements for delivery, storage, and recordkeeping related to their handling of controlled substances. In addition, the Act allows emergency medical services professionals to administer controlled substances outside the physical presence of a medical director or authorizing medical professional pursuant to a valid standing or verbal order. The Drug Enforcement Administration is publishing this final rule to conform its regulations to the statutory amendments of the CSA and to otherwise implement its requirements. This final rule adopts, with minor modifications, the notice of proposed rulemaking published on October 5, 2020.
Full Text
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[Federal Register Volume 91, Number 24 (Thursday, February 5, 2026)]
[Rules and Regulations]
[Pages 5216-5242]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-02288]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1300, 1301, 1304, 1306, and 1307
[Docket No. DEA-377]
RIN 1117-AB37
Registering Emergency Medical Services Agencies Under the
Protecting Patient Access to Emergency Medications Act of 2017
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
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SUMMARY: The ``Protecting Patient Access to Emergency Medications Act
of 2017,'' (the Act) which became law on November 17, 2017, amended the
Controlled Substances Act (CSA) to allow for a new registration
category for emergency medical services agencies that handle controlled
substances. It also established standards for registering emergency
medical services agencies, and set forth new requirements for delivery,
storage, and recordkeeping related to their handling of controlled
substances. In addition, the Act allows emergency medical services
professionals to administer controlled substances outside the physical
presence of a medical director or authorizing medical professional
pursuant to a valid standing or verbal order. The Drug Enforcement
Administration is publishing this final rule to conform its regulations
to the statutory amendments of the CSA and to otherwise implement its
requirements. This final rule adopts, with minor modifications, the
notice of proposed rulemaking published on October 5, 2020.
DATES: This rule is effective March 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:
Outline
I. Background and Purpose
A. Legal Authority
B. Purpose
C. Background
D. Summary of the Act and Changes to the CSA
E. Summary of the Notice of Proposed Rulemaking
II. Discussion of Public Comments
III. Section-by-Section Summary of the Final Rule
IV. Regulatory Analyses
I. Background and Purpose
A. Legal Authority
On November 17, 2017, the ``Protecting Patient Access to Emergency
Medications Act of 2017,'' Public Law 115-83 (131 Stat. 1267) (the
Act), became law.
The Act amended a section of the CSA, 21 U.S.C. 823, by adding a
new subsection, 21 U.S.C. 823(k). This new subsection alters a number
of CSA requirements ``[f]or the purpose of enabling emergency medical
services professionals to administer controlled substances in schedule
II, III, IV, or V to ultimate users receiving emergency medical
services.'' 21 U.S.C. 823(k)(1). The Act also specifically authorizes
the Attorney General (and thus the Administrator of the Drug
Enforcement Administration (DEA) by delegation) \1\ to issue certain
regulations to implement the Act. Id. 823(k)(11).
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\1\ 21 U.S.C. 871(a); 28 CFR 0.100(b).
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B. Purpose
The purposes of this final rule are two-fold. First, this final
rule codifies, in DEA regulations, the statutory amendments made by the
Act, conforming DEA's implementing regulations to statutory amendments
of the CSA that have already taken effect. Second, this final rule
makes limited additional changes that are authorized by the CSA, as
amended by the Act, and to further implement the Act and effectuate its
purposes.
C. Background
When an individual experiences a medical emergency, the entry into
the healthcare system may not start with the care of a physician within
a traditional clinical setting, but instead with the intervention of
emergency medical services (EMS) personnel affiliated with a local EMS
agency at the incident site. EMS personnel, who provide emergency
medical services by ground, air, or otherwise, respond to 60 million
calls in 2024. EMS involves the evaluation and management of patients
with acute traumatic and medical conditions in a prehospital
environment,\2\ and is an important component of medical care, as early
medical intervention saves lives and often reduces the severity of
injury.\3\ The nature of medical
[[Page 5217]]
intervention at the incident site and during transport to the hospital
can vary widely depending on the severity and type of injury or
impairment, and may include the administering of controlled
substances.\4\
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\2\ Federal Interagency Committee on Emergency Medical Services
(FICEMS) 2011 National EMS Assessment.
\3\ Kuehl, Alexander. ``25.'' Prehospital Systems and Medical
Oversight. Dubuque, IA: Kendall/Hunt Pub., 2002. (``For most
prehospital medical conditions, patient outcome is assumed to be
beneficially influenced by early medical intervention, and
contemporary prehospital care systems are a well-defined practice of
medicine in the United States.'').
\4\ A non-exhaustive list of common controlled substance
pharmaceuticals utilized by EMS include the benzodiazepine class of
drugs for seizures and sedation as well as morphine (schedule II),
fentanyl (schedule II), and meperidine (schedule II) for pain
management.
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The delivery of emergency medical care is primarily a local
function; and, accordingly, a wide variety of organizational structures
are utilized across the nation. EMS programs may be a part of the local
municipal government, hospital, or independent government agency, or
may be contracted by local government with a private entity. Each State
has a State EMS licensing office that is responsible for the overall
planning, coordination, and regulation of the State EMS system, as well
as licensing or certifying EMS providers and ambulances.\5\ These
agencies are often located within the State health department but may
also be found as part of the public safety department or as independent
agencies.\6\
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\5\ <a href="http://www.ems.gov">http://www.ems.gov</a>.
\6\ Id.
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D. Summary of the Act and Changes to the CSA
The Act established uniform EMS agency requirements for the
administration of controlled substances while ensuring adequate
safeguards against theft and diversion. The Act added a new subsection
to the CSA, 21 U.S.C. 823(k). The new 21 U.S.C. 823(k) makes several
notable changes to the CSA.
First, the Act creates a new registration category under the CSA
for EMS agencies, directing the Attorney General (and thus the
Administrator of DEA by delegation) to register such an agency under
the CSA if the agency submits an application demonstrating that it is
authorized to conduct emergency medical services under the laws of each
State in which the agency practices. 21 U.S.C. 823(k)(1)(A). Pursuant
to 21 U.S.C. 823(k)(1)(B), the Act authorizes the Attorney General to
deny the application of an EMS agency if registering it is inconsistent
with other requirements of 21 U.S.C. 823(k) or with the public interest
based on the factors of 21 U.S.C. 823(g).
Second, the Act directs the Attorney General (and thus the
Administrator) to allow a registered EMS agency to obtain a single
registration for each State in which the EMS agency administers
controlled substances, rather than requiring the agency to obtain a
separate registration for each location at which it operates within
that State. 21 U.S.C. 823(k)(2). The Act also provides that a hospital-
based emergency medical services agency registered under 21 U.S.C.
823(g) may use the registration of the hospital to administer
controlled substances under 21 U.S.C. 823(k), without requiring the
agency to acquire a separate registration. 21 U.S.C. 823(k)(3).
Third, subject to certain restrictions, the Act authorizes EMS
professionals of a registered EMS agency to administer controlled
substances in schedule II, III, IV, or V outside the physical presence
of a medical director or authorizing medical professional while
providing emergency medical services. 21 U.S.C. 823(k)(4). EMS
professionals are only allowed to make such administrations if
authorized by State law and pursuant to standing or verbal orders that
satisfy a number of statutory conditions. Id.
Fourth, the Act provides a variety of requirements for how
registered EMS agencies must deliver controlled substances from
registered to unregistered locations, store controlled substances,
restock EMS vehicles at a hospital, maintain records, and otherwise
conduct their operations. 21 U.S.C. 823(k)(5)-(10).
Fifth, the Act specifically authorizes the Attorney General (and
thus the Administrator) to issue regulations regarding the delivery and
storage of controlled substances by EMS agencies. Id. 823(k)(11).
E. Summary of the Notice of Proposed Rulemaking
DEA published a notice of proposed rulemaking (NPRM) in the Federal
Register on October 5, 2020 to (1) codify in DEA regulations the
statutory amendments of the CSA that have already taken effect; and (2)
amend DEA regulations to implement the Act and effectuate its purposes,
including by adding new regulations regarding the registration,
security, recordkeeping, inventory, and administration requirements for
EMS agencies.\7\ DEA invited comments from the public on all of the
topics covered in the NPRM to be submitted on or before December 4,
2020. This final rule responds to comments received concerning the
proposed rule and adopts the proposed regulations with minor
modifications.
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\7\ Registering Emergency Medical Services Agencies Under the
Protecting Patient Access to Emergency Medications Act of 2017, 85
FR 62634 (Oct. 5, 2020).
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II. Discussion of Public Comments
DEA received eighty-one comments in response to the publication of
the NPRM. The commenters included EMS medical directors, physicians,
medical associations, and members of the general public. DEA thanks all
commenters for their comments and appreciates the input received during
the rulemaking process. While the majority of the commenters expressed
support for various provisions in the proposed rule, some commenters
offered only partial support for the rule--agreeing with the general
purpose of the rule, but disagreeing with particular provisions.
Several commenters also disagreed with the proposed changes entirely,
and two comments were entirely outside the scope of the rule. These
comments and suggested changes to the rule, along with DEA's responses,
are further described below.
Designated Location
Issue: DEA received nine comments which suggested eliminating the
definition and concept of a stationhouse as a brick-and-mortar building
that is primarily used for EMS and houses EMS vehicles. One commenter
stated that EMS systems will likely need to designate locations where
EMS vehicles, equipment or personnel are housed, even though such
locations may not actually house vehicles inside that location. A
commenter suggested that this is particularly true in urban systems
that use central supply facilities, air ambulance bases, and other
arrangements where vehicles are not permanently housed or stored
indoors. Some commenters believe that this rule is too narrow an
interpretation of congressional intent. Specifically, commenters stated
that if Congress wanted to limit the designated location to a physical
structure that houses an emergency medical services vehicle, then
Congress would have done so. Another commenter objected to any
requirement that EMS agencies designate locations to which they deliver
controlled substances as unduly interfering with EMS agencies'
flexibility.
DEA Response: The CSA and DEA regulations generally require
dispensers of controlled substances to separately register each
principal place of business from where they dispense controlled
substances, allowing DEA to ensure that substances at those locations
are not at
[[Page 5218]]
unnecessary risk of diversion. See 21 U.S.C. 822(e)(1); 21 CFR 1301.12.
The Act creates an exception to this requirement, authorizing an EMS
agency to deliver controlled substances to unregistered locations
designated by the agency with advance notice to DEA. 21 U.S.C.
823(k)(5). The Act, however, also expressly provides in 21 U.S.C.
823(k)(11)(A)(i) that DEA may by regulation ``specify[ ] . . . the
types of locations that may be designated.'' Thus, Congress intended
DEA to be able to place limitations on which locations could be
designated, and authorized DEA to determine what those limitations
should be, recognizing the need to avoid undermining the CSA's general
requirement of registration and to avoid applying this exception in a
way that would unnecessarily increase the risk of diversion.
In the proposed rule, DEA sought to fulfill this purpose by
limiting designated locations to ``stationhouses'' and defining
stationhouses as enclosed structures housing EMS agency vehicles within
the State of the emergency medical services agency's registration, and
which are actively and primarily being used for emergency response. By
limiting designated locations to those clearly being used by EMS
personnel to house and resupply EMS vehicles, the proposed rule sought
to reduce the opportunities for controlled substances to be stolen by
non-EMS personnel or mislaid. Through such limitations, the proposed
rule also sought to ensure that designated locations would be readily
identifiable to DEA investigators.
Commenters, however, have identified several situations in which
EMS agency facilities may be used clearly and primarily for official
EMS purposes--generally fulfilling purposes of the proposed rule's
limitations--but not actually ``house'' associated EMS vehicles. Such
purposes include but are not limited to the storage of medical
supplies, controlled substances, and equipment; staff training and
education; and administrative functions essential to EMS operations.
The commenters were concerned with defining a ``stationhouse'' strictly
as a brick-and-mortar structure that houses EMS vehicles. The
commenters expressed concern that a narrow definition could
inadvertently limit the operational flexibility of EMS agencies,
particularly in scenarios where EMS operations are conducted from
multiple locations.
In response to these concerns, in this final rule, DEA is amending
the definition of ``stationhouse'' by removing the requirement that a
stationhouse must house an EMS vehicle, removing the phrase ``for
emergency response,'' and adding the phrase ``at its premises'' to
accommodate locations where EMS vehicles are not housed or stored
indoors. These revisions aim to acknowledge the unique operational
demands of EMS agencies and ensure that this rule supports the
efficient and effective delivery of emergency medical services.
Specifically, the definition of stationhouse is revised to mean an
enclosed structure within a State where the emergency medical services
agency is registered, which may house EMS vehicles at its premises, and
which is actively and primarily being used by that emergency medical
services agency. DEA acknowledges the concerns raised about the
limitations of the stationhouse definition and recognizes that it is
important for EMS agencies to have the flexibility they need to
effectively serve their communities. DEA's revised definition of
stationhouse addresses the concerns raised and supports how EMS
agencies treat patients and provides greater flexibility for EMS
agencies to operate.
In response to the commenters' concern that EMS agency facilities
may at times be used primarily for various operational EMS purposes,
but not actually ``house'' associated EMS vehicles, DEA removed the
requirement that a stationhouse must house an EMS vehicle from the
stationhouse definition. DEA also removed the phrase ``for emergency
response'' from the stationhouse definition in response to the comments
received. DEA removed this phrase because in addition to housing EMS
vehicles, stationhouses may also be used for various non-emergency EMS
activities such as the storage of medical supplies, controlled
substances, and equipment; staff training and education; and
administrative functions essential to EMS operations. These regulatory
changes provide EMS agencies with greater flexibility in fulfilling the
operational activities involved in managing emergency medical services
and response efforts. For this reason, DEA is removing the requirement
that a stationhouse must house an EMS vehicle and removed the phrase
``for emergency response'' from the stationhouse definition. Thus, an
EMS agency may house an EMS vehicle at a stationhouse, however it is
not required. Additionally, although DEA has removed the phrase ``for
emergency response,'' DEA is retaining the requirement that a
stationhouse must actively and primarily be used by the emergency
medical services agency. This would preclude, for example, an apartment
or residence from being designated as a stationhouse.
Further, the addition of the phrase ``at its premises'' to
accommodate locations where EMS vehicles are not housed or stored
indoors, allows flexibility for an EMS agency to house a vehicle
outside of an enclosed registered or designated location. The primary
goal for this regulatory change is to provide EMS agencies with the
necessary flexibility to effectively serve the public. EMS agencies
play a critical role in responding to emergencies and providing life-
saving medical care. However, the housing of EMS vehicles inside of a
structure posed challenges for EMS agencies, particularly those with
larger vehicles and limited space. By allowing EMS vehicles to be
housed at the premises of an enclosed structure, but not necessarily
within the structure itself, the regulatory changes ensure that
agencies can maintain their vehicles in a manner that best suits their
operational needs. While an EMS vehicle may be parked outside of a
stationhouse, for security purposes, if it stores controlled substances
it must be locked, with the controlled substances stored in a securely
locked, substantially constructed cabinet or safe that cannot be
readily removed.
While emphasizing the need for flexibility, DEA remains diligent in
its commitment to preventing diversion and misuse of controlled
substances. As such, for security purposes and diversion safeguards, an
enclosed structure is necessary to securely store controlled substances
at a stationhouse or designated location, if those controlled
substances are being stored in the stationhouse or designated location,
but not in an EMS vehicle. An enclosed structure is also required to
maintain records, ensuring that these items are protected against
unauthorized access and potential diversion. The regulatory changes are
designed to create a balance between flexibility and diversion
safeguards. For instance, although EMS vehicles may now be housed or
stored at the premises of an enclosed structure, safeguards are in
place to ensure the security of controlled substances. Specifically,
EMS vehicles storing controlled substances must be locked when parked
outside of an enclosed registered or designated location, with the
controlled substances stored in a securely locked, substantially
constructed cabinet or safe that cannot be readily removed. This
measure mitigates the risk of diversion by ensuring that controlled
substances are inaccessible to unauthorized individuals.
[[Page 5219]]
The regulatory changes are also driven by a commitment to public
health and safety. DEA recognizes that EMS agencies often operate in
dynamic and unpredictable environments where rapid emergency response
is essential. By providing EMS agencies with greater flexibility in how
they house their vehicles, the regulatory changes enable them to
respond more effectively to emergencies, potentially saving lives in
the process. This public health benefit must be weighed against the
risk of diversion, and the regulatory changes are designed to strike an
appropriate balance between these considerations.
Additionally, DEA is issuing this final rule to amend its
regulations to make them consistent with the changes made to the CSA by
the Act and to otherwise implement the Act's requirements. DEA
recognizes that EMS agencies may at times need to utilize multiple
locations as a regular part of their distribution networks. This final
rule does not prevent them from doing so. For this reason and to be
consistent with the requirements established by the Act, DEA will allow
a single registration in each State where the agency operates.
Security Controls for Emergency Medical Services Agencies
Issue: DEA received five comments related to the possibility of
storing controlled substances in a jump bag (i.e., a mobile medical bag
that can be removed from the EMS vehicle when responding to an
emergency) in order for the EMS personnel to have quick access in an
emergency situation. The comments also requested clarification of
whether an EMS clinician can keep controlled substances on their
person. The commenters further stated that many systems currently do
not possess storage on their vehicles and prefer the EMS clinician
physically possess a tamper evident package containing the controlled
substances. These commenters suggested that this creates easier access
to emergency medications at the patient's side because returning to a
vehicle is not feasible with time sensitive emergencies like seizures.
DEA also received a comment seeking clarification on whether the
security requirements in the proposed rule applied in vehicles or only
buildings, and a comment suggesting that requiring the use of
``cumbersome'' safes would interfere with the flexibility EMS agencies
require.
DEA Response: The proposed rule offered EMS agencies several
options for storing and otherwise maintaining the security of
controlled substances. That portion of the final rule is unchanged: EMS
agencies would be authorized to store controlled substances at EMS
registered locations and designated locations inside of a securely
locked, substantially constructed cabinet or safe that cannot be
readily removed or an automated dispensing system; inside locked EMS
vehicles stationed at registered or designated locations; and inside
EMS vehicles that are actively in use by the agency.
The final rule incorporates changes to provide flexibility for EMS
agencies driven by the comments received. Except when EMS personnel are
carrying controlled substances on their person or in a jump bag as set
forth in Sec. 1301.80(d), a registered EMS agency must store
controlled substances in a storage component that is identified as a
securely locked, substantially constructed cabinet or safe that cannot
be readily removed; which is located at a secured location specified in
Sec. 1301.80(a)(1) through (4); or an automated dispensing machine as
defined in Sec. 1300.01. In addition, an emergency medical services
vehicle storing controlled substances must be locked when parked
outside of an enclosed registered or designated location, or when it is
actively in use, but unattended during non-emergency stops. An
emergency medical services vehicle storing controlled substances does
not need to be locked only if it is parked within an enclosed
registered or designated location, it is at the scene of an emergency,
or emergency services personnel are in attendance. Personnel are
considered to be in attendance when personnel are physically present
and able to monitor the vehicle; such as when the vehicle is traveling
to or from the scene of an emergency, or it is at public displays or
educational events. The presence of EMS personnel monitoring the
vehicle mitigates the risk of diversion by ensuring that controlled
substances are inaccessible to unauthorized individuals.
DEA recognizes the different and unique circumstances of EMS
agencies and the practical issues presented in an emergency response.
In response to the comments related to carrying controlled substances
in a jump bag, DEA revised Sec. 1301.80, adding new section (d).
Controlled substances are not considered ``stored'' when they are being
dispensed during an emergency response, or when EMS personnel are
preparing them to be dispensed to respond to a particular emergency.
Thus, this new provision allows EMS personnel to carry (as opposed to
store) controlled substances on their person or in a jump bag as long
as they are currently engaged in responding to an emergency. The goal
is to allow personnel to have immediate and ready access to controlled
substances to prepare for and provide emergency services during their
active duties. The controlled substances must be returned to a storage
component as described in Sec. 1301.80(c)(1), either inside of the
emergency medical services vehicle or at the registered or designated
location, when emergency medical services agency personnel are not
currently engaged in responding to an emergency, for example at the end
of the shift and when the EMS vehicle is actively in use but on call
and unattended (i.e., such as when personnel stop for a break or
meals). Additionally, EMS personnel may store controlled substances in
a jump bag, so long as that jump bag itself is stored within a secure
cabinet or safe.
Except when emergency medical services personnel are carrying
controlled substances on their person or in a jump bag as set forth in
(d), a registered emergency medical services agency must store
controlled substances in a storage component that is identified as: (1)
a securely locked, substantially constructed cabinet or safe that
cannot be readily removed; which is located at a secured location
specified in Sec. 1301.80(a)(1) through (4); or (2) an automated
dispensing machine as defined in Sec. 1300.01; which is located at a
secured location specified in 1301.80(a)(1) and (2); installed and
operated by the emergency medical services agency; not used to directly
dispense controlled substances to an ultimate user; and is in
compliance with the requirements of State law.
For purposes of this rule, as described in the definition for
actively in use, ``on call'' means that the EMS vehicle and its
personnel are ready and available to respond, but may not be responding
to an emergency at that precise moment. Examples of ``on call'' would
include providing standby medical coverage for public events;
participating in educational events; or parking and leaving the vehicle
unattended, such as when EMS personnel stop for lunch or a break.
The requirement that an EMS agency use a substantially constructed
cabinet or safe to store controlled substances on an EMS vehicle
parallels the security requirements for other registrants. See e.g., 21
CFR 1301.72(e), 1301.75(b). The requirement that an EMS vehicle contain
some sort of locked cabinet or safe to store controlled substances that
is not readily removable should not be onerous, even if some EMS
vehicles will need to have such storage installed. DEA believes that
such a requirement is necessary to prevent diversion while controlled
substances remain in an EMS
[[Page 5220]]
vehicle, including when an EMS vehicle is actively in use and left
unattended. And Congress clearly contemplated that some such
restrictions on storage would be necessary, expressly giving DEA
authority to issue regulations regarding ``the storage of controlled
substances . . . in emergency medical service vehicles.'' 21 U.S.C.
823(k)(11)(B); see also 21 U.S.C. 823(k)(6)(C)(ii) (controlled
substances may be stored by EMS agencies ``under circumstances that
provide for security of the control substances consistent with the
requirements established by regulations of the Attorney General.'').
DEA expects most currently unregistered EMS agencies to be operating in
a similar manner as registered EMS agencies, and such EMS agencies are
already in compliance with the minimum physical security requirements.
Therefore, DEA expects the physical security requirements of this rule,
on balance, to be a codification of existing practice that will impose
minimal costs.
Recordkeeping Requirements
Issue: Roughly thirty commenters, most of whom are members of the
National Association of EMS Physicians (NAEMSP), strongly urged DEA to
remove the requirement for the medical director or authorizing medical
professional to provide initials in the record in proposed Sec.
1304.27(a). The members of the NAEMSP further noted that the standard
electronic health records utilized for emergency medical services do
not routinely provide a means by which the medical director can initial
the chart.
Additionally, many commenters suggested that getting the medical
director to initial every time a controlled substance is administered
would create an undue burden on the EMS system and the medical
professionals overseeing them. The commenters further noted that the
law already requires that there be an existing protocol or verbal order
in place providing the paramedic permission to administer the
medication. Therefore, the commenters stated that physically or
electronically tracking down the medical professional giving the order
is impractical and problematic.
DEA Response: DEA works diligently to achieve operational
efficiencies. The goal of this rule is to create more consistent usage
and tracking nationally with respect to controlled substances for EMS
agencies. Further, by requiring recordkeeping, this rule provides
accountability, consistency, and clarity to the EMS community.
One important point of clarification: proposed Sec. 1304.27(a)
stated that the records of registered EMS agencies would be required to
include ``initials'' of the person who administered the controlled
substance, of the medical director or authorizing medical professional
issuing the standing or verbal order, and of the person who disposed of
a controlled substance (if applicable) and of the witness to the
disposal. The proposed rule, however, did not specify whether the
relevant individual had to personally write or input their initials, or
whether records merely had to reflect those initials, even if written
or entered by someone else.
The commenters objecting to this requirement generally based their
objections on the understanding that the medical director or
authorizing medical professional issuing the standing or verbal order
must personally initial each record. That is, they do not necessarily
object to the requirement that the records identify the medical
director or authorizing medical professional issuing the relevant
standing or verbal order, but they do object to the additional burden
that asking such directors or professionals to personally initial each
record would place on EMS agency operations or to the incompatibility
of this approach with their recordkeeping systems.
DEA, however, did not intend in proposed Sec. 1304.27(a) to
require that the person who administered the substance, the medical
director or authorizing medical professional who issued the standing or
verbal order, the person who disposed of the substance (if applicable),
or the witness to the disposal (if applicable) personally initial each
record. It is enough for DEA's purposes that the records clearly and
accurately reflect their identities to allow DEA to discern under whose
authority the controlled substance was administered. In many
situations, the best way to ensure that these records are accurately
maintained may be for the EMS agency to have individuals personally
initial these records themselves. But, as commenters highlight, there
are situations in which this is practically difficult, and thus DEA is
not requiring such personal initialing.
Accordingly, to further clarify that personal initialing is not
required in this context, DEA is revising Sec. 1304.27(a) in this
final rule. Instead of referring to ``initials,'' this provision now
refers to the ``last name or initials'' of the relevant people: the
person who administered the substance, the medical director or
authorizing medical professional who issued the standing or verbal
order, the person who disposed of the substance (if applicable), and
the witness to the disposal (if applicable). The medical director or
other authorizing medical professional is not required to initial the
records personally.
DEA also does not believe records need to specifically reference
the full name of the medical director or authorizing medical
professional that issued that order for that particular patient. If the
goal is to create efficiency, then writing the full name of the medical
director or authorizing medical professional would create additional
work and time for EMS personnel, and initials should generally suffice
to identify the relevant individual. For this reason, while a
registrant could satisfy this provision by writing out a full name, DEA
also will maintain the option that EMS agencies only record these
individuals' last name or initials.
Issue: Several commenters expressed other concerns related to the
proposed 21 CFR 1304.27(a) recordkeeping requirements, viewing them as
duplicative or inefficient. In addition to the requirement of initials
discussed previously, proposed Sec. 1304.27(a) would have required any
EMS personnel who dispose of or administer controlled substances to a
patient in the course of providing emergency medical care to record the
name of the controlled substance(s) and detailed information about the
circumstances surrounding the administration of the controlled
substance(s) (e.g., name of the substance, date dispensed,
identification of the patient). The commenters agree that EMS agencies
should maintain a record of all standing or verbal order protocols, but
urge DEA to not create new recordkeeping requirements that are
duplicative of systems that are currently in place.
Similarly, commenters stated that the Patient Care Record (PCR)
should be sufficient as it has the required additional record
requirement with the name of the medical director who issued the
standing order or the provider who gave a verbal order. Multiple
commenters stated that EMS providers are already required to complete
PCRs on all patient encounters and include all the information that is
being proposed by this regulation and that therefore having a separate
recordkeeping system to meet DEA's recordkeeping requirement is overly
burdensome and redundant.
DEA Response: Recordkeeping is necessary to allow DEA to conduct
meaningful investigations and guard against diversion. It is not DEA's
intent to place an undue burden on the public. DEA considers the burden
on the public in every rulemaking process by
[[Page 5221]]
performing a thorough economic analysis prior to publication.
Contrary to the commenter's suggestions, the recordkeeping
provisions of this rule does not impose any additional requirements on
EMS agencies other than what they are currently required to do. The
recordkeeping requirements outlined in this rule codify existing
practices. EMS agencies are required to record the details of any
administration, disposal, acquisition, distribution, or delivery of
controlled substances and make these records readily retrievable. DEA
believes that EMS agencies are already collecting and storing these
records as a normal course of their business operations.
As explained in the regulatory analyses section below, DEA
conducted an analysis of the statutory and regulatory changes of this
rule and concluded that benefits of the rule are expected to be
generated by reducing regulatory uncertainty among EMS agencies and
personnel regarding the administration, transfer, and disposal of
controlled substances. Furthermore, DEA believes that because EMS
agencies are already collecting and storing these records as a normal
course of their business operations, fulfilling the requirements of
Sec. 1304.27(a) should not create substantial additional burden.
Issue: NAEMSP members have stated that, instead of the requirements
in proposed Sec. 1304.27(a), including the following recordkeeping
requirements in the final rule will be far more effective in ensuring
compliance and oversight: 1. for standing orders, require that the
record specifically reference the standing order utilized to authorize
the administration of the controlled substance and that the EMS Agency
maintain appropriate copies of these standing orders, to include the
name of the authorizing EMS medical director; 2. for verbal orders,
require the record to specifically reference the name of medical
director or authorizing medical professional that issued that
particular verbal order for that particular patient; 3. require that
administration of controlled substances be included in the agency's
quality assurance or improvement program which is overseen by the
medical director to ensure retrospective compliance on a systemic
agency level; and 4. require an internal audit to be completed at least
annually by the agency and reviewed by the medical director to ensure
compliance with standing and verbal orders in the administration of
controlled substances. The NAEMSP members also added that the National
Emergency Medical Services Information System (NEMSIS) already includes
the name of the authorizing EMS medical director or medical
professional that issued the standing or verbal order as a data element
in the EMS electronic health record. The NAEMSP members further stated
that for verbal orders, the name of the physician or authorizing
medical professional is entered as well.
DEA Response: DEA appreciates these suggestions. With respect to
standing and verbal orders, while initials should generally be adequate
to identify the individual who gave the order, DEA has no objection to
EMS agencies listing last names instead of initials and has changed the
regulatory text in this rule accordingly. Thus, in Sec. 1304.27(a),
DEA has changed the requirement that EMS agency records reflect certain
individuals' ``initials'' to allow agencies to instead record a ``last
name or initials.''
For maintenance of standing orders, the Act (in 21 U.S.C.
823(k)(13)(M)) and proposed 21 CFR 1300.06(b)(13) already require that
a standing order be a ``written medical protocol'' containing a
determination by the medical director. To satisfy this requirement, an
EMS agency already will have to retain a copy of the standing order
that indicates the medical director's authorization. EMS agencies are
required to maintain complete and accurate records of patient care,
including any orders or protocols used in treatment. Retaining a copy
of standing orders ensures compliance with established standards of
care. No more is necessary.
NAEMSP members' suggestions regarding quality assurance or
improvement programs and internal audits provide potentially useful
ideas for how EMS agencies may ensure the integrity of their controlled
substance dispensing and maintain effective controls against diversion.
And DEA agrees that medical directors are responsible for monitoring
the dispensing of controlled substances by EMS personnel to ensure that
their orders are not being abused to divert controlled substances. DEA
has concluded, however, that EMS agencies can accomplish this in a
number of ways, and that specifically requiring the recommended
programs and audits is beyond the scope of these regulations.
DEA is aware that NEMSIS provides a framework for collecting,
storing, and sharing standardized EMS data from States nationwide. DEA
must ensure its ability to investigate registrants' dispensing of
controlled substances as appropriate. DEA may consider the efficacy of
NEMSIS-compliant patient care reporting software to fulfill the
recordkeeping requirement to ensure compliance with standing and verbal
orders in the administration of controlled substances.
Issue: An anonymous commenter stated that proposed Sec. 1304.27 is
sensible in theory, but in reality, EMS work is often chaotic with
back-to-back calls and distractions between patients. This commenter
further stated that it may be nearly impossible for an individual to
collect and retain such detailed information as the names of those who
are administered critical care involving controlled substances, beyond
the timeframe of the event, so to be recorded properly under proposed
Sec. 1304.27. This commenter was concerned about the protections that
will be put in place for EMS workers who are unable to provide this
information due to extenuating circumstances or who make mistakes in
their recordkeeping after a mass casualty.
DEA Response: DEA understands the need to balance the prevention of
diversion of controlled substances with the important ability for EMS
agencies to dispense controlled substances in the field to patients in
need, in challenging circumstances. Maintaining this balance is the
precise purpose of the proposed rule. DEA regulations have always
required that all registrants maintain effective recordkeeping
requirements to prevent diversion of controlled substances and tracking
if diversion does occur.
Thus, DEA cannot remove the requirement of recordkeeping here,
especially given the increased potential for diversion from EMS
vehicles operating in the field, as opposed to in a secure environment,
and where unregistered EMS personnel are relying on the authority of
others to administer controlled substances. That said, DEA considers
all relevant circumstances when assessing the severity of recordkeeping
violations by registrants and recognizes that some EMS agencies may
have occasional difficulty fully complying with the requirements of
Sec. 1304.27. Given the importance of these requirements, however, DEA
concludes that such difficulties are not a sufficient reason to
eliminate them.
Issue: In contrast to the previously noted comments, a commenter
suggested that DEA should consider stringent recordkeeping requirements
when allowing administration of controlled substances without direct
oversight due to EMS personnel's lack of independent authority to
administer controlled substances.
DEA Response: DEA agrees that the unique circumstances of EMS
[[Page 5222]]
administrations--and the heightened diversion risk associated with
these circumstances--require careful recordkeeping to ensure that EMS
agencies can maintain effective controls against diversion. As already
discussed, however, such concerns must be balanced against the need to
avoid overburdening EMS agencies and allowing them to operate
effectively. DEA has concluded that the recordkeeping requirements in
this rule strike that balance, ensuring DEA investigators have access
to the information they need without imposing unnecessary burdens on
EMS agencies.
Educational Training
Issue: Three commenters raised concern about EMS personnel having
the appropriate training. One commenter noted that the proposed rule
does not address the educational requirements related to delivering
emergency medication without physician supervision. This commenter
mentioned that there have been instances of over-medicating a patient
in the field resulting in death and stated that the proposed rule is
widening the scope of authority without mention of proposed additional
education on the proper weight-based dosage of schedule II to IV drugs.
Another commenter stated that, given that there are large ranges of
experience and knowledge among EMS personnel, ranging from volunteers
to veteran paramedics, effective certification and safety parameters
that EMS personnel are expected to uphold in the course of their
training and regular certification renewals should be put in place.
DEA Response: DEA agrees an EMS agency should ensure that its
personnel are properly trained before allowing them to dispense
controlled substances under the agency registration. Neither the CSA
nor the Act, however, authorizes DEA to set medical training
requirements or other medical qualifications for EMS personnel. Such
requirements may be set by other Federal, State, or local authorities.
Thus, the final rule (Sec. 1300.06(b)(6)), following the Act (21
U.S.C. 823(k)(13)(E)), requires EMS personnel administering controlled
substances to be ``licensed or certified by the State in which the
professional practices,'' but does not itself set educational or other
certification requirements for these professionals.
Other Comments
Issue: A commenter stated that EMS agencies located near State
borders respond to emergencies in neighboring States. This commenter
asked if EMS agencies could operate in these neighboring States without
registering in them.
DEA Response: EMS agencies that wish to operate in multiple States
must register with DEA in each State in which they operate. The Act
itself indicates this requirement when it directs DEA to allow an EMS
agency ``the option of a single registration in each State where the
agency administers controlled substances in lieu of requiring a
separate registration for each location of the emergency medical
services agency.'' 21 U.S.C. 823(k)(2) (emphasis added). Thus, the Act
removes the requirement of 21 U.S.C. 822(e)(1) and 21 CFR 1301.12(a)
that an EMS registrant separately register at each principal place of
business or professional practice for which the EMS agency dispenses
controlled substances. But it retains the requirement that registrants
separately register in each State in which they dispense controlled
substances. Because DEA registrations are based on compliance with
applicable State and local laws, including State licenses to dispense
controlled substances, a practitioner must maintain a DEA registration
in each State in which the practitioner dispenses controlled
substances. 21 U.S.C. 823.
Likewise, the Act directly ties DEA's registration of an EMS agency
to such State licensing, directing DEA to register an EMS agency if the
agency demonstrates that ``it is authorized to conduct [emergency
medical services] under the laws of each State in which the agency
practices'' and the registration is not inconsistent with the Act or
the public interest. 21 U.S.C. 823(k)(1). DEA thus relies on State
licensing bodies to determine that EMS agencies are qualified to
perform emergency medical services. State authority to conduct these
activities only confers rights and privileges within the issuing State;
consequently, a DEA registration based on a State license cannot itself
authorize controlled substance dispensing outside of the State. This
aspect of the CSA and DEA regulations also helps to ensure that each
State retains the primary authority to regulate the practice of
medicine within its borders.
Issue: A comment requested additional information on how EMS
agencies are to dispose of controlled substances under the rule.
DEA Response: DEA regulations regarding the disposal of controlled
substances are contained in 21 CFR part 1317. The purpose of the rules
set forth in 1317 is to provide prompt, safe, and effective disposal
methods while providing effective controls against the diversion of
controlled substances. In Sec. 1304.27, this rule sets certain
recordkeeping requirements for the disposal of controlled substances by
EMS agencies, but does not otherwise alter the existing regulatory
requirements for disposing of controlled substances. Any broader
changes to DEA's disposal requirements are outside the scope of this
rule.
Issue: A commenter requested that DEA clarify the extent of
proposed 21 CFR 1307.14, which would allow an EMS vehicle to restock at
a hospital under certain circumstances. The commenter, noting EMS
vehicles may operate at significant distances from the hospital whose
registration they are using, asked DEA to indicate whether such an EMS
vehicle may only restock at the hospital under whose registration they
are operating or may also restock at other hospitals. Another commenter
indicated that many EMS vehicles restock at hospitals far from their
registered location as a matter of course under State regulations and
objected to any further restrictions on their ability to do so.
DEA Response: Nothing in 21 CFR 1307.14 or 21 U.S.C. 823(k)(8), the
statutory text it implements, limits the hospitals at which EMS
vehicles may restock to those under whose registration they are
operating. Thus, an EMS agency satisfying the conditions of Sec.
1307.14 may restock their vehicle at one hospital even if they are
operating under the registration of another hospital. DEA has concluded
the proposed regulatory text in Sec. 1307.14 is sufficiently clear as
is, and that adding this clarification to the regulatory text would
unnecessarily complicate it. Moreover, the requirements of Sec.
1307.14 are not onerous, merely requiring appropriate recordkeeping to
document the restocking and notification to the EMS agency's registered
location. Thus, DEA has not changed Sec. 1307.14 in this final rule.
Issue: An anonymous commenter had a question regarding the
exemption from DEA application fees for EMS agencies. This commenter
understood the proposed rule as exempting fire department EMS from
paying the application fees, but not EMS-only agencies, and asked why
this was so.
DEA Response: Pursuant to the existing provisions of 21 CFR
1301.21(a)(1), ``any hospital or other institution which is operated by
an agency of the United States, . . . of any State, or any political
subdivision or agency thereof'' is exempt from application fees. If an
EMS agency were operated by the fire department, and the
[[Page 5223]]
fire department is operated by the local government, it would be exempt
from application fees. Even if the EMS agency is not operated by a
government fire department, if the EMS agency itself is operated by the
local government, it would also be exempt from application fees. A
privately-owned EMS agency, which is not operated by the local
government, is therefore not exempt from paying application fees due to
its non-governmental affiliation.
Issue: A healthcare management student expressed a concern
regarding EMS agencies who work under a parent hospital's registration.
This commenter stated that EMS agencies working under hospital
registration should be required to file for their own registration,
rather than operating under a hospital's registration as allowed by
proposed Sec. 1301.20(a)(2). This commenter believes that an EMS
agency working under a parent company's registration is not receiving
proper evaluation by DEA.
DEA Response: DEA has no discretion regarding this requirement. The
CSA, as amended by the Act, expressly allows hospital-based EMS
agencies to operate under the hospital's registration rather than
obtaining their own separate registration. 21 U.S.C. 823(k)(3). The
rule simply adds Sec. 1301.20(a)(2) to DEA regulations to reflect this
statutory allowance. Moreover, as explained in the NPRM, even before
the Act's passage, DEA had historically allowed EMS agencies to operate
under hospitals' registrations rather than separately registering.\8\
Based on this experience, DEA has found allowing hospitals to extend
their registration to certain EMS agencies to be consistent with the
public health and safety. This approach still allows DEA to monitor an
EMS agency's dispensing of controlled substances and enforce DEA
regulations through the hospital's registration. And it is in the best
interest of the public to allow certain EMS agencies to operate under
the registration of hospitals for purposes of efficiency and reducing
operation costs.
---------------------------------------------------------------------------
\8\ Registering Emergency Medical Services Agencies Under the
Protecting Patient Access to Emergency Medications Act of 2017, 85
FR 62634, 62637 (Oct. 5, 2020).
---------------------------------------------------------------------------
Issue: Another commenter expressed a concern about proposed Sec.
1307.15, which would allow EMS agencies to deliver controlled
substances to each other with the written approval of the Special Agent
in Charge (SAC) for the area or DEA Headquarters during shortages,
public health emergencies, or mass casualty events. The commenter
stated that this proposed provision is confusing and did not explain
why such approval is needed.
DEA Response: Under most circumstances, one hospital or EMS agency
cannot distribute controlled substances to another hospital or EMS
agency because they are registered with DEA to dispense controlled
substances to patients, not to distribute them. See, e.g., 21 U.S.C.
822(b) (registered persons only authorized to engage in activities
permitted by their registration); 21 CFR 1301.13(e)(1)(ii)
(establishing separate registration category for distributors); 21 CFR
1307.11 (authorizing practitioners registered to dispense to also
distribute small amounts of controlled substances to one another under
certain conditions without registering as distributors). By generally
restricting the distribution of controlled substances to registered
distributors, the CSA and DEA regulations allow DEA to better monitor
the movement of controlled substances through the closed system of
distribution and detect diversion of those substances.
The Act, however, as codified at 21 U.S.C. 823(k)(11)(C),
specifically authorizes DEA to issue regulations allowing hospitals and
EMS agencies to deliver controlled substances to one another during
shortages, public health emergencies, or mass casualty events. This
rule does so in 21 CFR 1307.15 and makes written approval from the SAC
for the area or DEA Headquarters a condition of this allowance.
This approval requirement serves two primary purposes. First, as
noted, the Act only authorized this allowance in limited circumstances:
shortages, public health emergencies, and mass casualty events.
Requiring SAC or Headquarters approval allows DEA to keep this
allowance appropriately limited to the circumstances specified in the
Act.
Second, as explained above, generally restricting distribution to
registered distributors enables DEA to better monitor distribution and
prevent diversion--because DEA is aware which registrants will be
distributing controlled substances. Requiring written approval fulfills
a similar purpose: hospitals and EMS agencies will be informing DEA
that they are also going to be engaged in temporary distributing,
thereby better enabling DEA to monitor that distributing and prevent
diversion.
To the degree that there is any confusion about how to contact
Headquarters or the relevant SAC, contact information is available on
the DEA Diversion Control Division's website,
<a href="http://www.DEAdiversion.usdoj.gov">www.DEAdiversion.usdoj.gov</a>.
Further, although the existence of a mass casualty incident is also
relevant to whether controlled substances may be administered pursuant
to a verbal order, see 21 U.S.C. 823(k)(4)(B), 21 CFR 1306.07,
Headquarters or SAC approval is not required before a medical director
or authorizing medical professional may issue such a mass casualty
incident verbal order. Headquarters or SAC confirmation of a mass
casualty is only necessary to make deliveries pursuant to 21 CFR
1307.15.
Finally, DEA acknowledges that restocking EMS vehicles with
controlled substances is a concern for some commenters, particularly
regarding the time constraints EMS personnel face after emergency
responses. Under Sec. 1307.14(a) of this final rule, a registered EMS
agency may receive controlled substances from a hospital for purposes
of restocking an EMS vehicle following an emergency response, and
without being subject to the requirements of Sec. 1305.03 of this
chapter, provided all of the following criteria are met: (1) the
registered or designated location of the agency operating the vehicle
maintains the record of such receipt in accordance with Sec.
1304.27(b) of this chapter; (2) the hospital maintains a record of such
delivery to the agency in accordance with Sec. 1304.22(c) of this
chapter; and (3) if the vehicle is primarily situated at a designated
location of an emergency medical services agency, such location
notifies the registered location of the agency within 72 hours of the
vehicle receiving the controlled substances.
Issue: Multiple commenters voiced concern that the proposed changes
would hinder effectiveness in providing services to underserved
smaller, rural, and urban communities. These commenters stated that the
proposed changes would cause a significant operating cost increase to
EMS agencies that are already on extremely tight budgets and struggling
to stay afloat.
DEA Response: DEA appreciates the concerns raised by commenters
that the proposed changes may hinder the effectiveness of the rule in
providing services to underserved small, rural, and urban communities.
The intent of the rule is to increase access to these communities,
while ensuring that certain recordkeeping and security requirements are
met to prevent the diversion of controlled substances. The need to
ensure that individuals in the underserved communities and remote
locations receive the care they need must be balanced against security
and recordkeeping requirements to ensure that the controlled substances
are not diverted for illicit use.
The specific reasons commenters gave for why the proposed rule
would allegedly hinder the ability of EMS
[[Page 5224]]
agencies to serve these communities include the definition of
stationhouse, difficulty getting a medical director to personally
initial records or returning to the hospital to restock, and stringent
security requirements.
Some commenters were concerned that the definition of
``stationhouse'' would not apply to some structures used in rural or
urban settings because the structures did not house EMS vehicles. Other
commenters noted that EMS vehicles operating in rural environments far
from their registered location may have difficulty getting a medical
director to personally initial records or returning to the hospital at
which they are registered to restock.
In this final rule, as discussed above, DEA is amending the
definition of ``stationhouse'' to provide clarity by removing the
requirement that a stationhouse must house an EMS vehicle, removing the
phrase ``for emergency response,'' and adding the phrase ``at its
premises'' to accommodate locations where EMS vehicles are not housed
or stored indoors. These revisions aim to acknowledge the unique
operational demands of EMS agencies and ensure that this rule supports
the efficient and effective delivery of emergency medical services. DEA
acknowledges the concerns raised about the limitations of the
stationhouse definition and recognizes that it is important for EMS
agencies to have the flexibility they need to effectively serve their
communities.
The addition of the phrase ``at its premises'' is intended to
accommodate locations where EMS vehicles are not housed or stored
indoors and allows flexibility for an EMS agency to house a vehicle
outside of an enclosed registered or designated location. However, an
EMS vehicle may be parked outside of a stationhouse, but for security
purposes, if it stores controlled substances, it must be locked with
the controlled substances stored in a securely locked cabinet or safe.
The primary goal for this regulatory change is to provide EMS agencies
with the necessary flexibility to effectively serve the public. EMS
agencies play a critical role in responding to emergencies and
providing life-saving medical care. However, the housing of EMS
vehicles inside of a structure posed challenges for EMS agencies,
particularly those with larger vehicles and limited space. By allowing
EMS vehicles to be housed at the premises of an enclosed structure, but
not necessarily within the structure itself, the regulatory changes
ensure that agencies can maintain their vehicles in a manner that best
suits their operational needs.
The final rule will also allow EMS agencies to administer
controlled substances via standing or verbal orders from the medical
director, thereby eliminating the requirement to personally initial
records.
With respect to commenters' request for more flexible security
requirements, the goal of this final rule is to provide flexibility for
EMS agencies to operate. DEA recognizes the different and unique
circumstances of EMS agencies and the practical issues presented in an
emergency response. In response to the commenters' concern about
flexible security requirements, this final rule will allow EMS
personnel to carry controlled substances on their person or in a jump
bag while responding to an emergency to have immediate and ready access
to controlled substances while providing emergency services. The final
rule also recognizes the critical need for EMS personnel to have swift
and easy access to controlled substances during emergencies by allowing
EMS personnel to carry controlled substances on their person or in a
jump bag during emergencies. This provision ensures immediate access to
necessary medications, enhancing the ability to provide rapid and
effective care. It maintains strict security protocols to prevent
diversion and supports the overall goal of improving patient outcomes
in emergency situations. While the rule allows for portability, it
maintains strict security measures. Controlled substances must be
returned to a storage component consistent with the requirements of 21
CFR 1301.80(c) when EMS personnel are not currently engaged in
responding to an emergency. This ensures compliance with regulatory
requirements and minimizes the risk of diversion.
Additionally, the Regulatory Flexibility Act (RFA) requires
agencies to analyze options for regulatory relief of small entities
unless it can certify that the rule will not have a significant impact
on a substantial number of small entities. For purposes of the RFA,
small entities include small businesses, nonprofit organizations, and
small governmental jurisdictions. DEA evaluated the impact of this rule
on small entities, such as the small rural or urban EMS agencies, and
concluded that the final rule will not have a significant impact on
small entities as a whole.
Out of Scope Comments
DEA appreciates all comments that were received during the comment
period. DEA received two comments which were outside of the scope of
this rule. These comments did not mention content related to actual
changes of the proposed regulatory text. An anonymous commenter made a
general complaint about alleged evidence of voter fraud and a State
representative's alleged deceptive voter registration. This comment was
clearly outside the scope of the rulemaking and therefore not
addressed. Another commenter sought clarification of certain provisions
within State legislation regarding EMS agencies, which is also outside
the scope of this rule.
III. Section-by-Section Summary of the Final Rule
The purposes and functions of this rule were discussed in the NPRM.
The Act amended the CSA to add regulatory provisions pertaining to the
handling of controlled substances by EMS professionals, and the
majority of the provisions of this final rule merely reiterate those
statutory requirements. The remainder of this rule includes changes to
the registration, security, recordkeeping, inventory, and administering
requirements for EMS agencies, which are discussed below.
Consistent with the Act, DEA is implementing regulations to
explicitly include EMS agencies handling controlled substances as
registrants under the CSA \9\ and to delineate the security and
recordkeeping requirements for EMS registrants who store, transport,
and administer controlled substances. DEA is also implementing
regulations to codify the Act's provisions that allow EMS personnel to
administer controlled substances in schedules II-V outside of the
physical presence of a medical director or authorizing medical
professional in the course of providing emergency medical services if
authorized in the State in which the medical service occurs and
pursuant to a standing order or verbal order.\10\ In
[[Page 5225]]
addition, DEA is implementing regulations that codify the Act's
amendments allowing EMS agencies to receive controlled substances from
hospitals for the purpose of restocking EMS vehicles, and allowing EMS
agencies and hospitals to deliver controlled substances to each other
in the event of shortages of such controlled substances, public health
emergencies, or mass casualty events.
---------------------------------------------------------------------------
\9\ Consistent with 21 U.S.C. 823(k)(3), DEA is implementing
regulations that will continue to allow an EMS agency based in a
hospital that is registered under Sec. 1301.13 to use the
hospital's registration to administer controlled substances, without
being separately registered as an EMS agency.
\10\ 21 U.S.C. 823(k)(13)(M) defines standing order as a written
medical protocol in which a medical director determines in advance
the medical criteria that must be met before administering
controlled substances to individuals in need of emergency medical
services. 21 U.S.C. 823(k)(13)(N) defines verbal order as an oral
directive that is given through any method of communication
including by radio or telephone, directly to an emergency medical
services professional, to contemporaneously administer a controlled
substance to individuals in need of emergency medical services
outside the physical presence of the medical director or authorizing
medical professional.
---------------------------------------------------------------------------
In this manner, DEA is bringing its regulations into conformity
with the Act's amendments to the CSA. In particular, 21 CFR 1300.06
adds 21 U.S.C. 823(k)(13)'s new definitions of relevant terms to DEA
regulations. Section 1301.12 is being amended to reflect the statutory
amendments of sections 823(k)(2) and 823(k)(5), and Sec. 1301.13 is
being amended to bring it into conformity with section 823(k)(1).
Section 1301.20(a) is adapted directly from the statutory amendment,
specifically from section 823(k)(1)-(3). The provisions of Sec.
1301.80(a) add provisions from section 823(k)(6). Section 1304.03(j) is
taken from section 823(k)(9)(A). Section 1306.07(g) adds the provisions
of sections 823(k)(4) and 823(k)(10)(D) to DEA regulations, while Sec.
1307.14 adds those of section 823(k)(8).
Not all of the proposed amendments to DEA regulations, however,
directly codify the Act's statutory amendments in DEA regulations. Some
of the changes--specifically, Sec. Sec. 1301.20(b), 1301.80(b),
1304.03(i), 1304.04, 1304.27, 1306.07(h), and 1307.15--implement the
purposes of the Act more broadly, consistent with the Administrator's
authority to promulgate regulations under 21 U.S.C. 821, 21 U.S.C.
823(k)(11), and 21 U.S.C. 871(b).
The regulatory text in this final rule is identical to that in the
proposed rule aside from the following changes:
<bullet> The definition for ``actively in use'' and ``on call''
were added to 21 CFR 1300.06. The definition of ``actively in use'' was
added to provide clarity under 21 U.S.C. 823(k)(6)(C)(ii) as to when an
EMS vehicle used by an agency may store controlled substances. This
definition would include instances when an EMS vehicle is responding to
an emergency, is transporting patients, or is on call. ``On call''
means that personnel are ready and available to respond, but may not be
responding to an emergency at that precise moment. EMS vehicles and
personnel are considered ``on call'' when they are prepared to respond
to emergencies, even if they are not actively engaged in an emergency
call. This includes periods when the vehicle is on standby for the next
call, which may include waiting in designated standby areas,
maintaining readiness for deployment. Examples of ``on call'' also
include, but are not limited to, participating in public safety or
educational events, and parking and leaving the vehicle unattended,
during lunch or a break, for example. The aim is to delineate when an
EMS vehicle is considered engaging in an emergency response or waiting
for the next call.
<bullet> In 21 CFR 1300.06, DEA is amending the definition of
``stationhouse'' to provide clarity by removing the requirement that a
stationhouse must house an EMS vehicle, removing the phrase ``for
emergency response,'' and adding the phrase ``at its premises'' to
accommodate locations where EMS vehicles are not housed or stored
indoors. ``At the premises'' specifically refers to the stationhouse
premises, where EMS vehicles are parked outside of a stationhouse. This
includes areas directly associated with the stationhouse where EMS
activities are conducted. DEA also removed the phrase ``for emergency
response'' from the stationhouse definition because stationhouses may
also be used for various non-emergency EMS activities such as the
storage of medical supplies, controlled substances, and equipment;
staff training and education; and administrative functions essential to
EMS operations. These revisions aim to acknowledge the unique
operational demands of EMS agencies and ensure that this rule supports
the efficient and effective delivery of emergency medical services.
Specifically, the definition of stationhouse is revised to mean an
enclosed structure within a State where the emergency medical services
agency is registered and may house EMS vehicles at its premises and is
actively and primarily being used by that emergency medical services
agency.
<bullet> The provisions outlined in Sec. 1301.80(b) specify when
an EMS vehicle storing controlled substances must be locked. An
emergency medical services vehicle storing controlled substances must
be locked when parked outside of an enclosed registered or designated
location, or when it is actively in use and left unattended during non-
emergency stops. An emergency medical services vehicle storing
controlled substances does not need to be locked if: (1) It is parked
within an enclosed registered or designated location; (2) It is at the
scene of an emergency; or (3) Emergency services personnel are in
attendance. If an EMS vehicle is not at a registered or designated
location of the agency, or traveling from, or returning to, a
registered or designated location of the agency in the course of
responding to an emergency, the Act and Sec. 1301.80(a) require that
it must be ``actively in use'' in order to store controlled substances.
<bullet> Sec. 1301.80(d) will allow EMS personnel to carry (as
opposed to store) controlled substances on their person or in a jump
bag that remains in their possession at all times while responding to
an emergency. When EMS personnel are not responding to an emergency,
the controlled substances must be returned to a storage component
consistent with the requirements of 21 CFR 1301.80(c), including at the
end of the shift and when personnel stop for breaks and meals. This
allows EMS personnel to have immediate and ready access to controlled
substances in the context of preparing for and providing emergency
services. If an EMS vehicle is not at a registered or designated
location of the agency, or traveling from, or returning to, a
registered or designated location of the agency in the course of
responding to an emergency, then the Act and Sec. 1301.80(a) require
that it must be ``actively in use'' in order to store controlled
substances.
<bullet> In Sec. 1304.27, the requirement that EMS agency records
reflect certain individuals' ``initials'' has been changed to allow
agencies to instead record a ``last name or initials.''
<bullet> The amendments to 21 CFR 1301.13(e) have been updated to
reflect the increased registration and reregistration fees for
controlled substance dispensers from $731 to $888 for a three-year
registration period. On July 24, 2020, DEA published a final rule, 85
FR 44710, to adjust registration and reregistration fees, in which
registration and reregistration fees for dispensing or instructing
business activities in Sec. 1301.13(e) were adjusted to $888 for a
three-year registration period. See 85 FR at 44718, 44733. Although the
EMS NPRM intended to set the EMS registration fee at the same level as
that of other controlled substance dispensers, it did not account for
the 2020 fee increase, instead retaining the $731 fee.\11\ Thus, this
rule reflects the current fee of $888 so that, as intended, the fee for
EMS registrants is the same as that for other dispensers of controlled
substances.
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\11\ Registering Emergency Medical Services Agencies Under the
Protecting Patient Access to Emergency Medications Act of 2017, 85
FR 62634, 62642-62649 (Oct. 5, 2020).
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[[Page 5226]]
A. Definitions
The Act contains a provision, 21 U.S.C. 823(k)(13), defining the
terms used throughout its other provisions. In order to conform to the
Act, DEA is adding these new definitions to its regulations as part of
a new section, 21 CFR 1300.06. This includes defining the terms
``actively in use,'' ``authorizing medical professional,'' ``designated
location,'' ``emergency medical services,'' ``emergency medical
services agency,'' ``emergency medical services professional,''
``emergency medical services vehicle,'' ``hospital-based,'' ``medical
director,'' ``medical oversight,'' ``on call,'' ``registered emergency
medical services agency,'' ``registered location,'' ``specific State
authority,'' ``standing order,'' ``stationhouse,'' and ``verbal
order.''
The definition of ``actively in use'' was added to provide clarity
under 21 U.S.C. 823(k)(6)(C)(ii) as to when an EMS vehicle used by an
agency may store controlled substances. This definition would include
instances when an EMS vehicle is responding to an emergency, is
transporting patients, or is on call. The aim is to delineate when an
EMS vehicle is considered engaging in an emergency response or waiting
for the next call. ``On call'' means that the emergency medical
services vehicle and its personnel are ready and available to respond,
but may not be responding to an emergency at that precise moment. EMS
vehicles and personnel are considered ``on call'' when they are
prepared to respond to emergencies, even if they are not actively
engaged in an emergency call. This includes periods when the vehicle is
on standby for the next call, which may include waiting in designated
standby areas, maintaining readiness for deployment. Examples of on
call also include participating in public safety/educational events,
going to lunch, and parking and leaving the vehicle unattended during a
break.
Additionally, the Act contains provisions that allows DEA to issue
regulations specifying, with regard to the delivery of controlled
substances under 21 U.S.C. 823(k)(5), the types of locations that may
be designated. 21 U.S.C. 823(k)(11)(A)(i). In order to conform with the
Act, DEA has identified this type of location as a ``stationhouse'' and
is adding the definition of a ``stationhouse'' to its regulations as
part of 21 CFR 1300.06. As discussed above, the definition of
``stationhouse'' in this final rule differs slightly from that in the
proposed rule. In this final rule, the definition of ``stationhouse''
is being amended to provide clarity by removing the requirement that a
stationhouse must house an EMS vehicle, removing the term ``for
emergency response,'' and adding the phrase ``at its premises'' to
accommodate locations where EMS vehicles are not housed or stored
indoors. These revisions aim to acknowledge the unique operational
demands of EMS agencies and ensure that this rule supports the
efficient and effective delivery of emergency medical services. In
response to the commenters concern that EMS agencies may at times be
used primarily for various operational EMS purposes, but not actually
``house'' associated EMS vehicles, DEA removed the requirement that a
stationhouse must house an EMS vehicle from the stationhouse
definition. DEA also removed the phrase ``for emergency response'' from
the stationhouse definition in response to the comments received. In
addition to housing EMS vehicles, stationhouses may also be used for
various EMS activities such as the storage of medical supplies,
controlled substances, and equipment; staff training and education; and
administrative functions essential to EMS operations.
Further, the addition of the phrase ``at its premises'' to
accommodate locations where EMS vehicles are not housed or stored
indoors, allows flexibility for an EMS agency to house a vehicle
outside of an enclosed registered or designated location. However, an
EMS vehicle may be parked outside of a stationhouse, but for security
purposes, if it stores controlled substances, it must be locked. The
primary goal for this regulatory change is to provide EMS agencies with
the necessary flexibility to effectively serve the public. ``At the
premises'' specifically refers to the stationhouse premises, where EMS
vehicles are parked outside of a stationhouse. This includes areas
directly associated with the stationhouse where EMS activities are
conducted. Examples of permissible locations at the stationhouse
premises may include, but are not limited to: nearby docks (secure
docking areas used for EMS boats or watercraft, part of the
stationhouse premises); airplane hangars (enclosed, secure hangars
within the stationhouse premises used for EMS aircraft); or garages and
parking areas (designated parking spaces within the stationhouse
premises where EMS vehicles are parked and secured). EMS vehicles
containing controlled substances must be locked, unless responding to
an emergency, at the scene of an emergency, or EMS personnel are in
attendance.
B. Registration for Emergency Medical Services Agencies
1. Current Regulations for EMS Registration
Pursuant to 21 CFR 1301.12(a), controlled substances may only be
delivered to and distributed or dispensed from a DEA registered
location. In addition, under the CSA and DEA regulations, a separate
registration is generally required for each principal place of business
or professional practice at one general physical location where
controlled substances are manufactured, distributed, imported,
exported, or dispensed by a person. 21 U.S.C. 822(e); 21 CFR
1301.12(a).
Until the passage of the Act, the CSA and its implementing
regulations did not directly mention EMS. Historically, DEA has not
specifically registered EMS agencies to procure or dispense controlled
substances. Instead, generally, EMS vehicles have obtained controlled
substances for dispensing pursuant to a physician's instructions by
operating under the registration of a hospital through one of two
options.
Under the first option, an EMS vehicle owned and operated by a
hospital handles controlled substances under the hospital's
registration.\12\ The EMS vehicle obtains controlled substances from
the hospital's pharmacy or emergency room, as an extension of the
hospital pharmacy. Under the second option, an EMS agency is registered
under a hospital registration by agreement--that is a private EMS
agency enters into a formal agreement with a specified hospital to act
as the hospital's agent. The hospital supplies each EMS vehicle with a
prepared kit containing controlled substances needed by the EMS agency
and replenishes the kit as necessary. Many EMS agencies are currently
using hospital registrations to stock and operate their EMS vehicles at
those hospitals in this manner. In the event of shortages of controlled
substances, public health emergencies, or mass casualty events, EMS
agencies may receive controlled substances from hospitals that they are
not affiliated with for the purpose of restocking EMS vehicles to
ensure EMS vehicles are adequately restocked. As a current practice, it
is important to note that when a DEA registrant obtains controlled
substances from a hospital that they are unaffiliated with, the
[[Page 5227]]
supplying registrant must follow the five percent rule \13\ and a DEA
222 form or an invoice is required to transfer between the supplying
registrant and the receiving registrant.
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\12\ EMS agencies' use of this option is now explicitly
authorized by the Act, 21 U.S.C. 823(k)(3), and DEA is adding this
option to its regulations as 21 CFR 1301.20(a)(2).
\13\ In accordance with 21 CFR 1307.11(a)(1)(iv), the five
percent rule permits a practitioner dispenser, under certain
circumstances, to distribute controlled substances to another
practitioner without having to obtain a separate DEA registration as
a distributor: ``[a] practitioner who is registered to dispense a
controlled substance may distribute (without being registered to
distribute) a quantity of such substance to . . . [a]nother
practitioner for the purpose of general dispensing by the
practitioner to patients, provided [inter alia] that . . . [t]he
total number of dosage units of all controlled substances
distributed by the practitioner . . . during each calendar year . .
. does not exceed 5 percent of the total number of dosage units of
all controlled substances distributed and dispensed by the
practitioner during the same calendar year.''
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2. Regulations for EMS Registration
The Act authorized the Attorney General (and thus, by delegation,
the Administrator) to register EMS agencies, which allowed for a new
registration category for EMS professionals to administer controlled
substances in schedule II-V to patients receiving emergency medical
services. 21 U.S.C. 823(k)(1). The Act thereby effectively amends the
CSA to add a new category of registrant--an EMS agency--and to require
DEA to grant registrations to those agencies if certain conditions are
met. Thus, in conformity with the Act, DEA is amending 21 CFR 1301.13
and adding 21 CFR 1301.20 to provide for the registration of EMS
agencies.
As part of this regulatory change, DEA is adding Sec. 1301.20(a)
to its regulations, which describes the registration requirements for
EMS agencies registered under Sec. 1301.13. The registration
requirements of Sec. 1301.20(a) are taken directly from the Act, 21
U.S.C. 823(k)(1)-(3).
DEA recommends three options to allow EMS agencies to transition
their registrations, in accordance with the Act. The three options for
EMS agencies to transition are: (1) transition immediately on the
effective date established by DEA; (2) transition at the expiration of
their current registration; or (3) transition three to six months prior
to their renewal date. DEA recommends that registrants contact their
local DEA field office to complete this transition.
C. Designated Location of an Emergency Medical Services Agency
To lessen the burden for EMS agencies with several stationhouses in
a single State, the Act allows EMS agencies to choose the option of a
single registration in each State where the EMS agency operates, 21
U.S.C. 823(k)(2), and DEA is amending its regulations accordingly
through provisions of Sec. 1301.20(a)(1). This rule would allow EMS
registrants to consolidate multiple registrations into a single
registration for each State in which they currently operate. EMS
agencies that operate EMS facilities in multiple States must still have
a separate registration in each State where the agency operates. In
addition, under the Act and Sec. 1301.20(a)(2) of this regulation,
hospital-based EMS agencies are allowed to operate under the
registration of a hospital to administer controlled substances without
being separately registered pursuant to 21 U.S.C. 823(k)(3).
Many EMS agencies currently utilize what is sometimes termed the
``hub-and-spoke'' model where the agency has a main or central location
and several stationhouses managed by the main location. The
stationhouses are strategically placed throughout a geographical area
to provide timely responses to the emergency medical needs of the
residents of the area. Under DEA's current registration regulations, if
only the main location is registered with DEA, the employees of each of
the separate (unregistered) stationhouses are not allowed to acquire or
store controlled substances at the unregistered stationhouse.
The Act amended the CSA to authorize EMS agencies to designate
specific unregistered locations where controlled substances will be
delivered and stored, but requires registered EMS agencies to provide
notice of these locations to the Attorney General at least 30 days
before delivery. 21 U.S.C. 823(k)(5). A registered EMS agency may
deliver controlled substances from a registered location of the agency
to an unregistered location of the agency only if the agency (1)
designates the unregistered location for such delivery; and (2)
notifies DEA at least 30 days prior to first delivering controlled
substances to the unregistered location.
DEA is bringing its regulations into conformity with the Act by
adding 21 CFR 1301.20(b). Under this regulatory framework, controlled
substances must be delivered to the registered location of the EMS
agency or the hospital if the EMS agency operates under the hospital's
DEA registration. EMS agencies may then distribute these substances to
designated unregistered locations, provided they designate the
unregistered location for such delivery and notify DEA at least 30 days
prior to first delivering controlled substances to the designated
unregistered location. Direct deliveries from distributors to
designated unregistered locations are not permitted under DEA
regulations. This process ensures secure management of the diversion of
controlled substances while accommodating the operational needs of EMS
agencies. Consistent with the Attorney General's authority under 21
U.S.C. 823(k)(11)(A)(ii) to prescribe how EMS agencies provide notice
of designated locations, this regulation requires notification of the
name and physical address of the designated location through DEA's
website, <a href="http://www.DEAdiversion.usdoj.gov">www.DEAdiversion.usdoj.gov</a>. After an EMS agency has been
approved for a DEA registration, the EMS agency may identify designated
locations through DEA's website, <a href="http://www.DEAdiversion.usdoj.gov">www.DEAdiversion.usdoj.gov</a>. An EMS
agency that has thus identified designated locations may begin
delivering controlled substances to that designated location 30 days
after notification to DEA.
The Act also authorizes the Attorney General to issue regulations
specifying the types of locations that may be designated by an EMS
agency. 21 U.S.C. 823(k)(11)(A)(i). Pursuant to this authority, DEA is
including a provision in Sec. 1301.20(b) that allows an EMS agency to
label stationhouses as the type of location that will be considered a
``designated location'' of the EMS agency. A registered EMS agency may
deliver controlled substances from a registered location of the agency
to an unregistered location of the agency only if the agency designates
the unregistered location as a stationhouse for such delivery; and
notifies the Administration at least 30 days prior to the first
delivery of controlled substances to the unregistered location. The
delivery of controlled substances by a registered emergency medical
services agency pursuant to this section shall not be treated as
distribution. Thus, for example, a location that serves primarily as a
residence does not meet the definition of a stationhouse and may not be
selected as a ``designated location'' by an EMS agency that is
registered with DEA. In contrast, a building that is actively serving
primarily to house the equipment of an EMS agency, such as a county
fire and rescue department that is a part of the EMS agency, for
example, would qualify as a stationhouse under this rule (and thus may
be selected as a ``designated location'' by an EMS agency that is
registered with DEA) regardless of whether the location is also used
for other purposes. The final rule, however, does not include a
requirement (as did the proposed rule) that the stationhouse
[[Page 5228]]
actually house EMS vehicles in an enclosed structure.
As discussed above, the provisions of Sec. 1301.20(b) outline the
process by which a stationhouse is ``designated'' under an existing EMS
agency registration. This notification must occur at least 30 days
prior to the first delivery of controlled substances to the
unregistered designated location of the agency. Unless an objection is
raised by DEA, an unregistered location automatically becomes a
designated location of the agency 30 days after notification of the
designated location is made to DEA.
Additionally, Sec. 1301.80(a) codifies in DEA regulations the
Act's list of the locations where a registered EMS agency may store
controlled substances. See 21 U.S.C. 823(k)(6). A registered EMS agency
may store controlled substances at a registered location of the agency,
a designated location of the agency 30 days following notification to
DEA in accordance with Sec. 1301.20, in an emergency medical services
vehicle situated at a registered location or designated location of the
agency, or in an emergency medical services vehicle used by the agency
that is traveling from, or returning to, a registered location or
designated location of the agency while responding to an emergency, or
when the emergency medical services vehicle is actively in use by the
agency. Id. These provisions directly incorporate the Act and make it
clear to registrants that under the specified conditions, DEA is
allowing the transportation of controlled substances between both
registered and designated locations of the agency. It is important to
emphasize that EMS vehicles must comply with the applicable state laws
when traveling to or from a registered or designated EMS agency
location while responding to an emergency, or when the EMS vehicle is
actively in use by the agency.
D. Emergency Medical Services Vehicles
Both the Act and section 1300.06 define an emergency services
vehicle as an ambulance, fire apparatus, supervisor truck, or other
vehicle used by an EMS agency for the purpose of providing or
facilitating emergency medical care and transport or transporting
controlled substances to and from the registered and designated
locations. See 21 U.S.C. 823(k)(13)(F). Under the control of the
practitioner registration or hospital registration, controlled
substances can be supplied to and stored in an EMS vehicle. Section
1301.80 allows a registered EMS agency to store controlled substances
in an EMS vehicle located at a registered location, a designated
location, or in an EMS vehicle used by the agency that is traveling
from, or returning to, a registered or designated location of the
agency in the course of responding to an emergency, or otherwise
actively in use by the agency. ``Actively in use'' for emergency
medical vehicles means the vehicle is currently engaged in responding
to an emergency call, is transporting patients, or is on call. ``On
call'' means that the emergency medical services vehicle and its
personnel are ready and available to respond, but may not be responding
to an emergency at that precise moment.
Furthermore, in accordance with new section 1301.80(d), registered
EMS agency personnel may carry controlled substances on their person or
in a jump bag instead of storing the controlled substances in a safe
when responding to an emergency. The controlled substances must be
returned to a storage component as described Sec. 1301.80(c), either
inside of the EMS vehicle or at the registered or designated location,
when EMS personnel are not responding to an emergency or the EMS
vehicle is actively in use.
E. Recordkeeping Requirements
1. Records and Inventories
The transportation of controlled substances for administration to
EMS patients presents unique recordkeeping concerns. Concerning non-
practitioners that transport controlled substances (e.g.,
manufacturers, distributors, exporters, importers), DEA can track the
movement of the controlled substances through recordkeeping and
reporting requirements within the two-registrant integrity system.
Generally, the registrant that transports controlled substances
maintains a record of, and will report delivery of the controlled
substances, while the registrant that receives the controlled
substances must account for the received controlled substances. Every
registrant is required to maintain complete and accurate records of
each substance manufactured, imported, received, sold, delivered,
exported, or disposed of. 21 CFR 1304.21(a). This two-registrant
integrity system provides an effective means of protection against
diversion in that the transfer of the controlled substances shall be
verified by two separate registrants, thus helping to ensure that
controlled substances are not diverted for illicit use.
EMS agencies are typically the last registrants to possess
controlled substances prior to administering to a patient at the scene
of an emergency. As such, the two-registrant integrity system does not
exist beyond the transfer to an EMS agency, in the traditional sense of
registrant recordkeeping. Therefore, DEA is implementing recordkeeping
regulations for EMS agencies to incorporate the Act's CSA amendments
regarding recordkeeping, and to ensure an accurate accounting of the
controlled substances outside the two-registrant integrity system.
DEA is implementing Sec. 1304.03(i) to require EMS agencies to
maintain records of the EMS personnel whose State license or
certification gives them the ability to administer controlled
substances, in compliance with their State laws. Because States have
differing requirements for the ability to handle controlled substances,
maintaining records of employees authorized to handle controlled
substances will help DEA identify the source of any diversion occurring
at EMS agencies.
Section 1304.03(i) is not based directly on the text of the Act,
but instead on DEA's general authority under the CSA to prevent
diversion of controlled substances by requiring registrants to maintain
records. See 21 U.S.C. 823(k)(12)(B) (nothing in the Act is to be
construed to limit the authority of the Attorney General to take
measures to prevent diversion).
a. Restocking
Following an emergency response where controlled substances were
administered, EMS personnel may not have enough time to return to their
stationhouse to restock their EMS vehicle with controlled substances.
Depending on the circumstances, the stationhouse may be a considerable
distance from the hospital where the EMS personnel brought a patient,
or the volume of emergencies may be so great that the ambulance does
not have time to return to the stationhouse. Rural EMS systems in the
United States may face transport distances of 20 to 100 miles to the
nearest hospital.\14\ Thus, the Act allows non-hospital-based EMS
agencies to receive controlled substances from a hospital for the
purpose of restocking an EMS vehicle following an emergency response.
This also allows hospital-based EMS agencies operating away from the
hospital at which they are registered to be restocked by other
hospitals. 21 U.S.C. 823(k)(8). Section 1307.14(a) codifies this
allowance--and the associated statutory conditions--in DEA regulations.
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\14\ Williamson, H.A., Jr. (2001). Emergency Care. In J.P.
Geyman, T.E. Norris & L.G. Hart (Eds.), Textbook of Rural Medicine
(pp. 93-102). New York: The McGraw-Hill Companies, Inc.
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[[Page 5229]]
b. Maintenance of Records
Under Sec. 1304.04(a), controlled substance records for all DEA
registrants are required to be maintained for at least two years from
the date of such inventory or records. Under this rule, DEA requires
maintenance of records of deliveries of controlled substances between
all locations of the agency. Following the Act, 21 U.S.C.
823(k)(9)(B)(ii), DEA also establishes in Sec. 1304.04(a)(5) the
requirement that records be maintained, whether electronically or
otherwise, at each registered and designated location of the agency
where the controlled substances involved are received, administered, or
otherwise disposed of.
Because EMS agencies have a unique registration that differs from
other types of registrants, DEA is also adding a new section to its
regulations that describes the recordkeeping requirements applicable to
EMS agencies. Consistent with the Act's amendments to the CSA, 21
U.S.C. 823(k)(9), Sec. 1304.27(a) requires an EMS agency to maintain
records for each controlled substance administered or disposed of in
the course of providing emergency medical services. Under the
provisions of Sec. 1304.27(a), any EMS personnel who disposes of or
administers controlled substances to a patient in the course of
providing emergency medical care must record the name of the controlled
substance(s) and detailed information about the circumstances
surrounding the administration of the controlled substance(s) (e.g.,
name of the substance, date dispensed, identification of the patient).
EMS personnel do not have independent authority to administer
controlled substances; therefore, more stringent recordkeeping
requirements are necessary when allowing administration of controlled
substances without direct oversight. In the proposed rule, Sec.
1304.27(a) would have required EMS agencies to record the ``initials''
of the person who administered the substance, of the medical director
or authorizing medical professional issues the relevant standing or
verbal order, of the person disposing of the substances (if
applicable), and of the witness to disposal. As discussed above, the
requirement of ``initials'' led to some questions from commenters, and
DEA is altering this provision in the final rule to instead indicate
that the individual's ``last name or initials'' are required. The
medical director or other authorizing medical professional is not
required to initial the records personally.
DEA provides in Sec. 1304.27(b)(3) that an EMS agency must
maintain records of controlled substances delivered between registered
and designated locations of the agency (except agencies restocking at
the hospital under which the EMS agency is operating, because the
hospital is required to keep records of such restocking). These
records, for example, should include the name of the controlled
substance(s), finished form, number of units in the commercial
container, date delivered, and the address of the EMS agency location
where the controlled substances were delivered. In the event of theft
or loss of controlled substances, registrants must report such
occurrence in accordance with the existing theft and loss reporting
requirements of 21 CFR part 1304.
Finally, under 21 U.S.C. 823(k)(8)(c) of the Act, designated
locations of an EMS agency must notify the registered location of their
EMS agency within 72 hours of receiving controlled substances from a
hospital for the purpose of restocking an EMS vehicle following an
emergency response. The provisions in Sec. 1304.27(c) codify this
requirement in DEA regulations. However, EMS agencies that operate
under a hospital-based registration and receive restock of controlled
substances from the hospital under which the agency is operating are
exempt from these requirements. In this specific instance, under Sec.
1307.14(a)(2), hospitals would already have a record of the controlled
substances that the hospital delivered to the EMS agency operating
under that hospital's registration. As such, it would be duplicative to
require that EMS agency to obtain a receipt of those controlled
substances because the EMS agency would be reporting receipt of the
controlled substances back to the hospital that issued the controlled
substances in the first place.
F. Changes for Security Requirements
1. Security Controls
Every DEA registrant must follow certain security requirements to
prevent the theft or loss of controlled substances, and the Act
authorizes the Attorney General to issue regulations specifying the
manner in which controlled substances must be stored by EMS agencies.
21 U.S.C. 823(k)(11)(B). Pursuant to this authorization, DEA will
implement physical security requirements for EMS agencies similar to
those already established for practitioners in Sec. 1301.75.
a. Storage of Controlled Substances
Pursuant to its authorization under the Act to issue regulations
regarding EMS agencies' storage of controlled substances, DEA is adding
Sec. 1301.80 to address additional security concerns for EMS agencies.
First, although designated locations of EMS agencies are not
individually registered, they are allowed to store controlled
substances in secured locations. The provisions of Sec. 1301.80(a)(1)
through (4) specify the secured locations within an EMS agency where
controlled substances may be stored, and implement the Act's allowance
in 21 U.S.C. 823(k)(6) of storage at EMS registered locations, at
designated locations, inside of EMS vehicles stationed at registered or
designated locations, and inside of EMS vehicles that are actively in
use by the agency.
Pursuant to Sec. 1301.80(a)(1) through (4), an EMS agency may
store controlled substances at a registered location of the agency; a
designated location of the agency 30 days following notification to DEA
in accordance with Sec. 1301.20; in an emergency medical services
vehicle situated at a registered location or designated location of the
agency; or in an emergency medical services vehicle used by the agency
that is traveling from, or returning to, a registered location or
designated location of the agency while responding to an emergency, or
when the emergency medical services vehicle is actively in use.
DEA's final rule provides a framework to effectively minimize the
risk of diversion while maintaining their readiness to respond to
emergencies and to ensure the security of controlled substances in EMS
vehicles, when parked outside stationhouses and designated locations.
As outlined in Sec. 1301.80, EMS vehicles must be equipped with secure
locking mechanisms for cabinets if they are to store controlled
substances. These locks are designed to prevent unauthorized access,
even when vehicles are parked outside stationhouses. Further, Sec.
1301.80(c)(1) mandates that controlled substances must be stored in a
securely locked, substantially constructed cabinet if not being carried
in a jump bag or on the person of EMS personnel when responding to an
emergency, whether within the vehicle or at a registered or designated
location. Alternatively, under Sec. 1301.80(c)(2), controlled
substances may also be stored in an automated dispensing machine at a
registered or designated location. This ensures secure storage at all
times, in order to minimize the risk of diversion.
b. Vehicle Locking Requirements
The provision outlined in Sec. 1301.80(b) specifies when an EMS
vehicle storing controlled substances must be locked.
[[Page 5230]]
An emergency medical services vehicle storing controlled substances
must be locked when parked outside of an enclosed registered or
designated location, or when it is actively in use, but unattended
(such as when EMS personnel stop for lunch, when EMS personnel are on
call and leaves the vehicle unattended, or when the vehicle is actively
in use). Because of the Act's requirements, in order to store
controlled substances, an EMS vehicle that is not parked at a
registered or designated location, or traveling from or returning to
such a location in the course of responding to an emergency, must be
``actively in use'' as defined in Sec. 1300.06((b)(1). An emergency
medical services vehicle storing controlled substances does not need to
be locked only if: (1) It is parked within an enclosed registered or
designated location; (2) It is at the scene of an emergency; or (3)
Emergency services personnel are in attendance. This includes
situations when personnel are physically present and able to monitor
the vehicle, such as when the vehicle is traveling to or from the scene
of an emergency, or it is at public displays or educational events.
Despite the vehicle being unlocked, the risk of diversion is mitigated
due to the presence of trained personnel.
Under Sec. 1301.80(b), an EMS vehicle storing controlled
substances is not required to be locked when EMS personnel are in
attendance, although the controlled substances must themselves still be
stored in a securely locked, substantially constructed cabinet or safe
that cannot be readily removed. ``In attendance'' refers to the
presence of authorized EMS personnel who are responsible for the
security and control of the EMS vehicle and its contents, particularly
controlled substances. ``In attendance'' could also encompass having
the EMS personnel physically present within the immediate vicinity of
the EMS vehicle, which allows for effective supervision and immediate
response to any security threats or emergencies. Examples of ``in
attendance'' include, but are not limited to, being at an emergency
scene, on standby at events, or when transporting patients. Being ``in
attendance'' at an EMS vehicle plays a critical role in deterring
diversion of controlled substances by ensuring continuous supervision
and immediate response capabilities, thereby ensuring the secure
handling of controlled substances. When EMS personnel are ``in
attendance,'' they can continuously monitor the vehicle, which
discourages unauthorized access.
By comparison, an EMS vehicle storing controlled substances must be
locked whenever the EMS vehicle is unattended, meaning there are no EMS
personnel in attendance, with the controlled substances stored in a
securely locked, substantially constructed cabinet or safe that cannot
be readily removed. This includes when the EMS vehicle is parked at a
stationhouse, hospital, or any other location. Additionally, an EMS
vehicle storing controlled substances must be locked when the vehicle
is actively in use but is not at an emergency scene and is parked in a
public or unsecured area, such as when EMS personnel are on call and
stop for lunch, or leave the vehicle unattended, such as during a
break. Requiring EMS vehicles storing controlled substances to be
locked, with the controlled substances stored in a separately locked
cabinet or safe that is substantially constructed and cannot be readily
removed, mitigates the risk of diversion by ensuring that controlled
substances are inaccessible to unauthorized individuals.
c. Storage Components
In addition, DEA is adding Sec. 1301.80(c) to allow several
options by which EMS agencies may store controlled substances. This
change is not taken directly from the Act's statutory amendments to the
CSA, but instead implements the Act's authorization to the Attorney
General to ``specify . . . the manner in which [controlled] substances
must be stored at registered and designated locations, including in EMS
vehicles.'' 21 U.S.C. 823(k)(11)(B).
The first option in Sec. 1301.80(c)(1) will allow for an EMS
agency to store controlled substances in a securely locked,
substantially constructed cabinet or safe that cannot be readily
removed. This storage component must be located at a secured location,
as stated in Sec. 1301.80(a). Such cabinets or safes can be used in
either vehicles or buildings meeting the requirements of a secure
location. Premises that are set aside for housing outdoor EMS vehicles
are required to securely lock the EMS vehicle and the controlled
substances must be stored in a securely locked cabinet or safe. If an
EMS vehicle is used to store controlled substances, it must have a
secure cabinet or safe. The controlled substances cannot be stored in a
vehicle that is locked, without putting them in a safe.
The second option in Sec. 1301.80(c)(2) will allow an EMS agency
to store controlled substances in an automated dispensing system (ADS)
machine, under specific conditions. An ADS is ``a mechanical system
that performs operations or activities, other than compounding or
administration, relative to the storage, packaging, counting, labeling,
and dispensing of medications, and which collects, controls, and
maintains all transactions in information.'' 21 CFR 1300.01. Currently,
DEA regulations permit retail pharmacies to install and operate ADS
machines at long-term care facilities as a way of preventing the
accumulation of surplus controlled substances at those facilities. See
id. Sec. 1301.27. At an EMS agency registered or designated location,
an ADS machine effectively will serve as a controlled substance storage
locker with advanced capabilities and will provide a mechanism for
storing stocks of controlled substances before they are secured in
emergency vehicles as well as for monitoring the dissemination of those
substances.
The conditions in Sec. 1301.80(c)(2) under which an EMS agency
could use an ADS machine to store controlled substances include the
following: (1) the ADS machine must be located at an EMS agency
registered location or designated location; (2) the EMS agency cannot
permit any entity other than the registered EMS agency to install and
operate the ADS machine; (3) the ADS machine cannot be used to directly
dispense controlled substances to an ultimate user; and (4) EMS agency
must operate the ADS machine in compliance with requirements of State
law. It is necessary that access to the ADS machine be limited to
employees of the EMS agency in order to account for and monitor
dissemination of controlled substances. Unlike a safe or cabinet, an
ADS machine cannot be used to provide secure storage on an EMS vehicle.
In sum, the provisions of Sec. 1301.80(c)(1)-(2) will provide
alternative options for short-term or long-term storage of controlled
substances that are actively being transported or stored in a fixed
location.
d. Carrying of Controlled Substances During Emergencies
The provisions set forth in Sec. 1301.80(d) will allow EMS
personnel to carry controlled substances on their person or in a jump
bag when responding to an emergency, instead of storing the controlled
substances in a safe during an emergency response. The controlled
substances must be returned to a storage component as described in
Sec. 1301.80(c)(1), either inside of the EMS vehicle or at the
registered or designated location, when EMS personnel are not currently
engaged in responding to an emergency.
[[Page 5231]]
EMS personnel will have immediate and ready access to controlled
substances in the context of preparing for and providing emergency
services during active duty. This would eliminate the need to return to
the EMS vehicle to get controlled substances from a locked safe during
an emergency response. Thus, the provisions of Sec. 1301.80(d) provide
options for carrying controlled substances in a jump bag or on EMS
personnel's person in preparation for or during an emergency response.
e. Delivery
The Act allows for controlled substances to be delivered between a
registered location and a designated location of an EMS agency. 21
U.S.C. 823(k)(5). Also, pursuant to its authorization to issue
regulations regarding the delivery of controlled substances under 21
U.S.C. 823(k)(11), DEA maintains that medical directors determine who
accepts deliveries of controlled substances because medical directors
provide oversight for EMS agencies. This rule will require that the
delivery of controlled substances at a registered or designated
location be accepted by a medical director of the agency or a person
designated in writing by the medical director. For record keeping
purposes of the delivery of controlled substances, Sec. 1304.27(b)(3)
will require the medical director of the agency or designated person
accepting the controlled substances to provide their signature, title,
date received, quantity, and any additional information required. These
regulations specify the requirements that will be set forth regarding
the delivery of controlled substances for emergency medical services.
As codified at 21 U.S.C. 823(k)(11)(C), the Act also authorizes DEA
to issue regulations allowing hospitals and EMS agencies to deliver
controlled substances to one another during shortages, public health
emergencies, or mass casualty events--rather than relying on
distributors or hospital restocking. This rule does so in 21 CFR
1307.15 and makes written approval from the SAC for the area or DEA
Headquarters a condition of this allowance.
2. Administration Requirements
DEA is adding Sec. 1306.07(g), which implements 21 U.S.C.
823(k)(4) in the DEA regulations, allowing EMS professionals of
registered EMS agencies to administer controlled substances outside the
physical presence of a medical director or authorizing medical
professional in the course of providing emergency medical services.\15\
Medical directors and EMS professionals authorized to administer
controlled substances under their State license may administer
controlled substances in the course of providing emergency medical
services. However, under 21 U.S.C. 823(k)(4) and Sec. 1306.07(g), an
EMS professional who is outside the physical presence of a medical
director or authorizing medical professional must not only have
authority from their EMS agency to administer controlled substances,
but such administration must also be pursuant to a proper standing or
verbal order issued and adopted by one or more medical directors of the
agency, as discussed below.
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\15\ Currently, the regulations in 21 CFR part 1306 relate
primarily to prescriptions, and thus 21 CFR 1306.01 states part
1306's scope as generally consisting of ``[r]ules governing the
issuance, filling and filing of prescriptions pursuant to . . . 21
U.S.C. 829.'' Because DEA is adding provisions related to the
administration of controlled substances by EMS agencies to part
1306, DEA is also amending Sec. 1306.01 to broaden part 1306's
stated scope to ``the process and procedures for dispensing, by way
of prescribing and administering controlled substances to ultimate
users.''
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a. Standing Orders
Many agencies have given their EMS personnel the autonomy to
administer controlled substances in the event of an emergency by
establishing what is commonly known as a standing order. The Act
defines a standing order as a written medical protocol in which a
medical director determines in advance the medical criteria that must
be met before administering controlled substances to individuals in
need of emergency medical services. 21 U.S.C. 823(k)(13)(M). The
provisions of Sec. 1300.06 incorporate this definition into DEA
regulations.
The Act and Sec. 1306.07(g) allow standing orders to be used by
EMS professionals. Under both the Act and the proposed regulation, such
EMS professionals must be authorized by their individual State to
administer controlled substances. See 21 U.S.C. 823(k)(4). Standing
orders that are developed by a State authority may be issued and
adopted by the medical director of an EMS agency. Under the Act and
Sec. 1306.07(g), only the medical director of an EMS agency is given
the authority to issue and adopt a standing order. See 21 U.S.C.
823(k)(4). Also, under both the Act and Sec. 1306.07(g), the EMS
agency is required to maintain a record of the standing orders issued
and adopted by a medical director at the registered location of the
agency. 21 U.S.C. 823(k)(10)(D).
b. Verbal Orders
In the absence of standing orders, EMS personnel may receive a
verbal order. Under the Act and Sec. 1300.06, a verbal order is an
oral directive through any method of communication including by radio
or telephone, directly to an EMS professional, to contemporaneously
administer a controlled substance to individuals in need of emergency
medical services outside the physical presence of the medical director
or authorizing medical professional. See 21 U.S.C. 823(k)(13)(N). The
Act and Sec. 1300.06 define ``authorizing medical professional'' as an
emergency or other physician, or other medical professional (including
an advanced practice registered nurse or physician assistant) who is
registered under 21 U.S.C. 823, who is acting within the scope of the
registration, and whose scope of practice under a State license or
certification includes the ability to provide verbal orders. See 21
U.S.C. 823(k)(13)(A).
Under the Act and Sec. 1306.07(g), an EMS professional may
administer directly a controlled substance in schedules II-V outside of
the presence of a practitioner in the course of providing emergency
medical services if the administration is authorized by State law and
is pursuant to a verbal order that is issued in accordance with the
policy of the agency. Such authorization must be provided by a medical
director or authorizing medical professional in response to a request
by the EMS professional with respect to a specific patient, either in
the case of a mass casualty incident, or to ensure the proper care and
treatment of a specific patient.
IV. Regulatory Analyses
As explained above, DEA is issuing this final rule to amend its
regulations in order to make them consistent with the changes made to
the CSA by the ``Protecting Patient Access to Emergency Medications Act
of 2017,'' and to otherwise implement the Act's requirements. DEA
conducted an analysis of the statutory and regulatory changes of this
rule, the results of which are discussed below.
Executive Orders 12866, 13563, and 14192 (Regulatory Review)
DEA has determined that this rulemaking is a ``significant
regulatory action'' under section 3(f) of Executive Order (E.O.) 12866,
Regulatory Planning and Review, but is not a section 3(f)(1)
significant action. Accordingly, this rule has been submitted to the
Office of
[[Page 5232]]
Management and Budget (OMB) for review. This 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.''
This rule is a deregulatory action for the purposes of E.O. 14192.
This rule is an enabling rule because it allows EMS agencies to
consolidate many registrations in the same State under a single
registration, and EMS personnel to administer controlled substances in
schedules II-V pursuant to a standing or verbal order, which was
previously not authorized.
On July 24, 2020, DEA published a final rule to adjust registration
and reregistration fees, effective October 1, 2020.\16\ The final rule
adjusted registration and reregistration fees for dispensing or
instructing business activities to $888 for a three-year registration
period. The fees had previously been set at $731 for such activities,
which was the fee rate proposed in the EMS NPRM for EMS registrants.
Because DEA intended to set EMS registration fees at the same level as
fees for other registrants that dispense controlled substances, this
final rule sets the fees for EMS registrants at $888 instead of $731.
Accordingly, the analysis below has been updated from that in the NPRM
to reflect the increase in EMS registration and reregistration fees
from $731 to $888 for a three-year registration period, in accordance
with 21 CFR 1301.13(e).
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\16\ Registration and Reregistration Fees for Controlled
Substance and List I Chemical Registrants, 85 FR 44710 (July 24,
2020).
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DEA expects the annual economic impact of this final rule to range
from a decrease of $555,888 to an increase of $1,010,544 in
registration fees paid to DEA depending on the number of registrations
that can be consolidated and the number of new separate registrations
that will be needed as a result of this rule. Detailed analysis is
provided below. Fees paid to DEA pertaining to registrations are
considered transfer payments and not costs.\17\
---------------------------------------------------------------------------
\17\ OMB Circular A-4.
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Annual changes in labor burden costs as a result of this rule are
expected to range from a decrease of $19,594 to an increase of $64,636.
Analysis of the Rule's Economic Impact
DEA analyzed the impact of the following provisions of the rule:
allowing EMS agencies to register under the CSA with a single
registration for each State in which an agency operates, along with the
security and recordkeeping requirements for such a registrant; allowing
EMS personnel to administer controlled substances in schedules II-V
outside the presence of a medical director or authorizing medical
professional when authorized in the State and pursuant to a standing or
verbal order; and allowing EMS agencies and hospitals to transfer
controlled substances between each other in order to restock EMS
vehicles or to deliver controlled substances in the event of shortages,
public health emergencies, or mass casualty events. Additionally, this
rule is incorporating into regulation several new terms defined in the
Act.
Benefits of the rule are expected to be generated by reducing
regulatory uncertainty among EMS agencies and personnel regarding the
administration, transfer, and disposal of controlled substances, and
these benefits will be discussed qualitatively. By allowing EMS
registrants to consolidate multiple registrations into a single
registration for each State in which they currently operate, there will
be a resulting reduction in transfer payments for current registrants.
This rule may also result in an increase in transfer payments for EMS
agencies that are currently not separately registered. The expected net
change in transfer payments is quantified below. There are also labor
burden costs associated with obtaining a DEA registration for any EMS
agencies that must become separately registered after this rule is
promulgated. These costs or cost savings are discussed and quantified
below. DEA expects the recordkeeping and security requirements of this
final rule to have no impact, as they are codifications of existing
practice among EMS agencies. Finally, the newly defined terms being
incorporated into regulation by this rule will have no impact on
regulated entities.
Registrations for Emergency Medical Services Agencies
While this rule is allowing for a new registration category for EMS
agencies that handle controlled substances, many EMS agencies have
already obtained separate DEA registrations as ``Mid-level
Practitioner--Ambulance Service'' (MLP-AS).\18\ As of November 2019,
there were 3,521 MLP-AS registrants, 1,413 of which are private sector
entities that pay a registration fee of $888 every three years. The
remaining 2,108 are governmental entities that are fee-exempt. DEA
reviewed its registration database and determined that 395 of the 1,413
fee-paying registrations are held by EMS agencies with other existing
registrations in the same State. Because the rule allows EMS agencies
to obtain a single registration for each State in which they operate,
these 395 registrations can be consolidated under other existing
registrations, reducing the total amount of registration fees collected
by DEA. The resulting annual reduction in transfer payments from
registrants to DEA amounts to $116,920.\19\
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\18\ These existing registrations will be transitioned to the
new ``Emergency Medical Services Agency'' registration category
created by this rule.
\19\ 395 x $888 = $350,760. Dividing this figure by three to
account for the three-year registration cycle and rounding to the
nearest whole dollar gives $116,920.
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Similarly, of the 2,108 fee-exempt registrations, 411 can be
consolidated into an agency's existing registration in the same State,
reducing the labor-related paperwork burden for these agencies, as they
no longer need to complete multiple registration renewal applications
for the same State every three years. Combining the 411 fee-exempt
registrations with the 395 fee-paying registrations results in a total
of 806 registration renewal applications that are eliminated. The
resulting annual cost savings generated from this reduction in labor
burden is $3,026.\20\
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\20\ See approved burden estimates for DEA form 224A within the
1117-0014 Supporting Statement <a href="https://www.reginfo.gov/public/do/PRAViewDocument?ref_nbr=201903-1117-005">https://www.reginfo.gov/public/do/PRAViewDocument?ref_nbr=201903-1117-005</a>. This labor burden estimate
is derived by multiplying the loaded hourly wage for physicians
($140.79) by the hour burden per electronic DEA form 224A (0.08), by
the estimated number of forms (806). The product ($9,078.14) is then
divided by three in order to account for the three-year registration
renewal period and rounded to the nearest whole dollar. The loaded
hourly wage of $140.79 is based on the median hourly wages for
Occupation Code 29-1069 Physicians and Surgeons, All Other ($96.58).
May 2018 National Occupational Employment and Wage Estimates, United
States, BUREAU OF LABOR STATISTICS, <a href="https://www.bls.gov/oes/current/oes_nat.htm#29-1069">https://www.bls.gov/oes/current/oes_nat.htm#29-1069</a> (last visited November, 2019). Average benefits
for employees are 31.4 percent of total compensation. Employer Costs
for Employee Compensation--June, 2019, BUREAU OF LABOR STATISTICS,
<a href="https://www.bls.gov/news.release/pdf/ecec.pdf">https://www.bls.gov/news.release/pdf/ecec.pdf</a> (last visited
November, 2019). The 31.4 percent of total compensation equates to a
45.77 percent (31.4/68.6) load on wages and salaries. $96.58 x (1 +
0.4577) = $140.79.
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DEA assumes that all other EMS agencies not registered as MLP-AS
currently operate under the registration of another DEA registrant in
one of two ways: a DEA registered practitioner, typically a licensed
physician, serves as the medical director of the EMS agency; or for EMS
agencies operated by hospitals, the agency will utilize that hospital's
registration. In the latter case,
[[Page 5233]]
hospital-based EMS agencies can continue to operate under the
registration of their hospital after promulgation of this rule. In the
former case, practitioners who serve as the medical director of an EMS
agency may utilize a single registration for their personal place of
business and EMS agency locations,\21\ or they may hold practitioner
registrations separate from their personal place of business
registration for each EMS agency location that they oversee. Because
this rule allows a medical director holding multiple registrations to
transfer those existing registrations directly to one EMS agency, EMS
agencies operating under this arrangement will not need a new
registration. However, for EMS agencies currently operating under their
medical director's registered personal place of business, a new EMS
agency registration at the location of the EMS agency for each State in
which they operate will be required. Additionally, affected non-
governmental EMS agencies must pay the $888 registration fee.
---------------------------------------------------------------------------
\21\ Under this scenario, the EMS agency must pick up controlled
substances from the practitioner's personal place of business.
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Accurately measuring how many EMS agencies fall into the two
aforementioned categories is not possible using DEA registration data
because DEA has not historically collected data on how many
practitioners hold multiple registrations for the purposes of serving
as the medical director of an EMS agency. Therefore, DEA chose to
estimate how many new registrations will be required by considering the
entire range of possible scenarios and calculated the outcome if either
0 percent, 50 percent, or 100 percent of EMS agencies will receive a
transferred practitioner registration from their medical director.
While DEA cannot accurately assess the likelihood of each of these
scenarios given the lack of available data, DEA considers the 50
percent scenario to be a reasonable estimate because it is the mid-
point of the upper and lower bounds.
In order to calculate the range of impacted entities, DEA must
first estimate the total population of EMS agencies active in the
United States. Because DEA registration data are insufficient for these
purposes, DEA used the latest data available from the National Highway
Traffic Safety Administration's (NHTSA) Office of EMS. According to an
NHTSA research note published in 2014,\22\ there are an estimated
21,283 governmental and non-governmental EMS agency locations
throughout the United States. The 21,283 figure is NHTSA's estimation
of the total population using data gathered from 49 of 50 States.\23\
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\22\ <a href="https://www.ems.gov/pdf/812041-Natl_EMS_Assessment_2011.pdf">https://www.ems.gov/pdf/812041-Natl_EMS_Assessment_2011.pdf</a>. The comprehensive national assessment
that this research note is based on, the first of its kind, has not
been updated since 2011. Prior to this national assessment, data on
the number and type of EMS agencies operating throughout the United
States was fragmented and considered to be inaccurate. Therefore,
DEA considers this is the most accurate data regarding EMS agency
demographics available.
\23\ CA data were not available.
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DEA then analyzed its registration database to match current MLP-AS
registrants with the corresponding EMS organizational types defined in
the NHTSA research note.\24\ Because the survey data used by NHTSA to
develop these organizational types did not include California (CA),
Illinois (IL), Washington (WA), or Virginia (VA), the total number of
EMS agency locations categorized by type amounts to 15,516 instead of
the total 21,283 estimated EMS agency locations throughout the United
States. DEA assumes that the distribution of EMS agencies by
organizational type in CA, IL, WA, and VA broadly matches the national
distribution. Therefore, DEA adjusted for this missing data by
calculating the percent of the total for each organizational type for
the 46 reporting States and applied those percentages to the estimated
21,283 EMS agencies in the entire United States.\25\ DEA was then able
to categorize current MLP-AS registrants as Fire-Department-Based,
Governmental Non-Fire-Based, Private Non-Hospital, or Tribal, according
to their registration name.\26\
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\24\ The NHTSA research note breaks down the demographics of EMS
agencies into the following organizational types: ``Fire-Department-
Based,'' ``Governmental Non-Fire-Based,'' ``Hospital-Based,''
``Private Non-Hospital,'' ``Tribal,'' ``Other EMS Agency,'' and
``Emergency Medical Dispatch.'' The ``Other EMS Agency''
organizational type is not defined in the research note or national
assessment survey on which the research note is based; however, for
the purposes of this analysis, DEA considers this category to be
made up of private sector entities. The ``Emergency Medical
Dispatch'' category is excluded from this analysis because dispatch
agencies will not be required to obtain a DEA registration.
\25\ For example, of the 15,516 EMS agency locations reported to
NHTSA by organizational type, 6,388 were Fire-Department-Based.
6,388 is 41.17 percent of 15,516. 41.17 percent of 21,283 is 8,762.
This calculation is repeated for each organizational type and the
results are reported in the ``Est. Pop'' column of Table 1.
\26\ In order to classify EMS agencies currently registered as
MLP-AS as either ``Fire-Department-Based'' or ``Governmental Non-
Fire-Based,'' DEA filtered all fee-exempt MLP-AS registrants into
two groups based on whether their registration name contained the
word ``fire.''
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It is reasonable to assume that a portion of these estimated EMS
agencies not separately registered operate multiple locations in the
same State. The NHTSA research note states that EMS agencies are
``licensed in each State to provide service to a specific location or
service area. EMS service areas can be very large, as in a geopolitical
boundary, such as a county, city or municipality, or as small as the
local service area of a single EMS agency station.'' This definition
suggests that the 21,283 total EMS agencies estimated by NHTSA includes
EMS agencies operating multiple stations in the same State. Because
only one registration is required for multiple ``agencies,'' as defined
by NHTSA, DEA must adjust its calculation of the number of EMS agencies
not separately registered to account for this.
In order to estimate how many EMS agencies not separately
registered operate at more than one location in a State, DEA used the
existing MLP-AS registrant category as a model. It is reasonable to
assume that the characteristics of the population of EMS agencies
registered as MLP-AS are broadly representative of the characteristics
of the population of EMS agencies that are not separately registered.
As discussed previously, the fee-paying MLP-AS registrant category
contains 1,413 registrations that can be consolidated into 1,018
registrations. Similarly, the fee-exempt category contains 2,108
registrations that can be consolidated into 1,697 registrations. DEA
used these figures to calculate a State-level ``agency-to-location''
ratio of 0.72 for fee-paying registrants,\27\ and 0.81 for fee-exempt
registrants.\28\ These ratios are then applied to the estimated 6,705
private-sector and 13,342 governmental EMS agency locations not
separately registered with DEA, respectively, to determine the expected
total number of EMS agencies that require separate registrations as a
result of this rule.\29\ This calculation yields an estimated total of
15,634 EMS agencies that will be separately registered, 4,827 of which
are fee-paying, and 10,807 of which are fee-exempt. Removing the 1,018
fee-paying and 1,697 fee-exempt MLP-AS registrants from these
respective totals yields an estimated 3,809 fee-paying and 9,110 fee-
exempt EMS agencies that must obtain a separate registration after this
rule is promulgated. These calculations are summarized in Table 1
below.
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\27\ 1,018/1,413 = 0.72.
\28\ 1,697/2,108 = 0.81.
\29\ An ``agency-to-location'' ratio is not applied to the
estimated 1,236 hospital-based EMS agencies, because this rule does
not impact their registration status.
[[Page 5234]]
Table 1
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% of Non-MLP-AS
EMS agency org type Reported reported Est. Est. number Current MLP-AS reg Post-rule reg Total reg Fee status
pop pop pop of reg * MLP-AS eliminated MLP-AS eliminated eliminated
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Fire-Dep't-Based................................ 6,388 41.17 8,762 7,097 1,145 251 894 1,414 1,665 Exempt.
Gov't Non-Fire.................................. 3,255 20.98 4,465 3,617 960 160 800 688 848 Exempt.
Hospital-Based.................................. 901 5.81 1,236 N/A N/A N/A N/A N/A N/A N/A.
Private Non-Hospital............................ 3,910 25.20 5,363 3,861 1,413 395 1,018 1,107 1,502 Paying.
Tribal.......................................... 84 0.54 115 93 3 0 3 22 22 Exempt.
Other EMS **.................................... 978 6.30 1,342 966 0 N/A 0 376 376 Paying.
-----------------------------------------------------------------------------------------------------------------------------------------------
Total....................................... 15,516 100 21,283 15,634 3,521 806 2,715 3,607 4,413. ...................................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
* Figures in this column are calculated by multiplying the corresponding row of the Est. Pop column by either the fee-paying ``Agency-to-Location'' ratio of 0.72 or the fee-exempt ``Agency-to-
Location'' ratio of 0.81, depending on each registrant's fee status reported in the Fee Status column.
** Category not defined in the 2011 National Assessment; assumed to be private-sector entities.
As discussed previously, DEA's methodology for estimating the
number of new EMS agency registrations must account for situations in
which a practitioner is currently using a single DEA registration to
serve as the medical director of multiple EMS agency locations. Because
DEA does not have the ability to identify how many EMS agencies are
currently operating in this manner, DEA chose to calculate a range of
between 0 percent and 100 percent of EMS agencies that may have a DEA
registration transferred from a practitioner. If 100 percent of the
estimated 3,809 fee-paying EMS agencies not separately registered are
currently operating under a practitioner registration that will be
transferred from their medical director, there will be no increase in
fees (transfer payments) from these future registrants to DEA. If 0
percent of these 3,809 fee-paying EMS agencies operate under a
practitioner registration that can be transferred from their medical
director, there will be an increase in fees (transfer payments) of
$1,127,464 to DEA on an annual basis.\30\ Likewise, calculations for
the 50 percent scenario yield an estimated increase in fees (transfer
payments) of $563,880.\31\
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\30\ 3,809 x $888 = 3,382,392. This figure is divided by three
in order to account for the three-year registration cycle, resulting
in $1,127,464 (figure is rounded).
\31\ 3,809 x .5 = 1,905 (rounded). (1,905 x $888)/3 = $563,880.
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Similarly, if 100 percent of the estimated 1,483 \32\ fee-paying
registrations able to be consolidated currently operate under a
practitioner that is using a single DEA registration to serve as the
medical director of an EMS, there will be an annual reduction in
transfer payments of $438,968.\33\ This transfer payment reduction is
combined with the previously calculated reduction in transfers of
$116,920 from the 806 MLP-AS registrations that will be consolidated,
resulting in a total reduction in transfers of $555,888. However, if 0
percent of agencies are operating in this manner, only the 806 MLP-AS
consolidated registrations are relevant, resulting in a net increase in
transfer payments of $1,010,544.\34\ Calculations for the 50 percent
scenario yield an estimated reduction in fees (transfer payments) of
$336,552.\35\ This results in a net increase of $227,328 for the
midpoint scenario.\36\ Therefore, DEA estimates the annual net change
in transfer payments as a result of this rule will range between a
decrease of $555,888 and an increase of $1,010,544, with the midpoint
of these estimates resulting in an increase of $227,328.
---------------------------------------------------------------------------
\32\ Sum of the ``Private Non-Hospital'' and ``Other EMS'' rows
of the Non-MLP-AS Registrations Eliminated column of Table 1. 1,107
+ 376 = 1,483.
\33\ 1,483 x $888 = $1,316,904. This figure is divided by three
in order to account for the three-year registration cycle, resulting
in $438,968.
\34\ $1,127,464 (calculated in note 27)-$116,920 = $1,010,544.
\35\ 1,483 x .5 = 742 (rounded). ((742 x $888)/3) + $116,920 =
$336,552.
\36\ $563,880 (calculated in note 28)-$336,552 = $227,328.
---------------------------------------------------------------------------
For the respective 0 percent, 50 percent, and 100 percent scenarios
for the estimated annual change in transfer payments, DEA calculated
the net present values at a 7 percent discount rate and a 3 percent
discount rate over 12 years, or three registration cycles. The results
of this analysis are summarized below in Table 2.
Table 2
----------------------------------------------------------------------------------------------------------------
100% of 50% of 0% of
registrations are registrations are registrations are
transferred transferred transferred
----------------------------------------------------------------------------------------------------------------
Annual Change in Transfer Payments--MLP-AS $(116,920) $(116,920) $(116,920)
(CONSOLIDATED)........................................
Annual Change in Transfer Payments--EMS Not Separately 0 563,880 1,127,464
Registered............................................
Annual change in Transfer Payments--EMS Not Separately (438,968) (219,632) 0
Registered (CONSOLIDATED).............................
--------------------------------------------------------
Net Annual Change in Transfer Payments............. (555,888) 227,328 1,010,544
Net Present Value Over 12 Years (Discounted 7%).... (4,415,244) 1,805,595 8,026,434
Net Present Value Over 12 Years (Discounted 3%).... (5,533,311) 2,262,824 10,058,959
----------------------------------------------------------------------------------------------------------------
All figures are rounded.
Labor Burden of Applications for DEA Registrations and Renewals
As detailed previously, of the estimated 4,827 fee-paying EMS
agency locations and 10,807 fee-exempt EMS agency locations not
separately registered, only 3,809 and 9,110 (a total of 12,919) will
require separate registrations after the promulgation of this rule,
respectively. If 100 percent of these 12,919 EMS agencies will have an
existing practitioner registration transferred from their medical
director, there will be a decrease in labor burden
[[Page 5235]]
of $16,568,\37\ due to the estimated 4,413 \38\ unnecessary
registration renewal applications that can be consolidated under one
registration in a State. The previously calculated annual cost savings
of $3,026 (see note 17) from the consolidation of existing MLP-AS
registrants is added to this total, resulting in an annual total labor
burden reduction of $19,594. The $19,594 decrease in labor burden
results in a net present value of $155,629 at a 7 percent discount rate
and $195,039 at a 3 percent discount rate over three registration
cycles, or 12 years.
---------------------------------------------------------------------------
\37\ See approved burden estimates for DEA form 224A within the
1117-0014 Supporting Statement <a href="https://www.reginfo.gov/public/do/PRAViewDocument?ref_nbr=201903-1117-005">https://www.reginfo.gov/public/do/PRAViewDocument?ref_nbr=201903-1117-005</a>. This labor burden estimate
is derived by multiplying the loaded hourly wage for physicians
($140.79) by the hour burden per electronic DEA form 224A (0.08), by
the estimated number of forms (4,413). The product ($49,704.50) is
then divided by three in order to account for the three-year
registration renewal period.
\38\ As calculated previously, there are 395 fee-paying and 411
fee-exempt MLP-AS registrations that will be consolidated under a
single registration in a State. Of the EMS agencies that are not
separately registered, an estimated 3,607 can be consolidated under
a single registration in a State. Combining 806 with 3,607 results
in 4,413.
---------------------------------------------------------------------------
However, if 0 percent of these 12,919 EMS agencies will have an
existing practitioner registration transferred from their medical
director, there will be a one-time increase in labor burden of $272,830
\39\ due to the initial registration application paperwork for 12,919
registrants, and a triennial labor burden increase of $136,431,\40\ due
to 12,919 registration renewals every three years. DEA converted the
one-time burden of $272,830 and the triennial burden of $136,431 into
an annualized burden of $64,636 at a 7 percent rate and $60,131 at a 3
percent rate over three registrations cycles, or 12 years.\41\
---------------------------------------------------------------------------
\39\ See approved burden estimates for DEA form 224 within the
1117-0014 Supporting Statement <a href="https://www.reginfo.gov/public/do/PRAViewDocument?ref_nbr=201903-1117-005">https://www.reginfo.gov/public/do/PRAViewDocument?ref_nbr=201903-1117-005</a>. This labor burden estimate
is derived by multiplying the loaded hourly wage for physicians
($140.79) by the hour burden per electronic DEA form 224 (0.15), by
the estimated number of forms (12,919). The result is rounded.
\40\ See approved burden estimates for DEA form 224A within the
1117-0014 Supporting Statement <a href="https://www.reginfo.gov/public/do/PRAViewDocument?ref_nbr=201903-1117-005">https://www.reginfo.gov/public/do/PRAViewDocument?ref_nbr=201903-1117-005</a>. This labor burden estimate
is derived by multiplying the loaded hourly wage for physicians
($140.79) by the hour burden per electronic DEA form 224A (0.08), by
the estimated number of forms (12,919), resulting in $145,509.28.
This figure is reduced by $9,078 to account for the triennial cost
savings from the consolidation of existing MLP-AS registrants
calculated in note 17, resulting in $136,431.
\41\ The present value of $272,830 in year 1 and $136,431 in
years 4, 7, and 10 equal $598,549.04 at 3 percent and $513,380.84 at
7 percent discount rates. Converting the respective present values
into equal annual amounts at 3 percent and 7 percent discount rates
for 12 years to account for three registration cycles yields the
annualized burdens.
---------------------------------------------------------------------------
Finally, under the 50 percent scenario, there would be a one-time
increase in labor burden of $136,426 \42\ due to the initial
registration application paperwork for 6,460 registrants, and a
triennial labor burden increase of $38,824,\43\ due to 4,253
registration renewals every three years. DEA converted the one-time
burden of $136,426 and the triennial burden of $38,824 into an
annualized burden of $25,311 at a 7 percent rate and $22,845 at a 3
percent rate over three registration cycles, or 12 years.\44\
---------------------------------------------------------------------------
\42\ 12,919 x 0.5 = 6,460 registrants. $140.79 x 0.15 x 6,460 =
$136,426. The result is rounded.
\43\ (12,919 x 0.5)-(4,413 x 0.5) = 4,253. $140.79 x 0.08 x
4,253 = $47,902 (rounded). This figure is reduced by $9,078 to
account for the triennial cost savings from the consolidation of
existing MLP-AS registrants calculated in note 17, resulting in
$38,824.
\44\ The present value of $136,426 in year 1 and $38,824 in
years 4, 7, and 10 equal $227,403.22 at 3 percent and $201,033.37 at
7 percent discount rates. Converting the respective present values
into equal annual amounts at 3 percent and 7 percent discount rates
for 12 years to account for three registration cycles yields the
annualized burdens.
---------------------------------------------------------------------------
Table 3 summarizes the estimated net change in labor burden cost
for both scenarios as a result of this rule.
Table 3
----------------------------------------------------------------------------------------------------------------
100% of 50% of 0% of
registrations are registrations are registrations are
transferred transferred transferred
----------------------------------------------------------------------------------------------------------------
Annualized Net Change in Labor Burden Over 12 Years $(19,594) $25,311 $64,636
(Discounted 7%).......................................
Annualized Net Change in Labor Burden Over 12 Years (19,594) 22,845 60,131
(Discounted 3%).......................................
----------------------------------------------------------------------------------------------------------------
Security and Recordkeeping Requirements
Because some EMS agencies are currently registered under the
practitioner business activity as MLP-AS, this rule adopts similar
physical security controls for EMS agencies as practitioners. EMS
agencies will be authorized to store controlled substances at EMS
registered locations and designated locations inside of a securely
locked, substantially constructed cabinet or safe that cannot be
readily removed or an automated dispensing system; inside EMS vehicles
stationed at registered or designated locations; inside locked EMS
vehicles stationed at registered or designated unenclosed locations;
and inside EMS vehicles that are actively in use by the agency. DEA
expects currently unregistered EMS agencies to be operating in a
similar manner as registered MLP-AS, and such EMS agencies are already
in compliance with the minimum physical security requirements outlined
above. Therefore, DEA expects the physical security requirements of
this rule to be a codification of existing practice that will impose no
costs.
The recordkeeping provisions of this rule require EMS agencies to
record the details of any administration, disposal, acquisition,
distribution, or delivery of controlled substances and make these
records readily retrievable. DEA believes that EMS agencies are already
collecting and storing these records as a normal course of their
business operations, and therefore these recordkeeping requirements
will have no economic impact on EMS registrants. Designated EMS
locations with vehicles that restock controlled substances at a
hospital after an emergency event or receive controlled substances from
another designated location must also notify the registered location of
the EMS agency within 72 hours. Because designated EMS locations have
72 hours to notify registered locations, and because designated and
registered locations are likely to communicate on a more frequent basis
during their normal course of business, DEA does not expect these
events to require any additional communication between designated and
registered locations. Therefore, this provision will also have no
economic impact on EMS registrants.
Reducing Regulatory Uncertainty
Prior to the CSA amendments of the ``Protecting Patient Access to
Emergency Medications Act of 2017,'' the CSA did not explicitly explain
exactly how its rules governing the administration, disposal, delivery,
acquisition, and
[[Page 5236]]
distribution of controlled substances applied to EMS agencies. Most
adhered to rules governing mid-level practitioners in the absence of
regulation that addressed the unique circumstances of EMS operations,
and advocacy groups frequently highlighted their concerns regarding the
need for regulations to specifically address EMS operations.
With the Act, and this rule codifying the resulting CSA amendments
into DEA regulation, EMS registrants have clear rules that direct their
behavior regarding controlled substances. DEA expects there to be
benefits resulting from this reduction in regulatory uncertainty,
especially the explicit authorization of standing and verbal orders, by
allowing EMS vehicles to restock their supply of controlled substances
at hospitals following an emergency, and by allowing EMS vehicles and
hospitals to transfer controlled substances between each other in the
event of a shortage, public health emergency, or mass casualty event.
DEA does not have a method to quantify the impact of these reductions
in regulatory uncertainty; however, DEA believes the regulatory clarity
provided by this rule will result in a benefit to EMS agencies, EMS
professionals, and the public.
Executive Order 12988, Civil Justice Reform
The provisions of this regulation meet 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, provide a clear legal
standard for affected conduct, and promote simplification and burden
reduction.
Executive Order 13132, Federalism
This rulemaking does not have federalism implications warranting
the application of E.O. 13132. The 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 rule does not have tribal implications warranting the
application of E.O. 13175. It does not have direct effects on one or
more Indian tribes via Indian Health Services.
Executive Order 14294, Overcriminalization of Federal Regulations
Executive Order 14294 specifies that all notices of proposed
rulemaking (NPRMs) and final rules published in the Federal Register,
the violation of which may constitute criminal regulatory offenses,
should include a statement identifying that the rule or proposed rule
is a criminal regulatory offense, the authorizing statute, and the mens
rea requirement for each element of the offense. Since this final rule
does not involve a criminal regulatory offense, E.O. 14294 does not
apply.
Regulatory Flexibility Act
The Administrator, in accordance with the Regulatory Flexibility
Act (5 U.S.C. 601-612) (RFA), has reviewed this rule and by approving
it, certifies that it will not have a significant economic impact on a
substantial number of small entities.
The RFA requires agencies to analyze options for regulatory relief
of small entities unless it can certify that the rule will not have a
significant impact on a substantial number of small entities. For
purposes of the RFA, small entities include small businesses, nonprofit
organizations, and small governmental jurisdictions. DEA evaluated the
impact of this rule on small entities, and discussions of its findings
are below.
As discussed in the above economic analysis of the rule, because
DEA is not able to identify how many EMS agencies currently operate
under the practitioner registration of their medical director, DEA
chose to assess the impact of this rule by considering the full range
of possible scenarios. Thus, DEA considered the impact of the rule if 0
percent, 50 percent, or 100 percent of EMS agencies receive an existing
DEA registration from a practitioner. For the purposes of this
analysis, DEA conservatively assumes that 0 percent of EMS agencies
will have a DEA registration transferred from a practitioner because
this is the scenario with the largest possible economic impact on
affected entities, including small entities.
There are three types of EMS agencies that are affected by this
rule: hospital-based, private, and governmental. Of these types, some
agencies currently hold their own DEA registrations while others
operate under the registration of another DEA registrant. As detailed
previously, DEA estimated that 3,809 private EMS agencies and 9,110
governmental EMS agencies are currently not separately registered with
DEA, while 1,018 private EMS agencies and 1,697 governmental EMS
agencies are currently registered with DEA. Additionally, there are an
estimated total of 1,236 hospital entities \45\ that are affected by
this rule. DEA assumes all EMS agencies are affected in some way by
this rule; therefore, this final rule is expected to affect a
substantial number of small entities.
---------------------------------------------------------------------------
\45\ DEA does not have the ability to identify how many hospital
registrants operate an EMS agency under the hospital's registration.
However, DEA used NHTSA's national EMS assessment data to estimate
the total number of hospital-based EMS agencies to be 1,236 (see
Table 1). Therefore, DEA considers 1,236 hospital entities to be
affected by this rule.
---------------------------------------------------------------------------
These three types of entities are affected by at least one of the
following four quantifiable impacts of the rule: registration fees,
recordkeeping and security requirements, the labor burden of obtaining
a DEA registration, and the labor burden of renewing a DEA
registration. Only the 4,827 private EMS agencies are affected by
registration fees. Governmental EMS agencies are fee-exempt and
hospital-based agencies can continue to operate under their hospital's
registration. All three types of entities, whether separately
registered or not, are affected by the security and recordkeeping
requirements of the rule. However, there is no impact because these
entities are expected to already be in compliance with these
requirements. Both the estimated 3,809 private agencies and 9,110
governmental agencies not separately registered must incur the labor
burden of registering and renewing their registration with DEA every
three years. Hospital-based agencies already incur this labor burden
and this rule will have no further impact on these entities. The
following table summarizes the estimated impact of the provisions of
the rule for each type of EMS agency.
[[Page 5237]]
Table 4
--------------------------------------------------------------------------------------------------------------------------------------------------------
Provisions of proposed rule
------------------------------------------------------------------------------------------------------------------
Registration fees Records & security DEA form 224 DEA form 224A
------------------------------------------------------------------------------------------------------------------
Affected Impact per Affected Impact per Affected Impact per Affected Impact per
entities entity \46\ entities entity entities entity \47\ entities entity \48\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hospital-based EMS................... N/A N/A 1,236 $0 N/A N/A N/A N/A
Private EMS.......................... 3,809 $265 4,827 0 3,809 $21 3,809 $4
Government EMS....................... N/A N/A 10,807 0 9,110 21 9,110 4
--------------------------------------------------------------------------------------------------------------------------------------------------------
DEA compared the combined annual economic impact per entity of the
rule with the annual revenue of the smallest of small entities in each
affected industry sector. For each of the affected industry sectors,
the annual increase was not more than 0.66 percent of average annual
revenue for the smallest entities. The table below summarizes the
results.
---------------------------------------------------------------------------
\46\ The impact per entity of registration fees is calculated by
dividing the net annual change in transfer payments for the 0
percent range in Table 2 ($1,010,544) by the number of affected
private entities (3,809). The final figure is rounded to the nearest
whole dollar.
\47\ The impact per entity of the labor burden for DEA form 224
is found by dividing the total labor burden for DEA form 224
calculated in note 36 ($272,830) by the number of affected entities
(12,919). The final figure is rounded to the nearest whole dollar.
\48\ The impact per entity of the labor burden for DEA form 224A
is found by first dividing the triennial labor burden for DEA form
224A calculated in note 37 ($145,509) by three to account for the
three-year registration cycle. This annualized labor burden
($48,503) is then divided by the number of affected entities
(12,919). The final figure is rounded to the nearest whole dollar.
Table 5
----------------------------------------------------------------------------------------------------------------
Number of Average
NAICS code Number of smallest revenue per Annual Impact %
NAICS code description affected affected smallest impact per of
entities entities entity entity ($) revenue
----------------------------------------------------------------------------------------------------------------
622110............. General Medical 1,236 20 $190,600 $0 0.00
and Surgical
Hospitals.
621910............. Ambulance 16,239 373 44,150 290 0.66
Services.
----------------------------------------------------------------------------------------------------------------
While this rule affects a substantial number of small entities,
because the economic impact for the smallest entities is not
significant, the final rule will not have a significant impact on small
entities as a whole. In summary, DEA's evaluation of economic impact by
size category indicates that the rule, if promulgated, will not have a
significant economic impact on a substantial number of small entities.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995,
2 U.S.C. 1501 et seq., DEA has determined that this action will not
result in any Federal mandate that may result ``in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted for inflation) in any
one year.'' Therefore, neither a Small Government Agency Plan nor any
other action is required under URMA of 1995.
Paperwork Reduction Act of 1995
Pursuant to section 3507(d) of the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501 et seq.), OMB approved the following information
collections related to this rule on April 11, 2025, issuing the new
expiration date of April 30, 2028.\49\ This final rule will update
DEA's regulations to provide for registration of EMS agencies and to
require EMS agencies to maintain certain records and provide notice to
DEA in certain circumstances. A person is not required to respond to a
collection of information unless it displays a valid OMB control
number. Copies of existing information collections approved by OMB may
be obtained at <a href="http://www.reginfo.gov/public/do/PRAMain">http://www.reginfo.gov/public/do/PRAMain</a>.
---------------------------------------------------------------------------
\49\ On January 10, 2025, DEA submitted Information Collection
1117-0060: Emergency Medical Services Recordkeeping and Notice
Requirement, and 1117-0014: Application for Registration (DEA Form
224), Application for Registration Renewal (DEA Form 224A) to the
Office of Management and Budget for review and approval. In
accordance with the Paperwork Reduction Act, OMB approved these
information collections on April 11, 2025. The new expiration date
for these information collections is April 30, 2028.
---------------------------------------------------------------------------
A. Collections of Information Associated With the Rule
1. Title: Emergency Medical Services Recordkeeping and Notice
Requirements.
OMB Control Number: 1117-0060.
Form Number: N/A.
OMB approved Information Collection 1117-0060: Emergency Medical
Services Recordkeeping and Notice Requirements on April 11, 2025. This
newly approved collection of information establishes new recordkeeping
and notice requirements for EMS agencies.
For each EMS professional employed by a registered EMS agency, the
agency is required to maintain documents, as required by the State in
which the professional practices, which describe the conditions and
extent of the professional's authorization to dispense or administer
controlled substances and must make such documents available for
inspection and copying by authorized employees of the Administration.
EMS agencies are also required to maintain records of all
controlled substances received, administered, or otherwise disposed of.
Such records must be maintained, whether electronically or otherwise,
at each registered and designated location of the agency where such
controlled substances are received, administered, or otherwise disposed
of.
For each dose of controlled substances administered or disposed of
in the course of providing emergency medical services, these records
must include: (1) the name of the substance; (2) the finished form of
the substance;
[[Page 5238]]
(3) the date the substance was administered or disposed of; (4)
identification of the patient, if applicable; (5) amount administered;
(6) the last name or initials of the person who administered the
substance; (7) the last name or initials of the medical director or
authorizing medical professional issuing the standing or verbal order;
(8) the amount disposed of, if applicable; (9) the manner disposed of;
and (10) the last name or initials of the person who disposed of the
substance and of one witness to the disposal.
For controlled substances acquired from or distributed to another
registrant, the records must include: (1) the name of the substance;
(2) the finished form of the substance; (3) the number of units or
volume of finished form in each commercial container; (4) the number of
units or volume of finished form and commercial containers transferred;
(5) the date of the transfer; (6) name, address, and registration
number of the person to or from whom the substance was transferred; and
(7) the name and title of the person in receipt of the transferred
substance.
For deliveries of controlled substances between a designated
location and a registered location--except hospital-based agencies
restocking at the hospital under which the agency is operating--the
records must include: (1) the name of the substance; (2) the finished
form of the substance; (3) the number of units or volume of finished
form in each commercial container; (4) the number of units or volume of
finished form and commercial containers transferred; (5) the date of
the transfer; (6) the name and address of the designated location to
which the substance is delivered; and (7) the name and title of the
person in receipt of the transferred substance.
For destruction of a controlled substance (e.g., expired
inventory), the records must include: (1) the name of the substance;
(2) the finished form of the substance; (3) the number of units or
volume of finished form in each commercial container; (4) the number of
units or volume of finished form and commercial containers destroyed;
(5) the date of the destruction; (6) the name, address, and
registration number of the person to whom the substance was
distributed, if applicable; and (7) the name and title of the person
destroying the substance.
Additionally, designated locations of EMS agencies must notify
their registered locations within 72 hours of any receipt of controlled
substances in the following circumstances: (1) an EMS vehicle primarily
situated at the designated location acquires controlled substances from
a hospital while restocking following an emergency response; or (2) a
designated location receives controlled substances from another
designated location of the same EMS agency.
DEA does not have a good basis to estimate the number of
respondents and burden related to this collection of information,
because there is no available data regarding the administration,
receipt, delivery, acquisition or distribution, and disposal of
controlled substances specific to the operation of EMS agencies.
Therefore, DEA submits the following estimated number of respondents
and burden associated with this collection of information and will
update this estimate with data when the collection is renewed:
Number of respondents: 21,283.
Frequency of response: average of 52 per year.
Number of responses: average of 1,106,716 per year.
Burden per response: .0833 hour.
Total annual hour burden: 92,226 hours.
Figures are rounded.
2. Title: Application for Registration-DEA 224, Application for
Registration Renewal-DEA 224A.
OMB Control Number: 1117-0014.
Form Numbers: DEA-224, DEA-224A.
OMB approved Information Collection 1117-0014: Application for
Registration-DEA 224, Application for Registration Renewal-DEA 224A on
April 11, 2025. This revised collection of information establishes new
registration rules for EMS agencies.
Under Sec. 1301.13, EMS agencies, if authorized by State law, may
register as a new type of business activity. A new ``EMS Agency''
business activity is added to the application for registration and
application for registration renewal forms to allow EMS agencies to
obtain a DEA registration that permits EMS agencies to deliver
controlled substances to their designated locations without obtaining a
separate registration as a Distributor. This registration allows EMS
personnel to administer controlled substances outside the physical
presence of a medical director or authorizing medical professional in
the course of providing emergency medical services. Upon issuance of an
EMS agency registration, the EMS agency should use the online system to
identify all of the locations it intends to designate under the EMS
agencies' DEA registration.
To lessen the burden for EMS agencies with several stationhouses in
a single State, DEA allows EMS agencies to choose the option of a
single registration in each State where the EMS agency operates. If the
agency operates EMS facilities in multiple States, the agency must have
a separate registration in each State where the agency operates.
DEA estimates the following number of respondents and burden
associated with this collection of information:
Number of respondents: 621,472.
Frequency of response: 1 per year.
Number of responses: 621,472 per year.
Burden per response: 0.10 hour.
Total annual hour burden: 65,943 hours.
Figures are rounded.
The activities described in this information collection are usual
and ordinary business activities and no additional cost is anticipated.
If you need additional information, please contact the Regulatory
Drafting and Policy Support Section (DPW), Diversion Control Divisions,
Drug Enforcement Administration; Mailing Address: 8701 Morrissette
Drive, Springfield, Virginia 22152; Telephone: (571) 776-2265.
Any additional comments on this collection of information may be
sent in writing to the Office of Information and Regulatory Affairs,
OMB, Attention: Desk Officer for DOJ, Washington, DC 20503. Please
state that your comments refer to RIN 1117-AB37/Docket No. DEA-377.
List of Subjects
21 CFR Part 1300
Chemicals, Drug traffic control.
21 CFR Part 1301
Administrative practice and procedure, Drug traffic control,
Exports, Imports, Security measures.
21 CFR Part 1304
Drug traffic control, Reporting and recordkeeping requirements.
21 CFR Part 1306
Drug traffic control, Prescription drugs.
21 CFR Part 1307
Drug traffic control.
For the reasons stated in the preamble, the Drug Enforcement
Administration is amending 21 CFR parts 1300, 1301, 1304, 1306, and
1307 as follows:
PART 1300--DEFINITIONS
0
1. The authority citation for part 1300 continues to read as follows:
Authority: 21 U.S.C. 802, 821, 822, 829, 871(b), 951, 958(f).
[[Page 5239]]
0
2. Add Sec. 1300.06 to read as follows:
Sec. 1300.06 Definitions relating to emergency medical services
agencies.
(a) Any term not defined in this part shall have the definition set
forth in section 102 of the Act (21 U.S.C. 802).
(b) As used in parts 1301, 1304, 1306, and 1307 of this chapter,
the following terms shall have the meanings specified:
(1) Actively in use means the vehicle is currently engaged in
responding to an emergency call, is transporting patients, or is on
call as defined in this Part.
(2) Authorizing medical professional means an emergency or other
physician, or other medical professional (including an advanced
practice registered nurse or physician assistant)--
(i) Who is registered under 21 U.S.C. 823;
(ii) Who is acting within the scope of the registration; and
(iii) Whose scope of practice under a State license or
certification includes the ability to provide verbal orders.
(3) Designated location means a location designated by an emergency
medical services agency under 21 U.S.C. 823(k)(5).
(4) Emergency medical services mean emergency medical response and
emergency mobile medical services provided outside of a fixed medical
facility.
(5) Emergency medical services agency means an organization
providing emergency medical services, including such an organization
that--
(i) Is governmental (including fire-based and hospital-based
agencies), non-governmental (including hospital-based agencies),
private, or volunteer-based;
(ii) Provides emergency medical services by ground, air, or
otherwise; and
(iii) Is authorized by the State in which the organization is
providing such services to provide emergency medical care, including
the administering of controlled substances, to members of the general
public on an emergency basis.
(6) Emergency medical services professional means a health care
professional (including a nurse, paramedic, or emergency medical
technician) licensed or certified by the State in which the
professional practices and credentialed by a medical director of the
respective emergency medical services agency to provide emergency
medical services within the scope of the professional's State license
or certification.
(7) Emergency medical services vehicle means an ambulance, fire
apparatus, supervisor truck, or other vehicle used by an emergency
medical services agency for the purpose of providing or facilitating
emergency medical care and transport or transporting controlled
substances to and from the registered and designated locations.
(8) Hospital-based means, with respect to an emergency medical
services agency, owned or operated by a hospital.
(9) Medical director means a physician who is registered under 21
U.S.C. 823(g) and provides medical oversight to an emergency medical
services agency.
(10) Medical oversight means supervision of the provision of
medical care by an emergency medical services agency.
(11) On call means that the emergency medical services vehicle and
its personnel are ready and available to respond but may not be
responding to an emergency at that precise moment.
(12) Registered emergency services agency means--
(i) An emergency medical services agency that is registered under
21 U.S.C. 823(k); or
(ii) A hospital-based emergency medical services agency that is
covered by the registration of the hospital under subsection 823(g).
(13) Registered location means, for purposes of emergency medical
services, a location that appears on a DEA certificate of registration
issued to an emergency medical services agency under 21 U.S.C. 823(k)
or 21 U.S.C. 823(g), which shall be where the agency receives
controlled substances from distributors.
(14) Specific State authority means a governmental agency or other
such authority, including a regional oversight and coordinating body,
that, pursuant to State law or regulation, develops clinical protocols
regarding the delivery of emergency medical services in the geographic
jurisdiction of such agency or authority within the State that may be
adopted by medical directors.
(15) Standing order means a written medical protocol in which a
medical director determines in advance the medical criteria that must
be met before administering controlled substances to individuals in
need of emergency medical services.
(16) Stationhouse means an enclosed structure within a State where
the emergency medical services agency is registered, which may house
EMS vehicles at its premises, and which is actively and primarily being
used by that emergency medical services agency.
(17) Verbal order means an oral directive that is given through any
method of communication including by radio or telephone, directly to an
emergency medical services professional, to contemporaneously
administer a controlled substance to individuals in need of emergency
medical services outside the physical presence of the medical director
or authorizing medical professional.
PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND
DISPENSERS OF CONTROLLED SUBSTANCES
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3. The authority citation for part 1301 is revised 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.
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4. In Sec. 1301.12, add paragraph (b)(5) to read as follows:
Sec. 1301.12 Separate registrations for separate locations.
* * * * *
(b) * * *
(5) A designated location that a registered emergency medical
services agency has identified to the Administration at least 30 days
prior to first delivering controlled substances to that unregistered
location.
* * * * *
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5. In Sec. 1301.13:
0
a. Revise paragraph (d);
0
b. Redesignate paragraphs (e)(1)(v) through (x) as paragraphs
(e)(1)(vi) through (xi); and
0
c. Add new paragraph (e)(1)(v).
The revision and addition read as follows:
Sec. 1301.13 Application for registration; time for application;
expiration date; registration for independent activities; application
forms, fees, contents and signature; coincident activities.
* * * * *
(d) At the time a retail pharmacy, hospital/clinic, practitioner,
emergency medical services agency or teaching institution is first
registered, that business activity shall be assigned to one of twelve
groups, which correspond to the months of the year. The expiration date
of the registrations of all registrants within any group will be the
last day of the month designated for that group. In assigning any of
the above business activities to a group, the Administration may select
a group the expiration date of which is not less than 28 months nor
more than 39 months from the date such business activity was
registered. After the initial registration period, the registration
expires 36 months from the initial expiration date.
(e) * * *
[[Page 5240]]
(1) * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Application fee Registration Coincident activities
Business activity Controlled substances DEA application forms ($) period (years) allowed
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
(v) Emergency Medical Services Agency Schedules II-V.......... New--224; Renewal--224a. 888 3
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * *
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6. Add Sec. 1301.20 under undesignated heading ``Registration'' to
read as follows:
Sec. 1301.20 Registration for emergency medical services agencies.
(a) An emergency medical services agency shall be issued a
registration under Sec. 1301.13 if the agency submits an application
demonstrating it is authorized to conduct such activity under the laws
of each State in which the agency practices, unless the Administration
determines that the issuance of such a registration would be
inconsistent with the requirements of 21 U.S.C. 823(k) or the public
interest based on the factors listed in 21 U.S.C. 823(g).
(1) An agency has the option of requesting a single registration in
each State where the agency administers controlled substances in lieu
of a separate registration for each location of the agency within a
State.
(2) If a hospital where an emergency medical services agency is
based is registered under Sec. 1301.13, the agency may use the
registration of the hospital to administer controlled substances in
accordance with Sec. 1306.07(g) of this chapter, without being
separately registered as an emergency medical services agency.
(b) A registered emergency medical services agency may deliver
controlled substances from a registered location of the agency to an
unregistered location of the agency only if the agency designates the
unregistered location as a stationhouse for such delivery; and notifies
the Administration at least 30 days prior to the first delivery of
controlled substances to the unregistered location. The delivery of
controlled substances by a registered emergency medical services agency
pursuant to this section shall not be treated as distribution. To
notify the Administration, the emergency medical services agency must
submit the name and physical address of the designated location online
at <a href="http://www.DEAdiversion.usdoj.gov">www.DEAdiversion.usdoj.gov</a>.
Sec. Sec. 1301.78 and 1301.79 [Reserved]
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7. Add and reserve Sec. Sec. 1301.78 and 1301.79 under undesignated
heading ``Security Requirements'';
0
8. Add Sec. 1301.80 under undesignated heading ``Security
Requirements'' to read as follows:
Sec. 1301.80 Security controls for emergency medical services
agencies.
(a) Secured Storage Locations. A registered emergency medical
services agency may store controlled substances at any of the following
secured locations:
(1) A registered location of the agency;
(2) A designated location of the agency 30 days following
notification to DEA in accordance with Sec. 1301.20;
(3) In an emergency medical services vehicle situated at a
registered location or designated location of the agency; or
(4) In an emergency medical services vehicle used by the agency
that is traveling from, or returning to, a registered location or
designated location of the agency while responding to an emergency, or
when the emergency medical services vehicle is actively in use by the
agency.
(b) Vehicle Locking Requirements. An emergency medical services
vehicle storing controlled substances must be locked when parked
outside of an enclosed registered or designated location, or when it is
actively in use and left unattended during non-emergency stops. An
emergency medical services vehicle storing controlled substances does
not need to be locked only if:
(1) It is parked within an enclosed registered or designated
location;
(2) It is at the scene of an emergency; or
(3) Emergency services personnel are in attendance. This includes
situations when personnel are physically present and able to monitor
the vehicle; such as when the vehicle is traveling to or from the scene
of an emergency, or it is at public displays or educational events.
(c) Storage Components. Except when emergency medical services
personnel are carrying controlled substances on their person or in a
jump bag as set forth in paragraph (d) of this section, a registered
emergency medical services agency must store controlled substances in a
storage component that is identified as:
(1) A securely locked, substantially constructed cabinet or safe
that cannot be readily removed; which is located at a secured location
specified in paragraphs (a)(1) through (4) of this section; or
(2) An automated dispensing machine as defined in Sec. 1300.01;
which is
(i) Located at a secured location specified in paragraphs (a)(1)
and (2) of this section;
(ii) Installed and operated by the emergency medical services
agency;
(iii) Not used to directly dispense controlled substances to an
ultimate user; and is
(iv) In compliance with the requirements of State law.
(d) Carrying Controlled Substances During Emergencies. Emergency
medical services agency personnel may carry controlled substances on
their person or in a jump bag instead of storing the controlled
substances in a safe when responding to an emergency. The controlled
substances must be returned to a storage component as described in
paragraph (c) of this section when emergency medical services agency
personnel are not currently engaged in responding to an emergency.
PART 1304--RECORDS AND REPORTS OF REGISTRANTS
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9. The authority citation for part 1304 is revised to read as follows:
Authority: 21 U.S.C. 821, 823(j), 827, 831, 871(b), 958(e)-(g),
and 965, unless otherwise noted.
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10. In Sec. 1304.03, add paragraphs (i) and (j) to read as follows:
Sec. 1304.03 Persons required to keep records and file reports.
* * * * *
(i) For each emergency medical services professional employed by a
registered emergency services agency,
[[Page 5241]]
the registered agency must maintain in a readily retrievable manner
those documents (as required by the State in which an emergency medical
services professional practices), which describe the conditions and
extent of the professional's authorization to dispense controlled
substances, and must make such documents available for inspection and
copying by authorized employees of the Administration. Examples of such
documentation include protocols, practice guidelines, or practice
agreements.
(j) A registered emergency medical services agency shall maintain
records, as described in Sec. 1304.27, of all controlled substances
that are received, administered, or otherwise disposed of pursuant to
the agency's registration.
0
11. In Sec. 1304.04, revise paragraph (a) introductory text and add
paragraphs (a)(4) and (5) to read as follows:
Sec. 1304.04 Maintenance of records and inventories.
(a) Except as provided in paragraphs (a)(1) and (2) of this
section, every inventory and other record required to be kept under
this part must be kept by the registrant and be available for
inspection and copying by authorized employees of the Administration,
for at least 2 years from the date of such inventory or record.
* * * * *
(4) Records shall include records of deliveries of controlled
substances between all locations of the agency.
(5) Records shall be maintained, whether electronically or
otherwise, at each registered and designated location of the agency
where the controlled substances involved are received, administered, or
otherwise disposed of.
* * * * *
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12. Add Sec. 1304.27 to read as follows:
Sec. 1304.27 Additional recordkeeping requirements applicable to
emergency medical services agencies.
(a) Each emergency medical services agency registered pursuant to
Sec. 1301.20 of this chapter (including a hospital-based emergency
medical services agency using a hospital registration under Sec.
1301.20(a)(2) of this chapter) must maintain records for each dose of
controlled substances administered or disposed of in the course of
providing emergency medical services. The following information shall
be included in each record:
(1) Name of the substance;
(2) Finished form of the substance (e.g., 10-milligram tablet or
10-milligram concentration per fluid ounce or milliliter);
(3) Date administered or disposed of;
(4) Identification of the patient (consumer), if applicable;
(5) Amount administered;
(6) Last name or initials of the person who administered the
controlled substance;
(7) Last name or initials of the medical director or authorizing
medical professional issuing the standing or verbal order;
(8) Whether a standing or verbal order was issued and adopted;
(9) Amount disposed of, if applicable;
(10) Manner disposed of; and
(11) Last name or initials of person who disposed and witness to
disposal, if applicable.
(b) For each acquisition of a controlled substance from another
registrant, or each distribution of a controlled substance to another
registrant, each emergency medical services agency registered pursuant
to Sec. 1301.20 of this chapter must maintain records with all of the
following information:
(1) For each acquisition of a controlled substance from another
registrant:
(i) Name of the substance;
(ii) Finished form of the substance (e.g., 10-milligram tablet or
10-milligram concentration per fluid ounce or milliliter);
(iii) Number of units or volume of finished form in each commercial
container;
(iv) Number of commercial containers acquired (e.g., 100-tablet
bottle or 3-milliliter vial);
(v) Date of the acquisition;
(vi) Name, address, and registration number of the person from whom
the substance was acquired; and
(vii) Name and title of the person acquiring the controlled
substance.
(2) For each distribution of a controlled substance to another
registrant:
(i) Name of the substance;
(ii) Finished form of the substance (e.g., 10-milligram tablet or
10-milligram concentration per fluid ounce or milliliter);
(iii) Number of units or volume of finished form in each commercial
container (e.g., 100-tablet bottle or 3-milliliter vial);
(iv) Number of commercial containers distributed;
(v) Date of the distribution;
(vi) Name, address, and registration number of the person to whom
the substance was distributed; and
(vii) Name and title of the person in receipt of the distributed
controlled substances.
(3) For each delivery of controlled substances between a designated
location and a registered location:
(i) Name of the substance;
(ii) Finished form of the substance (e.g., 10-milligram tablet or
10-milligram concentration per fluid ounce or milliliter);
(iii) Number of units or volume of finished form in each commercial
container (e.g., 100-tablet bottle or 3-milliliter vial);
(iv) Number of units or volume of finished form in each commercial
container and number of commercial containers delivered (e.g., 100-
tablet bottle or 3-milliliter vial);
(v) Date of the delivery;
(vi) Name and address of the designated location to which the
substance is delivered; and
(vii) Name and title of the person in receipt of the controlled
substances.
(4) For destruction of a controlled substance:
(i) Name of the substance;
(ii) Finished form of the substance (e.g., 10-milligram tablet or
10-milligram concentration per fluid ounce or milliliter);
(iii) Number of units or volume of finished form in each commercial
container (e.g., 100-tablet bottle or 3-milliliter vial);
(iv) Number of units or volume of finished form in each commercial
container and number of commercial containers destroyed (e.g., 100-
tablet bottle or 3-milliliter vial);
(v) Date of the destruction;
(vi) Manner of disposal of the substance, if applicable;
(vii) Name, address, and registration number of the person to whom
the substance was distributed, if applicable; and
(viii) Name and title of the person destroying the controlled
substance.
(c) A designated location of an emergency medical services agency
that receives controlled substances must notify the agency's registered
location within 72 hours of receipt of the controlled substances, in
the following circumstances:
(1) An emergency medical services vehicle primarily situated at a
designated location of the emergency medical services agency acquires
controlled substances from a hospital while restocking following an
emergency response;
(2) The designated location of the emergency medical services
agency receives controlled substances from another designated location
of the same agency.
PART 1306--PRESCRIPTIONS
0
13. The authority citation for part 1306 is revised to read as follows:
[[Page 5242]]
Authority: 21 U.S.C. 821, 823(k), 829, 831, 871(b), unless
otherwise noted.
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14. Revise Sec. 1306.01 to read as follows:
Sec. 1306.01 Scope of part 1306.
This part sets forth the process and procedures for dispensing, by
way of prescribing and administering controlled substances to ultimate
users. The purpose of such procedures is to provide safe and efficient
methods for dispensing co
[…truncated; see source link]Indexed from Federal Register on February 5, 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.