Notice2023-10216
Eleventh Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19
Primary source
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Published
May 12, 2023
Effective
May 11, 2023
Issuing agencies
Health and Human Services Department
Abstract
The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to update the determination of a public health emergency and clarify the disease threat, add two new limitations on distribution, extend the time period of coverage for certain Covered Countermeasures and Covered Persons, clarify the time period of coverage for Covered Persons authorized under the Declaration, extend the duration of the Declaration to December 31, 2024, and to republish the Declaration in full.
Full Text
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<title>Federal Register, Volume 88 Issue 92 (Friday, May 12, 2023)</title>
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[Federal Register Volume 88, Number 92 (Friday, May 12, 2023)]
[Notices]
[Pages 30769-30778]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-10216]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Eleventh Amendment to Declaration Under the Public Readiness and
Emergency Preparedness Act for Medical Countermeasures Against COVID-19
ACTION: Notice of amendment.
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SUMMARY: The Secretary issues this amendment pursuant to section 319F-3
of the Public Health Service Act to update the determination of a
public health emergency and clarify the disease threat, add two new
limitations on distribution, extend the time period of coverage for
certain Covered Countermeasures and Covered Persons, clarify the time
period of coverage for Covered Persons authorized under the
Declaration, extend the duration of the Declaration to December 31,
2024, and to republish the Declaration in full.
DATES: This amendment is effective as of May 11, 2023.
FOR FURTHER INFORMATION CONTACT: L. Paige Ezernack, Office of the
Assistant Secretary for Preparedness and Response, Office of the
Secretary, Department of Health and Human Services, 200 Independence
Avenue SW, Washington, DC 20201; 202-260-0365, <a href="/cdn-cgi/l/email-protection#89f9e8e0eeeca7ecf3ecfbe7e8eae2c9e1e1faa7eee6ff"><span class="__cf_email__" data-cfemail="b9c9d8d0dedc97dcc3dccbd7d8dad2f9d1d1ca97ded6cf">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The Public Readiness and Emergency
Preparedness Act (PREP Act) authorizes the Secretary of Health and
Human Services (the Secretary) to issue a Declaration to provide
liability immunity to certain individuals and entities (Covered
Persons) against any claim of loss caused by, arising out of, relating
to, or resulting from the manufacture, distribution, administration, or
use of medical countermeasures (Covered Countermeasures), except for
claims involving ``willful misconduct'' as defined in the PREP Act.
Under the PREP Act, a Declaration may be amended as circumstances
warrant.
The PREP Act was enacted on December 30, 2005, as Public Law 109-
148, Division C, Sec. 2. It amended the Public Health Service (PHS)
Act, adding section 319F-3, which addresses liability immunity, and
section 319F-4, which creates a compensation program. These sections
are codified at 42 U.S.C. 247d-6d and 42 U.S.C. 247d-6e, respectively.
Section 319F-3 of the PHS Act has been amended by the Pandemic and All-
Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5,
enacted on March 13, 2013, and the Coronavirus Aid, Relief, and
Economic Security (CARES) Act, Public Law 116-136, enacted on March 27,
2020, to expand Covered Countermeasures under the PREP Act.
On January 31, 2020, the former Secretary, Alex M. Azar II,
declared a public health emergency pursuant to section 319 of the PHS
Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United
States to aid in the response of the nation's health care community to
the COVID-19 outbreak. Pursuant to section 319 of the PHS Act, the
declaration was renewed effective April 26, 2020, July 25, 2020,
October 23, 2020, January 21, 2021, April 21, 2021, July 20, 2021,
October 15, 2021, January 14, 2022, April 12, 2022, July 15, 2022,
October 13, 2022, January 11, 2023, and February 11, 2023. The public
health emergency declared under section 319 of the PHS Act is
anticipated to no longer be in effect as of the end of the day on May
11, 2023. Nonetheless, as stated in section I of this amended PREP Act
Declaration, I have determined there is a credible risk that COVID-19
may in the future constitute such an emergency and am thus amending
this Declaration to prepare for and mitigate that risk.
On March 10, 2020, former Secretary Azar issued a Declaration under
the PREP Act for medical countermeasures against COVID-19 (85 FR 15198,
Mar. 17, 2020) (the Declaration). On April 10, 2020, the former
Secretary amended the Declaration under the PREP Act to extend
liability immunity to covered countermeasures authorized under the
CARES Act (85 FR 21012, Apr. 15, 2020). On June 4, 2020, the former
Secretary amended the Declaration to clarify that covered
countermeasures under the Declaration include qualified countermeasures
that limit the harm COVID-19 might otherwise cause. (85 FR 35100, June
8, 2020). On August 19, 2020, the former Secretary amended the
Declaration to add additional categories of Qualified Persons and amend
the category of disease, health condition, or threat for which he
recommended the administration or use of the Covered Countermeasures.
(85 FR 52136, Aug. 24, 2020).
On December 3, 2020, the former Secretary amended the Declaration
to incorporate Advisory Opinions of the General Counsel interpreting
the PREP Act and the Secretary's Declaration and authorizations issued
by the Department's Office of the Assistant Secretary for Health as an
Authority Having Jurisdiction to respond, added an additional category
of qualified persons under Section V of the Declaration i.e.,
healthcare personnel using telehealth to order or administer Covered
Countermeasures for patients in a state other than the state where the
healthcare personnel are permitted to practice; made explicit that the
Declaration covers all qualified pandemic and epidemic products as
defined under the PREP Act; added a third method of distribution to
provide liability protections for, among other things, private
distribution channels;
[[Page 30770]]
made explicit that there can be situations where not administering a
covered countermeasure to a particular individual can fall within the
PREP Act and the Declaration's liability protections; made explicit
that there are substantive federal legal and policy issues and
interests in having a unified whole-of-nation response to the COVID-19
pandemic among federal, state, local, and private-sector entities;
revised the effective time period of the Declaration; and republished
the Declaration in full. (85 FR 79190, Dec. 9, 2020).
On February 2, 2021, the Acting Secretary Norris Cochran amended
the Declaration to add additional categories of Qualified Persons
authorized to prescribe, dispense, and administer COVID-19 vaccines
that are covered countermeasures under the Declaration (86 FR 7872,
Feb. 2, 2021). On February 16, 2021, the Acting Secretary amended the
Declaration to add additional categories of Qualified Persons
authorized to prescribe, dispense, and administer COVID-19 vaccines
that are covered countermeasures under the Declaration (86 FR 9516,
Feb. 16, 2021) and on February 22, 2021, the Department filed a notice
of correction to the February 2 and February 16 notices correcting
effective dates stated in the Declaration, and correcting the
description of qualified persons added by the February 16, 2021
amendment. (86 FR 10588, Feb. 22, 2021). On March 11, 2021, the Acting
Secretary amended the Declaration to add additional Qualified Persons
authorized to prescribe, dispense, and administer covered
countermeasures under the Declaration. (86 FR 14462, Mar. 16, 2021).
On August 4, 2021, I amended the Declaration to clarify categories
of Qualified Persons and to expand the scope of authority for certain
Qualified Persons to administer seasonal influenza vaccines to adults.
(86 FR 41977, Aug. 4, 2021). On September 14, 2021, I amended the
Declaration to expand the scope of authority for certain Qualified
Persons to administer COVID-19 therapeutics subcutaneously,
intramuscularly, or orally (86 FR 51160, Sept. 14, 2021) and on
September 30, 2021, the Department filed a notice of correction to the
September 14 notice clarifying the terms ``ACIP recommendations'' and
``ACIP's standard immunization schedules.'' (86 FR 54696, Oct. 4,
2021). On January 7, 2022, I amended the Declaration to expand the
scope of authority for licensed pharmacists to order and administer and
qualified pharmacy interns to administer seasonal influenza vaccines.
(87 FR 982, January 7, 2022).
I am now amending section I of the Declaration to update the
determination of a public health emergency to state that COVID-19
presents a credible risk of a future public health emergency. While the
Public Health Emergency declared pursuant to section 319 of the PHS Act
is anticipated to no longer be in effect as of the end of the day on
May 11, 2023, COVID-19 continues to present a credible risk of a future
public health emergency. Continued coverage under the PREP Act, as
provided in this Declaration, is intended to prepare for and mitigate
that credible risk.
I am amending section VII of the Declaration to add a new
limitation on distribution to provide coverage under this PREP Act
Declaration through December 31, 2024 for manufacturing, distribution,
administration and use of Covered Countermeasures while they are
authorized for emergency use (EUA) by the Food and Drug Administration
(FDA) pursuant to section 564 of the Federal Food, Drug & Cosmetic
(FD&C) Act, regardless of any federal agreement related to
manufacturing, distribution, administration or use of the
countermeasures, and regardless of any federal, regional, state, or
local emergency Declaration. This extended PREP Act coverage extends to
manufacturers, distributors, program planners, qualified persons
authorized under state law to administer the Covered Countermeasures,
and qualified persons who are licensed pharmacists, pharmacy interns,
and pharmacy technicians authorized under this Declaration to order
and/or administer the Covered Countermeasures, when consistent with the
terms of the EUA and is intended to allay any concerns about liability
risks arising from continued manufacturing, distribution,
administration or use of Covered Countermeasures while they are
authorized under an EUA.
I am also amending section VII of the Declaration to add a new
limitation on distribution to provide coverage under this PREP Act
Declaration through December 31, 2024 for manufacturing, distribution,
administration and use of Covered Countermeasures that are COVID-19
vaccines licensed by FDA, and any FDA approved or cleared in vitro
diagnostic product or other device used to treat, diagnose, cure,
prevent, or mitigate COVID-19, or the transmission of SARS-CoV-2 or a
virus mutating therefrom regardless of any federal agreement related to
manufacturing, distribution, administration or use of the vaccines or
devices, and regardless of any federal, regional, state, or local
emergency Declaration. This extended PREP Act coverage is intended to
ensure that COVID-19 vaccines and devices remain eligible for coverage
under the Countermeasures Injury Compensation Program and to ensure
consistency in coverage for approved/cleared and authorized devices.
I am amending section VIII of the Declaration to clarify that the
category of disease, health condition or health threat includes the
burden on healthcare providers caused by coterminous seasonal influenza
infections and COVID-19 infections.
I am also amending section XII of the Declaration to extend the
time period of PREP Act coverage through December 31, 2024 to Qualified
Persons who are licensed pharmacists to order and administer, and
pharmacy interns and qualified pharmacy technicians to administer,
Covered Countermeasures that are COVID-19 vaccines, seasonal influenza
vaccines, and COVID-19 tests regardless of any federal agreement
related to manufacturing, distribution, administration or use of these
Covered Countermeasures and regardless of any federal, regional, state
or local emergency Declaration or other limitations on distribution
stated in section VII of the Declaration. Extending the time period for
PREP Act coverage for licensed pharmacists, pharmacy interns, and
qualified technicians allows for continued access by the recipient
Population to Covered Countermeasures that are COVID-19 vaccines,
seasonal influenza vaccines and COVID-19 tests.
As stated in prior amendments to this Declaration,\1\ licensed
pharmacists, pharmacy interns and qualified pharmacy technicians are
well positioned to provide continued access to Covered Countermeasures,
particularly in certain areas or for certain populations that have too
few primary-care providers or that are otherwise medically underserved.
As of 2022, nearly 90 percent of Americans lived within five miles of a
community pharmacy.\2\ During the COVID-19 pandemic, the majority of
Americans have received their COVID-19 vaccines and tests from a
pharmacy. In addition, continued access by the Population to seasonal
influenza vaccines mitigates risks that seasonal influenza infections,
in conjunction with COVID-19 infections, could overwhelm healthcare
providers.
As qualified persons, these licensed pharmacists, pharmacy interns,
and qualified pharmacy technicians will be afforded liability
protections in accordance with the PREP Act and the terms of this
amended Declaration. To the extent that any State law would otherwise
prohibit these healthcare
[[Page 30771]]
professionals who are a ``qualified person'' from prescribing,
dispensing, or administering Covered Countermeasures that are COVID-19
vaccines, seasonal influenza vaccines or COVID-19 tests, such law is
preempted.\3\
Finally, I am amending section XII of this Declaration to clarify
the time period of coverage for other qualified persons authorized
under section V of the Declaration, and to extend the duration of the
Declaration to December 2024 to coincide with the duration of other
COVID-19 response programs.\4\
Other conforming changes and technical corrections are made
throughout the Declaration for consistency and clarity.
Declaration, as Amended, for Public Readiness and Emergency
Preparedness Act Coverage for Medical Countermeasures Against COVID-19
To the extent any term previously in the Declaration, including its
amendments, is inconsistent with any provision of this Republished
Declaration, the terms of this Republished Declaration are controlling.
This Declaration must be construed in accordance with the Advisory
Opinions of the Office of the General Counsel (Advisory Opinions).\5\ I
incorporate those Advisory Opinions as part of this Declaration. This
Declaration is a ``requirement'' under the PREP Act.
I. Determination of Public Health Emergency
42 U.S.C. 247d-6d(b)(1)
I have determined that the spread of SARS-CoV-2 or a virus mutating
therefrom and the resulting disease COVID-19 constitutes a credible
risk of a future public health emergency. I further determine that use
of any respiratory protective device approved by NIOSH under 42 CFR
part 84, or any successor regulations, is a priority for use during the
public health emergency that former Secretary Azar declared on January
31, 2020 under section 319 of the PHS Act for the entire United States
to aid in the response of the nation's healthcare community to the
COVID-19 outbreak.
II. Factors Considered
42 U.S.C. 247d-6d(b)(6)
I have considered the desirability of encouraging the design,
development, clinical testing, or investigation, manufacture, labeling,
distribution, formulation, packaging, marketing, promotion, sale,
purchase, donation, dispensing, prescribing, administration, licensing,
and use of the Covered Countermeasures.
III. Recommended Activities
42 U.S.C. 247d-6d(b)(1)
I recommend, under the conditions stated in this Declaration, the
manufacture, testing, development, distribution, administration, and
use of the Covered Countermeasures.
IV. Liability Protections
42 U.S.C. 247d-6d(a), 247d-6d(b)(1)
Liability protections as prescribed in the PREP Act and conditions
stated in this Declaration are in effect for the Recommended Activities
described in Section III.
V. Covered Persons
42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B)
Covered Persons who are afforded liability immunity under this
Declaration are ``manufacturers,'' ``distributors,'' ``program
planners,'' ``qualified persons,'' and their officials, agents, and
employees, as those terms are defined in the PREP Act, and the United
States.
``Order'' as used herein and in guidance issued by the Office of
the Assistant Secretary for Health \6\ means a provider medication
order, which includes prescribing of vaccines, or a laboratory order,
which includes prescribing laboratory orders, if required.
``Qualified person'' includes (A) a licensed health professional or
other individual who is authorized to prescribe, administer, or
dispense such countermeasures under the law of the State in which the
countermeasure was prescribed, administered, or dispensed; or (B) ``a
person within a category of persons so identified in a Declaration by
the Secretary'' under subsection (b) of the PREP Act. 42 U.S.C. 247d-
6d(i)(8)
In addition, I have determined that the following additional
persons are qualified persons:
(a) Any person authorized in accordance with the public health and
medical emergency response of the Authority Having Jurisdiction, as
described in Section VII below, to prescribe, administer, deliver,
distribute or dispense the Covered Countermeasures, and their
officials, agents, employees, contractors and volunteers, following a
Declaration of an Emergency, as that term is defined in Section VII of
this Declaration; \7\
(b) Any person authorized to prescribe, administer, or dispense the
Covered Countermeasures or who is otherwise authorized to perform an
activity under an Emergency Use Authorization in accordance with
Section 564 of the FD&C Act.
(c) Any person authorized to prescribe, administer, or dispense
Covered Countermeasures in accordance with Section 564A of the FD&C
Act.
(d) A State-licensed pharmacist who orders and administers, and
pharmacy interns and qualified pharmacy technicians who administer (if
the pharmacy intern or technician acts under the supervision of such
pharmacist and the pharmacy intern or technician is licensed or
registered by his or her State board of pharmacy),\8\ (1) vaccines that
the Centers for Disease Control and Prevention (CDC)/Advisory Committee
on Immunization Practices (ACIP) recommend \9\ to persons ages three
through 18 according to CDC's/ACIP's standard immunization schedule or
(2) seasonal influenza vaccine administered by qualified pharmacy
technicians and interns that the CDC/ACIP recommends to persons aged 19
and older according to CDC's/ACIP's standard immunization schedule; or
(3) FDA authorized or FDA licensed COVID-19 vaccines to persons ages
three or older. Such State-licensed pharmacists and the State-licensed
or registered interns or technicians under their supervision are
qualified persons only if the following requirements are met:
i. The vaccine must be authorized, approved, or licensed by the
FDA.
ii. In the case of a COVID-19 vaccine, the vaccination must be
ordered and administered according to CDC's/ACIP's COVID-19 vaccine
recommendation(s).
iii. In the case of a childhood vaccine, the vaccination must be
ordered and administered according to CDC's/ACIP's standard
immunization schedule.
iv. In the case of seasonal influenza vaccine administered by
qualified pharmacy technicians and interns, the vaccination must be
ordered and administered according to CDC's/ACIP's standard
immunization schedule.
v. In the case of pharmacy technicians, the supervising pharmacist
must be readily and immediately available to the immunizing qualified
pharmacy technician.
vi. The licensed pharmacist must have completed the immunization
training that the licensing State requires for pharmacists to order and
administer vaccines. If the State does not specify training
requirements for the licensed pharmacist to order and administer
vaccines, the licensed pharmacist must complete a vaccination training
program of at least 20 hours that is approved by the ACPE to order and
administer vaccines. Such a training program must include hands on
injection technique,
[[Page 30772]]
clinical evaluation of indications and contraindications of vaccines,
and the recognition and treatment of emergency reactions to vaccines.
vii. The licensed or registered pharmacy intern and qualified
pharmacy technician must complete a practical training program that is
approved by the ACPE. This training program must include hands-on
injection technique, clinical evaluation of indications and
contraindications of vaccines, and the recognition and treatment of
emergency reactions to vaccines.
viii. The licensed pharmacist, licensed or registered pharmacy
intern and qualified pharmacy technician must have a current
certificate in basic cardiopulmonary resuscitation; \10\
ix. The licensed pharmacist must complete a minimum of two hours of
ACPE-approved, immunization-related continuing pharmacy education
during each State licensing period.
x. The licensed pharmacist must comply with recordkeeping and
reporting requirements of the jurisdiction in which he or she
administers vaccines, including informing the patient's primary care
provider when available, submitting the required immunization
information to the State or local immunization information system
(vaccine registry), complying with requirements with respect to
reporting adverse events, and complying with requirements whereby the
person administering a vaccine must review the vaccine registry or
other vaccination records prior to administering a vaccine;
xi. The licensed pharmacist must inform his or her childhood-
vaccination patients and the adult caregiver accompanying the child of
the importance of a well-child visit with a pediatrician or other
licensed primary care provider and refer patients as appropriate; and
xii. The licensed pharmacist, the licensed or registered pharmacy
intern and the qualified pharmacy technician must comply with any
applicable requirements (or conditions of use) as set forth in the
Centers for Disease Control and Prevention (CDC) COVID-19 vaccination
provider agreement and any other federal requirements that apply to the
administration of COVID-19 vaccine(s).
(e) Healthcare personnel using telehealth to order or administer
Covered Countermeasures for patients in a state other than the state
where the healthcare personnel are licensed or otherwise permitted to
practice. When ordering and administering Covered Countermeasures by
means of telehealth to patients in a state where the healthcare
personnel are not already permitted to practice, the healthcare
personnel must comply with all requirements for ordering and
administering Covered Countermeasures to patients by means of
telehealth in the state where the healthcare personnel are permitted to
practice. Any state law that prohibits or effectively prohibits such a
qualified person from ordering and administering Covered
Countermeasures by means of telehealth is preempted.\11\ Nothing in
this Declaration shall preempt state laws that permit additional
persons to deliver telehealth services.
(f) Any healthcare professional or other individual who holds an
active license or certification permitting the person to prescribe,
dispense, or administer vaccines under the law of any State as of the
effective date of this amendment, or a pharmacist or pharmacy intern as
authorized under the section V(d) of this Declaration, who prescribes,
dispenses, or administers COVID-19 vaccines that are Covered
Countermeasures under section VI of this Declaration in any
jurisdiction where the PREP Act applies, other than the State in which
the license or certification is held, in association with a COVID-19
vaccination effort by a federal, State, local Tribal or territorial
authority or by an institution in the State in which the COVID-19
vaccine covered countermeasure is administered, so long as the license
or certification of the healthcare professional has not been suspended
or restricted by any licensing authority, surrendered while under
suspension, discipline or investigation by a licensing authority or
surrendered following an arrest, and the individual is not on the List
of Excluded Individuals/Entities maintained by the Office of Inspector
General, subject to Documentation of completion of the Centers for
Disease Control and Prevention COVID-19 (CDC) Vaccine Training Modules
\12\ and, for healthcare providers who are not currently practicing,
documentation of an observation period by a currently practicing
healthcare professional experienced in administering intramuscular
injections, and for whom administering intramuscular injections is in
their ordinary scope of practice, who confirms competency of the
healthcare provider in preparation and administration of the COVID-19
vaccine(s) to be administered.
(g) Any member of a uniformed service (including members of the
National Guard in a Title 32 duty status) (hereafter in this paragraph
``service member'') or Federal government, employee, contractor, or
volunteer who prescribes, administers, delivers, distributes or
dispenses a Covered Countermeasure. Such Federal government service
members, employees, contractors, or volunteers are qualified persons if
the following requirement is met: The executive department or agency by
or for which the Federal service member, employee, contractor, or
volunteer is employed, contracts, or volunteers has authorized or could
authorize that service member, employee, contractor, or volunteer to
prescribe, administer, deliver, distribute, or dispense the Covered
Countermeasure as any part of the duties or responsibilities of that
service member, employee, contractor, or volunteer, even if those
authorized duties or responsibilities ordinarily would not extend to
members of the public or otherwise would be more limited in scope than
the activities such service member, employees, contractors, or
volunteers are authorized to carry out under this Declaration.
(h) The following healthcare professionals and students in a
healthcare profession training program subject to the requirements of
this paragraph:
1. Any midwife, paramedic, advanced or intermediate emergency
medical technician (EMT), physician assistant, respiratory therapist,
dentist, podiatrist, optometrist or veterinarian licensed or certified
to practice under the law of any state who prescribes, dispenses, or
administers COVID-19 vaccines that are Covered Countermeasures under
section VI of this Declaration in any jurisdiction where the PREP Act
applies in association with a COVID-19 vaccination effort by a State,
local, Tribal or territorial authority or by an institution in which
the COVID-19 vaccine covered countermeasure is administered;
2. Any physician, advanced practice registered nurse, registered
nurse, practical nurse, pharmacist, pharmacy intern, midwife,
paramedic, advanced or intermediate EMT, respiratory therapist,
dentist, physician assistant, podiatrist, optometrist, or veterinarian
who has held an active license or certification under the law of any
State within the last five years, which is inactive, expired or lapsed,
who prescribes, dispenses, or administers COVID-19 vaccines that are
Covered Countermeasures under section VI of this Declaration in any
jurisdiction where the PREP Act applies in association with a COVID-19
vaccination effort by a State, local, Tribal or territorial authority
or by an institution in which the COVID-19
[[Page 30773]]
vaccine covered countermeasure is administered, so long as the license
or certification was active and in good standing prior to the date it
went inactive, expired or lapsed and was not revoked by the licensing
authority, surrendered while under suspension, discipline or
investigation by a licensing authority or surrendered following an
arrest, and the individual is not on the List of Excluded Individuals/
Entities maintained by the Office of Inspector General;
3. Any medical, nursing, pharmacy, pharmacy intern, midwife,
paramedic, advanced or intermediate EMT, physician assistant,
respiratory therapy, dental, podiatry, optometry or veterinary student
with appropriate training in administering vaccines as determined by
his or her school or training program and supervision by a currently
practicing healthcare professional experienced in administering
intramuscular injections who administers COVID-19 vaccines that are
Covered Countermeasures under section VI of this Declaration in any
jurisdiction where the PREP Act applies in association with a COVID-19
vaccination effort by a State, local, Tribal or territorial authority
or by an institution in which the COVID-19 vaccine covered
countermeasure is administered;
Subject to the following requirements:
i. The vaccine must be authorized, approved, or licensed by the
FDA;
ii. Vaccination must be ordered and administered according to
CDC's/ACIP's COVID-19 vaccine recommendation(s);
iii. The healthcare professionals and students must have
documentation of completion of the Centers for Disease Control and
Prevention COVID-19 Vaccine Training Modules and, if applicable, such
additional training as may be required by the State, territory,
locality, or Tribal area in which they are prescribing, dispensing, or
administering COVID-19 vaccines;
iv. The healthcare professionals and students must have
documentation of an observation period by a currently practicing
healthcare professional experienced in administering intramuscular
injections, and for whom administering vaccinations is in their
ordinary scope of practice, who confirms competency of the healthcare
provider or student in preparation and administration of the COVID-19
vaccine(s) to be administered and, if applicable, such additional
training as may be required by the State, territory, locality, or
Tribal area in which they are prescribing, dispensing, or administering
COVID-19 vaccines;
v. The healthcare professionals and students must have a current
certificate in basic cardiopulmonary resuscitation; \13\
vi. The healthcare professionals and students must comply with
recordkeeping and reporting requirements of the jurisdiction in which
he or she administers vaccines, including informing the patient's
primary-care provider when available, submitting the required
immunization information to the State or local immunization information
system (vaccine registry), complying with requirements with respect to
reporting adverse events, and complying with requirements whereby the
person administering a vaccine must review the vaccine registry or
other vaccination records prior to administering a vaccine; and
vii. The healthcare professionals and students comply with any
applicable requirements (or conditions of use) as set forth in the
Centers for Disease Control and Prevention (CDC) COVID-19 vaccination
provider agreement and any other federal requirements that apply to the
administration of COVID-19 vaccine(s).
(i) A State-licensed pharmacist who orders and administers, and
pharmacy interns and qualified pharmacy technicians who administer (if
the pharmacy intern or technician acts under the supervision of such
pharmacist and the pharmacy intern or technician is licensed or
registered by his or her State board of pharmacy) \14\ FDA authorized,
approved, or licensed COVID-19 therapeutics. Such State licensed
pharmacists and the State licensed or registered interns or technicians
under their supervision are qualified persons only if the following
requirements are met:
i. The COVID-19 therapeutic must be authorized, approved, or
licensed by the FDA;
ii. In the case of a licensed pharmacist ordering a COVID-19
therapeutic, the therapeutic must be ordered for subcutaneous,
intramuscular, or oral administration and in accordance with the FDA
approval, authorization, or licensing;
iii. In the case of licensed pharmacists, qualified pharmacy
technicians, and licensed or registered pharmacy interns administering
the COVID-19 therapeutic, the therapeutic must be administered
subcutaneously, intramuscularly, or orally in accordance with the FDA
approval, authorization, or licensing;
iv. In the case of qualified pharmacy technicians, the supervising
pharmacist must be readily and immediately available to the qualified
pharmacy technician;
v. In the case of COVID-19 therapeutics administered through
intramuscular or subcutaneous injections, the licensed pharmacist,
licensed or registered pharmacy intern and qualified pharmacy
technician must complete a practical training program that is approved
by the ACPE. This training program must include hands-on injection
technique, clinical evaluation of indications and contraindications of
COVID-19 therapeutics, the recognition and treatment of emergency
reactions to COVID-19 therapeutics, and any additional training
required in the FDA approval, authorization, or licensing;
vi. The licensed pharmacist, licensed or registered pharmacy intern
and qualified pharmacy technician must have a current certificate in
basic cardiopulmonary resuscitation; \15\
vii. The licensed pharmacist must comply with recordkeeping and
reporting requirements of the jurisdiction in which he or she
administers COVID-19 therapeutics; including informing the patient's
primary-care provider when available and complying with requirements
with respect to reporting adverse events; and
viii. The licensed pharmacist, the licensed or registered pharmacy
intern and the qualified pharmacy technician must comply with any
applicable requirements (or conditions of use) that apply to the
administration of COVID-19 therapeutics.
(j) Any pharmacist who holds an active license or certification
permitting the person to prescribe, dispense, or administer vaccines
under the law of any State or who is authorized under Section V(d) of
this Declaration who prescribes, dispenses, or administers seasonal
influenza vaccines, or a pharmacy intern as authorized under the
section V(d) of this Declaration who administers seasonal influenza
vaccines, in any jurisdiction where the PREP Act applies, other than
the State in which the license or certification is held, so long as the
license or certification of the pharmacist or pharmacy intern has not
been suspended or restricted by any licensing authority, surrendered
while under suspension, discipline or investigation by a licensing
authority or surrendered following an arrest, and the individual is not
on the List of Excluded Individuals/Entities maintained by the Office
of Inspector General.
Nothing in this Declaration shall be construed to affect the
National Vaccine Injury Compensation Program, including an injured
party's ability to obtain compensation under that program. Covered
countermeasures that
[[Page 30774]]
are subject to the National Vaccine Injury Compensation Program
authorized under 42 U.S.C. 300aa-10 et seq. are covered under this
Declaration for the purposes of liability immunity and injury
compensation only to the extent that injury compensation is not
provided under that Program. All other terms and conditions of the
Declaration apply to such covered countermeasures.
VI. Covered Countermeasures
42 U.S.C. 247d-6b(c)(1)(B), 42 U.S.C. 247d-6d(i)(1) and (7)
Covered Countermeasures are:
(a) Any antiviral, any drug, any biologic, any diagnostic, any
other device, any respiratory protective device, or any vaccine
manufactured, used, designed, developed, modified, licensed, or
procured:
i. To diagnose, mitigate, prevent, treat, or cure COVID-19, or the
transmission of SARS-CoV-2 or a virus mutating therefrom; or
ii. to limit the harm that COVID-19, or the transmission of SARS-
CoV-2 or a virus mutating therefrom, might otherwise cause;
(b) a product manufactured, used, designed, developed, modified,
licensed, or procured to diagnose, mitigate, prevent, treat, or cure a
serious or life-threatening disease or condition caused by a product
described in paragraph (a) above;
(c) a product or technology intended to enhance the use or effect
of a product described in paragraph (a) or (b) above; or
(d) any device used in the administration of any such product, and
all components and constituent materials of any such product.
To be a Covered Countermeasure under the Declaration, a product
must also meet 42 U.S.C. 247d-6d(i)(1)'s definition of ``Covered
Countermeasure.''
VII. Limitations on Distribution
42 U.S.C. 247d-6d(a)(5) and (b)(2)(E)
I have determined that liability protections are afforded to
Covered Persons only for Recommended Activities involving:
(a) Covered Countermeasures that are related to present or future
federal contracts, cooperative agreements, grants, other transactions,
interagency agreements, memoranda of understanding, or other federal
agreements;
(b) Covered Countermeasures that are related to activities
authorized in accordance with the public health and medical response of
the Authority Having Jurisdiction to prescribe, administer, deliver,
distribute or dispense the Covered Countermeasures following a
Declaration of Emergency;
(c) Covered Countermeasures other than those described in
subsection (e) that are:
i. Licensed, approved or cleared by the FDA (or that are permitted
to be used under an Investigational New Drug Application or an
Investigational Device Exemption) under the FD&C Act or PHS Act to
treat, diagnose, cure, prevent, mitigate, or limit the harm from COVID-
19, or the transmission of SARS-CoV-2 or a virus mutating therefrom; or
ii. a respiratory protective device approved by NIOSH under 42 CFR
part 84, or any successor regulations, that the Secretary determines to
be a priority for use during a public health emergency declared under
section 319 of the PHS Act to prevent, mitigate, or limit the harm from
COVID-19, or the transmission of SARS-CoV-2 or a virus mutating
therefrom.
To qualify for this third distribution channel, a Covered Person
must manufacture, test, develop, distribute, administer, or use the
Covered Countermeasure pursuant to the FDA licensure, approval, or
clearance (or pursuant to an Investigational New Drug Application or
Investigational Device Exemption), or the NIOSH approval;
(d) Covered Countermeasures that are authorized by the FDA under
section 564 of the FD&C Act to treat, diagnose, cure, prevent,
mitigate, or limit the harm from COVID-19, or the transmission of SARS-
CoV-2 or a virus mutating therefrom. To qualify for this fourth
distribution channel, a Covered Person must manufacture, test, develop,
distribute, administer, or use the Covered Countermeasure pursuant to
the FDA authorization; or
(e) Covered Countermeasures that are COVID-19 vaccines licensed by
the FDA to prevent, mitigate, or limit the harm from COVID-19, or the
transmission of SARS-CoV-2 or a virus mutating therefrom and any
approved or cleared in vitro diagnostic product or other device used to
treat, diagnose, cure, prevent, or mitigate COVID-19, or the
transmission of SARS-CoV-2 or a virus mutating therefrom. To qualify
for this fifth distribution channel, a Covered Person must manufacture,
test, develop, distribute, administer, or use the Covered
Countermeasure pursuant to the FDA license, clearance, or approval.
As used in this Declaration, the terms ``Authority Having
Jurisdiction'' and ``Declaration of Emergency'' have the following
meanings:
(i) The Authority Having Jurisdiction means the public agency or
its delegate that has legal responsibility and authority for responding
to an incident, based on political or geographical (e.g., city, county,
tribal, state, or federal boundary lines) or functional (e.g., law
enforcement, public health) range or sphere of authority.
(ii) A Declaration of Emergency means any declaration by any
authorized local, regional, state, or federal official of an emergency
specific to events that indicate an immediate need to administer and
use the Covered Countermeasures, with the exception of a federal
declaration in support of an Emergency Use Authorization under Section
564 of the FD&C Act unless such declaration specifies otherwise.
I have also determined that, for governmental program planners
only, liability protections are afforded only to the extent such
program planners obtain Covered Countermeasures through voluntary
means, such as (a) donation; (b) commercial sale; (c) deployment of
Covered Countermeasures from federal stockpiles; or (d) deployment of
donated, purchased, or otherwise voluntarily obtained Covered
Countermeasures from state, local, or private stockpiles.
VIII. Category of Disease, Health Condition, or Threat
42 U.S.C. 247d-6d(b)(2)(A)
The category of disease, health condition, or threat for which I
recommend the administration or use of the Covered Countermeasures is
not only COVID-19 caused by SARS-CoV-2, or a virus mutating therefrom,
but also other diseases, health conditions, or threats that may have
been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom,
including the threat of increased burden on the healthcare system due
to seasonal influenza infections occurring at the same time as COVID-19
infections, which will lead to an increase in the rate of infectious
diseases.
IX. Administration of Covered Countermeasures
42 U.S.C. 247d-6d(a)(2)(B)
Administration of the Covered Countermeasure means physical
provision of the countermeasures to recipients, or activities and
decisions directly relating to public and private delivery,
distribution and dispensing of the countermeasures to recipients,
management and operation of countermeasure programs, or management and
operation of locations for the purpose of distributing and dispensing
countermeasures. Where there are limited Covered
[[Page 30775]]
Countermeasures, not administering a Covered Countermeasure to one
individual in order to administer it to another individual can
constitute ``relating to . . . the administration to . . . an
individual'' under 42 U.S.C. 247d-6d. For example, consider a situation
where there is only one dose \16\ of a COVID-19 vaccine, and a person
in a vulnerable population and a person in a less vulnerable population
both request it from a healthcare professional. In that situation, the
healthcare professional administers the one dose to the person who is
more vulnerable to COVID-19. In that circumstance, the failure to
administer the COVID-19 vaccine to the person in a less-vulnerable
population ``relat[es] to . . . the administration to'' the person in a
vulnerable population. The person in the vulnerable population was able
to receive the vaccine only because it was not administered to the
person in the less-vulnerable population. Prioritization or purposeful
allocation of a Covered Countermeasure, particularly if done in
accordance with a public health authority's directive, can fall within
the PREP Act and this Declaration's liability protections.
X. Population
42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(C)
The populations of individuals to whom the liability protections of
this Declaration extend include any individual who uses or is
administered the Covered Countermeasures in accordance with this
Declaration.
Liability protections are afforded to manufacturers and
distributors without regard to whether the countermeasure is used by or
administered to this population; liability protections are afforded to
program planners and qualified persons when the countermeasure is used
by or administered to this population, or the program planner or
qualified person reasonably could have believed the recipient was in
this population.
XI. Geographic Area
42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(D)
Liability protections are afforded for the administration or use of
a Covered Countermeasure without geographic limitation.
Liability protections are afforded to manufacturers and
distributors without regard to whether the Covered Countermeasure is
used by or administered in any designated geographic area; liability
protections are afforded to program planners and qualified persons when
the countermeasure is used by or administered in any designated
geographic area, or the program planner or qualified person reasonably
could have believed the recipient was in that geographic area.
COVID-19 is a global challenge that requires a whole-of-nation
response. There are substantial federal legal and policy issues, and
substantial federal legal and policy interests within the meaning of
Grable & Sons Metal Products, Inc. v. Darue Eng'g. & Mf'g., 545 U.S.
308 (2005), in having a unified, whole-of-nation response to the COVID-
19 pandemic among federal, state, local, and private-sector entities.
The world faced an unprecedented pandemic. To effectively respond,
there needed to be a more consistent pathway for Covered Persons to
manufacture, distribute, administer or use Covered Countermeasures
across the nation and the world. Thus, there are substantial federal
legal and policy issues, and substantial federal legal and policy
interests within the meaning of Grable & Sons Metal Products, Inc. v.
Darue Eng'g. & Mf'g., 545 U.S. 308 (2005), in having a uniform
interpretation of the PREP Act. Under the PREP Act, the sole exception
to the immunity from suit and liability of covered persons under the
PREP Act is an exclusive Federal cause of action against a covered
person for death or serious physical injury proximately caused by
willful misconduct by such covered person. In all other cases, an
injured party's exclusive remedy is an administrative remedy under
section 319F-4 of the PHS Act. Through the PREP Act, Congress delegated
to me the authority to strike the appropriate Federal-state balance
with respect to Covered Countermeasures through PREP Act
Declarations.\17\
XII. Effective Time Period
42 U.S.C. 247d-6d(b)(2)(B)
The effective time period for Covered Countermeasures and Covered
Persons depends on the means of distribution identified in Section VII
of this Declaration as applied to categories of Countermeasures and
Qualified Persons:
(a) Liability protections for any respiratory protective device
approved by NIOSH under 42 CFR part 84, or any successor regulations,
through the means of distribution identified in Section VII(a) of this
Declaration, begin on March 27, 2020 and extend through December 31,
2024.
(b) Liability protections for all other Covered Countermeasures
identified in Section VI of this Declaration, through means of
distribution identified in Section VII(a) of this Declaration, begin on
February 4, 2020 and extend through December 31, 2024.
(c) Liability protections for all Covered Countermeasures
administered and used in accordance with the public health and medical
response of the Authority Having Jurisdiction, as identified in Section
VII(b) of this Declaration, begin with a Declaration of Emergency as
that term is defined in Section VII (except that, with respect to
qualified persons who order or administer a routine childhood
vaccination that CDC/ACIP recommends to persons ages three through 18
according to CDC's/ACIP's standard immunization schedule, liability
protections began on August 24, 2020), and last through (a) the final
day the Declaration of Emergency is in effect, or (b) December 31,
2024, whichever occurs first.
(d) Liability protections for all Covered Countermeasures
identified in Section VII(c) of this Declaration that are licensed,
approved or cleared by the FDA begin on December 9, 2020, and last
through the final day the Declaration of Emergency is in effect or
December 31, 2024 whichever occurs first. Liability protections for all
Covered Countermeasures identified in Section VII(c) of this
Declaration that are approved by NIOSH last for the time period stated
in section (a) of this Section XII.
(e) Liability protections for all Covered Countermeasures
identified in Section VII(d) of this Declaration begin on December 9,
2020, and last until December 31, 2024, regardless of any Declaration
of Emergency that might otherwise terminate the time period of coverage
under paragraphs (c) or (d) of this Section XII.
(f) Liability protections for all Covered Countermeasures
identified in Section VII(e) of this Declaration begin on December 9,
2020, and last until December 31, 2024, regardless of any Declaration
of Emergency that might otherwise terminate the time period of coverage
under paragraphs (c) or (d) of this Section XII.
(g) Liability protections for Manufacturers, Distributors, and
Program Planners, as defined at 42 U.S.C. 247d-6d(i), begin on February
4, 2020, and last through the time periods stated in paragraphs (a)-(f)
of this Section XII.
(h) Liability protections for Qualified Persons who are a licensed
health professional or other individual who is authorized to prescribe,
administer, or dispense such countermeasures under the law of the State
in which the
[[Page 30776]]
countermeasure was prescribed, administered, or dispensed begin on
February 4, 2020, and last through the time periods stated in
paragraphs (a)-(f) of this Section XII.
(i) Liability protections for Additional Qualified Persons
identified under section V of the Declaration and in Guidance
implementing section V of the Declaration begin on the dates listed
below, and last through the time periods stated in paragraphs (a)-(d)
of this section XII of the Declaration, unless otherwise stated in this
paragraph (i).
i. Liability protections for Qualified Persons under section V(d)
of the Declaration who are licensed pharmacists to order and
administer, and licensed or registered pharmacy interns and qualified
pharmacy technicians to administer CDC/ACIP recommended vaccines for
persons aged three through 18 (other than seasonal influenza vaccines
and COVID-19 vaccines) begins on August 24, 2020.
ii. Liability protections for Qualified Persons under section V(d)
of the Declaration who are licensed pharmacists to order and
administer, and licensed or registered pharmacy interns and qualified
pharmacy technicians to administer CDC/ACIP recommended seasonal
influenza vaccines for persons aged three through 18 begins on August
24, 2020, and lasts through December 31, 2024 regardless of the time
periods stated in paragraphs (c)-(d) of this section XII or limitations
on distribution stated in section VII (a)-(b) of this Declaration.
iii. Liability protections for Qualified Persons under section V(d)
of the Declaration who are licensed pharmacists to order and
administer, and pharmacy interns and qualified pharmacy technicians to
administer, COVID-19 vaccines to individuals aged three and above
begins on February 4, 2020 and lasts through December 31, 2024
regardless of the time periods stated in paragraphs (c)-(d) of this
section XII or limitations on distribution stated in section VII (a)-
(b) of this Declaration.
iv. Liability protections for Qualified Persons under section V(d)
of the Declaration who are licensed pharmacists to order and
administer, and pharmacy interns and qualified pharmacy technicians to
administer, seasonal influenza vaccines to individuals aged nineteen
and above begins on August 4, 2021 and lasts through December 31, 2024,
regardless of the time periods stated in paragraphs (c)-(d) of this
section XII or limitations on distribution stated in section VII (a)-
(b) of this Declaration.
v. Liability protections for Qualified Persons under section V(e)
of the Declaration begin on February 4, 2020.
vi. Liability protections for Qualified Persons under section V(f)
of the Declaration begin on February 2, 2021.
vii. Liability protections for Qualified Persons under section V(g)
of the Declaration begin on February 16, 2021, and last through
December 31, 2024.
xiii. Liability protections for Qualified Persons who are
physicians, advanced practice registered nurses, registered nurses, or
practical nurses under section V(h) of the Declaration begin on
February 2, 2021 with additional conditions effective as of March 11,
2021 and liability protections for all other Qualified persons under
section V(h) begin on March 11, 2021.
ix. Liability protections for Qualified Persons under section V(i)
of the Declaration who are licensed pharmacists to order and administer
and qualified pharmacy technicians and licensed or registered pharmacy
interns to administer COVID-19 therapeutics identified in Section
VII(d) of the Declaration begin on September 9, 2021 and last through
December 31, 2024 regardless of time periods stated in paragraphs (c)-
(d) of this section or limitations on distribution stated in section
VII (a)-(b) of this Declaration.
x. Liability protections for Qualified Persons under section V(i)
of the Declaration who are licensed pharmacists to order and administer
and qualified pharmacy technicians and licensed or registered pharmacy
interns to administer COVID-19 therapeutics identified in Section
VII(c) of the Declaration begin on September 9, 2021.
xi. Liability protections for Qualified Persons under section V(j)
of the Declaration begin on December 30, 2021.
xii. Liability protections for Qualified Persons authorized under
Guidance issued by this Department as an Authority Having Jurisdiction
to respond to a declared emergency, incorporated into this Declaration
by reference,\18\ to administer COVID-19 tests who are licensed
pharmacists begin April 8, 2020 and last until December 31, 2024
regardless of any limitations stated in paragraphs (c)-(d) of this
Section XII or limitations on distribution stated in section VII (a)-
(b) of this Declaration.
xiii. Liability protections for Qualified Persons authorized under
Guidance issued by this Department as an Authority Having Jurisdiction
to respond to a declared emergency, incorporated into this Declaration
by reference,\19\ to administer COVID-19 tests who are licensed or
registered pharmacy interns or qualified pharmacy technicians begin
October 20, 2020 and last until December 31, 2024 regardless of any
limitations stated in paragraphs (c)-(d) of this Section XII or
limitations on distribution stated in section VII (a)-(b) of this
Declaration.
xiv. Liability protections for Qualified Persons authorized under
Guidance issued by this Department as an Authority Having Jurisdiction
to respond to a declared emergency, incorporated into this Declaration
by reference,\20\ who are pharmacies when their staff pharmacists order
and administer, or their pharmacy interns and pharmacy technicians
administer COVID-19 vaccines to individuals aged three and above,
seasonal influenza vaccines to individuals aged three through eighteen,
seasonal influenza vaccines to individuals aged nineteen and above,
COVID-19 tests, and COVID-19 therapeutics identified in Section VII(d)
of the Declaration begin October 29, 2020 and last until December 31,
2024 regardless of any limitations stated in paragraphs (c)-(d) of this
Section XII or limitations on distribution stated in section VII (a)-
(b) of this Declaration.
xv. Liability protections for Qualified Persons authorized under
Guidance issued by this Department as an Authority Having Jurisdiction
to respond to a declared emergency, incorporated into this Declaration
by reference,\21\ who are pharmacies when their staff pharmacists order
and administer, or their pharmacy interns and pharmacy technicians
administer CDC/ACIP recommended vaccines for persons aged three through
18 (other than seasonal influenza vaccines and COVID-19 vaccines) and
countermeasures identified in Section VII(c) of the Declaration begin
October 29, 2020.
xv. Liability protections for Qualified Persons authorized under
Guidance issued by this Department as an Authority Having Jurisdiction
to respond to a declared emergency, incorporated into this Declaration
by reference \22\ to prescribe or administer point-of-care COVID-19
tests, using anterior nares specimen collection or self-collection, for
screening in congregate facilities across the Nation who are licensed
healthcare practitioners begin August 31, 2020 and last until December
31, 2024 regardless of any limitations stated in paragraphs (c)-(d) of
this Section XII or limitations on distribution stated in section VII
(a)-(b) of this Declaration.
[[Page 30777]]
XIII. Additional Time Period of Coverage
42 U.S.C. 247d-6d(b)(3)(B) and (C)
I have determined that an additional 12 months of liability
protection is reasonable to allow for the manufacturer(s) to arrange
for disposition of the Covered Countermeasure, including return of the
Covered Countermeasures to the manufacturer, and for Covered Persons to
take such other actions as are appropriate to limit the administration
or use of the Covered Countermeasures.
Covered Countermeasures obtained for the SNS during the effective
period of this Declaration are covered through the date of
administration or use pursuant to a distribution or release from the
SNS.
XIV. Countermeasures Injury Compensation Program
42 U.S.C 247d-6e
The PREP Act authorizes the Countermeasures Injury Compensation
Program (CICP) to provide benefits to certain individuals or estates of
individuals who sustain a covered serious physical injury as the direct
result of the administration or use of the Covered Countermeasures, and
benefits to certain survivors of individuals who die as a direct result
of the administration or use of the Covered Countermeasures. The causal
connection between the countermeasure and the serious physical injury
must be supported by compelling, reliable, valid, medical and
scientific evidence in order for the individual to be considered for
compensation. The CICP is administered by the Health Resources and
Services Administration, within the Department of Health and Human
Services. Information about the CICP is available at the toll-free
number 1-855-266-2427 or <a href="http://www.hrsa.gov/cicp/">http://www.hrsa.gov/cicp/</a>.
XV. Amendments
42 U.S.C. 247d-6d(b)(4)
Amendments to this Declaration will be published in the Federal
Register, as warranted.
Authority: 42 U.S.C. 247d-6d.
Dated: May 9, 2023.
Xavier Becerra,
Secretary, U.S. Department of Health and Human Services.
\1\ Third Amendment to Declaration Under the Public Readiness
and Emergency Preparedness Act for Medical Countermeasures Against
COVID-19, 85 FR 53126 (August 24, 2020); Tenth Amendment to
Declaration Under the Public Readiness and Emergency Preparedness
Act for Medical Countermeasures Against COVID-19, 87 FR 982 (April
14, 2022).
\2\ Gallagher, A. ``Study: 88.9% of US Population Lives Within 5
Miles of a Community Pharmacy,'' Pharmacy Times (August 4, 2022)
available at: <a href="https://www.pharmacytimes.com/view/study-88-9-of-us-population-lives-within-5-miles-of-a-community-pharmacy">https://www.pharmacytimes.com/view/study-88-9-of-us-population-lives-within-5-miles-of-a-community-pharmacy</a> (last
visited Apr. 21, 2023).
\3\ Department of Health and Human Services General Counsel
Advisory Opinion on the Public Readiness and Emergency Preparedness
Act, May 19, 2020, available at: <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/advisory-opinion-20-02-hhs-ogc-prep-act.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/advisory-opinion-20-02-hhs-ogc-prep-act.pdf</a>. (last visited April 14, 2023). See also, Department of
Justice Office of Legal Counsel Advisory Opinion for Robert P.
Charrow, General Counsel of the Department of Health and Human
Services, January 12, 2021, available at: <a href="https://www.justice.gov/sites/default/files/opinions/attachments/2021/01/19/2021-01-19-prep-act-preemption.pdf">https://www.justice.gov/sites/default/files/opinions/attachments/2021/01/19/2021-01-19-prep-act-preemption.pdf</a> (last visited April 14, 2023).
\4\ Section 4113, Consolidated Appropriations Act, 2023, Public
Law 117-328 (December 29, 2022).
\5\ See, e.g., Advisory Opinion on the Public Readiness and
Emergency Preparedness Act and the March 10, 2020 Declaration under
the Act, Apr. 17, 2020, as Modified on May 19, 2020, available at
<a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/prep-act-advisory-opinion-hhs-ogc.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/prep-act-advisory-opinion-hhs-ogc.pdf</a> (last visited Apr.
3, 2023); Advisory Opinion 20-02 on the Public Readiness and
Emergency Preparedness Act and the Secretary's Declaration under the
Act, May 19, 2020, available at <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/advisory-opinion-20-02-hhs-ogc-prep-act.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/advisory-opinion-20-02-hhs-ogc-prep-act.pdf</a> (last visited Apr. 3, 2023); Advisory Opinion 20-03 on
the Public Readiness and Emergency Preparedness Act and the
Secretary's Declaration under the Act, Oct. 22, 2020, as Modified on
Oct. 23, 2020, available at <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/AO3.1.2_Updated_FINAL_SIGNED_10.23.20.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/AO3.1.2_Updated_FINAL_SIGNED_10.23.20.pdf</a> (last visited Apr. 3,
2023); Advisory Opinion 20-04 on the Public Readiness and Emergency
Preparedness Act and the Secretary's Declaration under the Act, Oct.
22, 2020, as Modified on Oct. 23, 2020, available at <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/AO%204.2_Updated_FINAL_SIGNED_10.23.20.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/AO%204.2_Updated_FINAL_SIGNED_10.23.20.pdf</a> (last visited Apr. 3,
2023).
\6\ Guidance for Licensed Pharmacists, COVID-19 Testing, and
Immunity Under the PREP Act, OASH, Apr. 8, 2020, available at
<a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf</a> (last visited Apr. 3, 2023); Guidance for
Licensed Pharmacists and Pharmacy Interns Regarding COVID-19
Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020,
available at <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf</a> (last visited Apr. 3,
2023).
\7\ See, e.g., Guidance for Licensed Pharmacists, COVID-19
Testing, and Immunity Under the PREP Act, OASH, Apr. 8, 2020,
available at <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf</a> (last visited Apr. 3, 2023); Guidance
for PREP Act Coverage for COVID-19 Screening Tests at Nursing Homes,
Assisted-Living Facilities, Long-Term-Care Facilities, and other
Congregate Facilities, OASH, Aug. 31, 2020, available at <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/prep-act-coverage-for-screening-in-congregate-settings.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/prep-act-coverage-for-screening-in-congregate-settings.pdf</a> (last
visited Apr. 3, 2023); Guidance for Licensed Pharmacists and
Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the
PREP Act, OASH, Sept. 3, 2020, available at <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf</a> (last visited Apr. 3, 2023); Guidance for PREP Act
Coverage for Qualified Pharmacy Technicians and State-Authorized
Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and
COVID-19 Testing, OASH, Oct. 20, 2020, available at <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf</a> (last visited Apr. 3, 2023); PREP Act
Authorization for Pharmacies Distributing and Administering Certain
Covered Countermeasures, Oct. 29, 2020, available at <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-authorization-pharmacies-administering-covered-countermeasures.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-authorization-pharmacies-administering-covered-countermeasures.pdf</a> (last visited Apr. 3, 2023) (collectively, OASH
PREP Act Authorizations). Nothing herein shall suggest that, for
purposes of the Declaration, the foregoing are the only persons
authorized in accordance with the public health and medical
emergency response of the Authority Having Jurisdiction.
\8\ Some states do not require pharmacy interns to be licensed
or registered by the state board of pharmacy. As used herein,
``State-licensed or registered intern'' (or equivalent phrases)
refers to pharmacy interns authorized by the state or board of
pharmacy in the state in which the practical pharmacy internship
occurs. The authorization can, but need not, take the form of a
license from, or registration with, the State board of pharmacy.
Similarly, states vary on licensure and registration requirements
for pharmacy technicians. Some states require certain education,
training, and/or certification for licensure or registration; others
either have no prerequisites for licensure or registration or do not
require licensure or registration at all. As used herein, to be a
``qualified pharmacy technician,'' pharmacy technicians working in
states with licensure and/or registration requirements must be
licensed and/or registered in accordance with state requirements;
pharmacy technicians working in states without licensure and/or
registration requirements must have a CPhT certification from either
the Pharmacy Technician Certification Board or National Healthcareer
[[Page 30778]]
Association. See Guidance for PREP Act Coverage for Qualified
Pharmacy Technicians and State-Authorized Pharmacy Interns for
Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH,
Oct. 20, 2020 at 2, available at <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf</a> (last
visited Apr. 3, 2023).
\9\ Where the term CDC/ACIP recommendations, standard
immunization schedules, or similar language is used, this includes
both direct CDC recommendations as well as recommendations adopted
by the CDC Director after recommendation by ACIP, which are commonly
referred to as ACIP recommendations or schedules.
\10\ This requirement is satisfied by, among other things, a
certification in basic cardiopulmonary resuscitation by an online
program that has received accreditation from the American Nurses
Credentialing Center, the ACPE, or the Accreditation Council for
Continuing Medical Education. The phrase ``current certificate in
basic cardiopulmonary resuscitation,'' when used in the September 3,
2020 or October 20, 2020 OASH authorizations, shall be interpreted
the same way. See Guidance for Licensed Pharmacists and Pharmacy
Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act,
OASH, Sept. 3, 2020, available at <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf</a> (last
visited Apr. 3, 2023); Guidance for PREP Act Coverage for Qualified
Pharmacy Technicians and State-Authorized Pharmacy Interns for
Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH,
Oct. 20, 2020, available at <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf</a> (last
visited Apr. 3, 2023).
\11\ See, e.g., Advisory Opinion 20-02 on the Public Readiness
and Emergency Preparedness Act and the Secretary's Declaration under
the Act, May 19, 2020, available at <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/advisory-opinion-20-02-hhs-ogc-prep-act.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/advisory-opinion-20-02-hhs-ogc-prep-act.pdf</a> (last visited Apr. 3, 2023).
\12\ See COVID-19 Vaccine Training Modules, available at <a href="https://www.cdc.gov/vaccines/covid-19/training.html">https://www.cdc.gov/vaccines/covid-19/training.html</a>.
\13\ This requirement is satisfied by, among other things, a
certification in basic cardiopulmonary resuscitation by an online
program that has received accreditation from the American Nurses
Credentialing Center, the ACPE, or the Accreditation Council for
Continuing Medical Education. The phrase ``current certificate in
basic cardiopulmonary resuscitation,'' when used in the September 3,
2020 or October 20, 2020 OASH authorizations, shall be interpreted
the same way. See Guidance for Licensed Pharmacists and Pharmacy
Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act,
OASH, Sept. 3, 2020, available at <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf</a> (last
visited Apr. 3, 2023); Guidance for PREP Act Coverage for Qualified
Pharmacy Technicians and State-Authorized Pharmacy Interns for
Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH,
Oct. 20, 2020, available at <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf</a> (last
visited Apr. 3, 2023).
\14\ Some states do not require pharmacy interns to be licensed
or registered by the state board of pharmacy. As used herein,
``State-licensed or registered intern'' (or equivalent phrases)
refers to pharmacy interns authorized by the state or board of
pharmacy in the state in which the practical pharmacy internship
occurs. The authorization can, but need not, take the form of a
license from, or registration with, the State board of pharmacy.
Similarly, states vary on licensure and registration requirements
for pharmacy technicians. Some states require certain education,
training, and/or certification for licensure or registration; others
either have no prerequisites for licensure or registration or do not
require licensure or registration at all. As used herein, to be a
``qualified pharmacy technician,'' pharmacy technicians working in
states with licensure and/or registration requirements must be
licensed and/or registered in accordance with state requirements;
pharmacy technicians working in states without licensure and/or
registration requirements must have a CPhT certification from either
the Pharmacy Technician Certification Board or National Healthcareer
Association. See Guidance for PREP Act Coverage for Qualified
Pharmacy Technicians and State-Authorized Pharmacy Interns for
Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH,
Oct. 20, 2020 at 2, available at <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf</a> (last
visited Apr. 3, 2023).
\15\ This requirement is satisfied by, among other things, a
certification in basic cardiopulmonary resuscitation by an online
program that has received accreditation from the American Nurses
Credentialing Center, the ACPE, or the Accreditation Council for
Continuing Medical Education. The phrase ``current certificate in
basic cardiopulmonary resuscitation,'' when used in the September 3,
2020 or October 20, 2020 OASH authorizations, shall be interpreted
the same way. See Guidance for Licensed Pharmacists and Pharmacy
Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act,
OASH Guidance for Licensed Pharmacists and Pharmacy Interns
Regarding COVID-19 Vaccines and Immunity under the PREP Act, OASH,
Sept. 3, 2020, available at <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf</a> (last
visited Apr. 3, 2023); Guidance for PREP Act Coverage for Qualified
Pharmacy Technicians and State-Authorized Pharmacy Interns for
Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH,
Oct. 20, 2020, available at <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf</a> (last
visited Apr. 3, 2023).
\16\ For simplicity, this example assumes a patient only
requires one dose of the vaccine.
\17\ 42 U.S.C. 247d-6d(b)(7) provides that ``[n]o court of the
United States, or of any State, shall have subject matter
jurisdiction to review, whether by mandamus or otherwise, any action
by the Secretary under this subsection.''
\18\ See, Guidance for Licensed Pharmacists, COVID-19 Testing,
and Immunity Under the PREP Act, OASH, Apr. 8, 2020, available at
<a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf</a> (last visited Apr. 3, 2023).
\19\ Guidance for PREP Act Coverage for Qualified Pharmacy
Technicians and State-Authorized Pharmacy Interns for Childhood
Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20,
2020, available at <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf</a> (last visited Apr. 3,
2023).
\20\ PREP Act Authorization for Pharmacies Distributing and
Administering Certain Covered Countermeasures, OASH, Oct. 29, 2020,
available at <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-authorization-pharmacies-administering-covered-countermeasures.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-authorization-pharmacies-administering-covered-countermeasures.pdf</a> (last visited Apr. 14, 2023).
\21\ PREP Act Authorization for Pharmacies Distributing and
Administering Certain Covered Countermeasures, OASH, Oct. 29, 2020,
available at <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-authorization-pharmacies-administering-covered-countermeasures.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-authorization-pharmacies-administering-covered-countermeasures.pdf</a> (last visited Apr. 14, 2023).
\22\ Guidance for PREP Act Coverage for COVID-19 Screening Tests
at Nursing Homes, Assisted-Living Facilities, Long-Term-Care
Facilities, and other Congregate Facilities, OASH, August 31, 2023,
available at <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/prep-act-coverage-for-screening-in-congregate-settings.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/prep-act-coverage-for-screening-in-congregate-settings.pdf</a> (last visited April 14, 2023).
[FR Doc. 2023-10216 Filed 5-11-23; 8:45 am]
BILLING CODE 4150-37-P
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</html>Indexed from Federal Register on May 12, 2023.
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.