SUMMARY: The Secretary issues this amendment pursuant to section 319F–3 of the Public Health Service Act to extend the duration of the Declaration to December 31, 2029, and to republish the Declaration in full. DATES: This amendment is effective as of January 1, 2025.FOR FURTHER INFORMATION CONTACT: L. Paige Ezernack, Administration for Strategic Preparedness and Response, U.S. Department of Health and Human Services, 400 7th StSW, Washington, DC 20024; 202-260-0365, paige.ezernack@hhs .gov.
SUPPLEMENTARY INFORMATION: The Public Readiness and Emergency Preparedness(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, section.
- 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
This document is scheduled to be published in the Federal Register on 12/11/2024 and available online at https://federalregister.gov/d/2024-29108, and on https://govinfo.gov
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
(PHE) 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 PHE declared under section 319 of the PHS Act
ended 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; 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).
On May 9, 2023, I amended the Declaration to update the determination of a PHE to state that
COVID-19 continues to present a credible risk of a future PHE after the end of the PHE declared
pursuant to section 319 of the PHS Act; to add a new limitation on distribution to provide
coverage under the 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 U.S. 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; 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, and regardless of
any Federal, regional, state, or local emergency 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; 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; 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 (88 FR 30769, May 12, 2023).
I am now amending section XII of the Declaration to extend the time period of PREP Act
coverage through December 31, 2029. COVID-19 continues to present a credible risk of a future
public health emergency. COVID-19 continues to cause significant serious illness, morbidity,
and mortality during outbreaks. The risk of domestic cases is high due to ongoing outbreaks that
continue domestically and internationally in the year since the PHE for COVID-19 ended.
Development of and stockpiling vaccines, therapeutics, devices, and diagnostics for COVID-19
continues to be needed for U.S. preparedness against the credible threat of a public health
emergency due to outbreaks of COVID-19. Continued coverage under the PREP Act, as
provided in this Declaration, is intended to prepare for and mitigate the credible risk presented by
COVID-19. This includes extending the time period for PREP Act coverage for licensed
pharmacists, pharmacy interns, and qualified technicians, which 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,
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. 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 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.
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). I incorporate those Advisory
Opinions as part of this Declaration. 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
have also determined that use of any respiratory protective device approved by the National
Institute for Occupational Safety and Health (NIOSH) under 42 CFR part 84, or any successor
regulations, was 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, and that
ended on May 11, 2023.
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 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;
(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), (1) vaccines that the Centers for Disease Control and
Prevention (CDC)/Advisory Committee on Immunization Practices (ACIP) recommend 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 Accreditation Council for Pharmacy Education (ACPE) to order and administer vaccines.
Such a 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;
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;
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 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. 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 COVID-19 (CDC)
Vaccine Training Modules 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:- 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; - 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 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; - 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
CDC 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;
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 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) 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;
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 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 licensed COVID-19 vaccines 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
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 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.
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, 2029.
(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, 2029.
(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, 2029, whichever occurs first.
(d) Liability protections for all Covered Countermeasures identified in section VII(c)(i) of this
Declaration begin on December 9, 2020, and last through the final day the Declaration of
Emergency is in effect or December 31, 2029, whichever occurs first. Liability protections for
all Covered Countermeasures identified in section VII(c)(ii) of this Declaration last for the time
period stated in section (a) of this section XII if applicable, or otherwise December 31, 2024.
(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, 2029, 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, 2029, 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 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, 2029, 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, 2029, 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, 2029, 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, 2029.
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, 2029, 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, to administer COVID-19 tests who are licensed
pharmacists begin April 8, 2020, and last until December 31, 2029, 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, 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, 2029, 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, 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, 2029, 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, 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 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, 2029, 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. 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 Strategic National Stockpile (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, including NIOSH Approved® respirators that
have been rescinded or are beyond their manufacturers’ declared shelf life.
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 U.S. Department
of Health and Human Services. Information about the CICP is available at the toll-free number
1–855–266–2427 or http://www.hrsa.gov/cicp/.
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: December 6, 2024
Xavier Becerra,
Secretary, U.S. Department of Health and Human Services.
BILLING CODE 4150-37
[FR Doc. 2024-29108 Filed: 12/10/2024 8:45 am; Publication Date: 12/11/2024]