[Federal Register Volume 86, Number 147 (Wednesday, August 4, 2021)]
[Notices]
[Pages 41977-41982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16681]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Eighth 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 clarify and expand the authority
for certain Qualified Persons authorized to prescribe, dispense, and
administer covered countermeasures under section VI of this
Declaration.
DATES: This amendment is effective as of August 4, 2021.
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, [email protected].
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
Secretary renewed that declaration effective on April 26, 2020, July
25, 2020, October 23, 2020, January 21, 2021, April 21, 2021 and July
20, 2021.
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, 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, 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, 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, August 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; 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
[[Page 41978]]
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, December 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, February 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, February 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,
February 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 March 16, 2021).
Secretary Xavier Becerra now amends section V of the Declaration to
revise subsections (d) and (f) to clarify that qualified pharmacy
technicians are Qualified Persons covered by the Declaration, and to
expand the scope of authority for qualified pharmacy technicians to
administer seasonal influenza vaccines to adults within the state where
they are authorized to practice and for interns to administer seasonal
influenza vaccines to adults consistent with other terms and conditions
of the Declaration.
Accordingly, subsection V(d) authorizes:
(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\ (1) vaccines that
the Advisory Committee on Immunization Practices (ACIP) recommends to
persons ages three through 18 according to ACIP's standard immunization
schedule or (2) seasonal influenza vaccine administered by qualified
pharmacy technicians and interns that the ACIP recommends to persons
aged 19 and older according to 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:
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\1\ 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 Certified Pharmacy Technician
(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 https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf (last visited Jan. 24,
2021).
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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 ACIP's COVID-19 vaccine
recommendation(s);
iii. In the case of a childhood vaccine, the vaccination must be
ordered and administered according to 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 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; \2\
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\2\ 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 https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last
visited Jan. 24, 2021); 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 https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf (last
visited Jan. 24, 2021).
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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),
[[Page 41979]]
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).
Further, the initial phrase of subsection V(f) is revised to state
authorize ``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. . . .''
Description of This Amendment by Section
Section V. Covered Persons
Under the PREP Act and the Declaration, a ``qualified person'' is a
``covered person.'' Subject to certain limitations, a covered person is
immune from suit and liability under Federal and State law with respect
to all claims for loss caused by, arising out of, relating to, or
resulting from the administration or use of a covered countermeasure if
a declaration under the PREP Act has been issued with respect to such
countermeasure. ``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)
By this amendment to the Declaration, the Secretary clarifies and
expands the authorization for a category of persons who are qualified
persons under section 247d-6d(i)(8)(B). First, the amendment clarifies
that qualified pharmacy technicians are authorized to administer
Childhood vaccinations and COVID-19 vaccinations that are Covered
Countermeasures under section VI of this Declaration. The Department
has authorized qualified pharmacy technicians to administer these
vaccines under section V(a) of the Declaration through Guidance issued
by the Assistant Secretary for Health.\3\ This amendment adds qualified
pharmacy technicians to section V(d) of the Declaration, to clarify
that these healthcare professionals are authorized subject to the
conditions stated in that subsection. In addition, the amendment
expands the authorization for qualified pharmacy technicians and
interns to administer seasonal influenza vaccines under the supervision
of a pharmacist to persons aged 19 and older consistent with ACIP
recommendations. The Secretary anticipates that there will be a need
for the adult population to receive both COVID-19 and seasonal
influenza vaccines throughout the 2021-2022 influenza season. Health
risks may increase for individuals who contract seasonal influenza
concurrently with COVID-19, thus expanding the scope of authorized
vaccinators for seasonal influenza lessens the harm otherwise caused by
COVID-19.
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\3\ 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 https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf (last visited June 17,
2021).
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While influenza incidence was lower than anticipated last fall and
winter, the same cannot be assumed for the 2021-2022 flu season, as
states have largely lifted the community mitigation measures previously
in place at the height of the COVID-19 pandemic. Seasonal influenza has
the potential to inflict significant burden and strain on the U.S.
healthcare system in its own right; and in conjunction with the ongoing
COVID-19 pandemic, a spike in influenza cases could overwhelm
healthcare providers. Like the vaccination against COVID-19, the
vaccination against influenza requires many people to be vaccinated
within a short period of time, potentially creating a surge on the
system. Concern also remains regarding the emergence of SARS-CoV-2
variants and their potential to cause disease both among vaccinated and
unvaccinated populations. It is yet to be determined if COVID-19
vaccine boosters will be recommended; however, if boosters become
necessary, allowing pharmacy interns and technicians to administer both
COVID-19 vaccines and influenza vaccines would allow states maximum
flexibility in limiting potential impacts of both illnesses. ACIP also
recently voted unanimously in favor of COVID-19 and influenza vaccine
co-administration.4 5 Like COVID-19 vaccines, influenza
vaccines are administered as intramuscular (IM) injections, and would
require minimal, if any, additional training to administer, and would
not place any undue training burden on providers.
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\4\ https://www.medpagetoday.com/meetingcoverage/acip/93283.
\5\ https://www.aappublications.org/news/2021/06/24/acip-flu-rabies-dengue-062421.
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As qualified persons, these qualified pharmacy technicians and
interns will be afforded liability protections in accordance with the
PREP Act and the terms of this amended Declaration. Second, to the
extent that any State law that would otherwise prohibit these
healthcare professionals who are a ``qualified person'' from
prescribing, dispensing, or administering COVID-19 vaccines or other
Covered Countermeasures, such law is preempted. On May 19, 2020, the
Office of the General Counsel issued an advisory opinion concluding
that, because licensed pharmacists are ``qualified persons'' under this
declaration, the PREP Act preempts state law that would otherwise
prohibit such pharmacists from ordering and administering authorized
COVID-19 diagnostic tests.\6\ The opinion relied in part on the fact
that the Congressional delegation of authority to the Secretary under
the PREP Act to specify a class of persons, beyond those who are
authorized to administer a covered countermeasure under State law, as
``qualified persons'' would be rendered a nullity in the absence of
such preemption. This opinion is incorporated by reference into this
declaration. Based on the reasoning set forth in the May 19, 2020
advisory opinion, any State law that would otherwise prohibit a member
of any of the classes of ``qualified persons''
[[Page 41980]]
specified in this declaration from administering a covered
countermeasure is likewise preempted. In accordance with section 319F-
3(i)(8)(A) of the Public Health Service Act, a State remains free to
expand the universe of individuals authorized to administer covered
countermeasures within its jurisdiction under State law.
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\6\ Department of Health and Human Services General Counsel
Advisory Opinion on the Public Readiness and Emergency Preparedness
Act, May 19, 2020, available at: https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/prep-act-advisory-opinion-hhs-ogc.pdf/ (last visited Jan. 24, 2021). 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: https://www.justice.gov/sites/default/files/opinions/attachments/2021/01/19/2021-01-19-prep-act-preemption.pdf (last visited Jan. 24, 2021).
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The plain language of the PREP Act makes clear that there is
preemption of state law as described above. Furthermore, preemption of
State law is justified to respond to the nation-wide public health
emergency caused by COVID-19 as it will enable States to quickly expand
the vaccination workforce with additional qualified healthcare
professionals where State or local requirements might otherwise inhibit
or delay allowing these healthcare professionals to participate in the
COVID-19 countermeasure program.
Amendments to Declaration
Amended Declaration for Public Readiness and Emergency Preparedness
Act Coverage for medical countermeasures against COVID-19.
Section V of the March 10, 2020 Declaration under the PREP Act for
medical countermeasures against COVID-19, as amended April 10, 2020,
June 4, 2020, August 19, 2020, as amended and republished on December
3, 2020, and as amended on February 2, 2021, and as amended March 11,
2021, is further amended pursuant to section 319F-3(b)(4) of the PHS
Act as described below. All other sections of the Declaration remain in
effect as republished at 85 FR 79190 (December 9, 2020).
1. Covered Persons, section V, delete in full and replace with:
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 \7\ means a
provider medication order, which includes prescribing of vaccines,
or a laboratory order, which includes prescribing laboratory orders,
if required. In addition, I have determined that the following
additional persons are qualified persons:
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\7\ See Guidance for Licensed Pharmacists, COVID-19 Testing, and
Immunity Under the PREP Act, OASH, Apr. 8, 2020, available at
https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf (last visited Jan. 24, 2021); Guidance for
Licensed Pharmacists and Pharmacy Interns Regarding COVID-19
Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020,
available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24,
2021).
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(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; \8\
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\8\ See, e.g., Guidance for Licensed Pharmacists, COVID-19
Testing, and Immunity Under the PREP Act, OASH, Apr. 8, 2020,
available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf (last visited Jan. 24, 2021); 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 https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/prep-act-coverage-for-screening-in-congregate-settings.pdf (last
visited Jan. 24, 2021); Guidance for Licensed Pharmacists and
Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the
PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24, 2021); 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 https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf (last visited Jan. 24, 2021); PREP Act
Authorization for Pharmacies Distributing and Administering Certain
Covered Countermeasures, Oct. 29, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-authorization-pharmacies-administering-covered-countermeasures.pdf (last visited Jan. 24, 2021) (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.
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(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),\9\ (1) vaccines
that the Advisory Committee on Immunization Practices (ACIP)
recommends to persons ages three through 18 according to ACIP's
standard immunization schedule or (2) seasonal influenza vaccine
administered by qualified pharmacy technicians and interns that the
ACIP recommends to persons aged 19 and older according to 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:
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\9\ 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 Certified Pharmacy Technician
(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 https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf (last visited Jan. 24,
2021).
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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 ACIP's COVID-19 vaccine
recommendation(s);
iii. In the case of a childhood vaccine, the vaccination must be
ordered and administered according to 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 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
[[Page 41981]]
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\
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\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 https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last
visited Jan. 24, 2021); 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 https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf (last
visited Jan. 24, 2021).
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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;
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\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 https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/advisory-opinion-20-02-hhs-ogc-prep-act.pdf (last visited Jan. 24, 2021).
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(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: (i) 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;
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\12\ See COVID-19 Vaccine Training Modules, available at https://www.cdc.gov/vaccines/covid-19/training.html.
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(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; and
(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 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,
[[Page 41982]]
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
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\
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\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 https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last
visited Jan. 24, 2021); 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 https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf (last
visited Jan. 24, 2021).
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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).
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.
2. Effective Time Period, section XII, delete in full and replace
with:
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 October 1, 2024.
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 October 1, 2024.
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 ACIP recommends to persons ages three
through 18 according to 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)
October 1, 2024, whichever occurs first.
Liability protections for all Covered Countermeasures identified
in Section VII(c) of this Declaration begin on December 9, 2020 and
last through (a) the final day the Declaration of Emergency is in
effect. or (b) October 1, 2024. whichever occurs first.
Liability protections for Qualified Persons under section V(d)
of the Declaration who are qualified pharmacy technicians and
interns to administer seasonal influenza vaccine to persons aged 19
and older begin on August 4, 2021.
Liability protections for Qualified Persons under section V(f)
of the Declaration begin on February 2, 2021, and last through
October 1, 2024.
Liability protections for Qualified Persons under section V(g)
of the Declaration begin on February 16, 2021, and last through
October 1, 2024.
Liability protections for Qualified Persons who are physicians,
advanced practice registered nurses, registered nurses, or practical
nurses under section V(h) of the Declaration begins on February 2,
2021 and last through October 1, 2024, with additional conditions
effective as of March 11, 2021and liability protections for all
other Qualified persons under section V(h) begins on March 11, 2021
and last through October 1, 2024.
Authority: 42 U.S.C. 247d-6d.
Dated: July 30, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-16681 Filed 8-2-21; 11:15 am]
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