[Federal Register Volume 86, Number 175 (Tuesday, September 14, 2021)]
[Notices]
[Pages 51160-51166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19790]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Ninth Amendment to Declaration Under the Public Readiness and 
Emergency Preparedness Act for Medical Countermeasures Against COVID-19

ACTION: Notice of amendment.

-----------------------------------------------------------------------

SUMMARY: The Secretary issues this amendment pursuant to section 319F-3 
of the Public Health Service Act to expand the authority for certain 
Qualified Persons authorized to prescribe, dispense, and administer 
COVID-19 therapeutics that are covered countermeasures under section VI 
of this Declaration.

DATE:  This amendment is effective as of September 14, 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, <a href="/cdn-cgi/l/email-protection#1c6c7d757b79327966796e727d7f775c74746f327b736a"><span class="__cf_email__" data-cfemail="ea9a8b838d8fc48f908f98848b8981aa828299c48d859c">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: The Public Readiness and Emergency 
Preparedness Act (PREP Act) authorizes

[[Page 51161]]

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, 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; 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, Secretary Xavier Becerra 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).
    Secretary Xavier Becerra now amends section V of the Declaration to 
add subsection (i) to expand the scope of authority for licensed 
pharmacists to order and administer and qualified pharmacy technicians 
and pharmacy interns to administer COVID-19 therapeutics 
subcutaneously, intramuscularly, or orally as authorized, approved, or 
licensed by the U.S. Food and Drug Administration (FDA).
    Accordingly, subsection V(i) authorizes:
    (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) \1\ 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:
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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;

[[Page 51162]]

    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 Accreditation Council for Pharmacy Education (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; \2\
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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;
    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.

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 licensed pharmacists are authorized to order and administer and 
licensed or registered pharmacy interns and qualified pharmacy 
technicians are authorized to administer COVID-19 therapeutics that are 
Covered Countermeasures under section VI of this Declaration. The 
Secretary anticipates that there will be a need to increase the 
available pool of providers able to order and administer COVID-19 
therapeutics to address rising COVID-19 cases, to expand patient access 
to these critical therapies, and to keep as many patients out of the 
hospital as possible. Rising COVID-19 cases, largely attributable to 
the Delta variant, is a public health threat caused by COVID-19, 
placing additional strains on our healthcare system. Pharmacists, 
pharmacy technicians, and pharmacy interns are well positioned to 
increase access to therapeutics and have played a critical role in this 
pandemic in overseeing COVID-19 testing and vaccine administration. 
Given their skill set and training, as well as looming provider 
shortages, pharmacists, pharmacy technicians, and pharmacy interns will 
quickly expand access to COVID-19 therapeutics.
    COVID-19 therapeutics may be administered as intramuscular 
injections, subcutaneous injections, or orally and would require 
minimal, if any, additional training to administer beyond training 
pharmacists, pharmacy technicians, and pharmacy interns have already 
received for vaccine administration, and would not place any undue 
training burden on providers.
    As qualified persons, these licensed pharmacists, 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 
therapeutics 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.\3\ 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'' 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

[[Page 51163]]

covered countermeasures within its jurisdiction under State law.
---------------------------------------------------------------------------

    \3\ 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).
---------------------------------------------------------------------------

    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, treatment and prevention workforces 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, as amended on February 2, 2021, as amended March 11, 2021, and 
as amended on August 4, 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 (Dec. 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 \4\ 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:
---------------------------------------------------------------------------

    \4\ 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).
---------------------------------------------------------------------------

    (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; \5\
---------------------------------------------------------------------------

    \5\ 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.
---------------------------------------------------------------------------

    (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),\6\ (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:
---------------------------------------------------------------------------

    \6\ Some states do not require pharmacy interns to be licensed 
or registered by the state board of pharmacy. As used herein, 
``State-licensed or registered intern'' (or equivalent phrases) 
refers to pharmacy interns authorized by the state or board of 
pharmacy in the state in which the practical pharmacy internship 
occurs. The authorization can, but need not, take the form of a 
license from, or registration with, the State board of pharmacy. 
Similarly, states vary on licensure and registration requirements 
for pharmacy technicians. Some states require certain education, 
training, and/or certification for licensure or registration; others 
either have no prerequisites for licensure or registration or do not 
require licensure or registration at all. As used herein, to be a 
``qualified pharmacy technician,'' pharmacy technicians working in 
states with licensure and/or registration requirements must be 
licensed and/or registered in accordance with state requirements; 
pharmacy technicians working in states without licensure and/or 
registration requirements must have a CPhT certification from either 
the Pharmacy Technician Certification Board or National Healthcareer 
Association. See Guidance for PREP Act Coverage for Qualified 
Pharmacy Technicians and State-Authorized Pharmacy Interns for 
Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, 
Oct. 20, 2020 at 2, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf (last 
visited Jan. 24, 2021).
---------------------------------------------------------------------------

    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

[[Page 51164]]

training that the licensing State requires for pharmacists to order and 
administer vaccines. If the State does not specify training 
requirements for the licensed pharmacist to order and administer 
vaccines, the licensed pharmacist must complete a vaccination training 
program of at least 20 hours that is approved by the ACPE to order and 
administer vaccines. Such a training program must include hands on 
injection technique, 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; \7\
---------------------------------------------------------------------------

    \7\ 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).
---------------------------------------------------------------------------

    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.\8\ Nothing in this 
Declaration shall preempt state laws that permit additional persons to 
deliver telehealth services;
---------------------------------------------------------------------------

    \8\ 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).
---------------------------------------------------------------------------

    (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 
\9\ 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;
---------------------------------------------------------------------------

    \9\ See COVID-19 Vaccine Training Modules, available at https://www.cdc.gov/vaccines/covid-19/training.html.
---------------------------------------------------------------------------

    (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,

[[Page 51165]]

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, 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; \10\
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    vi. The healthcare professionals and students must comply with 
recordkeeping and reporting requirements of the jurisdiction in which 
he or she administers vaccines, including informing the patient's 
primary-care provider when available, submitting the required 
immunization information to the State or local immunization information 
system (vaccine registry), complying with requirements with respect to 
reporting adverse events, and complying with requirements whereby the 
person administering a vaccine must review the vaccine registry or 
other vaccination records prior to administering a vaccine; and
    vii. The healthcare professionals and students comply with any 
applicable requirements (or conditions of use) as set forth in the 
Centers for Disease Control and Prevention (CDC) COVID-19 vaccination 
provider agreement and any other federal requirements that apply to the 
administration of COVID-19 vaccine(s).
    (i) A State-licensed pharmacist who orders and administers, and 
pharmacy interns and qualified pharmacy technicians who administer (if 
the pharmacy intern or technician acts under the supervision of such 
pharmacist and the pharmacy intern or technician is licensed or 
registered by his or her State board of pharmacy) \11\ 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

[[Page 51166]]

qualified persons only if the following requirements are met:
---------------------------------------------------------------------------

    \11\ Some states do not require pharmacy interns to be licensed 
or registered by the state board of pharmacy. As used herein, 
``State-licensed or registered intern'' (or equivalent phrases) 
refers to pharmacy interns authorized by the state or board of 
pharmacy in the state in which the practical pharmacy internship 
occurs. The authorization can, but need not, take the form of a 
license from, or registration with, the State board of pharmacy. 
Similarly, states vary on licensure and registration requirements 
for pharmacy technicians. Some states require certain education, 
training, and/or certification for licensure or registration; others 
either have no prerequisites for licensure or registration or do not 
require licensure or registration at all. As used herein, to be a 
``qualified pharmacy technician,'' pharmacy technicians working in 
states with licensure and/or registration requirements must be 
licensed and/or registered in accordance with state requirements; 
pharmacy technicians working in states without licensure and/or 
registration requirements must have a CPhT certification from either 
the Pharmacy Technician Certification Board or National Healthcareer 
Association. See Guidance for PREP Act Coverage for Qualified 
Pharmacy Technicians and State-Authorized Pharmacy Interns for 
Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, 
Oct. 20, 2020 at 2, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf (last 
visited Jan. 24, 2021).
---------------------------------------------------------------------------

    ix. The COVID-19 therapeutic must be authorized, approved, or 
licensed by the FDA;
    x. 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;
    xi. 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;
    xii. In the case of qualified pharmacy technicians, the supervising 
pharmacist must be readily and immediately available to the qualified 
pharmacy technician;
    xiii. 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;
    xiv. The licensed pharmacist, licensed or registered pharmacy 
intern and qualified pharmacy technician must have a current 
certificate in basic cardiopulmonary resuscitation; \12\
---------------------------------------------------------------------------

    \12\ This requirement is satisfied by, among other things, a 
certification in basic cardiopulmonary resuscitation by an online 
program that has received accreditation from the American Nurses 
Credentialing Center, the ACPE, or the Accreditation Council for 
Continuing Medical Education. The phrase ``current certificate in 
basic cardiopulmonary resuscitation,'' when used in the September 3, 
2020 or October 20, 2020 OASH authorizations, shall be interpreted 
the same way. See Guidance for Licensed Pharmacists and Pharmacy 
Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act, 
OASH Guidance for Licensed Pharmacists and Pharmacy Interns 
Regarding COVID-19 Vaccines and Immunity under the PREP Act, OASH, 
Sept. 3, 2020, available at 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).
---------------------------------------------------------------------------

    xv. 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;
    xvi. 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.
    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 
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.
    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 begin on September 9, 2021.
    Authority: 42 U.S.C. 247d-6d.

    Dated: September 9, 2021.
Xavier Becerra,
Secretary, U.S. Department of Health and Human Services.
[FR Doc. 2021-19790 Filed 9-9-21; 4:15 pm]
BILLING CODE 4150-28-P


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>