Notice2021-19790
Ninth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 14, 2021
Effective
September 14, 2021
Issuing agencies
Health and Human Services Department
Abstract
The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to 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.
Full Text
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<title>Federal Register, Volume 86 Issue 175 (Tuesday, September 14, 2021)</title>
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[Federal Register Volume 86, Number 175 (Tuesday, September 14, 2021)]
[Notices]
[Pages 51160-51166]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-19790]
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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.
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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:
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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 <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf</a> (last visited Jan. 24,
2021).
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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\
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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 <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf</a> (last
visited 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 <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf</a> (last
visited Jan. 24, 2021).
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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.
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\3\ Department of Health and Human Services General Counsel
Advisory Opinion on the Public Readiness and Emergency Preparedness
Act, May 19, 2020, available at: <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/prep-act-advisory-opinion-hhs-ogc.pdf/">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/prep-act-advisory-opinion-hhs-ogc.pdf/</a> (last visited 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: <a href="https://www.justice.gov/sites/default/files/opinions/attachments/2021/01/19/2021-01-19-prep-act-preemption.pdf">https://www.justice.gov/sites/default/files/opinions/attachments/2021/01/19/2021-01-19-prep-act-preemption.pdf</a> (last visited 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, 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:
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\4\ See Guidance for Licensed Pharmacists, COVID-19 Testing, and
Immunity Under the PREP Act, OASH, Apr. 8, 2020, available at
<a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf</a> (last visited 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 <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf</a> (last visited 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; \5\
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\5\ See, e.g., Guidance for Licensed Pharmacists, COVID-19
Testing, and Immunity Under the PREP Act, OASH, Apr. 8, 2020,
available at <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf</a> (last visited 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 <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/prep-act-coverage-for-screening-in-congregate-settings.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/prep-act-coverage-for-screening-in-congregate-settings.pdf</a> (last
visited 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 <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf</a> (last visited 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 <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf</a> (last visited Jan. 24, 2021); PREP Act
Authorization for Pharmacies Distributing and Administering Certain
Covered Countermeasures, Oct. 29, 2020, available at <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-authorization-pharmacies-administering-covered-countermeasures.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-authorization-pharmacies-administering-covered-countermeasures.pdf</a> (last visited 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),\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:
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\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 <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf</a> (last
visited 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
[[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\
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\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 <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf</a> (last
visited 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 <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf</a> (last
visited 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.\8\ Nothing in this
Declaration shall preempt state laws that permit additional persons to
deliver telehealth services;
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\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 <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/advisory-opinion-20-02-hhs-ogc-prep-act.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/advisory-opinion-20-02-hhs-ogc-prep-act.pdf</a> (last visited 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
\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;
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\9\ See COVID-19 Vaccine Training Modules, available at <a href="https://www.cdc.gov/vaccines/covid-19/training.html">https://www.cdc.gov/vaccines/covid-19/training.html</a>.
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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,
[[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\
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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 <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf</a> (last
visited 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 <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf</a> (last
visited 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:
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\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 <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf</a> (last
visited Jan. 24, 2021).
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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 <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf</a> (last
visited 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 <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf</a> (last
visited Jan. 24, 2021).
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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
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.