Preemption of State and Local Requirements Under a PREP Act Declaration

(Slip Opinion)

Preemption of State and Local Requirements

Under a PREP Act Declaration

The Public Readiness and Emergency Preparedness Act and the COVID -19 declaration

issued by the Secretary of Health and Human Services under that Act preempt state or

local requirements, such as state licensing laws, that would prohibit or effectively pro-

hibit qualifying state-licensed pharmacists from ordering and administering FDA-

approved COVID -19 tests and FDA-authorized or FDA-licensed COVID -19 vaccines.

January 19, 2021

MEMORANDUM OPINION FOR THE GENERAL COUNSEL

DEPARTMENT OF HEALTH AND HUMAN SERVICES

As the international pandemic coronavirus disease 2019 (“COVID -19”)

reached the United States early last year, the Secretary of Health and

Human Services (the “Secretary”) issued an emergency declaration trig-

gering the availability of emergency public health resources. 1 Shortly

thereafter, the President declared that “the COVID -19 outbreak in the

United States constitutes a national emergency.” Declaring a National

Emergency Concerning the Novel Coronavirus Disease (COVID -19)

Outbreak, Proclamation No. 9994, 85 Fed. Reg. 15,337 (Mar. 13, 2020).

That spring, the Food and Drug Administration (“FDA”) authorized the

use of numerous diagnostic tests for COVID -19, and health professionals

have administered millions of tests since. 2 In December 2020, FDA grant-

ed two emergency use authorizations for vaccines developed to treat the

disease. 3

1 See U.S. Department of Health and Human Services (“HHS”), Determination that a

Public Health Emergency Exists (Jan. 31, 2020), https://www.phe.gov/emergency/news/

healthactions/phe/Pages/2019-nCoV.aspx (relying on HHS authority under 42 U.S.C.

§ 247d).

2 See Johns Hopkins University & Medicine, Daily State-by-State Testing Trends,

https://coronavirus.jhu.edu/testing/individual-states (last visited Jan. 19, 2021); FDA, In

Vitro Diagnostics EUAs, https://www.fda.gov/medical-devices/coronavirus-disease-

2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas

(last visited Jan. 19, 2021) (displaying tables that list FDA emergency use authorizations

for COVID -19 diagnostic tests granted as early as March 2020).

3 See, e.g., FDA, FDA Takes Additional Action in Fight Against COVID -19 by Issuing

Emergency Use Authorization for Second COVID -19 Vaccine (Dec. 18, 2020), https://

1

45 Op. O.L.C. __ (Jan. 19, 2021)

On March 10, 2020, the Secretary invoked his authority under the Pub-

lic Readiness and Emergency Preparedness Act (the “PREP Act” or the

“Act”) to provide immunity to certain health care professionals tasked

with responding to the crisis. 42 U.S.C. §§ 247d-6d, 247d-6e. The Act

authorizes the Secretary, in response to what he determines to be a “public

health emergency,” to “make a declaration . . . recommending” the use of

certain “covered countermeasures.” Id. § 247d-6d(b)(1). That declaration

triggers immunity from suit or liability for “covered person[s],” such as

manufacturers and health care professionals, for “claims for loss” arising

from administration or use of the declaration’s recommended counter-

measures. Id. § 247d-6d(a)(1), (d)(1), (i)(2). 4 The PREP Act also

preempts “any provision of law or legal requirement that . . . is different

from, or is in conflict with, any requirement applicable under this section”

and that is “relate[d] to” those countermeasures. Id. § 247d-6d(b)(8).

The Secretary’s declaration, as amended, identifies properly trained and

certified state-licensed pharmacists who order or administer COVID -19

tests and vaccines authorized for emergency use as “covered persons.”

See Declaration Under the Public Readiness and Emergency Preparedness

Act for Medical Countermeasures Against COVID -19, § V, 85 Fed. Reg.

15,198, 15,201–02 (Mar. 17, 2020) (“March Declaration”); Fourth Am-

endment to the Declaration Under the Public Readiness and Emergency

Preparedness Act for Medical Countermeasures Against COVID -19 and

Republication of the Declaration, § V(a), (d)(2), 85 Fed. Reg. 79,190,

79,195–96 & n.20 (Dec. 9, 2020) (“Fourth Amendment to the Declara-

tion”). It designates FDA-approved COVID -19 tests and FDA-authorized

or FDA-licensed COVID -19 vaccines as “covered countermeasures.” See

March Declaration § VI, 85 Fed. Reg. at 15,202; Second Amendment to

Declaration Under the Public Readiness and Emergency Preparedness Act

for Medical Countermeasures Against COVID -19, § VI, 85 Fed. Reg.

35,100, 35,102 (June 8, 2020).

www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-

against-covid-19-issuing-emergency-use-authorization-second-covid.

4 The Act contains an exception to immunity, creating an exclusive federal cause of

action for willful misconduct that results in death or serious physical injury, 42 U.S.C.

§ 247d-6d(d)(1), and establishes an alternative federal compensation system for targeted

claims, id. § 247d-6e.

2

Preemption of State and Local Requirements Under a PREP Act Declaration

In May 2020, you asked for our advice about whether the PREP Act, in

conjunction with the Secretary’s declaration, preempts state and local

requirements that would prohibit or effectively prohibit state-licensed

pharmacists from ordering and administering COVID -19 tests that the

FDA has authorized. 5 We advised that the PREP Act preempts such laws

and regulations, and you subsequently issued an advisory opinion reach-

ing that conclusion. 6 You have now asked us to formalize our conclusion

in an opinion and, in addition, asked whether the same conclusion holds

for state-licensed pharmacists who administer COVID -19 vaccines. 7 Con-

sistent with our earlier advice, we conclude that the PREP Act preempts

state and local requirements that would prohibit or effectively prohibit

qualifying state-licensed pharmacists covered by a declaration from

ordering or administering COVID -19 tests or vaccines.

I.

Preemption is rooted in the Constitution’s Supremacy Clause, which

provides that federal statutes “shall be the supreme Law of the Land.”

U.S. Const. art. VI, cl. 2. The Clause acts as “a rule of decision,” estab-

lishing that federal law prevails over state law when the two conflict,

meaning that every preemption question is a question of statutory con-

struction. Murphy v. Nat’l Collegiate Athletic Ass’n, 138 S. Ct. 1461,

1479 (2018) (quotation marks omitted); Morales v. Trans World Airlines,

Inc., 504 U.S. 374, 383 (1992) (“The question, at bottom, is one of statu-

tory intent, and we accordingly begin with the language employed by

5 Although state-licensed pharmacists are generally “licensed health professionals”

who would be qualified persons under section 247d-6d(i)(8)(A), certain state laws or

regulations prohibit pharmacists from administering diagnostic tests or treatments such as

vaccinations in at least some circumstances. See, e.g., Fla. Stat. § 465.189 (2015) (restrict-

ing pharmacists to administration of vaccines to adults and to administration of specific

listed vaccines); N.C. Gen. Stat. § 90-85.15B(a) (2019) (generally restricting pharmacists

to administration of vaccines to adults pursuant to a specific prescription order).

6 See HHS, Advisory Opinion 20-02 on the Public Readiness and Emergency Prepar-

edness Act and the Secretary’s Declaration Under the Act (May 19, 2020), https://www.

hhs.gov/sites/default/files/advisory-opinion-20-02-hhs-ogc-prep-act.pdf.

7 See Letter for Steven A. Engel, Assistant Attorney General, Office of Legal Counsel,

from Robert P. Charrow, General Counsel, HHS (Dec. 1, 2020); E-mail for Jennifer

Mascott, Deputy Assistant Attorney General, Office of Legal Counsel, from Jonah Hecht,

Deputy General Counsel, HHS (Jan. 4, 2021, 4:47 PM).

3

45 Op. O.L.C. __ (Jan. 19, 2021)

Congress and the assumption that the ordinary meaning of that language

accurately expresses the legislative purpose.” (quotation marks omitted)).

The Court has recognized three categories of preemption—express,

conflict, and field preemption. See Kansas v. Garcia, 140 S. Ct. 791, 801

(2020); The Federalism Accountability Act, 23 Op. O.L.C. 172, 172–73

(1999). Express preemption—the category relevant here—occurs when a

federal statute explicitly states that it preempts certain state or local laws

or requirements and the particular state or local law or requirement falls

within those terms. See Morales, 504 U.S. at 383–90; see also Coventry

Health Care of Mo., Inc. v. Nevils, 137 S. Ct. 1190, 1196–98 (2017).

Where, as here, a statute “contains an express pre-emption clause,” we

“focus on the plain wording of the clause, which necessarily contains the

best evidence of Congress’[s] pre-emptive intent.” Puerto Rico v. Frank-

lin Cal. Tax-Free Trust, 136 S. Ct. 1938, 1946 (2016) (quotation marks

omitted). We conclude that the Act expressly preempts state and local

requirements to the extent that they would effectively prohibit qualifying

pharmacists from ordering and administering COVID -19 tests and vac-

cines authorized by the Secretary’s declaration.

II.

The PREP Act’s preemption provision states in full:

During the effective period of a declaration under subsection (b),

or at any time with respect to conduct undertaken in accordance with

such declaration, no State or political subdivision of a State may es-

tablish, enforce, or continue in effect with respect to a covered coun-

termeasure any provision of law or legal requirement that—

(A) is different from, or is in conflict with, any requirement ap-

plicable under this section; and

(B) relates to the design, development, clinical testing or inves-

tigation, formulation, manufacture, distribution, sale, donation,

purchase, marketing, promotion, packaging, labeling, licensing,

use, any other aspect of safety or efficacy, or the prescribing, dis-

pensing, or administration by qualified persons of the covered

countermeasure, or to any matter included in a requirement appli-

cable to the covered countermeasure under this section or any oth-

4

Preemption of State and Local Requirements Under a PREP Act Declaration

er provision of this chapter, or under the Federal Food, Drug, and

Cosmetic Act.

42 U.S.C. § 247d-6d(b)(8).

In determining whether this section preempts state and local require-

ments that would effectively prohibit qualifying state-licensed pharma-

cists from administering COVID -19 tests and vaccines, we must consider

whether such a state or local requirement “(A) is different from, or is in

conflict with, any requirement applicable under” section 247d-6d, and

whether the requirement “(B) relates to . . . administration by qualified

persons of the covered countermeasure.” Id. We conclude that those state

or local limits on state-licensed pharmacists “relate[] to” the administra-

tion of COVID -19 diagnostic tests and vaccines, and that the require-

ments would “differ[] from” and “conflict with” an authorization granted

to the pharmacists as “qualified persons” who may administer those

countermeasures. 8

We think the first conclusion is straightforward. State or local require-

ments that would effectively prohibit licensed pharmacists from ordering

and administering COVID -19 tests or vaccines “relate[] to” the “admin-

istration by qualified persons of [a] covered countermeasure[].” The

phrase “relates to” sweeps widely, covering anything that has “a connec-

tion with, or reference to” the particular topic. Nevils, 137 S. Ct. at 1197

(quotation marks omitted). Under the Act and the Secretary’s declaration,

state-licensed pharmacists are “qualified persons,” and FDA-approved

COVID -19 tests and vaccines are “covered countermeasures.” See March

Declaration § VI, 85 Fed. Reg. at 15,202; Fourth Amendment to the

Declaration § V(a), (d), 85 Fed. Reg. at 79,195–96 & n.20; see also 42

8 The analysis in this memorandum also applies to (1) pharmacist-supervised pharmacy

technicians, (2) pharmacist-supervised state-licensed or registered pharmacy interns, and

(3) National Guardsmen, whom the Secretary has identified as qualified persons to

administer COVID -19 tests or vaccines, subject to certain parameters. See Office of the

Assistant Secretary for Health (“OASH”), HHS, Guidance for PREP Act Coverage for

Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood

Vaccines, COVID -19 Vaccines, and COVID -19 Testing at 2–5 (Oct. 20, 2020), https://

www.hhs.gov/sites/default/files/prep-act-guidance.pdf; Fourth Amendment to the Decla-

ration § V(a), (d), 85 Fed. Reg. at 79,195–96 & nn.20–21; OASH, HHS, Guidance for

National Guard Personnel Regarding COVID -19 Vaccines and Immunity under the PREP

Act (Dec. 18, 2020), https://www.hhs.gov/about/news/2020/12/18/guidance-for-national-

guard-personnel-regarding-covid-19-vaccines-immunity-under-prep-act.html.

5

45 Op. O.L.C. __ (Jan. 19, 2021)

U.S.C. § 247d-6d(i)(1), (8)(B). State or local requirements that address

the ordering and administering of COVID -19 tests and vaccines unques-

tionably “relate[] to” administering COVID -19 tests and vaccines and

thus fall within the terms of this mandatory element for PREP Act

preemption. See Northwest, Inc. v. Ginsberg, 572 U.S. 273, 284 (2014)

(finding the term “relate[] to” in a federal express preemption clause to

reach all claims that have “a connection with, or reference to” the regulat-

ed object (quotation marks omitted)); see also Rutledge v. Pharm. Care

Mgmt. Ass’n, 141 S. Ct. 474, 479 (2020) (reaching the same conclusion

when interpreting the preemptive effect of the term “relate to” in the

Employee Retirement Income Security Act of 1974).

The second determination presents a more difficult question. Although

the Secretary’s declaration affirmatively authorizes action and provides

immunity for those actions to covered persons, it is less clear that the

conditions within the declaration would naturally be described as “re-

quirement[s] applicable under” section 247d-6d. See 42 U.S.C. § 247d-

6d(b)(8)(A) (emphasis added). Although Congress perhaps could have

chosen a better word than “requirement” in this context, we conclude that

the phrase does refer to the terms and conditions of the Secretary’s decla-

ration. The requirements “applicable under” this section include not only

obligations flowing directly from the PREP Act itself, such as immunity

from “claims for loss,” but also the terms and conditions contained within

the declarations issued by the Secretary under the Act that define the

metes and bounds of immunity and provide authorization to covered

persons to administer the required countermeasures. Although the immun-

ity itself would be unlikely to extend to actions to enforce state licensing

requirements—because the immunity applies only to “claims for loss”—

we think that state and local laws that prohibit or effectively prohibit

state-licensed pharmacists from ordering or administering the tests or

vaccines authorized by the PREP Act would be “in conflict with” and

“differ[] from” these “requirement[s] applicable under” section 247d-6d.

In using the word “requirement” in section 247d-6d(b)(8)(A), Congress

adopted language paralleling the express preemption instructions in other

statutes where the phrase would more naturally apply to the terms of the

federal action, which plainly impose obligations on regulated parties.

Compare, e.g., 7 U.S.C. § 136v(b) (“Such State shall not impose or con-

tinue in effect any requirements for labeling or packaging in addition to

6

Preemption of State and Local Requirements Under a PREP Act Declaration

or different from those required under this subchapter.”), with id. § 136a

(prohibiting the sale of unregistered pesticides); compare also 21 U.S.C.

§ 360k(a) (preempting certain state and local “requirement[s]” that are

“different from, or in addition to, any requirement applicable under this

chapter”), with id. §§ 351–352 (specifying circumstances under which

drugs and devices “shall be deemed to be” adulterated or misbranded).

Although the term “any requirement,” standing alone, may not be the

most natural way to describe the terms and conditions within the Secre-

tary’s declaration, the statutory context makes clear that those terms

reflect the “requirement[s] applicable under this [Act].” In interpreting

other statutory preemption provisions that reference “requirements,” the

Supreme Court has construed the term to mean “a rule of law that must be

obeyed.” Bates v. Dow Agrosciences LLC, 544 U.S. 431, 444–45 (2005)

(using the term “rule of law” to describe “requirements” that include state

common-law duties); see also Webster’s Third New International Dic-

tionary 1929 (2002) (defining “requirement” as, among other things,

“something called for or demanded”). The declaration will not ordinarily

impose an affirmative obligation on covered persons, but it is necessary

that those persons meet those terms and conditions to rely upon the im-

munity. We think that the terms and conditions of the declaration there-

fore establish “requirement[s]” by setting forth the terms and conditions

under which PREP Act immunity shields the actions of state-licensed

pharmacists in administering covered countermeasures, which must be

followed by anyone seeking to raise the immunity as a defense to liability

in a civil action.

The Act authorizes the Secretary to issue a declaration that “re-

commend[s]” the use of countermeasures and “stat[es]” that the PREP

Act’s immunity “is in effect” for those measures. 42 U.S.C. § 247d-

6d(b)(1). The “covered person[s]” include “qualified person[s] who

prescribe[], administer[], or dispense[]” those countermeasures. Id.

§§ 247d-6d(a)(1), 247d-6d(i)(2). The statutory category of “qualified

person” in turn consists of two key groups: “licensed health profess-

ional[s]” or other individuals authorized to administer countermeasures

under state law, or “person[s] within a category of persons so identified

in a declaration by the Secretary under subsection (b).” Id. § 247d-

6d(i)(8)(A)–(B). By including two categories of “qualified person[s]”—

both those professionals who are licensed or otherwise “authorized to”

7

45 Op. O.L.C. __ (Jan. 19, 2021)

dispense countermeasures under state law, and those whom the Secretary

identifies as “qualified”—the PREP Act specifically contemplates that a

declaration may authorize non-licensed persons to administer counter-

measures free from liability. The Secretary may identify someone as a

“qualified person” for purposes of “the administration or use of a covered

countermeasure” even if that person is not already authorized by state law

to perform those tasks.

Here, the Secretary’s declaration identifies as “qualified persons,”

among others, licensed pharmacists who order and administer FDA-

approved, FDA-authorized, or FDA-licensed COVID -19 tests and vac-

cines. See Fourth Amendment to the Declaration § V(a), (d), 85 Fed. Reg.

at 79,195–96 & n.20. Consequently, the Secretary’s declaration extends

PREP Act immunity to individuals licensed as pharmacists whether or not

they have authority under relevant state law to administer such tests and

vaccines. And although the PREP Act describes the Secretary’s declara-

tion as just “recommending” the administration or use of countermeas-

ures, the operative effect of that declaration makes clear that its terms and

conditions have a direct legal effect on those who do so. 42 U.S.C.

§ 247d-6d(b)(1) (emphasis added) (authorizing a declaration to state

that immunity protections are “in effect” for the activities covered by the

declaration).

We think that state or local requirements, such as licensing laws, that

prohibit or effectively prohibit qualifying pharmacists from ordering or

administering COVID -19 tests or vaccines therefore would conflict with,

or at least be different from, the terms and conditions of the Secretary’s

authorizing designation. See Fidelity Fed. Sav. & Loan Ass’n v. de la

Cuesta, 458 U.S. 141, 154–56 (1982) (applying the conflict preemption

doctrine to find that federal regulation permitting due-on-sale clauses in

certain instances preempted a state law forbidding such clauses). The

Secretary’s designation of certain state-licensed pharmacists as “qualified

persons” to order and administer COVID -19 tests and vaccines—thereby

facilitating such action free from liability from claims for loss—is at the

very least a requirement that is different from a state law that would stop

the pharmacists from so acting. See Bates, 544 U.S. at 447 (concluding

that state requirements that are not “equivalent to, and fully consistent

with” federal requirements “differ[]” from them for express preemption

purposes under the relevant statute).

8

Preemption of State and Local Requirements Under a PREP Act Declaration

Other language of the PREP Act supports this conclusion. The pre-

emption provision applies “with respect to conduct undertaken in ac-

cordance with” the Secretary’s declaration, suggesting that certain

behavior is consistent with the declaration and that the States may not

“establish, enforce, or continue in effect” requirements inconsistent with

it. 42 U.S.C. § 247d-6d(b)(8) (emphasis added). Further, in issuing a

PREP Act declaration, the Secretary must “consider the desirability of

encouraging the . . . administration, licensing, and use of such counter-

measure[s]”—expressly indicating that a declaration is to encourage the

covered behavior. Id. § 247d-6d(b)(6). A state-law requirement that, in

contrast, discourages such action by imposing prohibitive licensing re-

quirements, or sanctions, or liability for enforcement actions is “different

from” or in “conflict with” the declaration’s textually indicated intended

impact. Id. § 247d-6d(b)(8).

The statutory context further confirms this interpretation. Elsewhere in

the statute, Congress evidently knew how to refer to a requirement im-

posed by the statute, such as immunity, rather than the terms and condi-

tions of the Secretary’s declaration, when it so desired. In section 247d-

6d(d)(1), it listed willful misconduct claims as “the sole exception to the

immunity from suit and liability of covered persons set forth in subsection

(a).” Id. § 247d-6d(d)(1). Had Congress wanted to similarly tie the pre-

emption provision solely to requirements explicitly stated in the statute,

such as the provision of immunity, it could have preempted only state or

local requirements that differ from or conflict with “the immunity from

suit and liability of covered persons set forth in subsection (a).” The

provision instead broadly preempts all state or local legal requirements

that differ from the requirements applicable under section 247d-6d as a

whole. See Henson v. Santander Consumer USA Inc., 137 S. Ct. 1718,

1723 (2017) (noting that typically, “differences in language . . . convey

differences in meaning”). The difference here suggests that the section’s

“requirement[s]” are broader than the immunity granted in subsection (a).

Cf. Wis. Cent. Ltd. v. United States, 138 S. Ct. 2067, 2071–72 (2018)

(finding that a reference to the more specific phrase “money remunera-

tion” in one statute conveyed a distinct meaning from the reference to “all

remuneration” in another).

This result is also consistent with the structure of the statutory scheme,

because the opposite conclusion would effectively nullify the Secretary’s

9

45 Op. O.L.C. __ (Jan. 19, 2021)

authority to designate qualified persons other than those already author-

ized under state law to administer diagnostic tests and vaccines. See

Garcia, 140 S. Ct. at 803 (endorsing, in an express preemption analysis,

one view of a statute in part because “strange consequences would ensue”

under the alternative view). The Act plainly allows the Secretary to grant

immunity from suit and liability to people administering countermeasures

who are not already authorized under state law. We think that it would be

incongruous for Congress to grant the Secretary the authority to immunize

those persons from suit in connection with a public health emergency,

while nonetheless permitting the States, through licensing requirements,

to take the very action that the Secretary’s declaration identified as neces-

sary to respond to a public health emergency. Cf. County of Maui v. Haw.

Wildlife Fund, 140 S. Ct. 1462, 1473 (2020) (interpreting a statute to

avoid a reading that would allow a key piece of the law to be easily cir-

cumvented by others in part because it was implausible that “Congress . . .

intended to create such a large and obvious loophole”); McQuiggin v.

Perkins, 569 U.S. 383, 393–94 (2013) (noting that it would be “passing

strange” to read the Antiterrorism and Effective Death Penalty Act of

1996 to require “stricter enforcement of federal procedural rules than

procedural rules established and enforced by the States” given the stat-

ute’s aim “to promote federalism and comity”). Pharmacists, who would

be immune under the Secretary’s declaration, could hardly order and

administer COVID -19 tests or vaccines if the States could impose penal-

ties for the same activity by revoking their licenses. Such state or local

requirements would threaten to make the Secretary’s authorizing identifi-

cation a practical nullity.

We therefore conclude that the Secretary’s decision to identify licensed

pharmacists as “qualified persons” allowed to order and administer FDA-

approved COVID -19 tests and FDA-authorized or FDA-licensed vaccines

constitutes a requirement with preemptive effect under the terms of sec-

tion 247d-6d.

III.

We have considered two potential objections to this conclusion. Neither

overcomes the meaning evident from the preemption provision’s text and

the structure and context of the Act.

10

Preemption of State and Local Requirements Under a PREP Act Declaration

A.

First, it might be argued that the Secretary’s declaration does not itself

establish a “requirement,” because the declaration elements are not “re-

quirement[s]” listed in the statute itself. And the Act specifically de-

scribes a Secretary’s declaration as “recommending” measures—in con-

trast to requiring them. Compare 42 U.S.C. § 247d-6d(b)(1), with id.

§ 247d-6d(a)(1) (“a covered person shall be immune from suit and

liability” (emphasis added)); see also id. § 247d-6d(b)(1) (describing the

“activities so recommended” in a declaration); id. § 247d-6d(b)(2)(A)

(specifying how the Secretary is to specify the categories of threats to

health for which he “recommends the administration or use of [a] coun-

termeasure” (emphasis added)).

But the statutory phrase here, “requirement[s] applicable under this sec-

tion,” is not limited to rules established by statutes. Cf. Riegel v. Medtron-

ic, Inc., 552 U.S. 312, 319, 322–23 (2008) (finding that the “require-

ments” included in an express preemption provision included pre-market

approval for drugs authorized by federal regulation); Bates, 544 U.S. at

443 (concluding that “requirements” reaches “to embrace common-law

duties”); Medtronic, Inc. v. Lohr, 518 U.S. 470, 497–98 (1996) (recogniz-

ing that federal labeling regulations are federal “requirement[s]” under the

terms of an express preemption provision); Cipollone v. Liggett Group,

Inc., 505 U.S. 504, 521 (1992) (“The phrase ‘[n]o requirement or prohibi-

tion’ sweeps broadly and suggests no distinction between positive enact-

ments and common law[.]”). Moreover, the Secretary’s declaration was

naturally promulgated “under” the PREP Act, as the Act authorized its

issuance. See, e.g., Nat’l Ass’n of Mfrs. v. Dep’t of Def., 138 S. Ct. 617,

630 (2018) (interpreting “limitation under” to mean “pursuant to” or “by

reason of the authority of” (quotation marks omitted)); In re Hechinger

Inv. Co. of Del., 335 F.3d 243, 252 (3d Cir. 2003) (Alito, J.) (“When an

action is said to be taken ‘under’ a provision of law . . . , what is generally

meant is that the action is ‘authorized’ by the provision of law[.]”). The

terms within the Secretary’s declaration also plainly have a direct legal

effect on regulated parties. See, e.g., 42 U.S.C. § 247d-6d(b)(8) (relating

the time period “[d]uring” which the Act’s preemptive effect is operative

to the “effective period of a declaration”).

11

45 Op. O.L.C. __ (Jan. 19, 2021)

Moreover, the text of the Act describes a PREP Act declaration as con-

taining both “directions” or certain derivative “requirements”; they are not

just “recommend[ations].” For example, section 247d-6d(c)(4) establishes

a defense for “qualified person[s]” who have “acted consistent with appli-

cable directions, guidelines, or recommendations” by the Secretary related

to authorized countermeasures. And the statute defines “program plan-

ner[s]” eligible for immunity to include persons “who ha[ve] established

requirements . . . in accordance with a declaration.” Id. § 247d-6d(i)(6).

The statutory scheme thus supports the conclusion that the remaining

terms and conditions of the declaration themselves have mandatory opera-

tive effect for purpose of the PREP Act’s preemption provision.

That inference is reinforced by the description of those state laws that

the PREP Act preempts, which the statute specifies to include “any provi-

sion of law or legal requirement.” 9 Id. § 247d-6d(b)(8) (emphasis added).

The fact that Congress here distinguished a “provision of law” from a

“legal requirement” suggests that Congress intended the latter term to

include even action by a state that falls short of itself having the force of

law independent from its authorization in a statute. The term “require-

ment” that appears in the very next clause, section 247d-6d(b)(8)(A)—and

without the narrowing qualifier legal “requirement”—presumptively

should be afforded at least the same reach. See Powerex Corp. v. Reliant

Energy Servs., Inc., 551 U.S. 224, 232 (2007) (“A standard principle of

statutory construction provides that identical words and phrases within the

same statute should normally be given the same meaning.”). And that

identity, in turn, suggests that the term includes administrative or other

non-statutory mandates that establish terms and conditions even beyond

those set forth in the PREP Act itself, like the Secretary’s declaration.

B.

Second, one might argue that our reading of the statute gives the Secre-

tary authority to preempt an unduly great extent of state and local laws in

9 The only judicial decision of which we are aware to squarely address PREP Act

preemption of a state tort-law claim also notes that the Act’s broad preemption provision

applies to state common-law claims as well as regulations. See Parker v. St. Lawrence

County Pub. Health Dep’t, 102 A.D.3d 140, 143–44 (N.Y. App. Div. 2012) (applying the

Act’s “sweeping” immunity protection to a common-law tort claim challenging the

administration of a vaccine without parental consent).

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Preemption of State and Local Requirements Under a PREP Act Declaration

response to a public health emergency. But our interpretation must be

guided by the breadth of the statute itself. Little Sisters of the Poor Saints

Peter & Paul Home v. Pennsylvania, 140 S. Ct. 2367, 2380 (2020)

(giving force to broad statutory language while noting that “Congress

could have limited . . . discretion in any number of ways” in the Act “but

it chose not to do so”). And it is routine, and in keeping with numerous

provisions in the federal code, for Congress to confer broad statutory

authority to respond to emergencies. See, e.g., Defense Production Act of

1950, 50 U.S.C. § 4501 et seq.; Robert T. Stafford Disaster Relief and

Emergency Assistance Act, 42 U.S.C. §§ 5121–5207; Memorandum for

the Attorney General from Karl R. Thompson, Principal Deputy Assistant

Attorney General, Office of Legal Counsel, Re: Summary of Legal Au-

thorities for Use in Response to an Outbreak of Ebola in the United States

at 1 (Oct. 16, 2014) (noting the “substantial authorities” that the Execu-

tive Branch has to respond to the outbreak of disease in the United

States).

In any event, the scope of declarations with preemptive effect under

the Act must be tailored to the scope of critical needs during a public

health emergency. The PREP Act requires that the Secretary first make a

threshold determination that a “public health emergency” exists, and that

he then specify the time period, covered populations, and geographic

areas within which the declaration will apply, consider the desirability of

countermeasures, and submit a report to congressional committees ex-

plaining his determinations within 30 days. See 42 U.S.C. § 247d-

6d(b)(1), (2), (6), (9). The Secretary’s declaration thus must satisfy these

requirements in order to provide for the covered immunity and to preempt

conflicting state and local requirements. See id. § 247d-6d(b)(1) (authoriz-

ing a Secretary to make declarations “[s]ubject to” the requirement that

the Secretary identify the relevant health threats or diseases and the popu-

lation, geographic regions, and time periods for which the declaration is in

effect). The preemptive effect of a PREP Act declaration must thus be

directly tailored to the public health emergency that it seeks to address,

and it is consistent with the congressional power to equip the Executive

Branch to respond to national emergencies. Cf. Regan v. Wald, 468 U.S.

222, 227–28 (1984) (discussing additional federal statutes authorizing the

use of emergency authority, only subject to certain conditions); Dames &

Moore v. Regan, 453 U.S. 654, 662–63 & n.1, 672 (1981) (describing

13

45 Op. O.L.C. __ (Jan. 19, 2021)

congressional authorization of increased executive authority to respond to

national security, foreign policy, and economic threats during a national

emergency). In view of the magnitude of the COVID -19 pandemic here,

we think it evident under the statute that the Secretary had the authority to

act quickly to expand the number of covered persons who may administer

necessary countermeasures to deal with that crisis, and Congress specified

that state or local health officials lack authority to take measures that

would conflict with such an action.

IV.

For these reasons, we conclude that the PREP Act and the Secretary’s

declaration preempt state or local requirements, such as state licensing

laws, that would prohibit or effectively prohibit qualifying state-licensed

pharmacists from ordering and administering FDA-approved COVID -19

tests and FDA-authorized or FDA-licensed COVID -19 vaccines.

JENNIFER L. MASCOTT

Deputy Assistant Attorney General

Office of Legal Counsel

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