---
kind: "section"
citation: "42 U.S.C. § 247d–6d"
title: "42"
title_heading: "The Public Health and Welfare"
number: "247d–6d"
heading: "Targeted liability protections for pandemic and epidemic products and security countermeasures"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/42/247d-6d"
units:
  - "Chapter 6A — Public Health Service"
  - "Subchapter II — General Powers and Duties"
  - "Part B — Federal-State Cooperation"
---

# §247d–6d. Targeted liability protections for pandemic and epidemic products and security countermeasures

- (a) **Liability protections—**
  - (1) **In general—** Subject to the other provisions of this section, a covered person shall be immune from suit and liability under Federal and [State](/usc/42/201.md?p=f) law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure if a declaration under [subsection (b)](#b) has been issued with respect to such countermeasure.
  - (2) **Scope of claims for loss—**
    - (A) **Loss—** For purposes of this section, the term “loss” means any type of loss, including—
      - (i) death;
      - (ii) physical, mental, or emotional injury, illness, disability, or condition;
      - (iii) fear of physical, mental, or emotional injury, illness, disability, or condition, including any need for medical monitoring; and
      - (iv) loss of or damage to property, including business interruption loss.

      Each of clauses [(i)](#a-2-A-i) through [(iv)](#a-2-A-iv) applies without regard to the date of the occurrence, presentation, or discovery of the loss described in the clause.

    - (B) **Scope—** The immunity under [paragraph (1)](#a-1) applies to any claim for loss that has a causal relationship with the administration to or use by an individual of a covered countermeasure, including a causal relationship with the design, development, clinical testing or investigation, [manufacture](/usc/42/300aa–33.md?p=3), labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, or use of such countermeasure.
  - (3) **Certain conditions—** Subject to the other provisions of this section, immunity under [paragraph (1)](#a-1) with respect to a covered countermeasure applies only if—
    - (A) the countermeasure was administered or used during the effective period of the declaration that was issued under [subsection (b)](#b) with respect to the countermeasure;
    - (B) the countermeasure was administered or used for the category or categories of diseases, health conditions, or threats to health specified in the declaration; and
    - (C) in addition, in the case of a covered person who is a [program](/usc/42/274l–1.md?p=4) planner or qualified person with respect to the administration or use of the countermeasure, the countermeasure was administered to or used by an individual who—
      - (i) was in a population specified by the declaration; and
      - (ii) was at the time of administration physically present in a geographic area specified by the declaration or had a connection to such area specified in the declaration.
  - (4) **Applicability of certain conditions—** With respect to immunity under [paragraph (1)](#a-1) and subject to the other provisions of this section:
    - (A) In the case of a covered person who is a [manufacturer](/usc/42/300aa–33.md?p=3) or distributor of the covered countermeasure involved, the immunity applies without regard to whether such countermeasure was administered to or used by an individual in accordance with the conditions described in [paragraph (3)(C)](#a-3-C).
    - (B) In the case of a covered person who is a [program](/usc/42/274l–1.md?p=4) planner or qualified person with respect to the administration or use of the covered countermeasure, the scope of immunity includes circumstances in which the countermeasure was administered to or used by an individual in circumstances in which the covered person reasonably could have believed that the countermeasure was administered or used in accordance with the conditions described in [paragraph (3)(C)](#a-3-C).
  - (5) **Effect of distribution method—** The provisions of this section apply to a covered countermeasure regardless of whether such countermeasure is obtained by donation, commercial sale, or any other means of distribution, except to the extent that, under [paragraph (2)(E)](#b-2-E) of subsection (b), the declaration under such subsection provides that [subsection (a)](#a) applies only to covered countermeasures obtained through a particular means of distribution.
  - (6) **Rebuttable presumption—** For purposes of [paragraph (1)](#a-1), there shall be a rebuttable presumption that any administration or use, during the effective period of the emergency declaration by the [Secretary](/usc/42/201.md?p=c) under [subsection (b)](#b), of a covered countermeasure shall have been for the category or categories of diseases, health conditions, or threats to health with respect to which such declaration was issued.
- (b) **Declaration by Secretary—**
  - (1) **Authority to issue declaration—** Subject to [paragraph (2)](#b-2), if the [Secretary](/usc/42/201.md?p=c) makes a determination that a disease or other health condition or other threat to health constitutes a public health emergency, or that there is a credible risk that the disease, condition, or threat may in the future constitute such an emergency, the [Secretary](/usc/42/201.md?p=c) may make a declaration, through publication in the Federal Register, recommending, under conditions as the [Secretary](/usc/42/201.md?p=c) may specify, the [manufacture](/usc/42/300aa–33.md?p=3), testing, development, distribution, administration, or use of one or more covered countermeasures, and stating that [subsection (a)](#a) is in effect with respect to the activities so recommended.
  - (2) **Contents—** In issuing a declaration under [paragraph (1)](#b-1), the [Secretary](/usc/42/201.md?p=c) shall identify, for each covered countermeasure specified in the declaration—
    - (A) the category or categories of diseases, health conditions, or threats to health for which the [Secretary](/usc/42/201.md?p=c) recommends the administration or use of the countermeasure;
    - (B) the period or periods during which, including as modified by [paragraph (3)](#b-3), [subsection (a)](#a) is in effect, which period or periods may be designated by dates, or by milestones or other description of events, including factors specified in [paragraph (6)](#b-6);
    - (C) the population or populations of individuals for which [subsection (a)](#a) is in effect with respect to the administration or use of the countermeasure (which may be a specification that such subsection applies without geographic limitation to all individuals);
    - (D) the geographic area or areas for which [subsection (a)](#a) is in effect with respect to the administration or use of the countermeasure (which may be a specification that such subsection applies without geographic limitation), including, with respect to individuals in the populations identified under [subparagraph (C)](#b-2-C), a specification, as determined appropriate by the [Secretary](/usc/42/201.md?p=c), of whether the declaration applies only to individuals physically present in such areas or whether in addition the declaration applies to individuals who have a connection to such areas, which connection is described in the declaration; and
    - (E) whether [subsection (a)](#a) is effective only to a particular means of distribution as provided in [subsection (a)(5)](#a-5) for obtaining the countermeasure, and if so, the particular means to which such subsection is effective.
  - (3) **Effective period of declaration—**
    - (A) **Flexibility of period—** The [Secretary](/usc/42/201.md?p=c) may, in describing periods under [paragraph (2)(B)](#b-2-B), have different periods for different covered persons to address different logistical, practical or other differences in responsibilities.
    - (B) **Additional time to be specified—** In each declaration under [paragraph (1)](#b-1), the [Secretary](/usc/42/201.md?p=c), after consulting, to the extent the [Secretary](/usc/42/201.md?p=c) deems appropriate, with the [manufacturer](/usc/42/300aa–33.md?p=3) of the covered countermeasure, shall also specify a date that is after the ending date specified under [paragraph (2)(B)](#b-2-B) and that allows what the [Secretary](/usc/42/201.md?p=c) determines is—
      - (i) a reasonable period for the [manufacturer](/usc/42/300aa–33.md?p=3) to arrange for disposition of the covered countermeasure, including the return of such product to the [manufacturer](/usc/42/300aa–33.md?p=3); and
      - (ii) a reasonable period for covered persons to take such other actions as may be appropriate to limit administration or use of the covered countermeasure.
    - (C) **Additional period for certain strategic national stockpile countermeasures—** With respect to a covered countermeasure that is in the stockpile under [section 247d–6b of this title](/usc/42/247d–6b.md), if such countermeasure was the subject of a declaration under [paragraph (1)](#b-1) at the time that it was obtained for the stockpile, the effective period of such declaration shall include a period when the countermeasure is administered or used pursuant to a distribution or release from the stockpile.
  - (4) **Amendments to declaration—** The [Secretary](/usc/42/201.md?p=c) may through publication in the Federal Register amend any portion of a declaration under [paragraph (1)](#b-1). Such an amendment shall not retroactively limit the applicability of [subsection (a)](#a) with respect to the administration or use of the covered countermeasure involved.
  - (5) **Certain disclosures—** In publishing a declaration under [paragraph (1)](#b-1) in the Federal Register, the [Secretary](/usc/42/201.md?p=c) is not required to disclose any matter described in [section 552(b) of title 5](/usc/5/552.md?p=b).
  - (6) **Factors to be considered—** In deciding whether and under what circumstances or conditions to issue a declaration under [paragraph (1)](#b-1) with respect to a covered countermeasure, the [Secretary](/usc/42/201.md?p=c) shall consider the desirability of encouraging the design, development, clinical testing or investigation, [manufacture](/usc/42/300aa–33.md?p=3), labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of such countermeasure.
  - (7) **Judicial review—** No court of the United States, or of any [State](/usc/42/201.md?p=f), shall have subject matter jurisdiction to review, whether by mandamus or otherwise, any action by the [Secretary](/usc/42/201.md?p=c) under this subsection.
  - (8) **Preemption of State law—** During the effective period of a declaration under [subsection (b)](#b), or at any time with respect to conduct undertaken in accordance with such declaration, no [State](/usc/42/201.md?p=f) or political subdivision of a [State](/usc/42/201.md?p=f) may establish, enforce, or continue in effect with respect to a covered countermeasure any provision of law or legal requirement that—
    - (A) is different from, or is in conflict with, any requirement applicable under this section; and
    - (B) relates to the design, development, clinical testing or investigation, formulation, [manufacture](/usc/42/300aa–33.md?p=3), distribution, sale, donation, purchase, marketing, promotion, packaging, labeling, licensing, use, any other aspect of safety or efficacy, or the prescribing, dispensing, or administration by qualified persons of the covered countermeasure, or to any matter included in a requirement applicable to the covered countermeasure under this section or any other provision of this chapter, or under the Federal Food, [Drug](/usc/42/11851.md?p=4), and Cosmetic Act [[21 U.S.C. 301](/usc/21/301.md) et seq.].
  - (9) **Report to Congress—** Within 30 days after making a declaration under [paragraph (1)](#b-1), the [Secretary](/usc/42/201.md?p=c) shall submit to the appropriate committees of the Congress a report that provides an explanation of the reasons for issuing the declaration and the reasons underlying the determinations of the [Secretary](/usc/42/201.md?p=c) with respect to [paragraph (2)](#b-2). Within 30 days after making an amendment under [paragraph (4)](#b-4), the [Secretary](/usc/42/201.md?p=c) shall submit to such committees a report that provides the reasons underlying the determination of the [Secretary](/usc/42/201.md?p=c) to make the amendment.
- (c) **Definition of willful misconduct—**
  - (1) **Definition—**
    - (A) **In general—** Except as the meaning of such term is further restricted pursuant to [paragraph (2)](#c-2), the term “willful misconduct” shall, for purposes of [subsection (d)](#d), denote an act or omission that is taken—
      - (i) intentionally to achieve a wrongful purpose;
      - (ii) knowingly without legal or factual justification; and
      - (iii) in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit.
    - (B) **Rule of construction—** The criterion stated in [subparagraph (A)](#c-1-A) shall be construed as establishing a standard for liability that is more stringent than a standard of negligence in any form or recklessness.
  - (2) **Authority to promulgate regulatory definition—**
    - (A) **In general—** The [Secretary](/usc/42/201.md?p=c), in consultation with the Attorney General, shall promulgate [regulations](/usc/42/201.md?p=d), which may be promulgated through interim final rules, that further restrict the scope of actions or omissions by a covered person that may qualify as “willful misconduct” for purposes of [subsection (d)](#d).
    - (B) **Factors to be considered—** In promulgating the [regulations](/usc/42/201.md?p=d) under this paragraph, the [Secretary](/usc/42/201.md?p=c), in consultation with the Attorney General, shall consider the need to define the scope of permissible civil actions under [subsection (d)](#d) in a way that will not adversely affect the public health.
    - (C) **Temporal scope of regulations—** The [regulations](/usc/42/201.md?p=d) under this paragraph may specify the temporal effect that they shall be given for purposes of [subsection (d)](#d).
    - (D) **Initial rulemaking—** Within 180 days after December 30, 2005, the [Secretary](/usc/42/201.md?p=c), in consultation with the Attorney General, shall commence and complete an initial rulemaking process under this paragraph.
  - (3) **Proof of willful misconduct—** In an action under [subsection (d)](#d), the plaintiff shall have the burden of proving by clear and convincing evidence willful misconduct by each covered person sued and that such willful misconduct caused death or serious physical injury.
  - (4) **Defense for acts or omissions taken pursuant to Secretary’s declaration—** Notwithstanding any other provision of law, a [program](/usc/42/274l–1.md?p=4) planner or qualified person shall not have engaged in “willful misconduct” as a matter of law where such [program](/usc/42/274l–1.md?p=4) planner or qualified person acted consistent with applicable directions, guidelines, or recommendations by the [Secretary](/usc/42/201.md?p=c) regarding the administration or use of a covered countermeasure that is specified in the declaration under [subsection (b)](#b), provided either the [Secretary](/usc/42/201.md?p=c), or a [State](/usc/42/201.md?p=f) or local health authority, was provided with notice of information regarding serious physical injury or death from the administration or use of a covered countermeasure that is material to the plaintiff’s alleged loss within 7 days of the actual discovery of such information by such [program](/usc/42/274l–1.md?p=4) planner or qualified person.
  - (5) **Exclusion for regulated activity of manufacturer or distributor—**
    - (A) **In general—** If an act or omission by a [manufacturer](/usc/42/300aa–33.md?p=3) or distributor with respect to a covered countermeasure, which act or omission is alleged under [subsection (e)(3)(A)](#e-3-A) to constitute willful misconduct, is subject to regulation by this chapter or by the Federal Food, [Drug](/usc/42/11851.md?p=4), and Cosmetic Act [[21 U.S.C. 301](/usc/21/301.md) et seq.], such act or omission shall not constitute “willful misconduct” for purposes of [subsection (d)](#d) if—
      - (i) neither the [Secretary](/usc/42/201.md?p=c) nor the Attorney General has initiated an enforcement action with respect to such act or omission; or
      - (ii) such an enforcement action has been initiated and the action has been terminated or finally resolved without a covered remedy.

      Any action or proceeding under [subsection (d)](#d) shall be stayed during the pendency of such an enforcement action.

    - (B) **Definitions—** For purposes of this paragraph, the following terms have the following meanings:
      - (i) **Enforcement action—** The term “enforcement action” means a criminal prosecution, an action seeking an injunction, a seizure action, a civil monetary proceeding based on willful misconduct, a mandatory recall of a product because voluntary recall was refused, a proceeding to compel [repair](/usc/42/300j–21.md?p=4) or [replacement](/usc/42/300j–21.md?p=5) of a product, a termination of an exemption under section [505(i)](/usc/42/505.md) or 520(g) of the Federal Food, [Drug](/usc/42/11851.md?p=4), and Cosmetic Act [[21 U.S.C. 355(i)](/usc/21/355.md?p=i), 360j(g)], a debarment proceeding, an investigator disqualification proceeding where an investigator is an [employee](/usc/42/300gg–91.md?p=d-5) or agent of the [manufacturer](/usc/42/300aa–33.md?p=3), a revocation, based on willful misconduct, of an authorization under section 564 of such Act [[21 U.S.C. 360bbb–3](/usc/21/360bbb–3.md)], or a suspension or withdrawal, based on willful misconduct, of an approval or clearance under chapter V of such Act [[21 U.S.C. 351](/usc/21/351.md) et seq.] or of a licensure under [section 262 of this title](/usc/42/262.md).
      - (ii) **Covered remedy—** The term “covered remedy” means an outcome—
        - (I) that is a criminal conviction, an injunction, or a condemnation, a civil monetary payment, a product recall, a [repair](/usc/42/300j–21.md?p=4) or [replacement](/usc/42/300j–21.md?p=5) of a product, a termination of an exemption under section [505(i)](/usc/42/505.md) or 520(g) of the Federal Food, [Drug](/usc/42/11851.md?p=4), and Cosmetic Act [[21 U.S.C. 355(i)](/usc/21/355.md?p=i), 360j(g)], a debarment, an investigator disqualification, a revocation of an authorization under section 564 of such Act [[21 U.S.C. 360bbb–3](/usc/21/360bbb–3.md)], or a suspension or withdrawal of an approval or clearance under [chapter 5](/usc/42/chch5.md)[^1] of such Act or of a licensure under [section 262 of this title](/usc/42/262.md); and
        - (II) that results from a final determination by a court or from a final [agency](/usc/42/8262.md?p=1) action.
      - (iii) **Final—** The terms “final” and “finally”—
        - (I) with respect to a court determination, or to a final resolution of an enforcement action that is a court determination, mean a judgment from which an appeal of right cannot be taken or a voluntary or stipulated dismissal; and
        - (II) with respect to an [agency](/usc/42/8262.md?p=1) action, or to a final resolution of an enforcement action that is an [agency](/usc/42/8262.md?p=1) action, mean an order that is not subject to further review within the [agency](/usc/42/8262.md?p=1) and that has not been reversed, vacated, enjoined, or otherwise nullified by a final court determination or a voluntary or stipulated dismissal.
    - (C) **Rules of construction—**
      - (i) **In general—** Nothing in this paragraph shall be construed—
        - (I) to affect the interpretation of any provision of the Federal Food, [Drug](/usc/42/11851.md?p=4), and Cosmetic Act [[21 U.S.C. 301](/usc/21/301.md) et seq.], of this chapter, or of any other applicable statute or regulation; or
        - (II) to impair, delay, alter, or affect the authority, including the enforcement discretion, of the United States, of the [Secretary](/usc/42/201.md?p=c), of the Attorney General, or of any other official with respect to any administrative or court proceeding under this chapter, under the Federal Food, [Drug](/usc/42/11851.md?p=4), and Cosmetic Act [[21 U.S.C. 301](/usc/21/301.md) et seq.], under [title 18](/usc/18.md), or under any other applicable statute or regulation.
      - (ii) **Mandatory recalls—** A mandatory recall called for in the declaration is not a Food and [Drug](/usc/42/11851.md?p=4) Administration enforcement action.
- (d) **Exception to immunity of covered persons—**
  - (1) **In general—** Subject to [subsection (f)](#f), the sole exception to the immunity from suit and liability of covered persons set forth in [subsection (a)](#a) shall be for an exclusive Federal cause of action against a covered person for death or serious physical injury proximately caused by willful misconduct, as defined pursuant to [subsection (c)](#c), by such covered person. For purposes of [section 2679(b)(2)(B) of title 28](/usc/28/2679.md?p=b-2-B), such a cause of action is not an action brought for [violation](/usc/42/2000e–16a.md?p=c) of a statute of the United States under which an action against an individual is otherwise authorized.
  - (2) **Persons who can sue—** An action under this subsection may be brought for wrongful death or serious physical injury by any person who suffers such injury or by any representative of such a person.
- (e) **Procedures for suit—**
  - (1) **Exclusive Federal jurisdiction—** Any action under [subsection (d)](#d) shall be filed and maintained only in the United States District Court for the District of Columbia.
  - (2) **Governing law—** The substantive law for decision in an action under [subsection (d)](#d) shall be derived from the law, including choice of law principles, of the [State](/usc/42/201.md?p=f) in which the alleged willful misconduct occurred, unless such law is inconsistent with or preempted by Federal law, including provisions of this section.
  - (3) **Pleading with particularity—** In an action under [subsection (d)](#d), the complaint shall plead with particularity each element of the plaintiff’s claim, including—
    - (A) each act or omission, by each covered person sued, that is alleged to constitute willful misconduct relating to the covered countermeasure administered to or used by the person on whose behalf the complaint was filed;
    - (B) facts supporting the allegation that such alleged willful misconduct proximately caused the injury claimed; and
    - (C) facts supporting the allegation that the person on whose behalf the complaint was filed suffered death or serious physical injury.
  - (4) **Verification, certification, and medical records—**
    - (A) **In general—** In an action under [subsection (d)](#d), the plaintiff shall verify the complaint in the manner stated in [subparagraph (B)](#e-4-B) and shall file with the complaint the materials described in [subparagraph (C)](#e-4-C). A complaint that does not substantially comply with subparagraphs [(B)](#e-4-B) and [(C)](#e-4-C) shall not be accepted for filing and shall not stop the running of the statute of limitations.
    - (B) **Verification requirement—**
      - (i) **In general—** The complaint shall include a verification, made by affidavit of the plaintiff under oath, stating that the pleading is true to the knowledge of the deponent, except as to matters specifically identified as being alleged on information and belief, and that as to those matters the plaintiff believes it to be true.
      - (ii) **Identification of matters alleged upon information and belief—** Any matter that is not specifically identified as being alleged upon the information and belief of the plaintiff, shall be regarded for all purposes, including a criminal prosecution, as having been made upon the knowledge of the plaintiff.
    - (C) **Materials required—** In an action under [subsection (d)](#d), the plaintiff shall file with the complaint—
      - (i) an affidavit, by a physician who did not treat the person on whose behalf the complaint was filed, certifying, and explaining the basis for such physician’s belief, that such person suffered the serious physical injury or death alleged in the complaint and that such injury or death was proximately caused by the administration or use of a covered countermeasure; and
      - (ii) certified medical records documenting such injury or death and such proximate causal connection.
  - (5) **Three-judge court—** Any action under [subsection (d)](#d) shall be assigned initially to a panel of three judges. Such panel shall have jurisdiction over such action for purposes of considering motions to dismiss, motions for summary judgment, and matters related thereto. If such panel has denied such motions, or if the time for filing such motions has expired, such panel shall refer the action to the chief judge for assignment for further proceedings, including any trial. [Section 1253 of title 28](/usc/28/1253.md) and [paragraph (3)](#b-3) of subsection (b) of [section 2284 of title 28](/usc/28/2284.md) shall not apply to actions under [subsection (d)](#d).
  - (6) **Civil discovery—**
    - (A) **Timing—** In an action under [subsection (d)](#d), no discovery shall be allowed—
      - (i) before each covered person sued has had a reasonable opportunity to file a motion to dismiss;
      - (ii) in the event such a motion is filed, before the court has ruled on such motion; and
      - (iii) in the event a covered person files an interlocutory appeal from the denial of such a motion, before the court of appeals has ruled on such appeal.
    - (B) **Standard—** Notwithstanding any other provision of law, the court in an action under [subsection (d)](#d) shall permit discovery only with respect to matters directly related to material issues contested in such action, and the court shall compel a response to a discovery request (including a request for admission, an interrogatory, a request for production of documents, or any other form of discovery request) under Rule 37, Federal Rules of Civil Procedure, only if the court finds that the requesting party needs the information sought to prove or defend as to a material issue contested in such action and that the likely benefits of a response to such request equal or exceed the burden or cost for the responding party of providing such response.
  - (7) **Reduction in award of damages for collateral source benefits—**
    - (A) **In general—** In an action under [subsection (d)](#d), the amount of an award of damages that would otherwise be made to a plaintiff shall be reduced by the amount of collateral source benefits to such plaintiff.
    - (B) **Provider of collateral source benefits not to have lien or subrogation—** No [provider](/usc/42/299b–21.md?p=8) of collateral source benefits shall recover any amount against the plaintiff or receive any lien or credit against the plaintiff’s recovery or be equitably or legally subrogated to the right of the plaintiff in an action under [subsection (d)](#d).
    - (C) **Collateral source benefit defined—** For purposes of this paragraph, the term “collateral source benefit” means any amount paid or to be paid in the future to or on behalf of the plaintiff, or any [service](/usc/42/201.md?p=a), product, or other benefit provided or to be provided in the future to or on behalf of the plaintiff, as a result of the injury or wrongful death, pursuant to—
      - (i) any [State](/usc/42/201.md?p=f) or Federal health, sickness, income-disability, accident, or workers’ compensation law;
      - (ii) any health, sickness, income-disability, or accident insurance that provides health benefits or income-disability coverage;
      - (iii) any contract or agreement of any group, organization, partnership, or [corporation](/usc/42/2297h.md?p=2) to provide, pay for, or reimburse the cost of medical, [hospital](/usc/42/300s–3.md?p=1), dental, or income disability benefits; or
      - (iv) any other publicly or privately funded [program](/usc/42/274l–1.md?p=4).
  - (8) **Noneconomic damages—** In an action under [subsection (d)](#d), any noneconomic damages may be awarded only in an amount directly proportional to the percentage of responsibility of a defendant for the harm to the plaintiff. For purposes of this paragraph, the term “noneconomic damages” means damages for losses for physical and emotional pain, suffering, inconvenience, physical impairment, mental anguish, disfigurement, loss of enjoyment of life, loss of society and companionship, loss of [consortium](/usc/42/17061.md?p=4), hedonic damages, injury to reputation, and any other nonpecuniary losses.
  - (9) **Rule 11 sanctions—** Whenever a district court of the United States determines that there has been a [violation](/usc/42/2000e–16a.md?p=c) of Rule 11 of the Federal Rules of Civil Procedure in an action under [subsection (d)](#d), the court shall impose upon the attorney, law firm, or parties that have violated Rule 11 or are responsible for the [violation](/usc/42/2000e–16a.md?p=c), an appropriate sanction, which may include an order to pay the other party or parties for the reasonable expenses incurred as a direct result of the filing of the pleading, motion, or other paper that is the subject of the [violation](/usc/42/2000e–16a.md?p=c), including a reasonable attorney’s fee. Such sanction shall be sufficient to deter repetition of such conduct or comparable conduct by others similarly situated, and to compensate the party or parties injured by such conduct.
  - (10) **Interlocutory appeal—** The United States Court of Appeals for the District of Columbia Circuit shall have jurisdiction of an interlocutory appeal by a covered person taken within 30 days of an order denying a motion to dismiss or a motion for summary judgment based on an assertion of the immunity from suit conferred by [subsection (a)](#a) or based on an assertion of the exclusion under [subsection (c)(5)](#c-5).
- (f) **Actions by and against the United States—** Nothing in this section shall be construed to abrogate or limit any right, remedy, or authority that the United States or any [agency](/usc/42/8262.md?p=1) thereof may possess under any other provision of law or to waive sovereign immunity or to abrogate or limit any defense or protection available to the United States or its [agencies](/usc/42/8262.md?p=1), instrumentalities, officers, or [employees](/usc/42/300gg–91.md?p=d-5) under any other law, including any provision of [chapter 171](/usc/28/chptVI/ch171.md) of title 28 (relating to tort claims procedure).
- (g) **Severability—** If any provision of this section, or the application of such provision to any person or circumstance, is held to be unconstitutional, the remainder of this section and the application of such remainder to any person or circumstance shall not be affected thereby.
- (h) **Rule of construction concerning National Vaccine Injury Compensation Program—** Nothing in this section, or any amendment made by the Public Readiness and Emergency Preparedness Act, shall be construed to affect the National Vaccine Injury Compensation [Program](/usc/42/274l–1.md?p=4) under subchapter XIX of this chapter.
- (i) **Definitions—** In this section:
  - (1) **Covered countermeasure—** The term “covered countermeasure” means—
    - (A) a qualified pandemic or epidemic product (as defined in [paragraph (7)](#i-7));
    - (B) a security countermeasure (as defined in [section 247d–6b(c)(1)(B) of this title](/usc/42/247d–6b.md?p=c-1-B));
    - (C) a [drug](/usc/42/11851.md?p=4) (as such term is defined in [section 201(g)(1)](/usc/42/201.md) of the Federal Food, [Drug](/usc/42/11851.md?p=4), and Cosmetic Act ([21 U.S.C. 321(g)(1)](/usc/21/321.md?p=g-1)), biological product (as such term is defined by [section 262(i) of this title](/usc/42/262.md?p=i)), or device (as such term is defined by [section 201(h)](/usc/42/201.md?p=h) of the Federal Food, [Drug](/usc/42/11851.md?p=4) and Cosmetic Act ([21 U.S.C. 321(h)](/usc/21/321.md?p=h)) that is authorized for emergency use in accordance with section 564, 564A, or 564B of the Federal Food, [Drug](/usc/42/11851.md?p=4), and Cosmetic Act [[21 U.S.C. 360bbb–3](/usc/21/360bbb–3.md), 360bbb–3a, 360bbb–3b]; or
    - (D) a respiratory protective device that is approved by the National Institute for Occupational Safety and Health under part 84 of title 42, Code of Federal [Regulations](/usc/42/201.md?p=d) (or any successor [regulations](/usc/42/201.md?p=d)), and that the [Secretary](/usc/42/201.md?p=c) determines to be a priority for use during a public health emergency declared under [section 247d of this title](/usc/42/247d.md).
  - (2) **Covered person—** The term “covered person”, when used with respect to the administration or use of a covered countermeasure, means—
    - (A) the United States; or
    - (B) a person or entity that is—
      - (i) a [manufacturer](/usc/42/300aa–33.md?p=3) of such countermeasure;
      - (ii) a distributor of such countermeasure;
      - (iii) a [program](/usc/42/274l–1.md?p=4) planner of such countermeasure;
      - (iv) a qualified person who prescribed, administered, or dispensed such countermeasure; or
      - (v) an official, agent, or [employee](/usc/42/300gg–91.md?p=d-5) of a person or entity described in clause [(i)](#i-2-B-i), [(ii)](#i-2-B-ii), [(iii)](#i-2-B-iii), or [(iv)](#i-2-B-iv).
  - (3) **Distributor—** The term “distributor” means a person or entity engaged in the distribution of [drugs](/usc/42/11851.md?p=4), biologics, or devices, including but not limited to [manufacturers](/usc/42/300aa–33.md?p=3); repackers; common carriers; contract carriers; air carriers; own-label distributors; private-label distributors; jobbers; brokers; warehouses, and wholesale [drug](/usc/42/11851.md?p=4) warehouses; independent wholesale [drug](/usc/42/11851.md?p=4) traders; and retail pharmacies.
  - (4) **Manufacturer—** The term “[manufacturer](/usc/42/300aa–33.md?p=3)” includes—
    - (A) a contractor or subcontractor of a [manufacturer](/usc/42/300aa–33.md?p=3);
    - (B) a supplier or licenser of any product, intellectual property, [service](/usc/42/201.md?p=a), research tool, or component or other article used in the design, development, clinical testing, investigation, or manufacturing of a covered countermeasure; and
    - (C) any or all of the parents, subsidiaries, affiliates, successors, and assigns of a [manufacturer](/usc/42/300aa–33.md?p=3).
  - (5) **Person—** The term “person” includes an individual, partnership, [corporation](/usc/42/2297h.md?p=2), association, entity, or public or [private corporation](/usc/42/2297h.md?p=7), including a Federal, [State](/usc/42/201.md?p=f), or local government [agency](/usc/42/8262.md?p=1) or department.
  - (6) **Program planner—** The term “[program](/usc/42/274l–1.md?p=4) planner” means a [State](/usc/42/201.md?p=f) or local government, including an Indian tribe, a person employed by the [State](/usc/42/201.md?p=f) or local government, or other person who supervised or administered a [program](/usc/42/274l–1.md?p=4) with respect to the administration, dispensing, distribution, provision, or use of a security countermeasure or a qualified pandemic or epidemic product, including a person who has established requirements, provided policy guidance, or supplied technical or scientific advice or assistance or provides a facility to administer or use a covered countermeasure in accordance with a declaration under [subsection (b)](#b).
  - (7) **Qualified pandemic or epidemic product—** The term “qualified pandemic or epidemic product” means a [drug](/usc/42/11851.md?p=4) (as such term is defined in [section 201(g)(1)](/usc/42/201.md) of the Federal Food, [Drug](/usc/42/11851.md?p=4), and Cosmetic Act ([21 U.S.C. 321(g)(1)](/usc/21/321.md?p=g-1)),[^2] biological product (as such term is defined by [section 262(i) of this title](/usc/42/262.md?p=i)), or device (as such term is defined by [section 201(h)](/usc/42/201.md?p=h) of the Federal Food, [Drug](/usc/42/11851.md?p=4) and Cosmetic Act ([21 U.S.C. 321(h)](/usc/21/321.md?p=h))[^2] that is—
    - (A)
      - (i) a product manufactured, used, designed, developed, modified, licensed, or procured—
        - (I) to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic; or
        - (II) to limit the harm such pandemic or epidemic might otherwise cause;
      - (ii) a product manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by a product described in [clause (i)](#i-7-A-i); or
      - (iii) a product or technology intended to enhance the use or effect of a [drug](/usc/42/11851.md?p=4), biological product, or device described in clause [(i)](#i-7-A-i) or [(ii)](#i-7-A-ii); and
    - (B)
      - (i) approved or cleared under chapter V of the Federal Food, [Drug](/usc/42/11851.md?p=4), and Cosmetic Act [[21 U.S.C. 351](/usc/21/351.md) et seq.] or licensed under [section 262 of this title](/usc/42/262.md);
      - (ii) the object of research for possible use as described by [subparagraph (A)](#i-7-A) and is the subject of an exemption under section [505(i)](/usc/42/505.md) or 520(g) of the Federal Food, [Drug](/usc/42/11851.md?p=4), and Cosmetic Act [[21 U.S.C. 355(i)](/usc/21/355.md?p=i), 360j(g)]; or
      - (iii) authorized for emergency use in accordance with section 564, 564A, or 564B of the Federal Food, [Drug](/usc/42/11851.md?p=4), and Cosmetic Act [[21 U.S.C. 360bbb–3](/usc/21/360bbb–3.md), 360bbb–3a, 360bbb–3b].
  - (8) **Qualified person—** The term “qualified person”, when used with respect to the administration or use of a covered countermeasure, means—
    - (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the [State](/usc/42/201.md?p=f) 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](/usc/42/201.md?p=c) under [subsection (b)](#b).
  - (9) **Security countermeasure—** The term “security countermeasure” has the meaning given such term in [section 247d–6b(c)(1)(B) of this title](/usc/42/247d–6b.md?p=c-1-B).
  - (10) **Serious physical injury—** The term “serious physical injury” means an injury that—
    - (A) is life threatening;
    - (B) results in permanent impairment of a body function or permanent damage to a body structure; or
    - (C) necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

## Footnotes

[^1]: So in original. Probably should be chapter “V”.
[^2]: So in original. A third closing parenthesis probably should appear.

## Source credit

(July 1, 1944, ch. 373, title III, § 319F–3, as added Pub. L. 109–148, div. C, § 2, Dec. 30, 2005, 119 Stat. 2818; amended Pub. L. 113–5, title IV, § 402(g)(2), (3), Mar. 13, 2013, 127 Stat. 196; Pub. L. 116–127, div. F, § 6005, Mar. 18, 2020, 134 Stat. 207; Pub. L. 116–136, div. A, title III, § 3103, Mar. 27, 2020, 134 Stat. 361.)

## Notes

### Editorial Notes

### References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (b)(8)(B), (c)(5)(A), (B)(i), (ii)(I), (C)(i), and (i)(7)(B)(i), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§ 301 et seq.) of Title 21, Food and Drugs. Chapter V of the Act is classified generally to subchapter V (§ 351 et seq.) of chapter 9 of Title 21. For complete classification of this Act to the Code, see section 301 of Title 21 and Tables.

The Federal Rules of Civil Procedure, referred to in subsec. (e)(6)(B), (9), are set out in the Appendix to Title 28, Judiciary and Judicial Procedure.

The Public Readiness and Emergency Preparedness Act, referred to in subsec. (h), is div. C of Pub. L. 109–148, Dec. 30, 2005, 119 Stat. 2818, which enacted this section, section 247d–6e of this title, and provisions set out as a note under section 201 of this title. For complete classification of this Act to the Code, see Short Title of 2005 Amendment note set out under section 201 of this title and Tables.

### Amendments

2020—Subsec. (i)(1)(D). Pub. L. 116–136 amended subpar. (D) generally. Prior to amendment, subpar. (D) read as follows: “a personal respiratory protective device that is—

“(i) approved by the National Institute for Occupational Safety and Health under part 84 of title 42, Code of Federal Regulations (or successor regulations);

“(ii) subject to the emergency use authorization issued by the Secretary on March 2, 2020, or subsequent emergency use authorizations, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (authorizing emergency use of personal respiratory protective devices during the COVID–19 outbreak); and

“(iii) used during the period beginning on January 27, 2020, and ending on October 1, 2024, in response to the public health emergency declared on January 31, 2020, pursuant to section 247d of this title as a result of confirmed cases of 2019 Novel Coronavirus (2019-nCoV).”

Pub. L. 116–127 added subpar. (D).

2013—Subsec. (i)(1)(C). Pub. L. 113–5, § 402(g)(3)(A), inserted “, 564A, or 564B” after “564”.

Subsec. (i)(7)(A)(iii). Pub. L. 113–5, § 402(g)(2), added cl. (iii).

Subsec. (i)(7)(B)(iii). Pub. L. 113–5, § 402(g)(3)(B), inserted “, 564A, or 564B” after “564”.