21 U.S.C. § 379r — National uniformity for nonprescription

Page 627 TITLE 21—FOOD AND DRUGS § 379r PART F—NATIONAL UNIFORMITY FOR NON- PRESCRIPTION DRUGS AND PREEMPTION FOR LABELING OR PACKAGING OF COSMETICS § 379r. National uniformity for nonprescription drugs (a) In general Except as provided in subsection (b), (c)(1), (d), (e), or (f), no State or political subdivision of a State may establish or continue in effect any re- quirement— (1) that relates to the regulation of a drug that is not subject to the requirements of sec- tion 353(b)(1) or 353(f)(1)(A) of this title; and (2) that is different from or in addition to, or that is otherwise not identical with, a require- ment under this chapter, the Poison Preven- tion Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.). (b) Exemption (1) In general Upon application of a State or political sub- division thereof, the Secretary may by regula- tion, after notice and opportunity for written and oral presentation of views, exempt from subsection (a), under such conditions as may be prescribed in such regulation, a State or po- litical subdivision requirement that— (A) protects an important public interest that would otherwise be unprotected, includ- ing the health and safety of children; (B) would not cause any drug to be in vio- lation of any applicable requirement or pro- hibition under Federal law; and (C) would not unduly burden interstate commerce. (2) Timely action The Secretary shall make a decision on the exemption of a State or political subdivision requirement under paragraph (1) not later than 120 days after receiving the application of the State or political subdivision under para- graph (1). (c) Scope (1) In general This section shall not apply to— (A) any State or political subdivision re- quirement that relates to the practice of pharmacy; or (B) any State or political subdivision re- quirement that a drug be dispensed only upon the prescription of a practitioner li- censed by law to administer such drug. (2) Safety or effectiveness For purposes of subsection (a), a require- ment that relates to the regulation of a drug shall be deemed to include any requirement relating to public information or any other form of public communication relating to a warning of any kind for a drug. (d) Exceptions (1) In general In the case of a drug described in subsection (a)(1) that is not the subject of an application approved under section 355 of this title or sec- tion 357 of this title (as in effect on the day be- fore November 21, 1997) or a final order under section 355h of this title by the Secretary es- tablishing conditions under which the drug is generally recognized as safe and effective, sub- section (a) shall apply only with respect to a requirement of a State or political subdivision of a State that relates to the same subject as, but is different from or in addition to, or that is otherwise not identical with— (A) a regulation or order in effect with re- spect to the drug pursuant to a statute de- scribed in subsection (a)(2); or (B) any other requirement in effect with respect to the drug pursuant to an amend- ment to such a statute made on or after No- vember 21, 1997. (2) State initiatives This section shall not apply to a State re- quirement adopted by a State public initiative or referendum enacted prior to September 1, 1997. (e) No effect on product liability law Nothing in this section shall be construed to modify or otherwise affect any action or the li- ability of any person under the product liability law of any State. (f) State enforcement authority Nothing in this section shall prevent a State or political subdivision thereof from enforcing, under any relevant civil or other enforcement authority, a requirement that is identical to a requirement of this chapter. (June 25, 1938, ch. 675, § 751, as added Pub. L. 105–115, title IV, § 412(a), Nov. 21, 1997, 111 Stat. 2373; amended Pub. L. 116–136, div. A, title III, § 3851(c), Mar. 27, 2020, 134 Stat. 454.) Editorial Notes REFERENCES IN TEXT The Poison Prevention Packaging Act of 1970, re- ferred to in subsec. (a)(2), is Pub. L. 91–601, Dec. 30, 1970, 84 Stat. 1670, which is classified principally to chapter 39A (§ 1471 et seq.) of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see Short Title note set out under section 1471 of Title 15 and Tables. The Fair Packaging and Labeling Act, referred to in subsec. (a)(2), is Pub. L. 89–755, Nov. 3, 1966, 80 Stat. 1296, which is classified generally to chapter 39 (§ 1451 et seq.) of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see Short Title note set out under section 1451 of Title 15 and Tables. AMENDMENTS 2020—Subsec. (d)(1). Pub. L. 116–136, § 3851(c)(1), in in- troductory provisions, substituted ‘‘final order under section 355h of this title’’ for ‘‘final regulation promul- gated’’ and struck out ‘‘and not misbranded’’ after ‘‘safe and effective’’. Subsec. (d)(1)(A). Pub. L. 116–136, § 3851(c)(2), sub- stituted ‘‘regulation or order in effect’’ for ‘‘regulation in effect’’. Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title. Page 628 TITLE 21—FOOD AND DRUGS § 379s § 379s. Preemption for labeling or packaging of cosmetics (a) In general Except as provided in subsection (b), (d), or (e), no State or political subdivision of a State may establish or continue in effect any requirement for labeling or packaging of a cosmetic that is different from or in addition to, or that is other- wise not identical with, a requirement specifi- cally applicable to a particular cosmetic or class of cosmetics under this chapter, the Poison Pre- vention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.). (b) Exemption Upon application of a State or political sub- division thereof, the Secretary may by regula- tion, after notice and opportunity for written and oral presentation of views, exempt from sub- section (a), under such conditions as may be pre- scribed in such regulation, a State or political subdivision requirement for labeling or pack- aging that— (1) protects an important public interest that would otherwise be unprotected; (2) would not cause a cosmetic to be in viola- tion of any applicable requirement or prohibi- tion under Federal law; and (3) would not unduly burden interstate com- merce. (c) Scope For purposes of subsection (a), a reference to a State requirement that relates to the pack- aging or labeling of a cosmetic means any spe- cific requirement relating to the same aspect of such cosmetic as a requirement specifically ap- plicable to that particular cosmetic or class of cosmetics under this chapter for packaging or labeling, including any State requirement relat- ing to public information or any other form of public communication. (d) No effect on product liability law Nothing in this section shall be construed to modify or otherwise affect any action or the li- ability of any person under the product liability law of any State. (e) State initiative This section shall not apply to a State re- quirement adopted by a State public initiative or referendum enacted prior to September 1, 1997. (June 25, 1938, ch. 675, § 752, as added Pub. L. 105–115, title IV, § 412(d), Nov. 21, 1997, 111 Stat. 2376.) Editorial Notes REFERENCES IN TEXT The Poison Prevention Packaging Act of 1970, re- ferred to in subsec. (a), is Pub. L. 91–601, Dec. 30, 1970, 84 Stat. 1670, which is classified principally to chapter 39A (§ 1471 et seq.) of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see Short Title note set out under section 1471 of Title 15 and Tables. The Fair Packaging and Labeling Act, referred to in subsec. (a), is Pub. L. 89–755, Nov. 3, 1966, 80 Stat. 1296, which is classified generally to chapter 39 (§ 1451 et seq.) of Title 15, Commerce and Trade. For complete classi- fication of this Act to the Code, see Short Title note set out under section 1451 of Title 15 and Tables. Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title. PART G—SAFETY REPORTS § 379v. Safety report disclaimers With respect to any entity that submits or is required to submit a safety report or other in- formation in connection with the safety of a product (including a product that is a food, drug, device, dietary supplement, or cosmetic) under this chapter (and any release by the Secretary of that report or information), such report or in- formation shall not be construed to reflect nec- essarily a conclusion by the entity or the Sec- retary that the report or information con- stitutes an admission that the product involved malfunctioned, caused or contributed to an ad- verse experience, or otherwise caused or contrib- uted to a death, serious injury, or serious ill- ness. Such an entity need not admit, and may deny, that the report or information submitted by the entity constitutes an admission that the product involved malfunctioned, caused or con- tributed to an adverse experience, or caused or contributed to a death, serious injury, or serious illness. (June 25, 1938, ch. 675, § 756, as added Pub. L. 105–115, title IV, § 420, Nov. 21, 1997, 111 Stat. 2379.) Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title. PART H—SERIOUS ADVERSE EVENT REPORTS § 379aa. Serious adverse event reporting for non- prescription drugs (a) Definitions In this section: (1) Adverse event The term ‘‘adverse event’’ means any health- related event associated with the use of a non- prescription drug that is adverse, including— (A) an event occurring from an overdose of the drug, whether accidental or intentional; (B) an event occurring from abuse of the drug; (C) an event occurring from withdrawal from the drug; and (D) any failure of expected pharma- cological action of the drug. (2) Nonprescription drug The term ‘‘nonprescription drug’’ means a drug that is— (A) not subject to section 353(b) of this title; and