--- kind: "section" citation: "21 U.S.C. § 379r" title: "21" title_heading: "Food and Drugs" number: "379r" heading: "National uniformity for nonprescription drugs" release: "119-102" date: "2026-07-12" url: "https://uscodex.org/usc/21/379r" units: - "Chapter 9 — Federal Food, Drug, and Cosmetic Act" - "Subchapter VII — General Authority" - "Part F — National Uniformity for Nonprescription Drugs and Preemption for Labeling or Packaging of Cosmetics" --- # §379r. National uniformity for nonprescription drugs - (a) **In general—** Except as provided in subsection [(b)](#b), [(c)(1)](#c-1), [(d)](#d), [(e)](#e), or [(f)](#f), no [State](/usc/21/321.md?p=a-1) or political subdivision of a [State](/usc/21/321.md?p=a-1) may establish or continue in effect any requirement— - (1) that relates to the regulation of a [drug](/usc/21/321.md?p=g-1) that is not subject to the requirements of section [353(b)(1)](/usc/21/353.md?p=b-1) or [353(f)(1)(A)](/usc/21/353.md?p=f-1-A) of this title; and - (2) that is different from or in addition to, or that is otherwise not identical with, a requirement under this chapter, the Poison Prevention Packaging Act of 1970 ([15 U.S.C. 1471](/usc/15/1471.md) et seq.), or the Fair [Packaging](/usc/21/364.md?p=3-C) and Labeling Act ([15 U.S.C. 1451](/usc/15/1451.md) et seq.). - (b) **Exemption—** - (1) **In general—** Upon application of a [State](/usc/21/321.md?p=a-1) or political subdivision thereof, the [Secretary](/usc/21/321.md?p=d) may by regulation, after notice and opportunity for written and oral presentation of views, exempt from [subsection (a)](#a), under such conditions as may be prescribed in such regulation, a [State](/usc/21/321.md?p=a-1) or political subdivision requirement that— - (A) protects an important public interest that would otherwise be unprotected, including the health and safety of children; - (B) would not cause any [drug](/usc/21/321.md?p=g-1) to be in violation of any applicable requirement or prohibition under Federal law; and - (C) would not unduly burden [interstate commerce](/usc/21/321.md?p=b). - (2) **Timely action—** The [Secretary](/usc/21/321.md?p=d) shall make a decision on the exemption of a [State](/usc/21/321.md?p=a-1) or political subdivision requirement under [paragraph (1)](#b-1) not later than 120 days after receiving the application of the [State](/usc/21/321.md?p=a-1) or political subdivision under [paragraph (1)](#b-1). - (c) **Scope—** - (1) **In general—** This section shall not apply to— - (A) any [State](/usc/21/321.md?p=a-1) or political subdivision requirement that relates to the practice of pharmacy; or - (B) any [State](/usc/21/321.md?p=a-1) or political subdivision requirement that a [drug](/usc/21/321.md?p=g-1) be dispensed only upon the prescription of a practitioner [licensed](/usc/21/360eee.md?p=9) by law to administer such [drug](/usc/21/321.md?p=g-1). - (2) **Safety or effectiveness—** For purposes of [subsection (a)](#a), a requirement that relates to the regulation of a [drug](/usc/21/321.md?p=g-1) 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](/usc/21/321.md?p=g-1). - (d) **Exceptions—** - (1) **In general—** In the case of a [drug](/usc/21/321.md?p=g-1) described in [subsection (a)(1)](#a-1) that is not the subject of an application approved under [section 355 of this title](/usc/21/355.md) or [section 357 of this title](/usc/21/357.md) (as in effect on the day before November 21, 1997) or a final order under [section 355h of this title](/usc/21/355h.md) by the [Secretary](/usc/21/321.md?p=d) establishing conditions under which the [drug](/usc/21/321.md?p=g-1) is generally recognized as [safe](/usc/21/321.md?p=u) and effective, [subsection (a)](#a) shall apply only with respect to a requirement of a [State](/usc/21/321.md?p=a-1) or political subdivision of a [State](/usc/21/321.md?p=a-1) 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 respect to the [drug](/usc/21/321.md?p=g-1) pursuant to a statute described in [subsection (a)(2)](#a-2); or - (B) any other requirement in effect with respect to the [drug](/usc/21/321.md?p=g-1) pursuant to an amendment to such a statute made on or after November 21, 1997. - (2) **State initiatives—** This section shall not apply to a [State](/usc/21/321.md?p=a-1) requirement adopted by a [State](/usc/21/321.md?p=a-1) 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 liability of any [person](/usc/21/321.md?p=e) under the [product](/usc/21/360eee.md?p=13) liability law of any [State](/usc/21/321.md?p=a-1). - (f) **State enforcement authority—** Nothing in this section shall prevent a [State](/usc/21/321.md?p=a-1) 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. ## Source credit (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.) ## Notes ### Editorial Notes ### References in Text The Poison Prevention Packaging Act of 1970, referred 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 introductory provisions, substituted “final order under section 355h of this title” for “final regulation promulgated” and struck out “and not misbranded” after “safe and effective”. Subsec. (d)(1)(A). Pub. L. 116–136, § 3851(c)(2), substituted “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.