§ 379r. National uniformity for nonprescription drugs

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 1938

   Food and Drug Administration Modernization Act of 1997

   Pub. L. 105–115 title IV § 412(a) · 111 Stat. 2296

   Enacted · 21 U.S.C. § 379r

   June 25, 1938, ch. 675, § 751, as added Pub. L. 105–115, title IV, § 412(a), Nov. 21, 1997, 111 Stat. 2373

   Source evidence

   Code source credit
   June 25, 1938, ch. 675, § 751, as added Pub. L. 105–115, title IV, § 412(a), Nov. 21, 1997, 111 Stat. 2373

   Enacted provision · exact public law section
   (a) Nonprescription Drugs.— Chapter VII (21 U.S.C. 371 et seq.), as amended by section 411, is farther amended by adding at the end the following: “Subchapter F— National Uniformity for Nonprescription Drugs and Preemption for Labeling or Packaging of Cosmetics “SEC. 751. 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 requirement— “(1) that relates to the regulation of a drug that is not subject to the requirements of section 503(b)(1) or 503(f)(1)(A); and “(2) that is different from or in addition to, or that is otherwise not identical with, a requirement under this Act, the Poison Prevention 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 subdivision thereof, the Secretary may by regulation, 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 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 to be in violation of any applicable requirement or prohibition 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 paragraph (1). “(c) Scope.— “(1) In general.— This section shall not apply to— “(A) any State or political subdivision requirement that relates to the practice of pharmacy; or “(B) any State or political subdivision requirement that a drug be dispensed only upon the prescription of a practitioner licensed by law to administer such drug. “(2) Safety or effectiveness.— For purposes of subsection (a), a requirement 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 505 or section 507 (as in effect on the day before the date of enactment of the Food and Drug Administration Modernization Act of 1997) or a final regulation promulgated by the Secretary establishing conditions under which the drug is generally recognized as safe and effective and not misbranded, subsection (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 in effect with respect to the drug pursuant to a statute described in subsection (a)(2); or “(B) any other requirement in effect with respect to the drug pursuant to an amendment to such a statute made on or after the date of enactment of the Food and Drug Administration Modernization Act of 1997. “(2) State initiatives.— This section shall not apply to a State requirement 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 liability 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 Act.”.

2. 2020

   Coronavirus Aid, Relief, and Economic Security Act

   Pub. L. 116–136 § 3851(c)(1) · 134 Stat. 281

   1. Substituted · 21 U.S.C. § 379r(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”

   2. Struck · 21 U.S.C. § 379r(d)(1)

      Pub. L. 116–136, § 3851(c)(1), in introductory provisions, struck out “and not misbranded” after “safe and effective”

   Source evidence

   Code amendment note
   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”.

   Enacted provision · exact public law section
   (1) in the matter preceding subparagraph (A)— (A) by striking “final regulation promulgated” and inserting “final order under section 505G”; and (B) by striking “and not misbranded”; and

3. 2020

   Coronavirus Aid, Relief, and Economic Security Act

   Pub. L. 116–136 § 3851(c)(2) · 134 Stat. 281

   Substituted · 21 U.S.C. § 379r(d)(1)(A)

   Pub. L. 116–136, § 3851(c)(2), substituted “regulation or order in effect” for “regulation in effect”

   Source evidence

   Code amendment note
   Subsec. (d)(1)(A). Pub. L. 116–136, § 3851(c)(2), substituted “regulation or order in effect” for “regulation in effect”.

   Enacted provision · exact public law section
   (2) in subparagraph (A), by striking “regulation in effect” and inserting “regulation or order in effect”.

4 of 4 references resolved to an enrolled provision