Federal · Title 21 — Food and Drugs

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

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that relates to the regulation of a drug that is not subject to the requirements of section 353(b)(1) or 353(f)(1)(A) of this title; and 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 et seq.), or the Fair Packaging and Labeling Act ( 15 U.S.C. 1451 et seq.). protects an important public interest that would otherwise be unprotected, including the health and safety of children; would not cause any drug to be in violation of any applicable requirement or prohibition under Federal law; and would not unduly burden interstate commerce. 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). any State or political subdivision requirement that relates to the practice of pharmacy; or 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. 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. a regulation or order in effect with respect to the drug pursuant to a statute described in subsection (a)(2); or any other requirement in effect with respect to the drug pursuant to an amendment to such a statute made on or after November 21, 1997 . This section shall not apply to a State requirement adopted by a State public initiative or referendum enacted prior to September 1, 1997 . 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. 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.

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