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

(a) In general. Except as allowed under subsections (b), (c)(1), (d), (e), or (f), a state or local government cannot create or keep in effect a requirement that (1) covers a drug that does not need a prescription (a drug not covered by section 353(b)(1) or 353(f)(1)(A)), and (2) is different from, adds to, or is not identical with a requirement under this chapter, the Poison Prevention Packaging Act of 1970, or the Fair Packaging and Labeling Act. (b) Exemption. (1) A state or local government can apply to the Secretary for an exemption from subsection (a). After giving notice and a chance for written and oral comment, the Secretary may grant the exemption, with conditions, if the state or local requirement: (A) protects an important public interest that federal law would otherwise leave unprotected, including the health and safety of children; (B) would not make any drug violate an applicable federal requirement or prohibition; and (C) would not unduly burden interstate commerce. (2) The Secretary must decide on an exemption application within 120 days of receiving it. (c) Scope. (1) This section does not apply to: (A) a state or local requirement about the practice of pharmacy; or (B) a state or local requirement that a drug can only be given out with a prescription from a licensed practitioner. (2) For subsection (a), a "requirement that relates to the regulation of a drug" includes any requirement about public information or other public communication that involves a warning about the drug. (d) Exceptions. (1) For a drug not covered by an approved application under section 355 or 357 (as section 357 stood before November 21, 1997), and not covered by a final order under section 355h finding it generally recognized as safe and effective, subsection (a) only blocks a state or local requirement that covers the same subject as — but differs from, adds to, or is not identical with — (A) a regulation or order in effect for the drug under one of the laws named in (a)(2); or (B) another requirement in effect for the drug because of an amendment to one of those laws made on or after November 21, 1997. (2) This section does not apply to a state requirement adopted through a public initiative or referendum enacted before September 1, 1997. (e) No effect on product liability law. Nothing in this section changes or affects any lawsuit or a person's liability under a state's product liability law. (f) State enforcement authority. Nothing in this section stops a state or local government from enforcing, under its own civil or other enforcement powers, a requirement that is identical to a requirement of this chapter.