§379r National Uniformity for Nonprescription Drugs

Summary

States may not make or keep laws about over-the-counter drugs that are different from or add to federal rules under this chapter, the Poison Prevention Packaging Act of 1970, or the Fair Packaging and Labeling Act. This rule covers drugs that are not governed by the federal provisions in section 353(b)(1) or 353(f)(1)(A). The Secretary can allow a State rule to stand after public notice and hearings if the rule protects an important public interest (for example, children’s health), does not make any drug break federal law, and does not unduly burden interstate commerce. The Secretary must decide on such an exemption within 120 days. The ban on different State rules does not apply to pharmacy practice rules or rules that require a drug to be dispensed only by prescription. For drugs without an approved application or final order as of November 21, 1997, the federal limit on State rules only covers State rules on the same subject as existing federal requirements or amendments on or after November 21, 1997. State initiatives passed before September 1, 1997 are not affected. This law does not change State product liability rules, and States may enforce rules that are identical to federal ones.