Final Rule: Requirements for Child-Resistant Packaging; Household Products With More Than 50 mg of Elemental Fluoride and More Than 0.5 Percent Elemental Fluoride; and Modification of Exemption for Oral Prescription Drugs with Sodium Fluoride

The Commission is issuing a rule to require child-resistant (``CR'') packaging for household products containing more than the equivalent of 50 mg of elemental fluoride and more than the equivalent of 0.5 percent elemental fluoride (on a weight-to-volume (``w/v'') or weight-to-weight (``w/w'') basis). For consistency, the Commission is also modifying the oral prescription drug exemption for sodium fluoride preparations. Instead of exempting drugs with no more than 264 mg of sodium fluoride per package as the current rule does, the Commission will exempt such drugs with either 50 mg or less of the equivalent of elemental fluoride (110 mg or less of sodium fluoride) per package or no more than the equivalent of 0.5 percent elemental fluoride on a w/v or w/w basis. The Commission determines that child-resistant packaging is necessary to protect children under 5 years of age from serious personal injury and serious illness resulting from handling or ingesting a toxic amount of elemental fluoride. The Commission takes this action under the authority of the Poison Prevention Packaging Act of 1970.