Child-resistant packaging; baloxavir marboxil tablets; Pharmaceutics (ICS 11.120), Domestic safety (ICS 13.120), Packaging materials and accessories (ICS 55.040)

Poison Prevention Packaging Requirements; Proposed Exemption of Baloxavir Marboxil Tablets in Packages Containing Not More Than 80 mg of the Drug

The Consumer Product Safety Commission (Commission or CPSC) is amending the child-resistant packaging requirements of CPSC's regulation to exempt baloxavir marboxil tablets, currently marketed as XOFLUZATM, in packages containing not more than 80 mg of the drug, from the special packaging requirements. XOFLUZA is used to treat the flu, and the drug is taken in one dose within 48 hours of experiencing flu symptoms. The final rule exempts this prescription drug product on the basis that child-resistant packaging is not needed to protect young children from serious injury or illness because the product is not acutely toxic and lacks adverse human experience associated with ingestion.

The rule is effective 20 May 2024.