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 (4 page(s), in English)
Notice of proposed rulemaking - The Consumer Product Safety Commission (Commission or CPSC) is proposing to amend the child-resistant packaging requirements to exempt baloxavir marboxil tablets in packages containing not more than 80 mg of the drug, currently marketed as XOFLUZA,TM from the special packaging requirements. XOFLUZA is used to treat the flu, and is taken in one dose within 48 hours of experiencing flu symptoms. The proposed rule would exempt 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.