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

Consumer information, labelling (TBT); Prevention of deceptive practices and consumer protection (TBT); Protection of human health or safety (TBT)

Child-resistant packaging; baloxavir marboxil tablets

Link to ePing

11.120 - Pharmaceutics; 11.120 - Pharmaceutics; 13.120 - Domestic safety; 13.120 - Domestic safety; 55.040 - Packaging materials and accessories; 55.040 - Packaging materials and accessories

Human health; Human health

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.Title 16 Code of Federal Regulations (CFR) Part 1700 This final rule and the notice of proposed rulemaking notified as G/TBT/N/USA/1777 are identified by Docket Number CPSC-2021-0027. The Docket Folder is available from Regulations.gov at https://www.regulations.gov/docket/CPSC-2021-0027/document and provides access to primary and supporting documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number. _x000D_

1:File here 2:File here 3:File here 4:File here 5:File here

EN:File here

FR:File here

ES:File here

Active Inactive