Data / Federal rules / 2024-07651

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

The Consumer Product Safety Commission published this final rule in the Federal Register on April 19, 2024. It took effect on May 20, 2024.

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What the agency says

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 XOFLUZA<SUP>TM</SUP>, 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.

Key facts

Document number: 2024-07651
Type: Final rule
Action: Final rule
Agency: Consumer Product Safety Commission
Published: April 19, 2024
Takes effect: May 20, 2024
Dates: The rule is effective May 20, 2024.
Docket: Docket No. CPSC-2021-0027
Code of Federal Regulations: 16 CFR 1700
Topics: Consumer protection; Drugs; Infants and children; Packaging and containers; Poison prevention
Pages: 3

The document on federalregister.gov PDF

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Everything from the Consumer Product Safety Commission · Rules on consumer protection · Rules on drugs · Rules on infants and children · Published in April 2024

Read from the Federal Register API, last updated 2026-10-24. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.