← Independent regulator rules (SEC/Fed/FDIC/SBA/FTC/NCUA/CPSC/FHFA/EEOC/NLRB)

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

CPSC · final-rule · Published 2024-04-19 · Effective 2024-05-20 · 89 FR 28604

Document

Document number
2024-07651
Federal Register citation
89 FR 28604
CFR reference
16 CFR 1700
Type
Rule
Action
Final rule.
Category
final-rule
Agency
US Consumer Product Safety Commission
Publication date
2024-04-19
Effective date
2024-05-20
Docket
Docket No. CPSC-2021-0027

Abstract

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.

Source

Authoritative
Federal Register document
Machine
JSON-LD · Markdown