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National Drug Schedules: Final Recommendations for Ophthalmic Brimonidine 0.025% and FDC of Acetaminophen and Ibuprofen

National Drug Schedule

The interim recommendations made by the National Drug Scheduling Advisory Committee (NDSAC) on December 3-4, 2023 that:

  • Acetaminophen and ibuprofen in oral, fixed-dose combinations, in package sizes containing 20,000 mg or less of acetaminophen and 6,000 mg or less of ibuprofen, remain in Schedule III and
  • Acetaminophen and ibuprofen in oral, fixed-dose combinations, in package sizes containing either more than 20,000 mg of acetaminophen or more than 6,000 mg of ibuprofen, remain in Schedule II
  • Brimonidine tartrate ophthalmic solution in concentrations up to and including 0.025%, used for the relief of redness of the eye due to minor eye irritations caused by environmental allergies, dryness and fatigue for adults of 18 years and older be granted Unscheduled status
  • Brimonidine or its salts, except when sold as brimonidine tartrate ophthalmic solution in concentrations up to and including 0.025%, used for the relief of redness of the eye due to minor eye irritations caused by environmental allergies, dryness and fatigue for adults of 18 years and older, will remain in Schedule I (as per the Prescription Drug List)

were finalized effective January 23, 2024. Final approval of the interim recommendations was made by NAPRA’s Board of Directors, in consideration of comments received during the 30-day consultation period. The National Drug Schedules will be revised accordingly.

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