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National Drug Schedules (NDS) Updates - July 28, 2022

National Drug Schedules: Final Recommendations for topical diclofenac diethylamine

The interim recommendations made by the National Drug Scheduling Advisory Committee (NDSAC) on June 5, 2022, that:

  • Diclofenac diethylamine – for human use - when sold as a single medicinal ingredient for topical use on the skin in concentrations greater than 1.16% and less than or equal to 2.32% for not more than 7 days - in package sizes containing greater than 2.6g of diclofenac diethylamine be granted Schedule III status
  • Diclofenac diethylamine – for human use - when sold as a single medicinal ingredient for topical use on the skin in concentrations greater than 1.16% and less than or equal to 2.32% for not more than 7 days - in package sizes containing no more than 2.6g of diclofenac diethylamine be granted Unscheduled status
  • Diclofenac diethylamine – for human use - when sold as a single medicinal ingredient for topical use on the skin in concentrations of not more than 1.16% for not more than 7 days remain Unscheduled

were finalized effective July 26, 2022. Final approval of the interim recommendations was made by NAPRA’s Board of Directors, in consideration of comments received during the 30-day review period. The National Drug Schedules will be revised accordingly.