Policy for Drugs Not Reviewed
Since the establishment of the National Drug Schedules, there have been a few cases in which a manufacturer of a new non-prescription drug or deregulated drug (one that was switched from prescription to over-the-counter status) has not requested a national drug scheduling recommendation by the National Drug Scheduling Advisory Committee (NDSAC) and accordingly, a national drug schedule assignment has not been made. This may occur because, among other reasons, the manufacturer decides not to market the new non-prescription drug in Canada or is unaware of the national scheduling process.
In the absence of an NDSAC review and information to support a specific non-prescription drug status, federally deregulated and newly approved non-prescription drugs are placed in Schedule I of the national drug scheduling model and identified accordingly.
Policy for Natural Health Products
Natural health products (NHPs) approved for sale under the Natural Health Product Regulations are not considered products for scheduling within the National Drug Schedules (NDS).
As of 2022, all products with a Natural Product Number (NPN) or Drug Identification Number-Homeopathic Medicine (DIN-HM) from Health Canada will be considered outside the scope of NAPRA’s National Drug Schedules.
The Background on update to NAPRA Policy for Natural Health Products explains the history of natural health products as they related to the NDS and the NAPRA Policy for Natural Health Products.