Mupirocin Scheduling Clarification

National Drug Schedule FAQ

The National Association of Pharmacy Regulatory Authorities (NAPRA) has received questions about the scheduling of mupirocin. Mupirocin is listed in Schedule I of the National Drug Schedules (NDS).

The National Drug Scheduling Advisory Committee (NDSAC) is an expert advisory committee that reviews the drug scheduling submissions received by NAPRA and formulates drug scheduling recommendations. The model for making drug scheduling recommendations embodies a “cascading principle” in which drugs are assessed against specific scheduling factors. A drug is first assessed using the factors for Schedule I. Should sufficient factors apply, the drug remains in that Schedule. If not, the drug is assessed against the Schedule II factors, and if warranted, subsequently against the Schedule III factors. Should the drug not meet the factors for any schedule, it becomes “Unscheduled” (the fourth category).

According to this cascading principle, it is possible, although rare, for NAPRA to place a product in Schedule I that Health Canada has classified as a non-prescription product. Mupirocin is an example of a medicinal ingredient that Health Canada has classified as non-prescription, but it has been placed in Schedule I of the NDS. Therefore, it will require a prescription for sale in provinces and territories that follow the NDS. This is an example of a situation where the NDS scheduling of a substance is more restrictive in terms of conditions for sale than that required by federal legislation. The NDS can be more restrictive, but never less restrictive than federal legislation.

A review by the NDSAC – to potentially change the conditions of sale for mupirocin – could be conducted if a submission were to be filed (by a sponsor/manufacturer) with NAPRA for that purpose.

Further, since the NDS are implemented in a slightly different manner in each of the provinces and territories, there may be exceptions to the scheduling of certain drugs in some provinces and territories (more information is posted on the NAPRA website). It is best to refer to the pharmacy regulatory authority (usually the college of pharmacists) of the province or territory in question for specific information on the drug scheduling rules in that jurisdiction.

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