Summary of the National Drug Scheduling Process
IMPORTANT: The following is a summary of the provisions set out in Bylaw No. 2 and the Rules of Procedure. In the event of any inconsistency or conflict between the provisions of the Bylaw or Rules of Procedure and this information, the provisions of the Bylaw or Rules of Procedure, as applicable, shall prevail.
The drug scheduling process usually begins when NAPRA receives a drug scheduling submission from a pharmaceutical company. 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.
There is a specific process that must be followed during each drug scheduling review, which is outlined in NAPRA’s Bylaw No. 2 and Rules of Procedures. This information is summarized in the following charts: Pre-NDSAC Meeting Procedure and Post-NDSAC Meeting Procedure.
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. This could occur because of the NAPRA Policy for Drugs Not Reviewed, which places drugs into Schedule I until they are reviewed, or because of a range of factors considered by the expert advisory committee when applying the cascading drug scheduling model. The provinces and territories can add additional conditions of sale for non-prescription drugs but can never be less restrictive than federal legislation. See the National Drug Schedules Program section for more information.
“Factors”, rather than “criteria”, are considered to be more appropriate assessment tools as they are contingent, conditional and dependent. A process using factors allows judgment by reviewers to find the best fit and facilitates a re-evaluation process of scheduled drugs when new knowledge or practice experience emerges. The factors were initially adapted from established standards for prescription drugs, proposed guidelines for drugs monitored by pharmacists, and the World Health Organization’s guidelines for non-prescription drugs, which were then modified through national consultation.
The NDSAC will meet upon receipt of a submission (on pre-determined dates, up to four times per year) to review applications for scheduling. An independent validation of the submitted material and additional research may be contracted by the Committee, to supplement the individual member’s private study. The applicant and Interested Parties are entitled to present before the Committee (see Participation in NDS Reviews for more information).
Once the NDSAC has reviewed a particular drug, it will make an interim drug scheduling recommendation. A 30-day consultation period follows, after which the NAPRA Board of Directors will make a final scheduling recommendation. The NDS are then amended and the final recommendation is implemented according to the rules in each particular province or territory.