Reporting of drug shortages and discontinuations
Project InformationDue Date:
Health Canada, Therapeutic Products Directorate: Guidance documents pertaining to drug shortages and discontinuations
Regulations Amending the Food and Drug Regulations (Shortages of Drugs and Discontinuation of Sale of Drugs) were published in the Canada Gazette, Part II on June 29, 2016. These regulations come into force in spring 2017, requiring drug authorization holders to report on a specific website all anticipated and current shortages and discontinuations.
To help drug manufacturers comply with the requirements arising from the amendments, Health Canada developed two draft documents:
- Draft – Guide to reporting drug shortages and discontinuations. This document helps manufacturers interpret how and when to report a drug shortage or discontinuation as well as notify Health Canada of an interruption in sale after 12 months of no sale.
- “Consultation on the Draft Guidance Document - Cancellation of a Drug Identification Number (DIN) and Notification of the Discontinuation of Sales. This document helps to interpret sections of the Regulations that relate to the cancellation of a DIN and the notification to Health Canada of the discontinuation of the sale of a drug.
How these guides (in draft form) apply to pharmacy practice
Access to timely, comprehensive, accurate, and reliable information about drug shortages or discontinuations helps manage the care of patients. These guidance documents should help you understand the conditions under which drug authorization holders are expected to notify Health Canada of a drug shortage or discontinuation and when that information is to be provided.
How CSHP members and individual supporters can participate in the consultation
- Read the guidance documents (provided below)
- Forward your feedback to Cathy Lyder, CSHP’s Coordinator of Professional and Membership Affairs, using the comments reporting forms provided below by Friday, September 23, 2016.