Health Canada has announced the release of two guidance documents to support the Controlled Drugs and Substances Act (CDSA), with the aim of mitigating the risk of diversion from the downstream supply chain. The guidance documents recognize the role pharmacy technicians can play in both the collection and destruction of outdated or unusable narcotics and controlled substances. Links to both documents are found below:
- Guidance Document for Pharmacists and Dealers Licensed to Destroy Narcotics, Controlled Drugs or Targeted Substances: Handling and Destruction of Post-Consumer Returns Containing Narcotics, Controlled Drugs or Targeted Substances
- Guidance Document for Pharmacists, Practitioners and Persons in Charge of Hospitals: Handling and Destruction of Unserviceable Stock Containing Narcotics, Controlled Drugs or Targeted Substances
The guidelines streamline, update, and clarify procedures, expectations, and practices related to the handling and destruction of unserviceable stock and post-consumer medications by various parties regulated under the CDSA. Key changes include the following:
- The post-consumer returns guidance document sets out procedures for pharmacy professionals involved in the collection, handling and destruction of unused or expired drug products containing a narcotic, controlled drug or targeted substance returned by an individual consumer.
- Health Canada will no longer require the recording of the name of the drug products associated with post-consumer returns. Consequently, the requirement to separate post-consumer returned controlled substances from other post-consumer returned prescription or non-prescription medications will no longer be in effect.
- The guidance documents require the treatment of post-consumer collection bins as if they contain controlled substances, regardless of the actual content. It is highly recommended that post-consumer returns are stored in single-use, one-way entry collection containers that are opaque, inconspicuous, tamper-evident and have a unique identifier.
- The guidance documents replace two Circular Letters (official notices sent to targeted stakeholders) previously sent to pharmacists, practitioners, persons in charge of hospitals, and dealers licensed to destroy narcotics, controlled drugs, or targeted substances.
- The unserviceable stock guidance document will set out procedures for practitioners, pharmacists, and persons in charge of a hospital involved in the handling and destruction of these products.
The guidance documents will be considered effective in six months to allow the industry to accommodate these changes. Please note that an updated Section 56(1) exemption has been issued to accommodate for these changes.
Comments or questions about either of these documents should be directed to hc.compliance-conformite.sc@canada.ca.
