Controlled Substances: Destruction of Unserviceable Stock and Post-Consumer Returns

FACT SHEET

Legislative References:

• Controlled Drugs and Substances Act (CDSA)
  • Narcotic Control Regulations, s. 31, 34, 40 – 43, 64
  • Benzodiazepine and Other Targeted Substances Regulation s.2, 9, 55, 61, 66
• Food and Drug Regulations, s. G.03.009 – G.03.013, G.05.002, G.05.003
• Safeguarding Our Communities Act (Patch for Patch Return Policy)
• O. Reg. 298/12: Collection of Pharmaceuticals and Sharps – Responsibilities of Producers

A fact sheet summarizes relevant legislation in one place. Registrants are reminded to refer to legislation for full context.

Additional References:

• Model Standards of Practice for Pharmacists, General Standard 1.43, 1.44, 1.51
• Model Standards of Practice for Pharmacy Technicians, General Standard 1.29
• Fact Sheet – Patch for Patch Fentanyl Return Program (October 1, 2016)

Background

Controlled substances are regulated federally by Health Canada (HC) and the Office of Controlled Substances (OCS). The Controlled Drugs and Substances Act (CDSA) provides a legislative framework aimed at controlling access to substances that can alter mental processes and produce harm to the health of an individual and/or society when diverted or misused.

Pharmacists and hospitals are required to comply with the Narcotic Control Regulations (NCR), the Benzodiazepines and Other Targeted Substances Regulations (BOTSR) made under the CDSA, and Part G of the Food and Drug Regulations (FDR-G) made under the Food and Drugs Act regarding the proper security, handling and destruction of unserviceable stock, including record keeping.

Pharmacists are responsible for the safety and security of all drugs, including post-consumer returns and unserviceable controlled substances, until they are destroyed. Destruction should occur on a regular basis as any accumulation may increase diversion risk. For more information, refer to the Fact Sheet – Controlled Substances: Security and Reconciliation.

The Standards of Operation expect that controlled substances are stored and managed according to national guidelines and provincial requirements. Designated Managers are responsible for establishing a method for identifying products that are outdated or otherwise unsuitable for dispensing and for the proper disposal of such products in accordance with the College’s Policy – Medication Procurement and Inventory Management.

Definitions

Controlled substance: A drug named in the federal Controlled Drug and Substances Act (CDSA), Schedules I, II, III, IV, V. These drugs are also listed in the schedules to the regulations as narcotics, controlled drugs, benzodiazepines and other targeted substances. (CDSA)

Destroy: to alter or denature a controlled substance to such an extent that its consumption is rendered impossible or improbable. (HC)

Licensed Dealer: a licensed dealer under the NCR, the FDR – Part G or the BOTSR. (HC)

Post-consumer return: unused or expired substance that is, or contains, a narcotic, targeted substance, or a controlled drug, that has been returned by an individual to a pharmacy for the purpose of destruction, but does not include any substance that has been returned to a hospital pharmacy from a patient ward. (HC)

Unserviceable stock: any drug product that is unusable, expired and/or that cannot be dispensed. In the hospital setting, this does not include partial or unusable doses outside of the pharmacy. (HC)

Guidance for Pharmacists and Hospitals

• To facilitate the destruction of unserviceable stock and post-consumer returns, Health Canada has issued a Section 56(1) Class Exemption for Pharmacists, Practitioners, Persons in Charge of a Hospital and Licensed Dealers for the Provision and Destruction of Unserviceable Stock and Post-Consumer Returns (February 23, 2018)
• Pharmacists and persons in charge of hospitals should refer to the applicable Health Canada Guidance Documents for recommended procedures for the collection, handling and destruction of controlled substances:

1) Unserviceable stock

Target audience: Community and hospital

Health Canada Guidance Document for Pharmacists, Practitioners and Persons in Charge of Hospitals: Handling and Destruction of Unserviceable Stock Containing Narcotics, Controlled Drugs or Targeted Substances

2) Post-consumer returns

Target audience: Community

Health Canada Guidance Document: Handling and destruction of post-consumer returns containing controlled substances (CS-GD-021)

• Questions about the guidance documents should be directed to the Compliance and Monitoring Division, Controlled Substances Directorate (CSD): hc.compliance-conformite.sc@canada.ca.

Destruction Process

Please refer to the applicable guidance document for detailed information on the options for destruction and suggestions for denaturing controlled substances.

Option 1: Enroll in a third party post-consumer return collection service

• In Ontario, community pharmacies may enroll in the Ontario Medication Returns Program (OMRP), which offers a third party post-consumer return service.
• The OMRP is managed by the Health Products Stewardship Association (HPSA) and sponsored by the pharmaceutical industry; the requirement to provide a free collection service for consumers is outlined in O. Reg 289/12 under the Environmental Protection Act, overseen by the province’s Ministry of the Environment.
• The OMRP does not apply to unserviceable stock.

Option 2: Send/return to licensed dealer

• Dealers licensed to destroy controlled substances can accept post-consumer returns as well as unserviceable stock.

Option 3: Local destruction

• As described in the guidance, when choosing local destruction, the controlled substance is denatured and placed in a suitable waste container for disposal in an appropriate manner (e.g. sent to a waste management company licensed by the Ministry of the Environment).
• The College does not evaluate, review, or approve specific processes or methods that may be used to achieve the desired result of rendering the drug unusable.

Patch for Patch Return Policy

Documentation of returned fentanyl patches is required to demonstrate that the dispenser has fulfilled their obligations under the provincial patch-for-patch legislation. For more information, refer to the Patch-For-Patch Fentanyl Return Program: Fact Sheet.

Published: November 2013
Version #: 2.00

College Contact: Pharmacy Practice

Revision History