- Controlled Drugs and Substances Act (CDSA)
- Narcotic Control Regulations, s. 31, 34, 40 – 43, 64
- Food and Drug Regulations, s. G.03.009 — G.03.013, G.05.002 – G.05.003
- Benzodiazepine and Other Targeted Substances Regulation, s.2, 9, 55, 61, 66
- Safeguarding Our Communities Act (Patch for Patch Return Policy)
- O.Reg. 298/12: Collection of Pharmaceuticals and Sharps – Responsibilities of Producers
- Standards of Practice for Pharmacists, General Standard 1.43, 1.44, 1.51
- Standards of Practice for Pharmacy Technicians, General Standard 1.29
- Fact Sheet – Narcotic Reconciliation and Security
- Patch for Patch Fentanyl Return Program: Fact Sheet (October 1, 2016)
- 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)
- Ontario Medication Returns Program
College Contact: Pharmacy Practice
The regulations regarding controlled substances (narcotics, controlled drugs, benzodiazepines and targeted substances) require pharmacists to take any steps necessary to protect the drugs in their possession. This includes ensuring that drugs are accounted for, inventory is accurate, security measures are in place to minimize diversion, outdated stock is identified and removed, and medications are disposed of properly.
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 — Narcotic Reconciliation and Security.
Designated Managers (DM) are responsible for establishing a method for identifying products that are outdated or otherwise unsuitable for dispensing and for the proper disposal of such products.
Pharmacy technicians support the DM through identification and removal of unusable inventory and assisting in its disposal, destruction or return.
Guidance for Pharmacists
Pharmacists should refer to the following Health Canada guidance documents which provide and clarify recommended procedures for the collection, handling and destruction of controlled substances. There are two separate categories:
1) Unserviceable stock
Target audience: Community and hospital pharmacists
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
Unserviceable stock means any drug product inventory 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
2) Post-consumer returns
Target audience: community pharmacists
Post-consumer returns refers to any drug product that has been previously dispensed and is returned by an individual to a community pharmacy for disposal.
Patch for Patch Return Policy
Although Health Canada no longer requires detailed information to be recorded for post-consumer returns, 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.
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 and is overseen by the province’s Ministry of the Environment. It 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 licenced 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.
Questions about the content of the guidance documents should be directed to:
Compliance and Monitoring Division
Controlled Substances Directorate (CSD)