Destruction of Controlled Substances: Expectations from Health Canada

Security and Storage of Controlled Substances for Destruction

Do not mix unserviceable stock with post-consumer returns, regardless of the destruction system you choose to use; these two should always be kept separate.
For unserviceable stock, you must maintain an active tally. This means that medication removed from live inventory should be tracked in real-time, through a physical or electronic record that can be verified. Unserviceable stock requires the same level of security as your regular inventory of controlled substances.
A final physical count of unserviceable stock should be conducted to verify and match the active tally before destroying it or sending it to a licensed dealer.
Bulk containers holding post-consumer returns must be kept as secure as possible (e.g., covered and out of sight) and should be located in an area where access is restricted to pharmacists, pharmacy technicians and authorized personnel. All containers of post-consumer returns must be assigned a unique identifier (e.g., container #2) that is verified prior to destruction and documented to support record keeping. Pharmacies do not need to track or document the individual drugs within the post-consumer returns container.

Reminder from Health Canada: If unexplained discrepancies are found in the final count of unserviceable stock, a Loss or Theft Report must be submitted to the Office of Controlled Substances at ocs.reporting-rapporter.bsc@hc-sc.gc.ca. For more information on loss or theft reporting, please visit Reporting loss or theft of controlled substances or precursors – Canada.ca.

Destruction Options for Unserviceable Stock and Post-Consumer Returns

Local Destruction at the Pharmacy

Pharmacies may choose to destroy controlled substances locally. However, you must keep the following requirements in mind:

Make it unusable. Controlled drugs, narcotics and targeted substances must be altered or denatured to such an extent that consumption is rendered impossible or improbable. Procedures may vary from substance to substance depending on chemical and physical properties, but a change of state is recommended (e.g., from solid to liquid). A mild detergent is often used as opposed to just water. Do not add bleach or any other substance that can cause an undesirable reaction.

Ensure proper personnel are involved. Local destruction must be performed by the pharmacist and must be witnessed. The witness may be a practitioner (as defined in the guidance documents), pharmacist, pharmacy intern or pharmacy technician. Both persons must sign and print their names on the generated record and indicate that they witnessed the destruction, and that the substance was altered or denatured to such an extent that its consumption was rendered impossible or improbable.

Follow the rules. Destruction must be done in accordance with all applicable federal, provincial and municipal environmental legislation and with staff safety in mind. Once subjected to local destruction, controlled substances may be placed in an appropriate container and disposed of in a manner that is safe, environmentally responsible, secure and in compliance with legal and professional requirements to protect confidential patient information.

For hospitals that do not have a pharmacist on site, the person in charge of the hospital can carry out local destruction activities. This responsibility cannot be delegated or discharged to another employee. The exception is where the unserviceable stock represents any partial or unusable dose and is already outside the pharmacy. In this case, local destruction can be carried out by a licensed health professional, at the discretion of the person in charge of the hospital.

Reminder from Health Canada: Destruction requests do not need to be sent to Health Canada for pre-authorization.

Reminder from Health Canada: The pharmacist and their witness both need to observe the verification of product inventory as well as the actual destruction of unserviceable stock.

Provide or Return to Licensed Dealer Authorized to Destroy Controlled Substances

Pharmacies may choose to provide unserviceable stock and post-consumer returns to a licensed dealer authorized to destroy controlled substances. These substances are provided without denaturing/local destruction.

Pharmacies may also be able to return unserviceable stock to the licensed dealer who sold or provided the controlled substances. The licensed dealer may place other conditions on returns (e.g., bottles must be unopened).

For post-consumer returns only, pharmacies can also enroll in take-back programs for the safe disposal of unwanted medications.

Reminder from Health Canada: Regardless of the method chosen for disposal of controlled substances, it is the pharmacist’s responsibility to ensure they are meeting the terms and conditions of Subsection 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 – Canada.ca .

Documentation and Record Retention

Documentation is the number one area of non-compliance seen during Health Canada community pharmacy inspections. While it is up to the individual pharmacy to determine the template for documentation, the following information must be included:

Documentation Requirements for Local Destruction - Click to expand

Local destruction of post-consumer returns	Local destruction of unserviceable stock
Date of destruction Method of destruction used Address where destruction took place Number of containers destroyed Unique identifier assigned to each destroyed container Signature, date signed and printed names of the pharmacist and witness to attest that they have witnessed the destruction	Date of destruction List of drugs destroyed, including quantity and strength Method of destruction used Address where destruction took place Signature, date signed and printed names of the pharmacist and witness to attest that they have witnessed the destruction

Documentation Requirements When Sending to a Licensed Dealer - Click to expand

Return of unserviceable stock to licensed dealer who sold or provided the controlled substances	Provide unserviceable stock to a licensed dealer authorized to destroy controlled substances	Provide post-consumer returns to a licensed dealer authorized to destroy controlled substances
Written order from the licensed dealer must include: Name, quantity and strength of each controlled substance provided Name and address of the licensed dealer Signature of licensed dealer and date signed Date items were shipped (waybill) Clear note that the sole purpose of the transaction is the destruction of unserviceable stock	Written order from the licensed dealer must include: Name, quantity and strength of each controlled substance provided Name and address of licensed dealer Signature of licensed dealer and date signed Date items were provided (waybill) Clear note that the sole purpose of the transaction is the destruction of unserviceable stock	Record must include: Number of containers being provided Date the containers were provided Unique identifiers assigned to each container collected Name and address of licensed dealer Signature of pharmacist and date signed on request for destruction of post-consumer returns

Records must be kept in an auditable manner and be retained on-site or easily retrievable for two years. If records are electronic, the system must meet the requirements of relevant regulations and be saved in a secure, legible format, with a backup system in place.

Patients do not need to be given any kind of receipt that they returned controlled substances to the pharmacy.

Reminder from Health Canada: Do not rely solely on electronic storage on a third-party platform.

Reminder from Health Canada: Street drugs received at the pharmacy should be reported to law enforcement first. They should not be destroyed right away as police might want to seize them. If you need to store them while waiting for law enforcement, keep them separate from regular stock but in a secure location. The pharmacy should keep a copy of a police report for their own records even if law enforcement confiscates the products. If law enforcement deems it appropriate for the pharmacy to destroy them, follow regular procedures for post-consumer returns.

Questions about the Guidance Documents can be directed to Health Canada’s Compliance and Monitoring Division within the Office of Controlled Substances at compliance-conformite@hc-sc.gc.ca.

Terms to Know

Unserviceable stock: Drug product containing a narcotic, controlled drug or targeted substance that is unusable, expired and/or that cannot be dispensed.

Post-consumer returns: 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. This includes controlled substances returned from hospice or other facilities to a pharmacy, but not any substance returned to a hospital pharmacy from a patient ward.

Local destruction: Controlled substances are denatured at the pharmacy with the appropriate witness and documentation.

Send to a licensed dealer: Controlled substances are returned to the supplier or to a company that is licensed by Health Canada for controlled substances and that is specialized in destruction.