Risk classification guide for controlled substances observations (CSP-GUI-017): Sample observations
The following are sample observations inspectors may note during an inspection. This list of sample observations, and their risk rating, is not intended to be exhaustive and inspectors may cite other observations where appropriate. Depending on the situation, the observations below may also be rated differently.
On this page
- Dealer’s licence
- Personnel
- Security
- Loss and theft
- Transportation
- Record keeping
- Importation and exportation
- Sales
- Orders
- Suspicious transactions
- Destruction
Dealer’s licence
| Regulation | Section or subsection |
|---|---|
| CSR | 5(1)-(2), 7(1), 12(2), 50, 54 |
Critical observations
- The licensed dealer was in possession of a controlled substance that is not listed on their licence.
- A company conducted regulated activities without a licence.
- The licensed dealer conducted regulated activities at a different address than the one listed on their licence.
Major observations
- The licensed dealer did not adhere to the conditions set out on their licence.
- The licensed dealer did not obtain a controlled substance in accordance with the Regulations
Minor observations
- The licensed dealer did not inform Health Canada of their name change.
Personnel
| Regulation | Section or subsection |
|---|---|
| CSR | 8(2), 9(3), 23(1), 27, 28(1), 53 |
Critical observations
- The licensed dealer conducted regulated activities with controlled substances without the presence of the qualified person in charge or an alternate qualified person in charge.
Major observations
- The senior person in charge did not have sufficient knowledge to carry out their duties.
- The licensed dealer did not obtain Health Canada’s approval prior to replacing the senior person in charge or the qualified person in charge.
Minor observations
- The licensed dealer did not notify Health Canada within five days of a person ceasing to act as a qualified person in charge and/or alternate qualified person in charge.
- The licensed dealer did not notify Health Canada within 10 days of a person ceasing to act as the senior person in charge.
Security
| Regulation | Section or subsection |
|---|---|
| CSR | 66 |
Critical observations
- The licensed dealer did not adequately restrict access to controlled substances to persons whose presence is required by their work responsibilities.
- The licensed dealer exceeded the maximum illicit value for their approved security level.
- The licensed dealer stored controlled substances in an unsecured and/or unapproved location.
Major observations
- The licensed dealer did not test all sensors and/or alarms for the secure environ regularly to confirm that the security system is operational.
- The licensed dealer stored a controlled substance in the cage that is not exempted in Appendix D of the Security Directive.
Minor observations
- The approved secure environ contained materials other than controlled substances.
- The licensed dealer did not comply with the lock combination requirements in the Security Directive.
Loss and theft
| Regulation | Section or subsection |
|---|---|
| CSR | 67, 68(1), 68(2), 83 |
Critical observations
- No system was in place to detect and report loss or theft.
- The licensed dealer did not report the theft of a controlled substance to a police force and Health Canada.
Major observations
- The licensed dealer did not adequately investigate the loss of a controlled substance.
- The licensed dealer did not have an adequate system in place to detect losses and thefts of controlled substances.
- The licensed dealer did not maintain complete and/or accurate records of losses that can be explained on the basis of normally accepted business activities.
Minor observations
- The licensed dealer did not report the unexplained loss of a controlled substance to Health Canada within the prescribed timelines.
- The licensed dealer submitted a loss or theft report to Health Canada that was inaccurate or incomplete.
Transportation
| Regulation | Section or subsection |
|---|---|
| CSR | 65(1) |
Critical observations
- The licensed dealer did not have adequate security measures in place for the transportation of controlled substances, resulting in a significant loss.
Major observations
- The licensed dealer did not use a method of delivery, sending or transportation that ensures the tracking of the controlled substance until the consignee receives it.
- The licensed dealer transported a controlled substance using an outer container that was conspicuous or had markings that identified its contents.
Minor observations
- The licensed dealer used a seal that was not tamper-evident or the seal was not adequate for detecting diversion of controlled substances; however other measures were in place to detect diversion in transit
Record keeping
| Regulation | Section or subsection |
|---|---|
| CSR | 55, 75-82, 85-90 |
Critical observations
- There is a complete lack of records for controlled substances ordered/received by the licensed dealer.
- The licensed dealer did not maintain complete and/or accurate records of monthly physical inventory.
Major observations
- The licensed dealer submitted several monthly reports that did not contain complete and/or accurate information.
- The licensed dealer did not retain records they are required to keep for two years.
- The licensed dealer could not access all records from the site specified in their licence.
- The documents provided by the licensed dealer were not legible and/or indelible.
- The licensed dealer did not provide requested documents in the time and manner specified.
Minor observations
- The date indicated on the records was not always the date that the products were received by the licensed dealer.
- The licensed dealer did not record the required details for receiving a written order for a controlled substance.
Importation and exportation
| Regulation | Section or subsection |
|---|---|
| CSR | 34(1), 35(2), 38, 39, 42(1), 43(2), 46, 47, 50 |
Critical observations
- The licensed dealer imported or exported a controlled substance without a valid permit.
- The licensed dealer modified the import or export permit issued by Health Canada.
Major observations
- The licensed dealer did not comply with the content of the export or import permit.
- The licensed dealer did not provide a declaration of import or export.
Minor observations
- The licensed dealer did not provide a declaration of export within 15 days after the day of export of the controlled substance.
- The licensed dealer did not provide a declaration of import within 15 days after the day of release of the controlled substances from customs.
Sales
| Regulation | Section or subsection |
|---|---|
| CSR | 56, 57(1), 57(2), 58(1)-(3), 59-62 |
Critical observations
- The licensed dealer sold or provided a controlled substance to an unauthorized person.
- The licensed dealer sold or provided a controlled substance to a pharmacist or practitioner that is the subject of a prohibition on their professional practice imposed by a provincial professional regulatory authority.
Major observations
- The licensed dealer did not have an adequate process in place to determine if a pharmacist or practitioner has a prohibition imposed by the provincial regulatory authority.
- The licensed dealer sold a quantity of controlled substances that exceeded the quantity specified on the letter of authorization.
Minor observations
- The licensed dealer sold controlled substances under a different name and/or address than indicated on the letter of authorization.
Orders
| Regulation | Section or subsection |
|---|---|
| CSR | 56, 57(1), 58(1)-(2), 59-64 |
Critical observations
- The licensed dealer sent controlled substances that exceeded the quantity on the order.
Major observations
- The licensed dealer sold a controlled substance without an adequate written order.
- The licensed dealer sold a controlled substance without verifying the signature or identity of the person placing the order and the signature was not known to them.
- The licensed dealer did not have a process in place for verifying the identity of persons from whom they’ve received a written order for controlled substances.
Minor observations
- The licensed dealer sold a controlled substance more than six months after the original order.
Suspicious transactions
| Regulation | Section or subsection |
|---|---|
| CSR | 69 |
Critical observations
- The licensed dealer failed to initiate or complete suspicious transaction investigations and continued filling orders for a customer suspected of diverting controlled substances.
Major observations
- The licensed dealer did not have an adequate system in place to detect suspicious transactions for controlled substances.
- The licensed dealer did not report one or more suspicious transactions to Health Canada.
Minor observations
- The licensed dealer submitted incomplete and/or inaccurate reports of suspicious transactions to Health Canada.
Destruction
| Regulation | Section or subsection |
|---|---|
| CSR | 71, 72, 84 |
Critical observations
- The licensed dealer did not maintain any records of destruction.
- The licensed dealer did not take all reasonable measures to ensure the security of controlled substances being transported elsewhere for destruction, resulting in a loss.
Major observations
- The licensed dealer destroyed a controlled substance without prior approval from Health Canada.
- The licensed dealer destroyed a controlled substance without two qualified witnesses.
- The licensed dealer did not ensure that controlled substances were destroyed by a business that specializes in the destruction of dangerous goods.
Minor observations
- The licensed dealer did not properly attest to the destruction of controlled substances.
- The licensed dealer destroyed a controlled substance without a second qualified witness present.