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The care provided in hospitals involves a number of potentially harmful substances, including drugs and nuclear materials. Hospitals are subject to various Acts to ensure these substances are managed and used safely. Some of the Acts in this section require certain records to be maintained. Please refer to the OHA's Records Retention Toolkit: A Guide to the Maintenance and Disposal of Hospital Records for specific details on these compliance requirements.
The following Acts are covered in this section:
Controlled Drugs and Substances Act, 1996 (CDSA) [federal]
Food and Drugs Act (FDA) [federal]
Narcotics Safety and Awareness Act, 2010 (NSAA)
Nuclear Safety and Control Act (NSCA) [federal]
Transportation of Dangerous Goods Act, 1992 (TDGA) [federal]
Overview
The CDSA provides a legislative framework for the control of substances that can alter mental processes and that pose risks to public health and public safety when used inappropriately or diverted to the illegal market.
Who does the CDSA apply to?
The CDSA applies to all individuals and organizations, including healthcare facilities such as hospitals, involved in handling controlled substances.
What are the key requirements for hospitals under the CDSA?
Compliance Deadlines
Reporting Timelines by Substance Type:
Substance Type
Reporting Timelines
Pinpoint
Precursors
Notify the police within 24 hours and Office of Controlled Substances (OCS) within 72 hours
Precursor Control Regulations, s 91.96
Narcotics
Notify OCS within 10 calendar days
Narcotics Control Regulations, s 63(c)
Targeted Substances (for example: benzodiazepines)
Benzodiazepines and Other Targeted Substances Regulations, ss 61(2), 72(2)
Controlled Drugs
Food and Drug Regulations, Part G, s G05.004
Restricted Drugs
Notify OCS within 72 hours
Food and Drug Regulations, Part J, s J.01.068(1)
Director Liability
The Act does not contain any director specific offence provisions.
Additional Resources
For more information about the CDSA, please refer to the following resources:
The FDA establishes a framework to ensure the safety, quality, and proper labelling of food, drugs, medical devices, and therapeutic products in Canada. It promotes patient safety by minimizing risks related to contaminated, misbranded, or substandard products used in various settings, including healthcare settings.
Who does the FDA apply to?
The Act applies generally to persons (which includes organizations). Additionally, certain provisions within the regulations under the Act apply explicitly to hospitals.
What are the key requirements for hospitals under the FDA?
New Amendment
The FDA was amended in June 2023 to apply to natural health products as the definition of “therapeutic product” was revised in the Act to include natural health products. However, until a date is fixed by order of the Governor in Council, this expanded definition does not apply with respect to hospital reporting obligations when ADRs or MDIs occur.
Hospitals must submit reports of serious ADRs and MDIs to Health Canada within 30 calendar days from the date of first documentation within the hospital. (CRC c870, s C.01.020.1; SOR/98-282, s 62)
A director or officer who “directs, authorizes, assents to or acquiesces or participates in the commission of” specified offences is “party to the offence and is liable on conviction to the punishment provided for by this Act, even if the hospital is not prosecuted for the offence”. (s 31.6). Such specified offences include:
For more information about the FDA, please refer to the following resource:
The NSAA was introduced with the purpose of monitoring prescribing and dispensing of narcotics and other monitored drugs, in order to contribute to appropriate practices. The NSAA is largely aimed at controlling inappropriate use, misuse, and diversion practices.
Who does the NSAA apply to?
The NSAA applies primarily to “prescribers” and “dispensers” of monitored drugs. That said, the NSAA also applies to “operators of a pharmacy” which includes pharmacies “operated in or by a hospital to which the Public Hospitals Act applies”. The NSAA therefore applies to hospitals if they operate pharmacies. For greater clarity, the NSAA does not apply to prescribing and/or dispensing to “in-patients” within the meaning of the Public Hospitals Act.
What are the key requirements for hospitals under the NSAA?
The Act does not contain any compliance deadlines.
For more information about the NSAA, please refer to the following resource:
For the purpose of this Guide, the NSCA establishes a comprehensive framework governing the possession, use, transfer, import, export, abandonment and storage of nuclear substances and radiation devices. In doing so, the NSCA establishes the Canadian Nuclear Safety Commission (Commission) and tasks it with the oversight and administration of the Act. One of the primary vehicles with which the Commission regulates the possession and use of nuclear substances and radiation devices is through a licensing scheme. This licensing scheme generally captures hospitals.
Who does the NSCA apply to?
The NSCA applies to those who receive a “licence” from the Commission. This includes hospitals, to the extent that they undertake licensed activities.
What are the key requirements for hospitals under the NSCA?
Any director or officer who “directed, authorized, assented to, acquiesced in or participated in” the commission of a violation under the Act is liable to an administrative monetary penalty determined in accordance with the respective regulation, which is not to exceed $25,000. (ss 65.03, 44(13))
The NSCA explicitly provides for a limited statutory due diligence defence. (s 51.1)
For more information about the NSCA, please refer to the following resources:
The TDGA and its regulations take aim at ensuring public safety when dangerous goods (as defined in the Act and regulations) are imported, offered for transport, handled or transported by road, rail, or water. The compliance requirements under the TDGA should be considered in close connection with those contained in Ontario’s Environmental Protection Act (EPA) and its regulations. The EPA, among other things, outlines additional responsibilities and requirements for generators of biomedical waste.
Who does the TDGA apply to?
For the purposes of this resource, the TDGA applies to anyone handling dangerous goods where handling is defined under the Act as “loading, unloading, packing or unpacking dangerous goods in a means of containment for the purposes of, in the course of or following transportation and includes storing them in the course of transportation”.
What are the key requirements for hospitals under the TDGA?
Under the TDGA, any director who “directed, authorized, assented to, acquiesced in or participated in the commission of the offence is a party to and guilty of the offence and is liable on conviction to the punishment provided for the offence”. (s 39) Section 33 further clarifies that offences under the Act and regulations may result in fines not exceeding $50,000 for first offences and $100,000 for subsequent offences; or imprisonment for a term not exceeding two years. (s 33)
That said, the TDGA includes an explicit due diligence defence provision confirming that no person will be found guilty of an offence if “the person took all reasonable measures to comply with this Act or to prevent the commission of the offence”. (s 40)
For more information about the TDGA, please refer to the following resources:
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