New Controlled Substances Regulations to consolidate existing regulatory scheme

As of October 1, 2026, the Controlled Substances Regulations¹ (CSR) will establish a comprehensive framework to govern the activity of controlled substances and cannabis under the Controlled Drugs and Substances Act (CDSA) and the Cannabis Act, respectively.

What you need to know

• The CSR will consolidate multiple existing regulations, including those under the CDSA and the Cannabis Act, into a single, modernized framework that harmonizes requirements and enhances clarity and consistency.
• The CSR will establish a licensing framework across all substance categories, reducing administrative burdens while introducing new requirements on suspensions and reporting.
• The newly defined “persons in charge of a hospital” will be authorized to administer, sell, provide, send, deliver, and transport controlled substances while incorporating class‑exemption permissions, such as on‑site destruction or transfers to licensed dealers for destruction.
• The Minister of Health will be authorized to communicate factual information regarding controlled substances with provincial regulators, governments, customs officers, and international bodies.
• Accompanying amendments will be made to various regulations, including the Cannabis Regulations, to align with the CSR.

The CSR will significantly reform the current regulatory framework for controlled substances

The CSR will consolidate previous regulations, providing consistency for various categories of controlled substances. By consolidating requirements that were previously found in several different regulations and instruments, Health Canada aims to create a unified framework to govern activities involving narcotics, controlled drugs, targeted substances, and restricted drugs, as listed in Schedules I-IV of the CSR.

Once the CSR takes effect, the following pieces of legislation will be repealed:

• the Narcotic Control Regulations;
• the Benzodiazepines and Other Targeted Substances Regulations;
• parts G and J of the Food and Drug Regulations;
• the New Classes of Practitioners Regulations; and
• the class exemptions under section 56(1) of the CDSA.

Other related regulations will also be amended to coordinate with the CSR, including the Cannabis Regulations, the Precursor Control Regulations, the Food and Drug Regulations, and certain fee regulations.

While the CSR will introduce an extensive framework of changes, below are a few of particular significance.

Licensed dealers

The CSR will introduce harmonized licensing requirements across substance categories, governing the activities of producers, distributors, importers, and exporters of controlled substances. While largely the same as the current regulations, changes are expected to reduce administrative burdens by replacing multiple regulatory regimes with a single framework. Changes include:

• Authorizing the Minister to partially suspend a licence regarding any activities with controlled substances.
• Requiring monthly, rather than annual, reports on regulated activities.
• Requiring reporting unexplainable losses only to Health Canada rather than both Health Canada and the police. However, thefts must still be reported to both. To reduce reporting duplication, neither unexplainable losses nor thefts will be required to be included in monthly reports.

Hospitals

The CSR includes a new definition of a “person in charge of a hospital” to mean an individual who has responsibility for managing all of a hospital’s activities with respect to controlled substances. This person will continue to be authorized to permit the administration, sale, and provision of a controlled substance, subject to limitations. Additionally, the CSR will:

• Authorize a hospital to sell or provide a controlled substance to a practitioner for emergency purposes, a licensed dealer, or the Minister.
• Allow hospitals to conduct certain activities by incorporating authorizations set out in class exemptions for a person in charge of a hospital, such as destroying a controlled substance on site or sending it to a licensed dealer specialized in destruction.

Minister of Health

The CSR will allow Health Canada to share certain information to protect public health and safety:

• The Minister will still be authorized to share information obtained under the CDSA or CSR about a health professional to the relevant provincial regulatory authority, in certain circumstances. This includes a new circumstance where the Minister has reasonable grounds to believe that such sharing is necessary to help monitor their professional conduct.
• The Minister will also be authorized to share, in some circumstances, certain information collected under the CSR or CDSA with a customs officer, the International Narcotics Control Board, and foreign competent authorities to mitigate the risk of diversion and fulfill Canada’s international obligations under the United Nations drug control conventions.

Government laboratories

The CSR will introduce a new framework permitting government-operated laboratories to produce, sell, provide, send, deliver, transport, import, or export a controlled substance without a licence—but they will still need a permit to import or export a controlled substance.

No such framework has been introduced for non-government or private laboratories.

Individuals

The CSR will authorize individuals to sell, provide, import, export, deliver, or transport a controlled substance under certain circumstances. Specifically, the CSR will:

• Authorize an individual to import or export a controlled substance, other than a restricted drug, which has been authorized by a healthcare provider to them for their personal use, or that of an accompanying individual or animal, up to a 90-day supply of the controlled substance (which is longer than the 30 days that apply to narcotics and controlled drugs under the subsection 56(1) exemption under the CDSA). The substance must be in the individual’s actual possession or in their baggage.
• Allow an individual to bring a controlled substance to a retail pharmacy for its destruction.
• Deliver a prescription drug containing a controlled substance to a patient.

Amendments to the Cannabis Regulations

As a result of the CSR coming into force, the Cannabis Regulations will be amended² to maintain consistency between the two pieces of legislation. Notable amendments to the Cannabis Regulations include revised responsibilities for master growers, exemptions allowing individuals to be excluded from section 21 of the Cannabis Act, and the allowance of pharmacists to distribute drugs containing cannabis for the purpose of destruction to licensed dealers and to other pharmacists for the purpose of filling prescriptions. Cannabis licence holders and licensed dealers will also have to record the drug identification number for prescription drugs containing cannabis when conducting activities such as import, sale, and distribution.

What’s next?

The CSR will come into force on October 1, 2026. In the meantime, regulated parties are encouraged to make adjustments to comply with the new requirements. Health Canada will also be publishing notices and guidance to assist parties in achieving compliance with the CSR.