Health Canada fast-tracks consultation on precursor chemicals

On January 30, 2025, Health Canada announced it was expediting consultation on proposed amendments to the Precursor Control Regulations (PCR) and Schedule IX of the Controlled Drugs and Substances Act (CDSA). The expedited consultation was announced in the wake of increased concern surrounding the impact of fentanyl and other illegal synthetic drugs on public safety. We highlight the key aspects of Health Canada’s consultation below.

Regulatory framework for precursor chemicals

Precursor chemicals can be used for certain legitimate activities, such as the production of pharmaceuticals, fragrances, flavouring agents or fertilizers. These uses of precursors are regulated by the CDSA and PCR. The CDSA prohibits use of controlled substances, including precursors to controlled substances, and the PCR provides a framework through which otherwise prohibited activities with precursors are authorized. 

As precursors continue to be used in the illegal production of dangerous substances like fentanyl and other synthetic opioids, Health Canada is re-examining existing regulations to address the public health and social harms caused by these drugs.

Proposed amendments 

Health Canada is proposing five amendments to the CDSA and PCR that would increase oversight of precursors, improve Health Canada’s regulatory flexibility and agility, and generally strengthen Canada’s regulatory framework surrounding precursor chemicals.

1. Make suspicious transaction reporting to Health Canada mandatory. Licensed and registered users of precursors would be required to report suspicious transactions to Health Canada. Reporting is currently voluntary. 
2. Require licensed and registered companies to conduct criminal record and background checks on key personnel dealing with precursors. Additional criminal record and background checks would be required as an additional step to prevent the diversion of precursors to the illegal market. Only senior personnel are currently required to consent to criminal record checks. 
3. Condition-of-sale restrictions for ephedrine and pseudoephedrine — two precursors that can be used to produce methamphetamine. Distributors would be prohibited from selling products containing these precursors to retail stores other than pharmacies. Products may also need to be kept behind counters, and there may be limits on the amount of these precursors that can be sold to individuals by pharmacies. 
4. Expand registration requirements for designated devices to include the importation of component parts. Registration would be required to import component parts of Schedule IX designated devices, addressing the concern that these devices are being broken down prior to importation. 
5. Introduce new regulatory flexibilities so that Health Canada can respond to public health or public safety risks in a more agile and timely manner. Health Canada would be allowed to add or remove terms and conditions to precursor chemical licenses and registrations at any time.

Canada’s border plan

The consultation on the proposed amendments is tied to Canada’s border plan, which was announced in December 2024. The border plan sets out a commitment from Health Canada to launch a new Precursor Chemical Risk Management Unit, which would provide better insight into the distribution channels of precursor chemicals and enhance monitoring and surveillance. To ensure that law and border enforcement can detect fentanyl and its precursors, the federal government is also investing in the expansion of Health Canada’s laboratory and regulatory capabilities. This involves the creation of a new Canadian Drug Profiling Centre to expand and enhance Health Canada’s laboratory drug testing. 

Canada’s border plan was recently expanded in response to the potential tariffs proposed by the U.S. government, including by creating a “Fentanyl Czar” to engage with U.S. counterparts to combat fentanyl. Indeed, fentanyl, particularly the smuggling of fentanyl across the Canada/U.S. border, was a driver of the potential tariffs, with the White House referencing “heightened domestic production of fentanyl” in Canada in their official fact sheet on the tariffs. Health Canada’s expedited consultation may be linked to this increasing international pressure to address the production of fentanyl in Canada and the alleged flow of fentanyl across the border. 

Consultation on proposed amendments

The consultation process opened on January 31, 2025, and will be open until March 3, 2025. More information, including how to submit comments, can be found here. If you have any questions on preparing comments, please contact the authors.

The authors would like to thank Chloe Loblaw, articling student, for her contribution to preparing this legal update.