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In an effort to combat Canada’s growing opioid crisis, Health Canada under the Government of Canada, has proposed significant regulatory changes to tighten controls over precursor chemicals and designated devices such as pill presses and encapsulators. The proposed changes to the Precursor Control Regulations (PCR) and Schedule IX of the Controlled Drugs and Substances Act (CDSA) were officially published in the Canada Gazette, Part I, on June 28, 2025, and are open for public consultation until August 12, 2025. 

The amendments are designed to disrupt the supply chain for illegally produced fentanyl, which continues to be the primary contributor to overdose deaths nationwide. 

What Are Precursor Chemicals and Designated Devices? 

• Precursor chemicals are chemical substances that can be used to produce controlled substances such as synthetic opioids like fentanyl. 

• Designated devices refer to equipment used in drug production, such as pill presses and encapsulators. The proposed rules would also regulate certain component parts such as 
   dies,  punches, and  molds. 

While these items often are used in legal manufacturing contexts, are increasingly being diverted for illegal drug production in clandestine labs operated by organized crime. 

Summary of Proposed Amendments 

According to the documents published in the Canada Gazette, the following regulatory changes are being proposed: 

1. Expanded Import Registration Requirements 

Currently, importers of designated devices (like pill presses) must register their importation with Health Canada. Under the new proposal component parts suitable for use in pill presses and encapsulators such as  dies, molds, punches, would also be subject to registration.  
Importers would be required to provide proof of registration at the time of import. 
 

2. New Definitions and Classification 

• The definition of "designated device" would be updated to include interchangeable or individual components. 
   

• Precursor chemicals would be categorized by risk level, allowing more focused regulatory control of high-risk substances (e.g. those commonly linked to fentanyl synthesis). 
   

3. Enhanced Compliance and Inspection Powers 

• Health Canada would be granted broader powers to inspect premises, collect records, and seize non-compliant materials,  
  including the right to audit production documentation, examine inventory logs, and issue compliance orders. 
   

4. Improved Regulatory Flexibility 

• The proposed changes would enable faster regulatory response to emerging synthetic drugs, and  
  allow provisional controls over new substances or equipment pending formal classification. 
   

Why Are These Changes Necessary? 

Canada is experiencing one of the worst public health crises in its history due to the opioid epidemic. According to national statistics: 

• Illegally produced fentanyl is involved in over 80 percent of opioid-related deaths in Canada. 
   

• Organized crime groups are increasingly using domestic labs to produce fentanyl using imported precursors and unregulated drug manufacturing equipment. 
   

• Law enforcement agencies have reported an increase in the illegal importation and diversion of precursor chemicals and components for designated devices. 
   

The regulatory framework aims to: 

• Prevent the diversion of legally traded materials into illicit drug manufacturing. 
   

• Disrupt domestic production capabilities of illegal fentanyl. 
   

• Protect communities from the devastating impact of synthetic opioids. 
   

Stakeholder Responsibilities 

If adopted, the new regulations would affect: 

Importers 

• Must register both designated devices and their components prior to import. 
   

• Provide proof of registration to border officers. 
   

• Maintain detailed records of sales and storage locations. 
   

Distributors and Manufacturers 

• Ensure compliance with handling and security protocols. 
   

• Participate in inspection procedures by Health Canada. 
   

• Report any suspicious orders or diversion risks. 
   

Timeline and Consultation 

• Publication Date: June 28, 2025 
   

• Public Consultation Ends: August 12, 2025 
   

• Expected Final Publication: Fall 2025 in Canada Gazette, Part II 
   

• Date of Entry into Force: Upon final publication 

Access Official Regulatory Texts 

For full details, consult the following Canada Gazette links: 

• Regulations Amending the Precursor Control Regulations (English) 
   

• Order Amending Schedule IX to the CDSA (English) 
   

Conclusion: Strengthening Canada’s Response to the Opioid Crisis 

Canada’s proposed amendments reflect an urgent, evidence-based strategy to combat synthetic opioid trafficking and reduce overdose-related deaths. By extending oversight to chemical precursors and the components of pill-making equipment, the government seeks to disrupt a critical link in the supply chain for illegal fentanyl production. 

Proactive stakeholder involvement during the consultation phase is essential to shaping a balanced regulatory framework that is both enforceable and aligned with legitimate industry needs. 

Keywords: Canada precursor chemical regulation, pill press import rules, Health Canada precursor oversight, CDSA amendments 2025, Canada Gazette, fentanyl regulation Canada, opioid crisis Canada, precursor control regulations 

On May 31, 2025, Canada’s Biocides Regulations under the Food and Drugs Act officially entered into force, establishing a single regulatory framework for surface disinfectants and sanitizers—collectively referred to as biocides. These new rules replace previous authorizations granted under either the Food and Drug Regulations (FDR) or the Pest Control Products Act (PCPA).

Pre-Market Authorisation Now Mandatory

Under the new framework, all biocides must undergo a pre-market assessment by Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) to obtain a market authorization. Only then can they be sold, imported, or advertised in Canada. Authorized products will carry a unique 8-digit identification number, signaling that they meet stringent standards for safety, efficacy, and quality.

Stronger Oversight for Public and Occupational Safety

This regulatory shift ensures greater consistency, improved transparency, and enhanced public and occupational safety, particularly for products used in healthcare facilities, food premises, households, schools, and veterinary settings.

Transition Deadlines for Existing Products

• Products previously authorized under the FDR or PCPA must transition to the new framework by May 31, 2029.

• Surface sanitizers used in food premises must obtain market authorization by May 31, 2031.

Post-Market Surveillance to Continue

Health Canada will continue post-market monitoring and enforcement through its Regulatory Operations and Enforcement Branch (ROEB) and Marketed Health Products Directorate (MHPD) to ensure ongoing compliance and risk management.