Consultation: regulations for reference standards under the CDSA

From Health Canada

Current status: The public consultation is now closed. Thank you for your interest.

You are invited to comment on a proposal to develop a regulatory framework to streamline the authorization of legitimate activities with controlled substances in the form of reference standards.

Why

We are proposing to develop a regulatory framework that would allow authorized laboratories to conduct activities with reference standards in a responsive and timely manner. This will help analytical and forensic laboratories fulfill their role supporting the public health and safety of Canadians.

Reference standards are small quantities of highly purified and standardized forms of a given substance. These quantities are used as a measurement base to confirm the identity, strength, quality and purity of a substance.

Drug testing and forensic laboratories indicated that the current processes to obtain controlled substances in the form of reference standards are burdensome. This process impacts their ability to fulfill their responsibilities.

This is largely due to the lack of appropriate regulatory mechanisms for obtaining controlled substances.

Regulations under the Controlled Drugs and Substances Act (CDSA) do not include specific provisions to authorize activities with controlled substances in the form of reference standards.

Instead, laboratories must either apply for a dealer's licence or apply for an exemption under subsection 56(1) of the CDSA for scientific purposes.

Who

We are seeking input from analytical and forensic laboratories, and all interested persons and organizations.

What

A Notice to Interested Parties was published in Canada Gazette, Part I on September 15, 2017. We encourage you to read the Notice and send us your comments about it.

How to participate

The consultation will be open for 60 days, between September 16 and November 14, 2017.

Send us your comments within the time given, by:

  • email
  • mail (at the address below)

Related information

Contact us

Health Canada
Office of Legislative and Regulatory Affairs
Address locator: 0302A
150 Tunney's Pasture Driveway, Main Stats Building 
Ottawa ON K1A 0K9
Email: ocs_regulatorypolicy-bsc_politiquereglementaire@hc-sc.gc.ca

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