Controlled Substances Regulations (SOR/2025-242)

Marginal note:Transportation

182 A hospital that delivers, sends or transports a controlled substance must record the following information:

• (a) its name and municipal address;

• (b) with respect to the agent or mandatary of the hospital delivering, sending or transporting the controlled substance, their name;

• (c) if the controlled substance is delivered, sent or transported to another person, the following information with respect to that person:

  • (i) if it is not a person referred to in subparagraph (ii), their name and, if applicable, title, or

  • (ii) if they are an individual who is named in a prescription or who is responsible for an animal identified in a prescription, their name and, if applicable, the name of the animal;

• (d) the municipal address of the place where the controlled substance will be delivered, sent or transported;

• (e) the date of the delivery, sending or transportation;

• (f) the means of transportation used;

• (g) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and

• (h) in the case of a finished product,

  • (i) subject to subparagraph (iv), its name or, if applicable, brand name,

  • (ii) subject to subparagraph (iv), its form, strength and quantity,

  • (iii) subject to subparagraph (iv), its drug identification number, if any, and

  • (iv) if the finished product has been previously returned by an individual for the purposes of destruction, only the identifier marked on the collection container of the finished product and the number of collection containers.

Marginal note:Destruction

183 A person who destroys a controlled substance in a hospital must record the following information:

• (a) their name;

• (b) the name of the witness to the destruction;

• (c) the municipal address of the hospital;

• (d) the date of destruction;

• (e) the method of destruction;

• (f) in the case of a controlled substance set out in any of Schedules 1 to 3, its name and quantity; and

• (g) in the case of a finished product,

  • (i) subject to subparagraph (iii), its name or, if applicable, brand name,

  • (ii) subject to subparagraph (iii), its quantity, and

  • (iii) if the finished product has been previously returned by an individual for the purposes of destruction, only the identifier marked on the collection container of the finished product and the number of collection containers.

Recording Information and Retention and Provision of Documents

Marginal note:Method of recording

184 Any person who records any information under sections 175 to 183 must do so using a method that permits an audit of it to be made at any time.

Marginal note:Documents to retain

185 A hospital or, if a hospital ceases its operations, the person who was responsible for those operations on the date those operations ceased must ensure that

• (a) any document containing the information that is required to be recorded under sections 175 to 183 is kept for two years after the day on which the last record is recorded in the document;

• (b) every written order and prescription is kept, in sequence as to date and number, for two years after the day on which it is received or issued respectively; and

• (c) every declaration and report is kept for two years after the day on which it is provided or received.

Marginal note:Place

186 The documents must be accessible

• (a) at the hospital where the information was recorded; or

• (b) if that hospital has ceased its operations, at a place in Canada.

Marginal note:Quality of documents

187 The documents must be complete and readily retrievable and the information in them must be legible and indelible.

Marginal note:Providing documents

188 A hospital or, if a hospital has ceased its operations, the person who was responsible for those operations on the date those operations ceased, must provide any documents that the Minister requests in the time and manner that the Minister specifies.

Minister

Authorizations and Conditions Applicable to Activities

Sale of Controlled Substances

Marginal note:Sale to practitioner

• 189 (1) The Minister may sell or provide a controlled substance to a practitioner that the Minister has named in a letter of authorization.

• Marginal note:Exception — prohibition

  (2) The Minister must not sell or provide to the practitioner a controlled substance that is the subject of a prohibition on the practitioner’s professional practice imposed by the provincial professional regulatory authority.

Marginal note:Sale to exempted person

190 The Minister may sell or provide a controlled substance to a person that the Minister has exempted under subsection 56(1) of the Act with respect to that substance.

Delivery, Sending and Transportation

Marginal note:Authorization

191 The Minister may deliver, send or transport a controlled substance.

Import and Export

Marginal note:Import

192 The Minister may import a controlled substance that is intended to be sold or provided to one of the following persons:

• (a) a practitioner named in a letter of authorization; or

• (b) a person exempted under subsection 56(1) of the Act with respect to that substance.

Marginal note:Export

193 The Minister may export a controlled substance.

Provision of Information to Third Parties

Marginal note:Provincial government or regulatory authority — entitled persons

• 194 (1) The Minister may provide in writing any factual information that has been obtained under the Act or these Regulations about a pharmacist, pharmacy technician, practitioner or any other health professional to any relevant provincial government or to any provincial professional regulatory authority of a province in which the person is or was entitled by that authority to practise their profession, if

  • (a) the government or authority submits to the Minister a written request that sets out the person’s name and municipal address, a description of the information being requested and a statement that the information is required for the purpose of assisting a lawful investigation by the government or authority;

  • (b) the Minister has reasonable grounds to believe that the person has

    • (i) contravened a rule of conduct established by the authority,

    • (ii) been convicted of a designated substance offence, or

    • (iii) contravened these Regulations; or

  • (c) the Minister has reasonable grounds to believe that the provision of the information is necessary to assist the government or authority in monitoring the person’s professional conduct for compliance with the laws of the province for the purpose of protecting public health or safety.

• Marginal note:Provincial government or regulatory authority — persons not entitled

  (2) The Minister may provide in writing any factual information that has been obtained under the Act or these Regulations about a pharmacist, pharmacy technician, practitioner or any other health professional to any relevant provincial government or any provincial professional regulatory authority of a province in which the person is not entitled by that authority to practise their profession, if the government or authority submits to the Minister

  • (a) a written request that sets out the person’s name and municipal address and a description of the information being requested; and

  • (b) a document that shows that

    • (i) the person has applied to that authority to practise in that province, or

    • (ii) the government or authority has reasonable grounds to believe that the person is practising in that province without being authorized to do so.

Marginal note:Customs officer

195 The Minister may, for the purpose of verifying whether an importation or exportation of a controlled substance complies with these Regulations, provide the following to a customs officer:

• (a) information provided in the permit application under section 34, 42, 205 or 213;

• (b) information listed on the permit under subsection 35(1), 43(1), 206(1) or 214(1);

• (c) information provided in the declaration under section 39, 47, 210 or 218; or

• (d) information concerning the suspension or revocation of an import or export permit.

Marginal note:International Narcotics Control Board

196 The Minister may provide to the International Narcotics Control Board any information that is obtained under the Act or these Regulations if the provision would allow Canada to respect its international obligations in relation to controlled substances.

Marginal note:Competent authorities

197 The Minister may, for the purposes of the administration or enforcement of the Act or these Regulations or if it would allow Canada to respect its international obligations in relation to controlled substances, provide to a competent authority

• (a) information obtained from a licensed dealer that has applied for or that holds an import or export permit;

• (b) information relating to

  • (i) an import or export permit, or

  • (ii) an activity specified on a dealer’s licence held by a licensed dealer that has applied for or that holds an import or export permit;

• (c) any document that the holder or former holder of an import or export permit is required to retain, including any document that relates to the dealer’s licence that the dealer holds or held; and

• (d) a copy of any import or export permit.

Temporary Scheduling

Marginal note:Restricted drugs

• 198 (1) The Minister may, by order, add to Part 3 of Schedule 4 to these Regulations any item or portion of an item listed in Schedule V to the Act.

• Marginal note:Deletion

  (2) The Minister may, by order, delete any item or portion of an item from Part 3 of Schedule 4.

• Marginal note:Deletion — Schedule V to Act

  (3) An item or portion of an item listed in Part 3 of Schedule 4 to these Regulations is deemed to be deleted on the day on which the equivalent item or portion of an item is no longer listed in Schedule V to the Act.

Government Laboratories

Production

Marginal note:Authorization

199 A government laboratory may produce a controlled substance.

Sale of Controlled Substances

Marginal note:Sale to licensed dealer

200 A government laboratory may sell or provide a controlled substance to a licensed dealer.

Marginal note:Sale to Minister

201 A government laboratory may sell or provide a controlled substance to the Minister.

Marginal note:Sale to another government laboratory

202 A government laboratory may sell or provide a controlled substance to another government laboratory.

Delivery, Sending and Transportation

Marginal note:Authorization

203 A government laboratory may deliver, send or transport a controlled substance.

Import and Export

Authorization

Marginal note:Condition

204 A government laboratory may import or export a controlled substance if it does so in accordance with an import or export permit issued under these Regulations.

Import Permit

Marginal note:Application

• 205 (1) A government laboratory must submit to the Minister, before each importation of a controlled substance, an application for an import permit that contains the following information:

  • (a) the government laboratory’s name and municipal address;

  • (b) the name and municipal address of the proposed customs broker for the government laboratory, if any;

  • (c) the name of the customs office where the importation is anticipated and the proposed date of importation;

  • (d) the name and municipal address, in the country of export, of the exporter from whom the controlled substance is being obtained;

  • (e) the name of the carrier that is proposed to transport the controlled substance to the customs office where the importation is anticipated;

  • (f) each proposed mode of transportation and any proposed country of transit or transhipment;

  • (g) in the case of a controlled substance set out in any of Schedules 1 to 4,

    • (i) its name,

    • (ii) its CAS registry number, if any,

    • (iii) if it is a salt, the name of the salt,

    • (iv) its form,

    • (v) its purity and anhydrous content, and

    • (vi) its quantity; and

  • (h) in the case of a mixture or finished product,

    • (i) its name or, if applicable, brand name, as well as the name of the controlled substance it contains,

    • (ii) its form, its strength, the number of containers and, if applicable, the number of units per container, and

    • (iii) its drug identification number, if any.

• Marginal note:Signature and attestation

  (2) The application must

  • (a) be signed and dated by the person in charge of the government laboratory; and

  • (b) include an attestation by that person that, to the best of their knowledge,

    • (i) the importation does not contravene the laws of the country of exportation or any country of transit or transhipment, and

    • (ii) all of the information and documents submitted in support of the application are correct and complete.

• Marginal note:Additional information and documents

  (3) The government laboratory must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application.

Marginal note:Issuance

• 206 (1) Subject to section 208, on completion of the review of the import permit application, the Minister must issue to the government laboratory an import permit that contains

  • (a) the permit number;

  • (b) the information set out in subsection 205(1);

  • (c) the effective date of the permit;

  • (d) the expiry date of the permit, which must be not later than 180 days after its effective date; and

  • (e) any terms and conditions that the Minister has reasonable grounds to believe are necessary to

    • (i) ensure that an international obligation is respected, or

    • (ii) reduce a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use.

• Marginal note:Permit integrity

  (2) A person must not alter or deface in any manner an import permit.