GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Controlled Substances Regulations — 177
Substances sold or administered — individuals 177 A hospital that sells or provides a controlled substance to an individual for their own use, for the use of another individual or for an animal, or that administers a controlled substance to an individual or an animal, must record the following information: (a) the name of the person selling, providing or administering the controlled substance; (b) the name of the individual who is named in the prescription or who is responsible for the animal identified in the prescription and, if applicable, the name of the animal; (c) the date of the sale, provision or administration; (d) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and (e) in the case of a finished product, (i) its name or, if applicable, brand name, (ii) its form, strength and quantity, and (iii) its drug identification number, if any.
Controlled Substances Regulations — 178
Finished products compounded 178 A hospital that compounds a finished product must record the following information: (a) the name of the person compounding the finished product; (b) the name of the individual who is named in the prescription or who is responsible for the animal identified in the prescription and, if applicable, the name of the animal; (c) the name of the practitioner who issued the prescription, as well as the name and municipal address of the place where they practise; (d) the number assigned to the prescription; (e) the date of compounding; and (f) with respect to the finished product, (i) its name, and (ii) its form, strength and quantity.
Controlled Substances Regulations — 179
Controlled substance substitutions 179 A hospital that substitutes a controlled substance for another controlled substance identified in a prescription must record the following information: (a) the name of the person who carries out the substitution; (b) the number assigned to the original prescription; (c) the date of the substitution; (d) the name of the controlled substance identified in the prescription; and (e) the name of the substitute controlled substance.
Controlled Substances Regulations — 180
Written orders 180 A hospital that receives a written order for a controlled substance must record the following information: (a) the name of the person receiving the order; and (b) the date of the order and the date on which it was received.
Controlled Substances Regulations — 181
Verbal orders 181 A hospital that receives a verbal order for a controlled substance must record the following information: (a) the name of the person receiving the order; (b) with respect to the person placing the order, (i) their name, municipal address and, in the case of another hospital, the name of the person permitted to place the order on its behalf, and (ii) a declaration that they require the controlled substance for emergency purposes or, in the case of another hospital, a declaration from the person placing the order that the other hospital requires the controlled substance for emergency purposes; (c) the date of receipt of the order; (d) in the case of a controlled substance set out in any of Schedules 1 to 3, its name, form and quantity; and (e) in the case of a finished product, (i) its name or, if applicable, brand name, (ii) its form, strength and quantity, and (iii) its drug identification number, if any.
Controlled Substances Regulations — 182
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.
Controlled Substances Regulations — 183
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.
Controlled Substances Regulations — 184
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.
Controlled Substances Regulations — 185
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.
Controlled Substances Regulations — 186
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.
Controlled Substances Regulations — 187
Quality of documents 187 The documents must be complete and readily retrievable and the information in them must be legible and indelible.
Controlled Substances Regulations — 188
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.
Controlled Substances Regulations — 189
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. 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.
Controlled Substances Regulations — 190
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.
Controlled Substances Regulations — 191
Authorization 191 The Minister may deliver, send or transport a controlled substance.
Controlled Substances Regulations — 192
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.
Controlled Substances Regulations — 193
Export 193 The Minister may export a controlled substance.
Controlled Substances Regulations — 194
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. 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.
Controlled Substances Regulations — 195
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.
Controlled Substances Regulations — 196
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.
Controlled Substances Regulations — 197
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.
Controlled Substances Regulations — 198
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. Deletion (2) The Minister may, by order, delete any item or portion of an item from Part 3 of Schedule 4. 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.
Controlled Substances Regulations — 199
Authorization 199 A government laboratory may produce a controlled substance.
Controlled Substances Regulations — 200
Sale to licensed dealer 200 A government laboratory may sell or provide a controlled substance to a licensed dealer.
Controlled Substances Regulations — 201
Sale to Minister 201 A government laboratory may sell or provide a controlled substance to the Minister.
Controlled Substances Regulations — 202
Sale to another government laboratory 202 A government laboratory may sell or provide a controlled substance to another government laboratory.
Controlled Substances Regulations — 203
Authorization 203 A government laboratory may deliver, send or transport a controlled substance.
Controlled Substances Regulations — 204
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.
Controlled Substances Regulations — 205
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. 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. 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.
Controlled Substances Regulations — 206
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. Permit integrity (2) A person must not alter or deface in any manner an import permit.
Controlled Substances Regulations — 207
Validity 207 An import permit is valid until the earliest of (a) the expiry date set out in the permit, (b) the date of the suspension or revocation of the permit under section 211 or 212 , and (c) the date of the expiry, suspension or revocation of the export authorization that applies to the controlled substance to be imported and that is issued by the competent authority in the country of export.
Controlled Substances Regulations — 208
Refusal 208 (1) The Minister must refuse to issue an import permit if (a) the Minister has reasonable grounds to believe that the importation would contravene an international obligation; (b) the government laboratory has not provided the Minister with the information or documents required under subsection 205 (3) or before the date specified in the written request referred to in that subsection, or the information or documents that it has provided before that date are not sufficient to complete the review of the permit application; (c) the Minister has reasonable grounds to believe that the government laboratory has submitted false or misleading information or false or falsified documents in or in support of the permit application; (d) the Minister has reasonable grounds to believe that the importation would contravene the laws of the country of export or any country of transit or transhipment; or (e) the Minister has reasonable grounds to believe that the issuance of the permit would likely create a risk to public health or safety, including the risk that a controlled substance could be diverted to an illicit market or use. Prior notice (2) Before refusing to issue an import permit, the Minister must (a) provide the government laboratory with a prior written notice that sets out the Minister’s reasons and gives the government laboratory an opportunity to be heard; and (b) consider the government laboratory’s submissions, if applicable.
Controlled Substances Regulations — 209
Providing copy of permit 209 The holder of an import permit must provide a copy of the permit to the customs office at the time of importation.
Controlled Substances Regulations — 210
Declaration 210 The holder of an import permit must provide the Minister, within 15 days after the day of release of the controlled substance specified in the permit in accordance with the Customs Act , with a declaration that contains the following information: (a) the permit holder’s name; (b) the number of the import permit; (c) the name of the customs office from which the controlled substance was released and the date of the release; (d) in the case of a controlled substance set out in any of Schedules 1 to 4, (i) its name, (ii) if it is a salt, the name of the salt, (iii) its form, and (iv) its quantity; and (e) 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.
Controlled Substances Regulations — 211
Suspension 211 (1) Subject to subsection (2), the Minister must immediately suspend an import permit if (a) the Minister has reasonable grounds to believe that the suspension is necessary to protect public health or safety, including to prevent a controlled substance from being diverted to an illicit market or use; or (b) the Minister has reasonable grounds to believe that the importation would contravene the laws of the country of export or any country of transit or transhipment. Notice (2) The suspension takes effect as soon as the Minister provides the government laboratory with a written notice that (a) sets out the reasons for the suspension; (b) gives the government laboratory an opportunity to be heard; and (c) if applicable, specifies the corrective measures that must be carried out and the date by which they must be carried out. Reinstatement of permit (3) The Minister must reinstate the import permit if the Minister has reasonable grounds to believe that the suspension is no longer necessary.
Controlled Substances Regulations — 212
Revocation 212 (1) The Minister must revoke an import permit if (a) the government laboratory requests the Minister to do so or informs the Minister of the loss or theft of the permit or the actual or potential unauthorized use of the permit; (b) the government laboratory does not carry out the corrective measures specified by the Minister under paragraph 211 (2)(c) by the specified date; or (c) the Minister has reasonable grounds to believe that the government laboratory submitted misleading information or falsified documents in or in support of the application for the permit. Prior notice (2) Before revoking an import permit, the Minister must (a) provide the government laboratory with a prior written notice that sets out the Minister’s reasons and gives the government laboratory an opportunity to be heard; and (b) consider the government laboratory’s submissions, if applicable.