Food and Drug Regulations (C.R.C., c. 870)

Regulations are current to 2017-07-03 and last amended on 2017-06-20. Previous Versions

 Subject to section G.03.002.2 and notwithstanding sections G.03.002, G.03.003 and G.03.005, no pharmacist shall

  • (a) sell or provide a controlled drug, other than a preparation, to a pharmacist named in a notice given by the Minister under section G.03.017.2;

  • (b) sell or provide a preparation to a pharmacist named in a notice given by the Minister under section G.03.017.2;

  • (c) dispense, sell or provide a controlled drug, other than a preparation, to, or pursuant to a prescription or order given by, a practitioner named in a notice given by the Minister under section G.04.004.2; or

  • (d) dispense, sell or provide a preparation to a practitioner or pursuant to a prescription or order given by a practitioner named in a notice given by the Minister under section G.04.004.2.

  • SOR/2003-135, ss. 7, 8;
  • SOR/2004-238, s. 15.

 Section G.03.002.1 does not apply to a pharmacist to whom the Minister has issued a notice of retraction of the notice

  • (a) under section G.03.017.3, in respect of a pharmacist named in a notice issued by the Minister under section G.03.017.2; or

  • (b) under section G.04.004.3, in respect of a practitioner named in a notice issued by the Minister under section G.04.004.2.

  • SOR/2003-135, s. 4.
  •  (1) A pharmacist may sell or provide a controlled drug to a practitioner for use in their practice

    • (a) upon a written order, signed and dated by that practitioner, that has been verified if the signature of the practitioner is unknown to the pharmacist; or

    • (b) upon a verbal order specifying the name and quantity of the drug if the pharmacist has taken reasonable precautions to satisfy themself that the person making the order is a practitioner.

  • (2) For the purpose of subsection (1), for greater certainty, a pharmacist may sell or provide a controlled drug to a midwife, nurse practitioner or podiatrist only if the midwife, nurse practitioner or podiatrist is permitted to prescribe or possess the controlled drug, or to conduct an activity with it, in accordance with sections 3 and 4 of the New Classes of Practitioners Regulations.

  • SOR/85-550, s. 5;
  • SOR/2004-238, s. 16;
  • SOR/2012-230, s. 11.

 A pharmacist shall, in respect of controlled drugs sold or provided to a practitioner under section G.03.003, keep in a special prescription file a record showing the date, the name and address of the practitioner, and the quantity and kind of controlled drug sold or provided.

  • SOR/2004-238, s. 17.

 A pharmacist may provide a controlled drug to a hospital employee or to a practitioner in a hospital on receipt of a written order signed and dated by the pharmacist in charge of the dispensary of the hospital or by a practitioner authorized by the person in charge of the hospital to sign the order, if the signature of that pharmacist or practitioner is known to the pharmacist or, if unknown, has been verified.

  • SOR/85-550, s. 6;
  • SOR/2004-238, s. 18(E).

 A pharmacist shall not refill a prescription for a controlled drug unless

  • (a) the practitioner, at the time that he issued the prescription, directed in writing, in the case of a controlled drug listed in Part I of the schedule to this Part, or directed in writing or orally, in the case of a controlled drug listed in Part II or III of the schedule to this Part, that the prescription be refilled, the number of times that it may be refilled and the dates for or the intervals between refills; and

  • (b) the pharmacist keeps a record of each refilling of a prescription.

  • SOR/78-427, s. 6;
  • SOR/97-228, s. 13.

 A pharmacist who dispenses, pursuant to an order or prescription, a controlled drug listed in Part I of the schedule to this Part, other than a preparation, shall forthwith enter in a book, register or similar record maintained for such purposes

  • (a) the name and address of the person named in the order or prescription;

  • (b) the name, initials and address of the practitioner who issued the order or prescription;

  • (c) the name or initials of the pharmacist who dispensed the controlled drug;

  • (d) the name, quantity and form of the controlled drug dispensed;

  • (e) the date on which the controlled drug was sold or provided; and

  • (f) the number assigned to the order or prescription.

  • SOR/78-427, s. 7;
  • SOR/81-359, s. 1(F);
  • SOR/97-228, s. 14;
  • SOR/2004-238;
  • s. 19.

 A pharmacist shall, before dispensing a controlled drug pursuant to a prescription given orally or a verbal order, make a written record thereof, setting forth,

  • (a) the name and address of the person named in the prescription;

  • (b) the name, quantity and form of such controlled drug;

  • (c) the directions for use given therewith;

  • (d) the name, initials and address of the practitioner who issued the prescription;

  • (e) the name or initials of the pharmacist who dispensed such controlled drug;

  • (f) the date on which the controlled drug was sold or provided; and

  • (g) the number assigned to the prescription.

  • SOR/85-550, s. 7;
  • SOR/2004-238, s. 20.

 A pharmacist shall maintain a special prescription file in which shall be filed in sequence as to date and number all written orders or prescriptions in writing for controlled drugs dispensed and the written record of all controlled drugs dispensed pursuant to a prescription or order verbally given.

 A pharmacist shall retain in his possession for a period of at least two years, any records which he is required to keep by this Part.

 A pharmacist shall

  • (a) furnish such information respecting the dealings of the pharmacist in any controlled drug in such form and at such times as the Minister may require;

  • (b) make available and produce to an inspector upon request his special prescription file together with any books, records or documents which he is required to keep;

  • (c) permit an inspector to make copies of or to take extracts from such files, books, records or documents; and

  • (d) permit an inspector to check all stocks of controlled drugs on his premises.

 A pharmacist shall take all reasonable steps that are necessary to protect controlled drugs on his premises or under his control against loss or theft.

  • SOR/85-550, s. 8.

 A pharmacist shall report to the Minister any loss or theft of a controlled drug within 10 days of his discovery thereof.

 A pharmacist may, upon receiving a written order for a controlled drug signed and dated by

  • (a) the licensed dealer who sold or provided that drug to them, return that drug to that licensed dealer;

  • (b) another pharmacist, sell or provide any quantity of that drug to that other pharmacist that is specified in the order as being required for emergency purposes;

  • (c) a Regional Director of the Department, sell or provide to or in accordance with the order of that Director any quantity of that drug, specified in the order, that is required by the Director in connection with their duties; and

  • (d) a person exempted under section 56 of the Controlled Drugs and Substances Act with respect to that controlled drug, sell or provide to that person any quantity of that drug that is specified in the order.

  • SOR/81-359, s. 2;
  • SOR/85-550, s. 9;
  • SOR/99-125, s. 3;
  • SOR/2004-238, s. 21;
  • SOR/2014-260, s. 8(E).

 A pharmacist shall immediately after receiving, selling or providing a controlled drug under paragraph G.03.014(b) or (c) or subsection G.05.003(4) enter the details of the transaction in a book, register or other record maintained for the purpose of recording such transactions.

  • SOR/85-550, s. 10;
  • SOR/2004-238, s. 22.

 A pharmacist shall forthwith after removing, transporting or transferring a controlled drug from his place of business to any other place of business operated by him notify the Minister, setting out the details.

 The Minister shall provide in writing any factual information about a pharmacist that has been obtained under the Act or these Regulations to the provincial professional licensing authority responsible for the registration or authorization of the person to practise their profession

  • (a) in the province in which the pharmacist is registered or entitled to practise if

    • (i) the authority submits a written request that states the name and address of the pharmacist, a description of the information being sought and a statement that the information is required for the purpose of assisting a lawful investigation by the authority, or

    • (ii) the Minister has reasonable grounds to believe that the pharmacist has

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

      • (B) been found guilty in a court of law of a designated drug offence or of a contravention of this Part, or

      • (C) contravened a provision of this Part; or

  • (b) in a province in which the pharmacist is not registered or entitled to practise, if the authority submits to the Minister

    • (i) a written request for information that states

      • (A) the name and address of the pharmacist, and

      • (B) a description of the information being sought, and

    • (ii) documentation that shows that the pharmacist has applied to that authority to practise in that province.

  • SOR/86-881, s. 1;
  • SOR/97-228, s. 15;
  • SOR/2003-135, s. 5;
  • SOR/2010-222, s. 15.
 
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