Food and Drug Regulations

Marginal note:Record — controlled drugs

• G.05.001 (1) A person who is in charge of a hospital shall keep or cause to be kept a record of the following information:

  • (a) the name and quantity of any controlled drug received for the hospital by a hospital employee or a practitioner in the hospital;

  • (b) the name and address of the person from whom any controlled drug was received and the date on which it was received;

  • (c) the name and quantity of any controlled drug used in the making or assembling of a product or compound containing that controlled drug, the name and quantity of the product or compound made or assembled and the date on which the product or compound was placed in stock;

  • (c.1) the name and quantity of any controlled drug produced and the date on which it was placed in stock;

  • (d) the name of the patient for whom a controlled drug was dispensed;

  • (e) the name of the practitioner ordering or prescribing a controlled drug; and

  • (f) the date on which a controlled drug was ordered or prescribed and the form and quantity thereof.

• Marginal note:Record keeping

  (2) Subject to subsections (3) and (4), the record of information referred to in subsection (1) shall be kept

  • (a) in a manner that permits an audit to be made;

  • (b) in a book, register or similar record maintained exclusively for controlled drugs; and

  • (c) for a period of at least two years.

• Marginal note:Exception — preparation

  (3) The information referred to in paragraphs (1)(d) to (f) may, with respect to a preparation, be kept in a form other than that specified in paragraph (2)(b).

• Marginal note:Exception — Part II or III of schedule

  (4) The information referred to in subsection (1) may, with respect to a controlled drug listed in Part II or III of the schedule to this Part, be kept in a form other than that specified in paragraph (2)(b).