Controlled Substances: Purchase & Sales Record Requirements (Federal)

FACT SHEET

Legislative References:

A fact sheet summarizes relevant legislation in one place. Registrants are reminded to refer to legislation for full context.

Additional References:

Background

Canada’s Controlled Drugs and Substances Act (CDSA) provides a legislative framework aimed at controlling access to substances that can alter mental processes and produce harm to the health of an individual and/or society when diverted or misused.

The Narcotic Control Regulations (NCR), the Benzodiazepines and Other Targeted Substances Regulations (BOTSR) made under the CDSA and Part G of the Food and Drug Regulations (FDR-G) made under the Food and Drugs Act govern the records pharmacists and hospitals are required to keep for purchases and sales of each class of controlled substances.

Definitions

Controlled substance: A drug named in the federal Controlled Drug and Substances Act (CDSA), Schedules I, II, III, IV, V. These substances are also listed in the schedules to regulations made under the Act as either narcotics, controlled drugs, or benzodiazepines and other targeted substances. (CDSA)

Licensed Dealer: an individual or corporation granted a licence from the federal Minister of Health to conduct activities with (e.g, make, sell, provide, transport, deliver, etc.) the controlled substances specified in their licence. (NCR s.9)

Controlled Substance Signer: a pharmacist who is designated by a pharmacy to be authorized to sign the documentation required under the Controlled Drug and Substances Act (Canada) or the regulations thereunder in order to obtain controlled substances for the pharmacy.

Verbal Prescription Narcotic: a narcotic that is contained in medication that may be prescribed verbally and that has the following characteristics:

(a) it contains two or more medicinal ingredients that are not narcotics, in a recognized therapeutic dose;

(b) it is not intended for parenteral administration; and

(c) it does not contain diacetylmorphine (heroin), hydrocodone, methadone, oxycodone or pentazocine.

Purchase Records

Pharmacists and persons who are in charge of a hospital are required to maintain up-to-date records of all controlled substances received, in a book, register or other record maintained for the purpose of recording such transactions:

  • In a book or register: For manual records, pharmacies may use the Pharmacy Narcotic and Controlled Drug Register.
  • Invoice-based[1]: Purchase receipts, packing slips, invoices or copies thereof should be filed in chronological order and/or stored electronically in a dedicated file.
  • Computer-based (electronic): Utilizing software capable of generating a printout or report of purchase records on demand.

Purchase records for a narcotic[2], controlled drug in Part I of the schedule to Part G[3] or benzodiazepines and other targeted substance[4] contains the following information about each drug received:

  • Name and strength
  • Quantity (i.e., units per package and number of packages)
  • Date on which it was received
  • Name and address of the person (licensed dealer, pharmacist or hospital) from whom the drug was received.
Sale Records

Pharmacists are required to maintain up-to-date records of selling or providing controlled substances sales in a book, register or other record maintained for such purposes:

  • In a book or register: For manual records, pharmacies may use the Pharmacy Narcotic and Controlled Drug Register.
  • Computer-based (electronic): Utilizing software capable of generating a printout or report of sales or dispensing records on demand.

A sales record for a narcotic[5] or controlled drug[6] in Part I of the schedule to Part G must contain the following:

  • Pharmacist name or initials
  • Name, initials and address of the prescriber
  • Name and address of the patient
  • Name, form and quantity of the drug
  • Date on which the drug was dispensed
  • Number assigned to the order or prescription
  • Written record of a verbal order or prescription must also include the directions for use given
  • A sales record for a verbal prescription narcotic, controlled drug preparation, or controlled drug in Part II or III of the schedule to Part G is not required, unless provided to:
    • a practitioner for use in their practice (G.03.003)
    • another pharmacist or a hospital for emergency use (G.03.015)
  • A sales record for a benzodiazepines and other targeted substance[7] is only required for activities without a prescription (e.g., sale to a practitioner, another pharmacist or a hospital) and must contain:
    • The written order or hard copy created of a verbal order
    • The name, quantity and strength per unit of the targeted substance sold
    • The name and address of the person to whom the targeted substance was sold
    • The date of the transaction

Retention of Purchase & Sale Records

  • Records required to be kept by federal regulations must be retained for a period of at least two years and be readily retrievable and in the pharmacist’s possession (i.e., on the pharmacy premises)
  • Regardless of the manner in which records are maintained, all records must be complete, legible, indelible and permit an audit to be made.
  • Records must be made available on request to a Health Canada inspector, or a representative of the College for the purposes of carrying out an assessment or investigation.
    • Health Canada is responsible for verifying compliance or preventing non-compliance with the provisions of the CDSA or its regulations to ensure controlled substances are managed and monitored appropriately. For questions please contact: hc.compliance-conformite.sc@canada.ca.
    • Health Canada may share information regarding pharmacies that have received a non-compliant inspection rating with the College[8]

Published: August 2012
Version #: 2.00

College Contact: Pharmacy Practice

Revision History
Version # Date Action
1 August 2012 Published as “Narcotic Purchase Records”
2 October 2021 Revised to include sales records, all controlled substances, and hospitals

 

  1. Invoices are financial records and may be subject to longer retention periods for the purposes of Canada Revenue Agency. Pharmacists should verify these requirements with their accountant.
  2. NCR, s63
  3. FDR, s G.05.001(1)
  4. BOTSR, s 55(1), 66
  5. NCR, s 38, 39, 40, 45(2)
  6. FDR, s G.03.003, G.03.007, G.03.008, G.03.009, G.03.015
  7. BOTSR, s 51(3), 53, 55(2), (3), (4), 66
  8. Community Pharmacy Inspection Program Annual Report, Fiscal Year 2019-2020