Controlled Substances: Orders, Purchases and Sales (Federal)

FACT SHEET

Legislative References:

• Controlled Drugs and Substances Act (CDSA)
  • Narcotic Control Regulations (NCR)
  • Benzodiazepine and Other Targeted Substances Regulations (BOTSR)
• Food and Drug Regulations, Part G (FDR)

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

Additional references:

• College By-Law No. 6
• Prescription Regulation Summary Chart
• Fact Sheet – Controlled Substances: Purchase & Sales Record Requirements (Federal)
• Form – Request for Controlled Substance Signing Authority for Community Pharmacies
• Form – Request for Controlled Substance Signing Authority for Hospital Pharmacies

Background

Controlled substances are regulated federally by Health Canada and the Office of Controlled Substances (OCS). The 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 ordering and selling or providing of each class of controlled substances by pharmacists and hospitals from licensed dealers and each other.

Definitions

Controlled Substance: A substance included in Schedule I, II, III, IV or V of the federal Controlled Drug and Substances Act (CDSA). 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)

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.

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)

Signing Authority

• In a community pharmacy, the Designated Manager (DM) is authorized as a controlled substance signer.
  • The DM, owner or director may designate additional pharmacists to have controlled substance signing authority.
• In a hospital pharmacy, the pharmacist in charge is authorized as a controlled substance signer.
  • The person in charge of the hospital (CEO) may designate a practitioner to have controlled substance signing authority.
• The name and location of every pharmacy (workplace) where a pharmacist is authorized to sign for controlled substances appears on the public register where it can be verified.

Orders, Purchases & Sales (other than pursuant to a patient-specific prescription)

From a licensed dealer

• A licensed dealer may sell a controlled substance to a pharmacist^[1] or hospital^[2] upon receipt of a signed and dated written order that specifies its name and quantity and the dealer has verified the signature of the pharmacist (i.e., that the pharmacist has controlled substance signing authority^[3]).
  • For electronic ordering, refer to Health Canada’s Policy Statement on the Electronic Ordering of Controlled Substances.
• Where a narcotic or controlled drug is ordered verbally, if permitted by regulations^[4], the licensed dealer must obtain a signed and dated receipt, specifying the name and quantity of drug received, within five (5) working days after filling the order.
  • If this requirement is not met, the licensed dealer must withhold future verbal orders from the pharmacist^[5].

Sale, Provision or Transfer for Emergency Supply

• Pharmacist to pharmacist
  • A pharmacist may sell or provide a narcotic or controlled drug to another pharmacist on receipt of a signed and dated written order, where the quantity is specified as being required for emergency purposes^[6].
  • A pharmacist may sell or provide, a benzodiazepine or other targeted substance to another pharmacist who states in writing or verbally that it is required because of a delay or shortfall in an order placed with a licensed dealer^[7].
• Controlled substance signing authority is not required for the above transactions.
• Hospital to/from pharmacist
• A pharmacist may sell or provide a narcotic or controlled drug to a hospital if the pharmacist receives a written order for the narcotic signed and dated by the pharmacist in charge of the hospital’s pharmacy^[8].
• The person in charge of a hospital may permit a narcotic or controlled drug to be sold or provided to a pharmacist for emergency purposes, on receipt of a written order signed and dated by a pharmacist who is a controlled substance signer^[9].
  • A pharmacist may sell or provide a benzodiazepine or other targeted substance to a hospital if the written or verbal order is placed by a pharmacist who is authorized to order the targeted substance on behalf of the hospital^[10].
• Hospital to hospital
  • The person in charge of a hospital may provide a narcotic or controlled drug to another hospital for emergency purposes, on receipt of a written order signed and dated by a pharmacist in the other hospital who is a controlled substance signer^[11].
  • A hospital pharmacist may sell or provide a benzodiazepine or other targeted substance to another hospital, on receipt of an order stating that it is required because of a delay or shortfall in an order placed with a licensed dealer or pharmacist, from a pharmacist in the other hospital who is a controlled substance signer.

Note: Under the CDSA, s.2(1), the definition of “provide” also means “to transfer”. Health Canada advises that these provisions are not intended to be used for stock management purposes. Typically, the quantities involved would be limited to what is necessary to fill a single prescription. An emergency order transaction must be captured by both pharmacist’s respective receiving and dispensing records^[12].

Exception: Health Canada Notices of Restriction

• A notice of restriction may be issued by Health Canada to pharmacies and licensed dealers not to sell or provide controlled substances to the pharmacist named in a notice of prohibition or restriction^[13].
• Access Health Canada’s website for the list of health care practitioners and pharmacists named in a notice of restriction.

Published: September 2021
Version #: 2.2

College Contact: Pharmacy Practice

Revision History

1. NCR, s 25.1, FDR, s G.02.052, BOTSR, s 32 ↑
2. NCR, s 25.3, FDR, s G.02.054, BOTSR, s 32, 63(2) ↑
3. NCR, s 25.6, FDR, s G.02.057, BOTSR, s 33 ↑
4. A verbal prescription narcotic or controlled drug in Part II or III of the Schedule to Part G ↑
5. NCR, s 25.7, FDR, s G.02.058 ↑
6. NCR, s45(1)(2), FDR G.03.014 (b) ↑
7. BOTSR, s 55(1)(b)(ii) ↑
8. NCR, s35, FDR s G.03.005 ↑
9. NCR s65(4)(5.1), ), FDR s G.05.003 (4) ↑
10. BOTSR, s 55(1)(b)(iii) ↑
11. NCR, s65(3)(5.1), FDR s G.05.003 (3) ↑
12. Controlled substances guidance for community pharmacists: security, inventory reconciliation and record-keeping (Health Canada January 2023) ↑
13. NCR s 25.1(2), 32