1.2 Controlled Drugs and Substances Act (CDSA) & Controlled Substances Regulations (CSR)

Controlled Drugs and Substances Act (CDSA) and the Controlled Substances Regulations (CSR)

Controlled substances sit on top of the ordinary prescription rules. The Controlled Drugs and Substances Act (CDSA) creates the offences (possession, trafficking, production, import and export) and lists substances in its schedules. Regulations made under the Act say who may lawfully handle those substances and how.

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The CDSA Schedules vs. the CSR Schedules

The two sets of schedules do different jobs:

• CDSA Schedules I–VI decide criminal penalties. Schedule I includes most opioids, cocaine, amphetamines and methamphetamine. Schedule III includes hallucinogens such as LSD and psilocybin, as well as methylphenidate. Schedule IV includes benzodiazepines, barbiturates and anabolic steroids. Schedule VI lists precursor chemicals such as ephedrine and pseudoephedrine used in illicit synthesis.
• CSR Schedules 1–4 decide the practice rules for pharmacists, practitioners and licensed dealers. Every controlled substance falls into exactly one CSR class.

Restricted drugs (Schedule 4) cannot be sold to patients through a community pharmacy. Access runs through clinical trials, the Special Access Program combined with a subsection 56(1) exemption, or a letter of authorization.

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Sale to an Individual: What Counts as a Valid Prescription

Under CSR section 98(1), a pharmacist may sell or provide a controlled substance to an individual when all of these conditions are met:

1. The sale is for the individual's own use, for another individual, or for an animal.
2. The substance is a finished product (DIN product or a pharmacy compound) that does not contain a restricted drug.
3. Before the sale, the pharmacist receives one of the following:
   • a written prescription presented by the patient;
   • a written or verbal prescription directly from the practitioner; or
   • from another pharmacist or pharmacy technician, the written prescription or a copy of the record of a verbal prescription (a transfer).

This rule applies to all four non-restricted schedules, including Schedule 1 narcotics such as oxycodone and hydromorphone. The old NCR barrier that banned verbal prescriptions for "straight" narcotics is gone federally. A pharmacist or a pharmacy technician may receive and record a verbal prescription (s. 117). The record includes:

• the name of the person who received it;
• the prescriber's name and practice address;
• the date received;
• the drug name, form, strength and quantity (plus DIN for a finished product); and
• any authorized refills and intervals.

Only a pharmacist sells or provides the controlled substance to the patient. Technicians may prepare, compound and record, but the final hand-off and counselling stay with the pharmacist.

Verification of identity (s. 103). Anyone receiving an order or prescription for a controlled substance must verify the person's name and title. They must also verify the person's signature if the pharmacist does not know it. Forged or altered prescriptions remain a common diversion route. Call the prescriber's office using an independently confirmed number, not the number printed on the prescription.

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Refills, Part-Fills, Extensions, Transfers, and Substitution

The CSR replaced several NCR and BOTSR restrictions with a single set of rules:

Practice consequences:

• Extension is a pharmacist act; both parts must be satisfied. The province must allow pharmacist renewals or adaptations, and the CSR two-year outer limit applies.
• Transfers move the original written prescription or the verbal-prescription record. Both the sending and the receiving professional record:
  • their names and practice addresses;
  • the prescription number;
  • the dates;
  • the date of the last fill; and
  • the refills remaining (s. 119).
• Substitution depends on the province. For example, Ontario pharmacists may adapt but may not therapeutically substitute a controlled substance. A pharmacist who substitutes must record the original and substitute drug (s. 115).

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Low-Dose Codeine Without a Prescription

Under CSR s. 98(2), a pharmacist may sell a low-dose codeine product without a prescription only when all of these conditions are met:

• Strength: not more than 8 mg codeine phosphate per solid unit, or 20 mg per 30 mL of liquid.
• Other ingredients: the product contains two or three additional non-narcotic medicinal ingredients at the minimum doses the regulation sets.
• Use: the pharmacist has reasonable grounds to believe it will be used only for recognized medical purposes.
• Labelling: the label carries the caution: "This product contains codeine and should not be administered to children except on the advice of a physician, dentist or nurse practitioner."

NAPRA lists these products in Schedule II. They stay behind the counter, and the pharmacist must be involved in the sale. Many provinces add further limits (for example, recording sales or restricting pack sizes), and Health Canada advises against codeine for children under 12.

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Storage, Delivery, Loss and Theft, and Destruction

• Storage (s. 105, 108): The pharmacist keeps every controlled substance in a secure location. Only people the pharmacist authorizes may access it, and all reasonable security measures must be taken.
• Delivery (s. 106–107): Pharmacists and technicians may deliver, send or transport controlled substances. They must use a trackable method and secure the package during transit.
• Loss or theft (s. 109): An employee or agent who becomes aware of a loss or theft tells the pharmacist immediately. The pharmacist then sends a written report to the Minister (Health Canada) within 10 days of becoming aware. Report theft or break-ins to police as well. The report cannot be used to incriminate the pharmacist in other criminal proceedings.
• Destruction (s. 110, 121): Only a pharmacist or pharmacy technician may destroy a controlled substance in a pharmacy, and the following conditions apply:
  • Another pharmacist, technician or intern, a practitioner, or another health professional must witness it.
  • The method must meet environmental law.
  • Both people sign a joint declaration immediately afterwards, with printed names.
  • No prior federal approval is needed.
  • Patient-returned substances that are not destroyed on site go to a licensed dealer specialized in destruction.

Patient returns are kept in a marked collection container in a secure area (s. 104). They are never returned to dispensing stock.

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Records and Retention

The CSR require records of every controlled-substance event:

• ordering and receipt (s. 111);
• sales to individuals (s. 113), compounding (s. 114) and substitution (s. 115);
• written and verbal prescriptions (s. 116–117);
• refills and extensions (s. 118) and transfers (s. 119);
• deliveries (s. 120) and destruction (s. 121).

Records must:

• allow an audit at any time (s. 122);
• be kept for 2 years, with sales documents filed separately in date and number order (s. 123);
• stay legible, indelible and retrievable at the pharmacy (s. 124–125); and
• be produced on request by the Minister (s. 126).

Pharmacists practising in hospitals follow the hospital provisions of the CSR rather than the community pharmacy sections.

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Clinical & Regulatory Case Scenario: Three Requests on the First Day Under the CSR

On October 2, 2026, a community pharmacy in a province that authorizes pharmacist prescription renewals receives three requests:

1. A telephone prescription for hydromorphone 2 mg tablets, #20, from a known surgeon. A technician takes the call, confirms the prescriber's identity through the clinic's listed number, and records the s. 117 details. The pharmacist reviews the opioid history in the provincial monitoring program and counsels the patient. The pharmacist then dispenses, because federal law now permits verbal narcotic prescriptions and the provincial standard does not prohibit them.
2. A request to transfer a lorazepam prescription for the third time. Under BOTSR this would have been refused, because a targeted-substance prescription could be transferred only once. Under s. 102 the technician may transfer it, because the prescription is within 2 years of receipt. The technician sends the written prescription or verbal record and documents the remaining refills.
3. A bin of expired fentanyl patches. The pharmacist denatures them, with a pharmacy technician as witness. Both sign and date a joint declaration with printed names, and the destruction record is filed with the controlled-substance records for 2 years.