On October 1, 2026, the federal rules that govern narcotics, controlled drugs and benzodiazepines in Canadian pharmacies were replaced by a single regulation: the Controlled Substances Regulations, SOR/2025-242. For anyone preparing for the PEBC Qualifying Exam Part 1, this is the largest change to pharmacy law content in years. Rules that candidates have memorized for a generation, such as "no refills on a narcotic" and "one transfer only for a benzodiazepine", are no longer the federal position.

This article explains what was replaced, what the new regulations say, where the provinces still decide, and how to rebuild this part of your notes.

What was replaced on October 1, 2026

Before October 1, 2026, the rules sat in several separate instruments under the Controlled Drugs and Substances Act, each with its own requirements. The Controlled Substances Regulations replaced all of the following:

• The Narcotic Control Regulations
• The Benzodiazepines and Other Targeted Substances Regulations
• Part G (controlled drugs) and Part J (restricted drugs) of the Food and Drug Regulations
• The temporary class exemptions that had been in place

The Act itself remains. What changed is that one regulation now sets the rules for prescribing, dispensing, records, transfers and reporting across every class.

The classes still matter

The new regulations did not abolish classification. The class still fixes which Schedule a product belongs to, whether a low-dose codeine product may be sold without a prescription, and which provincial restrictions apply. Name the class first.

• Narcotic drugs (straight narcotics): one narcotic alone, one narcotic with a single non-narcotic ingredient, more than one narcotic, any narcotic for parenteral use, or any product containing one of the "Big 5".
• Narcotic preparations: one narcotic with two or more non-narcotic active ingredients, not for parenteral use and not containing a Big 5 drug. Tylenol No. 3 is the usual example.
• Exempted codeine preparations: codeine at no more than 8 mg per tablet or capsule, or 20 mg per 30 mL of liquid, with at least two non-narcotic active ingredients. No prescription is needed, but the pharmacist makes the sale personally.
• Controlled drugs: Part 1 (amphetamines, methylphenidate, lisdexamfetamine), Part 2 (barbiturates and others) and Part 3 (anabolic steroids such as testosterone).
• Targeted substances: the benzodiazepines, together with zolpidem and a small number of others. Carisoprodol has been a targeted substance since December 19, 2025. Zopiclone is not a controlled substance.

One point that catches candidates: the Act's own Schedules I to V rank substances for offences and penalties. They are not the prescribing classes. The class comes from the Schedules to the Regulations, not from the Act's schedule number.

Before and after: the rules that changed

The transitional rule: Health Canada's guidance allows a prescription received before October 1, 2026 to be extended or transferred until October 1, 2028, whatever its date of receipt, subject to provincial or territorial requirements.

What did not change

• Pharmacists are not practitioners under the Act. A pharmacist does not start controlled-substance therapy. The new powers to extend a prescription or substitute one controlled substance for another apply only where the province authorizes them.
• A verbal prescription comes from the practitioner. A patient, a relative or a clinic receptionist cannot telephone in a controlled-substance prescription for any class.
• A written prescription is signed and dated by the practitioner. A fax of the signed and dated prescription counts as written.
• Loss or theft is reported within 10 days. The pharmacist makes a written report to the Minister, through Health Canada, within 10 days of becoming aware of it.
• Records are kept for two years, complete, legible and retrievable.
• Stock is ordered in writing. An order to a licensed dealer is written, signed and dated by the pharmacist.

The federal rule and the provincial rule

The new regulations set what federal law permits. They do not oblige a province to permit all of it. Several of the new powers, including extension and substitution by a pharmacist, exist only "where provincial law authorizes", and provinces commonly restrict repeats on narcotics through their own standards.

Two habits will protect you on exam questions:

• Read which rule the question asks for. "Under federal law" and "in Ontario" can have different answers to the same scenario.
• When both apply, the stricter rule governs. A refill that federal law permits is still unavailable where the provincial standard prohibits it.

For validity periods, the province decides. Ontario legislates no expiry for prescriptions, so the pharmacist judges whether a prescription still reflects current therapy.

Worked examples

A verbal order for Tylenol No. 3, 150 tablets, 50 at a time, from the physician. Valid. This is a narcotic preparation, a verbal prescription from the practitioner is accepted, and three instalments of one total is a part-fill, not a refill.

The same kind of order for morphine tablets, telephoned in by the patient's daughter. Invalid. A verbal prescription is accepted only from the practitioner. Had the physician called, the order would have been valid, part-fill included.

A clinic printout for controlled-release oxycodone with two repeats and no signature. Invalid, but not because of the repeats. A written prescription must be signed and dated by the practitioner. The remedy is a signed fax or a verbal prescription from the prescriber. Then check the provincial standard, which may restrict repeats on a narcotic.

A request to transfer a lorazepam prescription with three refills left, received by the pharmacy 26 months ago, before October 1, 2026. Valid under Health Canada's transitional guidance, which allows prescriptions received before October 1, 2026 to be transferred until October 1, 2028, subject to provincial requirements. Without that guidance the two-year limit would have applied.

"60 capsules plus two more times of 60 capsules every 30 days." This is a refill authorization even though the word "refill" never appears. If the total quantity authorized increases, it is a refill. If the same total is dispensed in portions, it is a part-fill.

How to update your notes

• Start a fresh page. Correcting the old class-by-class table line by line invites mistakes. Rebuild it from the new regulations.
• Learn the federal rule, then the provincial overlay. Keep them in separate columns so you can answer either version of a question.
• Keep the classification skills. Counting ingredients and spotting the Big 5 are as important as before.
• Retire your old flashcards. Any card that says "narcotics cannot be refilled" or "targeted substances may be transferred once" now teaches the wrong answer.
• Check the date on every law resource. Anything written before October 2026 describes the previous regime unless it says otherwise.

This article is a summary for exam preparation and is not legal advice. The Controlled Substances Regulations, Health Canada's guidance and your provincial regulator are the authority.