Pharmacy Law and Drug Schedules for the PEBC® Exam: Canadian Federal Rules and Practice Questions

Law and ethics questions on the PEBC® Pharmacist Qualifying Examination Part I come mainly from Distribution (20% of the Blueprint Ver. 03-2026) and Professionalism (12%). They reward precise knowledge: which list makes a drug prescription-only, where a non-prescription product may be displayed, what to do when a narcotic count comes up short, and who you may share patient information with.

This page covers federal and national principles: the Food and Drugs Act and the Prescription Drug List, the Controlled Drugs and Substances Act and the new Controlled Substances Regulations that took effect on October 1, 2026, and the NAPRA National Drug Schedules. Practice details such as prescription validity, refills and technician scope are set provincially. Requirements vary by province; check your regulator.

Last reviewed October 18, 2026 · Based on the Pharmacist Qualifying Examination Blueprint, Ver. 03-2026

The federal framework at a glance

Who controls what
Law or listWhat it doesKey exam point
Food and Drugs Act and Food and Drug RegulationsGovern safety, labelling, sale and advertising of drugs in CanadaDrugs need market authorization (a DIN for most products).
Prescription Drug List (PDL)Health Canada's list of medicinal ingredients that require a prescription federallyReplaced Schedule F in December 2013. Updated administratively, so changes happen faster than under Schedule F.
Controlled Drugs and Substances Act (CDSA)Prohibits activities with controlled substances unless authorized by regulation or exemptionCovers opioids, stimulants, benzodiazepines, anabolic steroids and more.
Controlled Substances Regulations (CSR)Single set of rules for pharmacists, practitioners, hospitals and licensed dealersIn force October 1, 2026. Replaced the Narcotic Control Regulations, Parts G and J of the Food and Drug Regulations, and the Benzodiazepines and Other Targeted Substances Regulations.
NAPRA National Drug SchedulesA national model for conditions of sale, adopted provinciallySchedule I, II, III and Unscheduled. Federal lists take precedence if they conflict.

Controlled substances: old structure, new regulations

Until September 30, 2026, controlled substances were split across three sets of pharmacy-relevant regulations: the Narcotic Control Regulations (mainly opioids and cocaine), Part G of the Food and Drug Regulations (controlled drugs such as amphetamines, phenobarbital and anabolic steroids) and the Benzodiazepines and Other Targeted Substances Regulations (mainly benzodiazepines). Older study materials and question banks are organized around these titles.

The Controlled Substances Regulations now hold these rules in one place. They keep four classes of substance (narcotics, controlled drugs, targeted substances and restricted drugs) but apply largely the same pharmacy requirements across them.

  • Sale to a patient requires a prescription from a practitioner. Practitioners may now prescribe any controlled substance verbally, and the pharmacist records the verbal prescription.
  • Transfers: a pharmacist or pharmacy technician may transfer a controlled substance prescription to another pharmacist or technician within 2 years of when it was first received, passing on the written prescription or the record of the verbal one.
  • Extensions: a pharmacist may extend a prescription as long as the new end date is no later than 2 years after the pharmacy received it, where provincial law allows.
  • Adapting the formulation, dose or regimen, deprescribing and part-filling are permitted, provided the total quantity does not exceed what the practitioner prescribed. Therapeutic substitution with another controlled substance is allowed only where the province authorizes it.
  • Low-dose codeine products may be sold without a prescription if each solid unit has no more than 8 mg codeine phosphate (or 20 mg per 30 mL of liquid), contain at least two other active ingredients, carry the required caution, and the pharmacist believes the use is legitimate.
  • Security: store controlled substances in a secure area that only authorized people can access. Deliveries must use a trackable method.

Records, loss and theft

  • Federal law requires pharmacists to keep controlled substance records, prescriptions and orders for at least 2 years. Provinces often require longer retention for all prescriptions.
  • Loss or theft of any controlled substance: send a written report to Health Canada within 10 days of becoming aware of it. Staff acting for the pharmacist must tell the pharmacist immediately.
  • Local police reporting for theft and notice to your provincial regulator may also be required by provincial rules or practice standards.
  • Unwanted or expired controlled substances, including patient returns, must be destroyed according to the CSR, with records kept.

NAPRA National Drug Schedules

Provinces and territories adopt the national schedules in different ways. Some adopt NAPRA decisions automatically by reference, while others approve each change separately, so a product's schedule can differ temporarily between provinces. Quebec does not use the NAPRA schedules and has its own provincial system. If a question asks about a specific province, the provincial regulation governs.

Conditions of sale under the national model
SchedulePrescription needed?Where it is kept and sold
Schedule IYesDispensed by a pharmacist on a prescription from a practitioner. Includes everything on the PDL and the CSR.
Schedule IINoBehind the counter in an area with no public access. The pharmacist must be involved in every sale and may refer.
Schedule IIINoSelf-selection area of the pharmacy (the professional services area) under direct pharmacist supervision, with the pharmacist available to advise.
UnscheduledNoAny retail outlet. Labelling must be adequate for safe self-care.

Professional ethics basics

  • Confidentiality: share personal health information only with the patient's consent or where the law permits, such as with other members of the patient's care team. A spouse, parent of an adult child or employer is not automatically entitled to it.
  • Informed consent: the patient needs enough information to decide, including the option to decline.
  • Duty of care first: if you will not provide a service for personal reasons, provincial standards set out how you must still protect the patient's timely access to care. Requirements vary by province.
  • Documentation: record professional decisions such as extensions, adaptations, refusals and referrals.
  • Scope: stay within your provincial scope of practice even when a federal rule permits an activity. Federal authority is a ceiling, not a licence.

Common exam traps

  • Answering "Schedule F". It was replaced by the Prescription Drug List in 2013.
  • Confusing NAPRA Schedule II (behind the counter) with Schedule III (self-selection in the pharmacy).
  • Saying narcotic prescriptions can never be transferred. That was the old federal rule; the CSR now allow transfers within 2 years.
  • Reporting a narcotic loss only to police, or waiting until the next monthly count. Health Canada must receive a written report within 10 days.
  • Assuming a federal permission (such as therapeutic substitution) automatically applies in every province.
  • Releasing information to a family member without the patient's consent.

Practice questions

Original questions written for this page. Answer each one before you open the explanation.

Question 1Pharmacy law: drug schedules
Providing Care: Distribution

A new pharmacy assistant is stocking shelves and asks where to put a box of tablets containing acetaminophen 300 mg, caffeine 15 mg and codeine phosphate 8 mg. The product is sold without a prescription in your province, which follows the NAPRA schedule for it (Schedule II).

Where should the product be kept, and how may it be sold?

  1. A.On the open shelf in the general store, sold by any cashier
  2. B.In the self-selection area near the dispensary, with the pharmacist available if asked
  3. C.Behind the counter with no public access, sold only after the pharmacist is involved
  4. D.In the narcotic safe, sold only on a written prescription
Show answer and explanation

Answer: C

NAPRA Schedule II products need no prescription but must be kept in an area the public cannot access, and the pharmacist must be involved in each sale. Federally, low-dose codeine combinations like this may be sold without a prescription only if the pharmacist is satisfied the use is legitimate. The pharmacist can refuse a sale or refer the patient when there are concerns about misuse.

Why the other options are wrong

  • A:Open shelves anywhere in the store describe Unscheduled products.
  • B:Self-selection under supervision describes Schedule III.
  • D:A prescription is required for Schedule I products. This combination meets the federal low-dose exemption, so a prescription is not required where the province follows the NAPRA schedule.

Reference: NAPRA National Drug Schedules (current); Controlled Substances Regulations, SOR/2025-242, s. 98(2) (in force 2026)

Question 2Pharmacy law: loss and theft
Providing Care: Distribution

During a scheduled narcotic count, the pharmacist finds that the pharmacy has 60 fewer hydromorphone 2 mg tablets than the perpetual inventory shows. A review of prescriptions, invoices and the count sheet does not explain the difference.

Which federal requirement applies?

  1. A.Adjust the inventory record and note the discrepancy at the next annual count
  2. B.Submit a written loss or theft report to Health Canada within 10 days of discovering the discrepancy
  3. C.Notify the supplying wholesaler, who reports to Health Canada on the pharmacy's behalf
  4. D.Report only to local police, since Health Canada is notified only for licensed dealers
  5. E.Report to Health Canada only if the loss exceeds a set percentage of stock
Show answer and explanation

Answer: B

Under federal controlled substance rules, a pharmacist who becomes aware of a loss or theft of any controlled substance must send a written report to Health Canada within 10 days. An unexplained shortage counts as a loss. Provincial regulators and police may also need to be notified depending on provincial rules and whether theft is suspected.

Why the other options are wrong

  • A:Simply adjusting the record hides a reportable loss and could mask diversion.
  • C:The pharmacist holds the reporting duty for the pharmacy's stock. The wholesaler does not report for them.
  • D:Pharmacists must report losses and thefts to Health Canada themselves. Police reporting is an addition for theft, not a replacement.
  • E:There is no minimum threshold. Any unexplained loss of a controlled substance must be reported.

Reference: Controlled Substances Regulations, SOR/2025-242, s. 109 (in force October 1, 2026); same 10 day timeline as the former Narcotic Control Regulations

Question 3Pharmacy law: controlled substance transfers
Providing Care: Distribution

In late October 2026, a patient moving to another city asks you to transfer her prescription for hydromorphone 1 mg, which your pharmacy received 8 months ago from her family physician. Two fills remain on the prescription, and the receiving pharmacy is in the same province.

Under the current federal rules, what is correct?

  1. A.Narcotic prescriptions can never be transferred, so the patient needs a new prescription
  2. B.A transfer is allowed only during a declared public health emergency
  3. C.The prescription may be transferred because it was received within the past 2 years, along with the prescription or the record of a verbal prescription, subject to provincial requirements
  4. D.The prescription may be transferred, but only to a pharmacy outside the province
  5. E.The prescription may be transferred only after Health Canada approves the transfer
Show answer and explanation

Answer: C

Since the Controlled Substances Regulations took effect on October 1, 2026, a pharmacist or pharmacy technician may transfer a controlled substance prescription within 2 years of receiving it. The written prescription, or the record of a verbal prescription, goes to the receiving pharmacy. Provincial standards may add documentation or other requirements.

Why the other options are wrong

  • A:This was the federal position before the COVID-era exemption. It no longer applies under the CSR.
  • B:Transfers were first allowed through a temporary pandemic exemption, but the CSR made the authority permanent.
  • D:The federal rules allow transfers within Canada. There is no requirement that the receiving pharmacy be in another province.
  • E:No case-by-case approval from Health Canada is needed.

Reference: Controlled Substances Regulations, SOR/2025-242, s. 102 and Regulatory Impact Analysis Statement (Canada Gazette Part II, December 2025)

Question 4Pharmacy law: prescription status
Providing Care: Distribution

A pharmacy student asks how to confirm whether a newly marketed medicinal ingredient requires a prescription federally. She has found an older textbook that refers to "Schedule F of the Food and Drug Regulations".

Which source should she check?

  1. A.Schedule F of the Food and Drug Regulations
  2. B.Health Canada's Prescription Drug List
  3. C.The NAPRA Schedule III list
  4. D.The provincial drug benefit formulary
Show answer and explanation

Answer: B

Health Canada's Prescription Drug List replaced Schedule F in December 2013 and lists the medicinal ingredients that require a prescription federally. Because it is updated administratively, it changes faster than Schedule F did. Ingredients on the PDL are also Schedule I under the NAPRA model.

Why the other options are wrong

  • A:Schedule F no longer exists. Its drugs were moved onto the Prescription Drug List.
  • C:Schedule III covers non-prescription products sold from the pharmacy's self-selection area.
  • D:A formulary shows public coverage, not whether a drug legally requires a prescription.

Reference: Food and Drug Regulations; Health Canada, About the Prescription Drug List (PDL in effect since December 19, 2013)

Question 5Ethics: confidentiality
Professionalism

A man phones the pharmacy and says his 34-year-old wife is a patient there. He asks which medications she has been filling recently because he is worried about her. There is no note on her profile authorizing anyone to receive her information.

What is the most appropriate response?

  1. A.Provide the list because spouses are entitled to each other's health information
  2. B.Provide the list if he can confirm her date of birth and address
  3. C.Politely decline to share her information, and offer to speak with her directly or to share information once she gives consent
  4. D.Tell him the names of her medications but not the doses
Show answer and explanation

Answer: C

Personal health information belongs to the patient, and it may be disclosed only with her consent or where the law allows. Being a spouse does not create a right to access. The pharmacist can respond with empathy, invite the patient to contact the pharmacy, and record any consent she later gives.

Why the other options are wrong

  • A:Marriage does not give legal access to another adult's health information.
  • B:Knowing identifying details proves nothing about consent. It is a common route for privacy breaches.
  • D:Disclosing drug names alone still reveals health information and breaches confidentiality.

Reference: NAPRA Model Standards of Practice for Pharmacists and Pharmacy Technicians in Canada (2022); provincial privacy legislation

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Frequently asked questions

Is Schedule F still used in Canada?

No. Health Canada replaced Schedule F with the Prescription Drug List in December 2013. Use "PDL" in exam answers.

What are the Controlled Substances Regulations?

Federal regulations under the CDSA that took effect on October 1, 2026. They replaced the Narcotic Control Regulations, Part G and Part J of the Food and Drug Regulations, and the Benzodiazepines and Other Targeted Substances Regulations, and made the pandemic-era pharmacist authorities permanent.

How quickly must a pharmacy report a lost or stolen controlled substance?

A written report to Health Canada within 10 days of becoming aware of it. Provincial rules may require additional notifications.

Do all provinces use the NAPRA drug schedules?

All provinces and territories except Quebec use the national schedules in some form, but how and when they adopt changes differs. Check your provincial regulator for the conditions of sale that apply where you practise.

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Sources

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