The Prescription Drug List: Overview
On this page
- Purpose
- A note about terminology
- Introduction to the Prescription Drug List
- How to interpret the Prescription Drug List
- Controlled substances and radiopharmaceutical drugs
- Prescription drugs in your province or territory
- Deciding which medications should be prescription drugs
- Processes for changing the Prescription Drug List
- Appendix A: Listings dated 2013
Purpose
This document provides general information about the federal Prescription Drug List.
This document does not include information on financial coverage for prescription drug costs.
A note about terminology
We are using the term “medication” to specify products that are not foods, consumer products, industrial products, etc. Examples of medications are prescription drugs, non-prescription drugs and natural health products but not medical devices. In technical contexts, the term “drug”, as defined under the Food and Drugs Act, would be used in place of “medication”.
In this document, a “practitioner” is a physician, dentist, veterinarian or other professional with prescribing rights. This may include nurse practitioners, pharmacists, midwives, naturopaths or other health care providers depending on the province or territory.
Introduction to the Prescription Drug List
The Prescription Drug List identifies which medications are prescription drugs at the federal level, under the Food and Drugs Act. Prescription drugs are subject to certain requirements in the Food and Drug Regulations.
A main requirement for prescription drugs is that they can only be sold to the public by pharmacists, veterinarians or commercial feed mills, based on a prescription from a practitioner.
Other requirements for prescription drugs include, for example:
- restrictions on advertising
- specific labelling requirements
- in the case of prescription drugs for human use, an obligation to report potential and actual drug shortages
The Prescription Drug List catalogs listings for medicinal ingredients and classes of medicinal ingredients. Medicinal ingredients are the ingredients in a medication that make your symptoms or illness better. In the case of pets or livestock, it’s the active ingredients that make their clinical signs or illness better. In addition, some medicinal ingredients are active ingredients that can prevent illness.
Note that the listing for a medicinal ingredient or class of medicinal ingredients in some cases includes a qualifier. The qualifier describes certain characteristics of the medication that determine which medications containing the medicinal ingredient are prescription drugs and which are not. Examples of characteristics include:
- the purpose
- the daily dose
- the way the medication is put on or into the body (for example, by injection)
Without a qualifier indicating otherwise, any medication that contains a medicinal ingredient that is on the Prescription Drug List is considered a prescription drug.
The list has 2 parts:
- the list for human use
- the list for veterinary use
Access the Prescription Drug List.
How to interpret the Prescription Drug List
The Prescription Drug List is presented in the form of tables containing the listings for the medicinal ingredients or classes of medicinal ingredients.
The following table shows some examples of listings taken from either the human or veterinary use list in 2025.
| Drugs containing any of the following | Including | Qualifier | Effective date |
|---|---|---|---|
| Acetaminophen | (empty) | when recommended for administration by intravenous injection | 2013-12-20 |
| Omeprazole or its salts | Omeprazole magnesium | except when sold for the 14-day treatment for frequent heartburn at a daily dose of 20 milligrams | 2016-12-19 |
| Praziquantel | (empty) | except when sold for the treatment of the tapeworm Anoplocephala perfoliata in horses | 2013-12-19 |
| Thyroxin or its salts | Levothyroxine sodium | (empty) | 2013-12-19 |
The 4 columns are consistent throughout the list and should be interpreted as follows.
First column (drugs containing any of the following)
The first column contains the name of the:
- medicinal ingredient or
- class of medicinal ingredients
Second column (including)
The second column may be empty or, where it may help clarify the listing, it may contain examples of medicinal ingredients. In the table, levothyroxine sodium is given as an example of “thyroxin or its salts”.
Third column (qualifier)
The third column may be empty or may contain a qualifier.
If the qualifier cell is empty, it means that any medication containing that medicinal ingredient is a prescription drug. This is the case for thyroxin and its salts.
If present, the qualifier should be read as “A medication containing this medicinal ingredient is a prescription drug” then the text of the qualifier. For example:
In the listing for acetaminophen, you would read it as “A medication containing acetaminophen is a prescription drug when recommended for administration by intravenous injection.”
In other words, a medication containing acetaminophen in pill form is not captured by this listing on the Prescription Drug List and therefore it is not a prescription drug. However, a medication containing acetaminophen for intravenous injection is captured by this listing and therefore is a prescription drug.
The veterinary use listing for praziquantel should be read as “A medication containing praziquantel is a prescription drug except when sold for the treatment of the tapeworm Anoplocephala perfoliata in horses.”
This means praziquantel that is sold as a medication for any other use is a prescription drug.
Fourth column (effective date)
The fourth column contains the date that the medicinal ingredient or class of medicinal ingredients was added to the list or the date that the listing was last changed.
Note: If the date is 2013-12-19 or 2013-12-20, this isn’t necessarily the first time the medicinal ingredient or class of medicinal ingredients was given prescription status or the last time the listing was changed. This relates to the Prescription Drug List replacing Schedule F to the Food and Drug Regulations on December 19, 2013. (For more details, refer to Appendix A).
Controlled substances and radiopharmaceutical drugs
The Prescription Drug List does not include all the medicinal ingredients that require a prescription federally.
Specifically, most medications containing controlled substances (such as morphine or diazepam) must be sold to the public by prescription under federal law. However, they are not listed in the Prescription Drug List. Instead, they are listed in the Schedules to the Controlled Drugs and Substances Act.
Radiopharmaceutical drugs are radioactive drugs. They help in diagnosing or treating diseases. Radiopharmaceutical drugs are also not on the Prescription Drug List. Instead, other measures are in place to ensure the appropriate access and the safe use of radiopharmaceutical drugs.
Learn about the regulation of radiopharmaceutical drugs.
Prescription drugs in your province or territory
The provinces and territories also play a role in determining how medications are sold.
Prescription drugs for human use
Products that are prescription drugs under federal law are prescription drugs in all of Canada.
In contrast, for products that are non-prescription medications (non-prescription drugs or natural health products) under federal law, the provincial and territorial governments can:
- leave them as non-prescription medications (for general sale) or
- further restrict how they are sold
These further restrictions on the conditions of sale of federally non-prescription medications can make the medications available only:
- in a self-selection area that’s under direct supervision of a pharmacist
- through a pharmacist (“behind-the-counter” medications) or
- by prescription
Therefore, when you buy a medication, it could require a prescription where you live, even if none of its medicinal ingredients are captured by listings on the federal Prescription Drug List or the Schedules to the Controlled Drugs and Substances Act.
Learn more by contacting your provincial or territorial government, or:
- Office des professions du Québec for Quebec (available in French only)
- National Association of Pharmacy Regulatory Authorities (NAPRA) for human drugs excluding natural health products, for all of Canada except Quebec
Prescription drugs for veterinary use
Products for veterinary use that are prescription drugs under federal law are prescription drugs in all of Canada.
In contrast, if under federal law products are non-prescription drugs for veterinary use, the provinces and territories can further restrict how the products are sold. To learn more, contact your provincial or territorial government.
Deciding which medications should be prescription drugs
Health Canada looks at available information to determine if a practitioner should be involved in the use of the medication.
If a practitioner should be involved, generally we’ll make the medication a prescription drug by listing the medicinal ingredients (with or without qualifiers) on the Prescription Drug List.
We use a set of principles and factors to help make these decisions about prescription status. These principles and factors help us assess different aspects of the medication and its use, such as:
- Can a consumer or an animal owner diagnose and treat the symptoms (humans) or signs (animals), condition or disease on their own?
- Is a practitioner needed to monitor the patient or animal’s health while on this medication?
- Are the instructions for use complicated? Would a consumer or an animal owner need help to follow the instructions?
- For human medications, could the use of the medication lead to a substance use disorder?
Sometimes we make an exception for health and safety reasons, even though the drug would normally be a prescription drug. In these cases, we would ensure the Prescription Drug List does not capture the medication such that under federal law, you won’t need a prescription to buy it. (Your province and territory may still add restrictions as described in the section Prescription drugs in your province or territory.)
For example, epinephrine can be used to help treat anaphylaxis (a strong allergic reaction). Epinephrine auto-injectors are non-prescription drugs because we made them an exception. That is, we made sure they are not captured by the listing for epinephrine on the Prescription Drug List. This was done because the benefits of allowing greater access to this medication (saving lives) outweigh the benefits of the prescription requirements.
For more information on the principles and factors, as well as exceptions, consult the guidance document:
Processes for changing the Prescription Drug List
This section provides a simplified description of what leads to changes to the Prescription Drug List and what the processes are for changing the list.
For a more detailed and technical description of these processes, consult:
There are 3 main types of amendments (changes) to the Prescription Drug List:
- Routine additions
- Special additions
- Switches (removals)
Routine additions
When we authorize a medication that’s new to the Canadian market, we determine if it should only be used with the help of a practitioner. If so, we check the Prescription Drug List to see if there’s already a listing that captures the medication.
If the medication is already captured, no further action is required to make the medication a prescription drug.
If the medication is not captured, but should be, we will do a routine addition.
The process for a routine addition:
- We add a listing or modify the existing listing for the medicinal ingredient or class of medicinal ingredients on the Prescription Drug List to capture the medication.
- We publish a notice of amendment to alert the public and other stakeholders to the change to the Prescription Drug List.
Special additions
Typically, special additions are the result of new safety information about an existing non-prescription medication on the Canadian market. For example, a new study is published in a scientific journal that raises concerns about a non-prescription drug for human or veterinary use, or a natural health product.
We evaluate the new safety information and information from other sources. We determine if the new safety risk could be lessened or eliminated by involving a practitioner. If so, we amend (change) the Prescription Drug List to ensure that the medication is captured. Depending on the current listings on the list, we would do this by:
- adding the medicinal ingredient
- adding the medicinal ingredient with a qualifier or
- modifying the qualifier for the existing listing for the medicinal ingredient.
The process for a special addition to the Prescription Drug List:
- We post a notice of consultation and hold a public consultation about the proposed addition.
- After considering the feedback from the consultation, we post a notice of intent with our decision on whether we will stop, modify or continue with the proposed addition. If we decide to continue with the addition, the notice will say that the addition will occur after a stated time period. This transition period is typically a minimum of 6 months.
- During this transition period, affected companies adjust to the requirements for prescription drugs if they wish to continue to sell their product.
- After the transition period, we change the Prescription Drug List and then post a notice of amendment to let everyone know that the Prescription Drug List has been changed.
For current and past notices, visit Notices of changes to the Prescription Drug List.
In rare cases, the safety issue requires immediate action to protect consumers. In these cases, we significantly shorten or skip the consultation and the time delay before the addition to the Prescription Drug List. At a minimum, we’ll post a notice of amendment. In the notice, we’ll provide information about the addition and the reasons for choosing a faster process.
Switches (removals)
In a switch, a request is made to remove a medicinal ingredient (or a medicinal ingredient for specific conditions of use) from the Prescription Drug List. The request is made so that a prescription drug could be sold as a non-prescription drug (for human use or veterinary use) or a natural health product (human use). This is called a “switch” because of the change from prescription to non-prescription status.
In the most common situation, it’s a company that requests a switch for 1 of its prescription drugs along with a request for its market authorization (the official permission to sell in Canada).
Another situation is where the company requesting the switch does not have an authorized prescription drug. The company is seeking market authorization for a new medication to be sold as a natural health product or non-prescription drug. However, the medicinal ingredient in the new medication is captured by an existing listing on the Prescription Drug List.
In either case, the company provides evidence to support the request for a switch and a market authorization, which we review. If we agree that the medication meets the requirements for market authorization and is appropriate for use without a practitioner, we launch the amendment process to propose the removal of its medicinal ingredient from the Prescription Drug List.
Note: Sometimes the medicinal ingredient is removed from the Prescription Drug List only for certain conditions of use (for example, for some uses or daily doses). This is done through use of a qualifier as described in the examples in the section How to interpret the Prescription Drug List.
The process for removal:
- We post a notice of consultation and hold a public consultation about the removal from the Prescription Drug List.
- If, after considering the feedback from the consultation, we decide to continue with the removal, we post a notice of intent saying the removal from the list will occur after 6 months.
- During the 6 months, affected companies adjust to the requirements for non-prescription drugs for human or veterinary use, or natural health products, if they wish to continue to sell their product.
- After 6 months, we revise the Prescription Drug List. Then, we post a notice of amendment to let everyone know that the Prescription Drug List has been changed.
For more information on switches related to medications for human use, consult the guidance document:
For more information on switches related to medications for veterinary use, contact the Veterinary Drugs Directorate:
Appendix A: Listings dated 2013
The fourth column in the Prescription Drug List shows the date the ingredient was added to the Prescription Drug List or the date the listing was last modified.
If the date shown is 2013-12-19 or 2013-12-20, it means either the:
- medicinal ingredient listing was added or modified in 2013 or
- medicinal ingredient had prescription status before 2013
About this second possibility: Between 1963 and 2013, medicinal ingredients and classes of medicinal ingredients with prescription status were listed in Schedule F to the Food and Drug Regulations. When the Prescription Drug List replaced Schedule F in 2013, we transferred the ingredients with prescription status from Schedule F to the list.
When the date in the fourth column is 2013-12-19 or 2013-12-20, you’ll need to do some research to determine when the listing for a medicinal ingredient or class of medicinal ingredients was originally added or last modified. This information can generally be found in 1 of the following sources:
- Notices of changes to the Prescription Drug List from 2013
- the Canada Gazette
- earlier versions of the Food and Drugs Act or the Food and Drug Regulations