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Responsible use of Medically Important Antimicrobials in animals

As of December 1, 2018, all Medically Important Antimicrobials (MIAs) for veterinary use will be sold by prescription only. The responsible use of MIAs is intended to preserve their effectiveness and minimize the development and spread of antimicrobial resistance.

On this page

Actions to promote responsible use of Medically Important Antimicrobials

We are working with stakeholders on a number of important actions to promote responsible use, such as:

These actions are aimed at:

We all have a role to play.

Learn more about how Canada is tackling AMR and antimicrobial use.

Learn more about antimicrobial resistance and animals, including the regulatory changes made to promote responsible use.

What is changing

All MIAs currently sold over the counter will become prescription status, and will be sold and distributed like other veterinary prescription drugs in Canada. The existing way that prescription (Pr) drugs are sold in Canada is not changing.

There will also be changes to the labels of MIAs, for example:

Information for stakeholders

This section further explains the federal rules on how prescription drugs (in dosage form) may be accessed and sold in Canada. These rules do not apply to the non-prescription drug context.

The distribution and sale of prescription drugs is a shared authority. Some provinces and territories may authorize certain facilities, beyond veterinary clinics and pharmacies, to sell prescription drugs.

This occurs in Quebec, for example, where a permit regime exists. Consult your provincial or territorial authority for further details.

The important terminology section defines some of the key terms that apply to different stakeholders.

Animal owners

In order to purchase a prescription drug for your animal, you first need to get a prescription from your veterinarian. This applies to animal owners, including food animal producers (who may make their own feed) and companion animal owners.

With a prescription, veterinarians and pharmacists can sell you a prescription drug, including:

With a prescription, commercial feed mills can sell you a medicated feed containing a prescription drug. It must be sold in the form of a:

A veterinarian is also allowed to sell you a prescription medicated feed. However, most do not have facilities to produce mixed feeds in these forms.

You cannot give or sell a prescription drug in any form to someone else.

Drug companies

Drug companies can sell a prescription drug (including a DIN drug premix) to:

Drug companies must comply with drug good manufacturing practices (GMP) and obtain a Drug Establishment Licence (DEL) from Health Canada.

Drug companies cannot sell a prescription drug to:

Veterinarians and pharmacists

Veterinarians and pharmacists can sell a prescription drug (including a DIN drug premix and medicated feed) to animal owners. However, these end users must have a prescription.

Veterinarians and pharmacists cannot sell a prescription drug to a retail store.

If you wholesale DIN drug premixes (for mixing in feed) or other prescription drugs, refer to the information for wholesalers. Other prescription drugs can include:

Note the good manufacturing practices (GMP) and Drug Establishment Licence (DEL) wholesale requirements.

Commercial feed mills

A commercial feed mill is a facility that mixes and manufactures feed for commercial sale. This must be done in accordance with the Feeds Act and Regulations.

Drug companies can sell a DIN drug premix (for mixing in feed) directly to commercial feed mills without a prescription. You can then mix the DIN drug premix with feed ingredients to make medicated feed.

With a prescription, you may sell a prescription medicated feed to end users in the form of a:

End users can include food-animal producers or an on-farm feed mill. These activities do not require you to comply with drug GMPs or obtain a DEL from Health Canada.

Commercial feed mills cannot sell a DIN drug premix to end users even with a prescription. End users include food-animal producers with on-farm feed mills.

The only exception is if you are authorized under the laws of a province or territory to do so with a prescription. This is possible in Quebec, for example, because of its permit regime.

There are specific rules if you want to wholesale DIN drug premixes to:

You must comply with drug GMP (where products are to be stored and handled in accordance with the label). However, you do not need to obtain a DEL.

If you want to wholesale prescription drugs other than DIN drug premixes, refer to the information for wholesalers. Note the GMP and DEL wholesale requirements.

Wholesalers

Drug companies can sell prescription drugs directly to wholesalers without a prescription, including:

As a wholesaler, you can sell these prescription drugs and DIN drug premixes without a prescription to:

If you wholesale prescription drugs other than DIN drug premixes, you need to comply with GMP. You must also obtain a DEL for the activity of wholesale.

You only need to comply with drug GMP if you only wholesale DIN drug premixes to:

You do not need to obtain a DEL.

A prescription drug cannot be sold to:

Retail stores

Retail stores cannot access or sell prescription drugs in any form to anyone (even with a prescription).

Prescription Status: affected drugs and dosage forms

The Prescription Drug List (PDL) is a list of medicinal ingredients. Any drug containing an ingredient on this list must be sold by prescription.

Since 2004, new MIAs approved by Health Canada have been included on the PDL and must be sold by prescription.

Further to public consultation, we are now moving all remaining MIAs approved for veterinary use before 2004 to the PDL. With this change, we establish the same level of oversight for those MIAs approved before 2004 as for those approved after.

These MIA ingredients (and their salts or derivatives) will be included on the PDL for Veterinary Use:

This includes all dosage forms whether:

You can also find more information about the PDL process by consulting our Prescription Drug List Questions and Answers.

Timelines for the changes

Drugs listed in the prescription status: affected drugs and dosage forms will continue to be available without a prescription until December 1, 2018.

After December 1, 2018, these drugs will only be sold if there is a prescription from a veterinarian.

You may see some label changes on the market during the transition between old and new labels in early 2018.

Who we are working with

Over the last several years we have been engaging stakeholders about these changes. We will continue to support these actions with ongoing engagement and communication.

We will continue working with:

Important Terminology

Some of the terms used on this page are defined in the Foods and Drugs Act and/or Regulations. The definitions provided have been edited for clarity:

Other important terms that don't have regulatory definitions include:

Who to contact

For questions about Veterinary prescription drugs, email: hc.vetdrugs-medsvet.sc@canada.ca.

For questions about drug GMP:

For questions about the Feeds Act and Regulations, email: FEED_MILL_INSP@inspection.gc.ca.

For questions about DELs, email: DEL_Questions_LEPPP@hc-sc.gc.ca. Learn more about obtaining a Drug Establishment Licence.

Contact your provincial/territorial authority for questions about:

For more information

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