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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.

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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:

  • adding MIAs now sold over the counter to our Prescription Drug List (PDL), to make sure they are sold by prescription only
    • veterinary oversight is an important part of antimicrobial stewardship. Veterinarians have the training to assess and diagnose animal disease. They can decide if antimicrobial drugs are needed and prescribe the right treatment.
  • removing growth promotion claims from MIA drug labels
    • the use of MIAs in food-producing animals should only be to treat or prevent diseases
  • labelling all in-feed and in-water MIAs with responsible use statements

These actions are aimed at:

  • aligning with international best practices
  • promoting responsible use of MIAs in animals
  • protecting human and animal health and food safety

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:

  • removing growth promotion claims and related directions for use
  • including responsible use statements on labels of all in-feed and in-water MIAs
  • including a prescription on the principal display panel to show that it is a prescription drug

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:

  • implants
  • injectables
  • in-water drugs
  • drug identification number (DIN) drug premixes for mixing in feed

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:

  • supplement
  • micro premix
  • macro premix
  • complete feed

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:

  • pharmacists
  • veterinarians
  • other drug companies (manufacturers)
  • wholesale druggists (such as other wholesalers and commercial feed mills who may access DIN drug premixes to support their operations)

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:

  • an animal owner
  • a retail store, such as:
    • feed stores
    • farm supply stores
    • livestock medicine outlets

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:

  • implants
  • injectables
  • in-water drugs

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:

  • supplement
  • micro premix
  • macro premix
  • complete feed

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:

  • a pharmacist
  • a veterinarian
  • another commercial feed mill or wholesaler

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:

  • implants
  • injectables
  • in-water drugs
  • DIN drug premixes

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

  • pharmacists
  • veterinarians
  • other drug companies (manufacturers)
  • wholesale druggists (such as other wholesalers and commercial feed mills)

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:

  • a pharmacist
  • a veterinarian
  • another commercial feed mill or wholesaler

You do not need to obtain a DEL.

A prescription drug cannot be sold to:

  • a retail store
  • animal owners/end users

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:

  • Tiamulin
  • Neomycin
  • Bacitracin
  • Tilmicosin
  • Apramycin
  • Penicillin G
  • Lincomycin
  • Erythromycin
  • Virginiamycin
  • Spectinomycin
  • Sulphonamides
  • Tylosin/Tylvalosin
  • Streptomycin/Dihydrostreptomycin
  • Tetracycline/Chlortetracycline/Oxytetracycline

This includes all dosage forms whether:

  • otic
  • oral
  • topical
  • in feed
  • implant
  • in water
  • injectable
  • intrauterine
  • intramammary
  • dusting powder

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:

  • wholesaler: this person sells a prescription drug other than at retail sale.
  • drug premix: a drug for veterinary use that is assigned a drug identification number (DIN). The directions on its label specify that it is to be mixed with feed. On this page, the term used is "DIN drug premix."
  • sell: in the context of veterinarians and pharmacists, sell includes dispensing for sale.

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

  • wholesale druggist: examples of wholesale druggists include commercial feed mills (who may access DIN drug premixes to support their operations) and wholesalers
  • commercial feed mill (a type of wholesale druggist): a facility that mixes and manufactures feed for commercial sale in accordance with the Feeds Act and Regulations
  • retail stores (not including pharmacies or veterinary clinics): these include facilities such as:
    • feed stores
    • farm supply stores
    • livestock medicine outlets

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:

  • licensing
  • dispensing
  • other rules within your province/territory

For more information

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