Introduction

In Ontario, livestock owners may purchase livestock medicines from licenced retail outlets, called Livestock Medicine Outlets (LMOs). LMOs are authorized to sell designated over-the-counter livestock medicines that do not require a veterinary prescription. Their sale is regulated under the Animal Health Act, 2009, specifically:

  • Ontario Regulation 583/20 “Livestock Medicines”
  • Ontario Regulation 584/20 “Licences to Sell Livestock Medicines”

These will be referred throughout the document as “the regulations”.

The regulations require LMOs to obtain a licence to sell livestock medicines as well as specify what types of medicines can be sold and to whom they can be sold.

The regulations help to:

  • provide access to approved, safe and effective non-prescription medicines to livestock producers in Ontario
  • contribute to the health and welfare of livestock
  • protect the health of farm families and consumers
  • contribute to a safe food system

The Ontario Ministry of Agriculture, Food and Rural Affairs (OMAFRA) is responsible for the administration and enforcement of the Animal Health Act, 2009 and the regulations. Under the regulations, LMOs are subject to ministry inspections. OMAFRA uses a risk-based inspection system to assess compliance, helping us to better utilize resources to ensure the safe and responsible sale of over-the-counter livestock medicines.

This manual provides information on licensing, designated livestock medicines, conditions of sale, sales procedures, advertising, record keeping and inspector procedures to help livestock medicines licence holders understand their responsibilities and achieve compliance.

Keep this manual close to the medicine storage area as a reference. It is the responsibility of the LMO manager to ensure each staff person understands the contents of this manual. Managers should:

  • ensure all new and existing staff are familiar with the regulations and the responsibilities of a licensed livestock medicines outlet
  • file any inspection reports received and keep track of any deficiencies and suggestions

Managers can use inspection reports and compliance communications to identify strengths or weaknesses in the facility and implement any necessary changes.

O. Reg. 583/20 and 584/20

In 2018 and 2020, the sale of livestock medicines underwent regulatory changes with an update to the list of products that LMOs may sell, the repeal of the Livestock Medicines Act and Regulation 730, and the implementation of these regulations under the Animal Health Act, 2009.

Any person who, on July 31, 2020, holds a licence to sell livestock medicines issued under the Livestock Medicines Act is deemed, on or after January 1, 2021, to hold a licence to sell livestock medicines issued under subsection 12 (1) of the Animal Health Act, 2009.

Designated livestock medicines

Designated livestock medicines are a drug or class of drugs designated as a livestock medicine in the Livestock Medicines regulation. They are generally considered to have a low risk to animal or human health. Designated livestock medicines include biologics, corticosteroids, antiparasitics, topicals and low risk antimicrobials, such as ionophores. Consult Health Canada’s website to search allowable livestock medicines by Drug Identification Number (DIN).

As of December 1, 2018, all livestock producers require a prescription for Medically Important Antimicrobials (MIAs) to better manage antimicrobial use in animal agriculture and as part of a global effort to address antimicrobial resistance. MIAs for veterinary use are no longer permitted to be sold at LMOs. MIAs are dispensed by a veterinarian, pharmacist or wholesale druggist like other veterinary prescription drugs.

Licensing

A licence is required to sell livestock medicines in Ontario for every permanent location where sales are conducted. Where no such permanent location exists, (for example, sales conducted by internet or temporary locations such as booths at fairs and mobile operations) a licence is required for the place where livestock medicines are stored for use by the operation.

A person holding a permanent licence must display the permanent licence number at all temporary locations where they sell livestock medicines, including online.

A licence is required when livestock medicine sales are made by anyone other than a:

  • person authorised to sell livestock medicines under the Drug and Pharmacies Regulation Act (Ontario)
  • veterinarian licensed to practise veterinary medicine under the Veterinarians Act (Ontario)
  • person selling feeding stuffs registered under the Feeds Act (Canada) and sold in accordance with its provisions

Regulation 584/20

A licence is subject to the following conditions:

  1. The licensee must have a place in Ontario for the storage of livestock medicines sold under the licence.
  2. The licensee shall display a copy of the licence at,
    1. the place at which the licensee’s livestock medicines are stored, and
    2. any place at which livestock medicines are sold in person by or on behalf of the licensee.
  3. If the licensee sells livestock medicines online, the licensee must ensure that the licence number is prominently displayed on the website.
  4. In the case of a sale of any livestock medicine bearing a warning or caution on the label, the licensee must draw the purchaser’s attention to the warning or caution.
  5. The licensee must not sell a livestock medicine,
    1. to any person other than the owner of livestock or a person acting on behalf of the owner, or
    2. for any purpose other than the treatment of livestock.
  6. The licensee must provide notice to the director of any changes to the information required in an application for a licence to sell livestock medicines under subsection 3 (2).

No licensing fee

There is no charge for the licensee to obtain a licence to sell livestock medicines. Licences issued under O. Reg. 584/20 are issued for the lifetime of the licensee, unless the Ministry:

  • is notified of changes of business or licence status by the licensee
  • revokes the licence for non-compliance reasons in accordance with ministry inspection and enforcement requirements under the Animal Health Act, 2009 and/or the O. Reg. 583/20 and 584/20

Although regular renewal of the licence is not required, a licensee must notify OMAFRA of any changes to the licence information such as owner name, address/location or active status of the LMO. A licensee may surrender his or her licence to a director at any time.

Conditions of a licence

The licensee must comply with the conditions of the licence and notify the ministry of any changes to licensing information.

Regulation 584/20

  1. A person who wishes to apply for a licence to sell livestock medicines to owners of livestock, or to other persons on behalf of the owner, for treatment of the owner’s livestock shall apply for the licence to a director appointed under section 6 of the Act.
  2. An application for a licence to sell livestock medicines shall include the following information:
    1. The name and contact information for the individual responsible for the sale of livestock medicines under the licence.
    2. The business name of the operation, if different from the name of the person applying for the licence.
    3. The address of,
      1. the place at which the applicant sells or intends to sell livestock medicines on a permanent basis, or
      2. if the applicant intends to sell livestock medicines only online or at temporary locations, the place at which livestock medicines are stored for purposes of the sales.
  3. If an applicant for a licence to sell livestock medicines intends to sell livestock medicines from more than one place on a permanent basis, the applicant shall apply for a licence for each place separately.

Conditions of sale

Livestock medications must be stored according to each product label’s storage instructions to maintain safety and physical appearance and prevent reduced efficacy and potency (possibly resulting in an adverse reaction or inactivity). The information contained on a drug product label explains how to store and use the product safely. Each product has specific indications and instructions that must be followed, such as refrigeration at a specific temperature, to ensure that the drug performs safely as intended and does not pose a risk to animals or humans.

Medicine packaging and labels must remain intact, be legible and should not be dirty or water damaged. LMO operators must ensure staff are aware of storage requirements for each product.

Other requirements include:

  • not offering livestock medicines for sale after the expiry date printed on the label
  • ensuring all staff understand the importance of expiry dates
  • not selling or giving away outdated products
  • removing all outdated livestock medicines from store shelves
  • returning outdated stock to the manufacturer or disposing of it appropriately

Disposal of unwanted livestock medicines is not covered by provincial legislation, but some products may require disposal as hazardous waste depending on local regulations and by-laws.

Regulation 584/20

A licensee shall not store livestock medicines in a manner or for a period of time that is likely to result in the spoiling or denaturing of the medicines so as to become ineffective for their purposes or likely to harm the animals to which they are administered.

Limits on sale

A licensee shall not sell, distribute, use or store any livestock medicine if,

  1. it has been stored in a manner or for a period of time that is contrary to section 9;
  2. it has been adulterated; or
  3. the manufacturer’s original packaging or labelling has been changed, altered or otherwise tampered with.

Sales procedures

Medicines are sold only to owners of livestock or to other persons on behalf of the owner, such as family or employees, for treatment of the owner’s livestock. Sales can take place at permanent locations, by internet or at temporary locations such as booths at fairs and mobile operations.

Recordkeeping

LMOs must retain designated livestock medicine purchasing records, such as records of their drug purchases from a supplier, typically included in paper or electronic form with an inventory order, for the remainder of the year it was purchased, plus two years.

Store and manage records appropriately so that the information is available to the Ministry upon request.

In certain circumstances, OMAFRA may require an LMO to collect information regarding the sales of livestock medicines. This will include:

  • product name and lot number
  • name and address to whom it was sold
  • quantity sold
  • date on which it was sold
  • species of animal it is intended for
  • any other information the director may deem necessary to determine risk to human or animal health

Regulation 584/20

Records

  1. Every licensee shall keep accurate records of the livestock medicines purchased by the licensee, and the record of each purchase shall include,
    1. the date of the purchase;
    2. the name and address of the vendor; and
    3. the type and quantity of livestock medicines purchased.
  2. Every record of a purchase shall be kept for the remainder of the calendar year in which the purchase occurred and for two years thereafter.

Information required by the director

  1. If a licensee is notified by the director in writing that the director requires specified information about a livestock medicine for the purpose of assessing or determining if the livestock medicine is contributing to a risk to public health or to animal health, the licensee shall collect the following information respecting sales of the livestock medicine on and after the day the licensee receives the notification:
    1. The product name and lot number of the livestock medicine sold by the licensee.
    2. The name and address of persons to whom the licensee sold the livestock medicine.
    3. The quantity of the livestock medicine sold to each purchaser.
    4. The date on which the livestock medicine was sold to each purchaser.
    5. The species of animal to which the purchaser intended to provide the livestock medicine.
    6. Any other information the director specifies as being necessary for the purpose of assessing or determining if the livestock medicine is contributing to a risk to public health or to animal health.
  2. The licensee shall provide the information collected under subsection (1) to the director at the frequency, within the times and in the manner the director specifies in the notice.

Inspector Procedures

Inspectors are appointed under the Animal Health Act, 2009 and use a risk-based, progressive compliance approach to inspection.

Any deficiencies found will be discussed with the operator and/or outlet staff and recorded on an inspection report.

Risk-based and progressive compliance approach to deficiencies

The livestock medicines inspection program will prioritize inspection around areas of highest risk. Highest risk activities include activities that have a potential or actual risk to animal or human health.

When an LMO is not in compliance with legislated requirements, a progressive compliance approach is followed. The approach depends on the potential or actual risk to animal or human health, compliance history and intent of the non-compliance. There is a range of tools available including education, verbal warning, re-inspection, a warning letter, product detention, product seizure, provisional licence suspension or permanent revocation and fines or imprisonment depending on the seriousness of the offence.

Non-Compliance of Regulation

Persons found selling designated livestock medicines in the province of Ontario without a valid licence under the regulation will be advised of this requirement and must cease from selling livestock medicines until a licence is issued. Continued sale of these medicines without a livestock medicines licence will result in appropriate enforcement action.

Deliberate violation of regulations (including repackaging of products, improper storage, offering for sale a product not designated under the regulation, products instructed for disposal being re-offered for sale, removal of label expiry dates) will result in appropriate enforcement action by OMAFRA inspection staff in accordance with the progressive compliance approach described above.

Suspension of licence

Licences may be suspended for non-compliance.

Regulation 584/20

A director may suspend or revoke a licence if he or she is of the opinion that,

  1. the licensee no longer meets the requirements for the issuance of a licence;
  2. the premises, facilities or equipment used in the business do not comply with this Regulation or the conditions of the licence;
  3. the licensee has contravened, or has permitted any person under the licensee’s control or direction in connection with the business to contravene,
    1. any provision of the Act, this Regulation or any other regulation under the Act,
    2. an order issued under the Act,
    3. a condition of the licence,
    4. a provision of any other Act or regulation, or
    5. any law applying to the carrying on of the business;
  4. the licensee has unlawfully sold a drug, other than a livestock medicine;
  5. the licensee has not sold livestock medicines within the last year or is no longer in the business of selling livestock medicines; or
  6. it is necessary to do so for the immediate protection of the safety or health of persons or livestock.

Animal Health Act, 2009 and O. Reg. 583/20 and 584/20

For a detailed outline of specific requirements for Livestock Medicines Outlets and dispensing of livestock medicines, please see the Animal Health Act, 2009 and O. Reg. 583/20 and 584/20. These documents can be ordered by calling Publications Ontario.

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