Livestock Medicines Act

Agdex#:	400
Publication Date:	02/93
Order#:	93-029
Last Reviewed:	01/04
History:	Original Factsheet Revised-Jan /04
Written by:	Bill Holley - Chief Veterinary Inspector/OMAFRA; Craig Richardson - Animal Care Specialist/OMAFRA; Jack Honey/OMAFRA

Table of Contents

1. Introduction
2. Outlets
3. Storage
4. Expired Products
5. Inducement
6. Sales Procedure
7. The Livestock Medicine Advisory Committee
8. Summary

Introduction

The Drug and Pharmacy Regulations Act regulates the professions of dentistry, medicine, nursing, optometry and pharmacy in Ontario. This legislation restricts the retail sale of livestock medicines to those members of the professions listed above, as well as 'lay' persons licensed under the Livestock Medicines Act.

In 1974, the Ontario Ministry of Agriculture, Food and Rural Affairs, in consultation with the College of Veterinarians of Ontario, the Ontario College of Pharmacy, representatives from the livestock, poultry and fur industries, feed manufacturers and pharmaceutical companies, drafted the Regulations for the Livestock Medicines Act. Licenses for retail sale were first issued in 1978.

The Livestock Medicines Act provides access to a restricted group of animal health products for livestock producers through regulated retailers.

There are presently 540 licensed livestock medicine outlets in Ontario. Unannounced inspections are conducted annually to monitor compliance. All complaints are addressed with a prompt response. Compliance is achieved through education, the discussion of deficiencies and the development of an action plan with the outlet operator to rectify problems. The compliance audit process monitors medicine handling and sales activities and ensures only drugs designated as livestock medicines are offered for sale. Licensees are encouraged to routinely check expiry dates of products in order to prevent the inadvertent sale of expired goods. A written report is completed on site and this information is used to forecast inspection frequency.

All new licensees receive a copy of the 'Livestock Medicines Act Compliance Manual' and a visit with the inspector to discuss the requirements of the Act and promote awareness of the operator's role in food safety and quality assurance initiatives.

Outlets

A 1974 survey found medicines were commonly sold at feed mills, tack shops, race tracks, grocery stores, equipment dealers, as well as from vehicles used by door-to-door sales representatives. This unregulated activity raised concern about the nature of the medicines sold, questionable sales practices, medicine storage conditions and unsubstantiated claims for products.

The Livestock Medicines Act requires all licensees to have an 'established place of business' for the storage and sale of livestock medicines. Operators can apply for licenses that allow them to sell livestock medicines at a temporary, fixed location other than their licensed establishment. A temporary licence to sell livestock medicines is required thirty days prior to an event such as a horse race or agricultural fair. Door-to-door sales or peddling are prohibited under the Regulations. Licensees cannot deliver a livestock medicine to a live stock owner without an order from that owner authorizing such delivery, evidenced by an invoice prepared by the licensee in advance of delivery.

Storage

Manufacturers clearly state specific storage requirements on the labels of their products. Failure to store these products according to these recommendations may result in the product not performing as intended, or possibly causing ill side effects when administered.

Some storage considerations include temperature, light, humidity and potential for breakage. Vaccines and some other medicines are particularly sensitive to temperature fluctuations. The Act requires livestock medicines that require refrigeration be kept in a working refrigerator that is solely used for livestock medicines. It is advisable to leave a thermometer in this unit to ensure it is functioning properly.

Foods intended for human consumption must not be stored in the same refrigerator used to store livestock medicines. Storage shelves and cabinets must be constructed or located so that animal health products do not come in contact with human food or medicine. This reduces the risk of humans accidentally ingesting animal medicines that may have leaked onto food, as well as the potential for cross-contamination of molds from human foods to animal medicines. The refrigerator and other storage facilities should be maintained in a clean and sanitary condition.

Expired Products

Expired medicines must not be offered for sale under any circumstances. Immediately after the expiration date indicated on the label, the licensee must remove the livestock medicine from the display area. The expired product must be kept separate from other livestock medicines and disposed of in an appropriate manner. As the chemical composition of products may change over time, manufacturers have carefully calculated the shelf life of the product including reasonable 'use time' for producers. Sale of the product after the label expiry date provides no guarantee with respect to the safety or efficacy of the product. Pharmaceutical companies will not support their products' claims once the expiry date has lapsed. Operators are encouraged to check expiry dates and rotate inventory on a regular basis.

Inducement

Livestock medicines are not to be held out as an inducement for the purchase of additional livestock medicine or other goods. As well, other goods cannot be held out as an inducement for the purchase of livestock medicines. The licensee at the retail level may reduce the price of livestock medicines on a per item basis. For example: reducing the price 20% is permissible, but offering "Buy four, get one free" is not. Livestock owners should not be encouraged to purchase more medicine than they need.

Livestock medicines may not be given away in conjunction with the purchase of a tonne of feed or a halter. Likewise, a bag of feed or a brush may not be given away with the purchase of livestock medicines.

Inducements could encourage over-buying. This creates the potential for products to expire before they might be used. Expired medicines have an unknown withdrawal period. Administration of these products may result in drug residues in meat or milk.

Sales Procedure

Licensed livestock medicines outlet operator are required to record the name and address of the purchaser, as well as the lot number of biologicals. The brand name and quantity of any other livestock medicines sold are recorded on sales invoices. This provides a 'trace-back' system in the event of a product recall or adverse reaction.

Retail operators are not permitted to repackage live stock medicines. Each product must be sold in the original package as it was received from the manufacturer. The label on the manufacturer's package gives the purchaser the directions for use, storage, any cautions, withdrawal period and expiry date. The licensee must make the purchaser aware of any warnings or cautions on the label. No advertising by the licensee can exceed the claims or information printed on the manufacturer's label.

Disciplinary measures for contravention of the Livestock Medicines Act or its regulations, include, hearings, license suspensions or revocation and/or prosecutions in provincial court.

The Livestock Medicine Advisory Committee

This committee represents all aspects of the livestock industry. The Ontario Minister of Agriculture, Food and Rural Affairs appoints members. They meet regularly to review the legislation and address concerns pertaining to sale of livestock medicines. The Minister is advised on matters concerning the Livestock Medicines Act and its Regulations.

Pharmaceutical manufacturers or distributors may make application to the committee for consideration of new products to be included on the list of medicines approved for retail sale. Upon approval, the committee recommends to the Minister that the product be authorized for sale by licensed livestock medicine outlets.

Summary

The Livestock Medicines Act provides an avenue for livestock owners to have access to animal health products at licensed outlets in order that they can treat their animals and reduce suffering.

Indiscriminate use of drugs can not replace good live stock management practices. Properly used, drugs are an important tool to minimize stress and enhance animal welfare in animal agriculture. Producers are encouraged to consult with their veterinarian if in doubt about either diagnosis or treatment.

Table 1. Responsibilities of Livestock Medicine Retailer and Purchaser.