2019-2020 Compliance Monitoring Project: Good manufacturing practices and testing of veterinary products for food-producing animals

Health Canada actively monitors the compliance of regulated parties and health products in Canada.

We did a proactive review to verify if veterinary products for food-producing animals and their suppliers comply with Health Canada’s regulations. Learn about how we conducted our review, what we found and what actions we took.

On this page

• Why this review was done
• What we reviewed
• What we found and what enforcement actions we took
• What we will do with the results
• For more information

Why this review was done

Health Canada’s Veterinary Health Product Notification Program replaced the Interim Notification Pilot Program for Low-Risk Veterinary Health Products (LRVHPs) in November 2017. Now, Health Canada must be notified of all veterinary health products (VHPs) manufactured, labelled/packaged, imported, distributed or wholesaled in Canada. These products must also comply with the Food and Drugs Act (FDA) and Food and Drug Regulations (FDR). VHP requirements include labelling, claims, permitted substances and ingredients, and post-market responsibilities. VHPs are drugs under the FDR. Companies who manufacture, package, label, import, distribute and/or store VHPs are required to follow the Part 3 - Good Manufacturing Practices (GMPs) in the Natural Health Products Regulations.

On December 1, 2018, medically important antimicrobials (MIAs) important to human medicine and once sold over-the-counter for veterinary use were put on the Prescription Drug List. This change is to strengthen veterinary oversight and promote the prudent use of MIAs in animals. The responsible use of MIAs is intended to preserve their effectiveness and minimize the development and spread of antimicrobial resistance. All MIAs in Canada must have a drug identification number (DIN) issued by Health Canada. They must also be sold by prescription only and comply with the FDA and the FDR.

Any company that:

• imports for the purpose of sale into Canada a drug is an importer
• sells a drug is a distributor
• sells a drug, other than at retail, is a wholesaler

We conducted this project to verify compliance with:

• regulatory requirements of selected VHPs and MIAs
• selected suppliers (wholesalers, distributors and importers)

Our findings will give us insight in the industry’s compliance with these recent regulatory changes.

What we reviewed

We visited 9 companies in November and December 2019 to verify compliance with the above requirements. We made 6 visits focused on VHPs and 3 visits focused on MIAs, with visits in Alberta, Ontario and Quebec. At each visit, inspectors verified specific regulatory requirements (see Table 1).

For visits focusing on MIAs, inspectors also sampled 6 products, which were tested in Health Canada laboratories to verify their compliance to specific requirements. We wanted to know if the MIAs contained:

• the amount of active ingredient(s) listed on the product label
• any drug ingredients not listed on the product label
• any microbial contaminants

These visits were not regular GMP inspections and no compliance rating was assigned. Inspectors provided companies with a summary of their findings at the end of each visit.

All suppliers (wholesalers, distributors and importers) of VHPs and MIAs for food-producing animals were considered for site visits. When selecting the sites, we considered both small and large companies, so we would have a general overview of the industry across Canada.

What we found and what enforcement actions we took

During our visits, we found areas where companies needed to improve their practices to comply with regulatory requirements. Compliance issues ranging in severity were found at most companies. Based on the severity of a risk identified, we took the most appropriate compliance and enforcement actions.

Health Canada results obtained through this review are specific to the lot tested. Of the 6 products tested:

• 5 products met the specific requirements noted above in the “What we reviewed” section
• 1 product did not meet the specific requirements because a drug ingredient (impurity) not listed on the product label was detected

For the product that did not comply, the company discontinued the product licence. With no remaining product expected on the market, no other actions were taken.

Our laboratories also reviewed each company’s documentation to identify any issues related to analytical methods, specifications, data validation and certificate of analysis. We found that 5 out of 6 products had some issues with product documentation. We informed the companies of their issue(s) and followed up with them. We continue to work with the companies to address these issues.

During our visits, we considered the nature and extent of all issues found. We took the necessary actions to protect the health and safety of people in Canada based on our compliance and enforcement policy (POL-0001). This included a request to stop the sale of 2 products, which was implemented by the company.

Companies are responsible for:

• putting measures in place to ensure they meet the regulatory requirements
• taking action to eliminate or mitigate risks when they occur

Details on the issues identified and actions taken for each company visited (Table 2) and product tested (Table 3) are listed below.

Table 3: Results of products tested and enforcement actions

Product name	DIN and Lot number	Where it was sampled [product licence holder if different from where it was sampled]	Testing results	Actions
Cocci Scour Bolus	DIN 02243017 Lot # 881010	Alberta Veterinary Laboratories Ltd (AB) [Can-Vet Animal Health Supplies Ltd. (ON)]	An impurity was detected in the product.	We informed the company of the issues identified. The company discontinued the product licence. With no remaining product expected on the market, no other actions were deemed necessary at the time.
Neo-Tetra Med	DIN 01976338 Lot # 192071023	Bio Agri Mix LP (ON)	The testing results met the specific requirements of the tests performed.	No action taken
Onycin 1000	DIN 00530646 Lot # 501797	Vetoquinol N A Inc. (QC)	The testing results met the specific requirements of the tests performed.	No action taken
Penicillin G Potassium USP Soluble Powder	DIN 02139219 Lot # 192088021	Bio Agri Mix LP (ON)	The testing results met the specific requirements of the tests performed.	No action taken
Pot-pen	DIN 02379406 Lot # 503024	Vetoquinol N A Inc. (QC)	The testing results met the specific requirements of the tests performed.	No action taken
Sulfamethazine	DIN 02391368 Lot # 19SM020101	Alberta Veterinary Laboratories Ltd (AB)	The testing results met the specific requirements of the tests performed.	No action taken

What we will do with the results

This compliance monitoring project allowed us to collect information on how veterinary products for food-producing animals and their suppliers comply with Health Canada’s regulations. Although we visited and tested a small number of companies and products, we use what we find to provide better guidance to the industry on how to meet regulatory requirements.

The results also tell us where we can improve our overall oversight of VHPs and MIAs. This helps to improve the quality and safety of veterinary products in Canada. Going forward, we will continue to inform people of Canada on our proactive monitoring activities.

For more information

• Monitoring health products on the Canadian market
• Health Product Complaint