ARCHIVED Notice to Stakeholders - Implementation of Establishment Licensing Requirements for Atypical Active Pharmaceutical Ingredients for Veterinary Use

July 25, 2018

Health Canada is notifying stakeholders of an interim approach concerning the implementation of Establishment Licensing requirements for certain Active Pharmaceutical Ingredients (APIs) for veterinary use that are of lower risk and widely used outside of the pharmaceutical industry, as communicated to stakeholders in the May 22, 2018 DEL Bulletin #25. These APIs, considered as atypical APIs for the purpose of this notice, are currently used as pharmaceutical excipients, or as ingredients in natural health products (NHPs), veterinary health products (VHPs), as well as foods and meet recognised standards other than Good Manufacturing Practices (GMP).

Health Canada has compiled a list of atypical APIs for veterinary use and is presenting an opportunity for the public to provide comments through the Consultation on the List of Atypical Active Pharmaceutical Ingredients for Veterinary Use.

Importers of the listed atypical APIs and finished dosage form importers of products formulated using listed atypical APIs, who are not able to obtain appropriate GMP evidence, can complete the Foreign Building Information Table (Table A) on the Drug Establishment Licence Application: Forms and Instructions (FRM-0033) in accordance with the following instructions:

1. Column L - Indicate 'Exception' and include the standard that the API is manufactured against (e.g. 'Exception - ISO' or 'Exception - HACCP').
2. Columns M, N, O and P can be indicated as "Exception".
3. All other columns should be filled out as per regular Table A instructions.

It is important to note that each lot or batch of the atypical API shall, prior to its availability for sale, be tested against and comply with the specifications for that API. In cases where there is a pharmacopoeial standard (Schedule B to the Food and Drugs Act) for the atypical API, the API should be manufactured and tested against that standard.

Importers continue to be responsible for having written agreements with foreign buildings and evidence of the foreign building's compliance to the quality standard indicated. Furthermore, the dosage form fabricator, the DIN-holder, and the dosage form importer are responsible to assure the acceptable quality and safety by meeting all applicable requirements of Part C, Division 2 of the Food and Drug Regulations, including Raw Material Testing sections C.02.009 and C.02.010. Should a risk to health be identified, Health Canada will take appropriate compliance and enforcement action proportional to the risk.

This approach will remain in place until Health Canada notifies stakeholders otherwise.

Atypical Active Pharmaceutical Ingredients for Veterinary Use

• Biotin (Vitamin B7)
• Calcium Gluconate
• Calcium iodate
• Calcium Propionate
• Chlorhexidine acetate
• Choline bitartrate
• Cobalt carbonate
• Cobalt gluconate
• Copper gluconate
• Copper Naphthenate
• Copper oxide
• Dexpanthenol (panthotenic acid, B family)
• Dipiperazine sulfate/piperazine
• Hydrogen peroxide
• Inositol
• Iodine (topical)
• Linear dodecyl benzene sulfonic acid
• Manganese sulphate
• Menadione sodium bisulfite
• Niacinamide (Vit B3)
• Poloxalene
• Potassium iodide
• Pyridoxine Hydrochloride (Vitamin B6)
• Riboflavin (as 5-sodiumphosphate) Vit B2
• Salicylic acid (topical products for vet use)
• Sodium chlorite
• Sodium iodide
• Sodium linear alkylate sulfonate
• Sodium propionate
• Sodium selenite
• Thiamine Hydrochloride