Health Canada Introduces New Rules for Pharmacies that Compound APIs for Veterinary Use
Published April 26, 2018, 3:05 p.m.
Do you provide pharmacy services for veterinarians or pet owners? If so, please note the following important information regarding federal regulation changes that may apply to you or your practice.
Regulatory changes to federal Food and Drug Regulations, meant to ensure the responsible use of antimicrobials in animals, may affect you if:
- You import active pharmaceutical ingredients (APIs) that are set out on List A: List of Certain Antimicrobial Active Pharmaceutical Ingredients; and/or
- You are a pharmacy professional who compounds antimicrobial drugs using APIs on List A: List of Certain Antimicrobial Active Pharmaceutical Ingredients for animal use.
The increased oversight on APIs for veterinary use require:
- manufacturing according to good manufacturing practices (GMPs)
- persons who fabricate, import, package, label and test active pharmaceutical ingredients (APIs) for veterinary use to hold a drug establishment license (DEL)
- pharmacists, veterinarians or those compounding a drug under the supervision of a licensed veterinarian to hold a drug establishment license (DEL) when importing medically important antimicrobials that are on List A: List of Certain Antimicrobial Active Pharmaceutical Ingredients.
Therefore, as of May, 17 2018, you may need to:
- Be inspected by Health Canada,
- Comply with GMP and/or
- Obtain a DEL (see below regarding transition period)
Health Canada has established a 14 month transition period to obtain a DEL. If you were already performing activities with respect to API for veterinary use before May 17, 2018, then you must submit a complete DEL application by July 17, 2019. If you were not already undertaking these activities before May 17, 2018, then you cannot conduct licensable activities until you obtain an appropriate DEL. There is no transition period for meeting GMP requirements – they must be met by May 17, 2018.
If you are a manufacturer, importer, or compounder of antimicrobial drugs for veterinary use that contain an active pharmaceutical ingredient on List A, you will need to report annual sales data to Health Canada. This means you will need to collect data throughout 2018 and report by March 31, 2019.
Health Canada has made available the following resources:
- Health Canada Webinar Session 1: An introduction to the new requirements under the Food and Drug Regulations affecting industry and health care practitioners who compound veterinary drugs
- Health Canada Webinar Session 2: How to submit an application or an amendment to a Drug Establishment License for veterinary active pharmaceutical ingredients
- Drug Establishment License Q&As – Anti-Microbial Resistance Regulatory Amendment
For any questions, please contact Health Canada at firstname.lastname@example.org using the subject line “AMR Info Request.”