Most of SCCL’s products are designated as “Veterinary Biologics”. This important classification ensures that our products meet the highest regulatory standards placed upon colostrum products globally.
Veterinary Biologics are typically defined as “animal health products such as vaccines, antibody products, and in vitro diagnostic test kits that are used for the prevention, treatment, or diagnosis of infectious diseases in animals”. Veterinary Biologics specifically stimulate or involve an immunologic response to infectious disease(s) unlike Veterinary Drugs which have a different mode of action. Bovine dried colostrum may be categorized as a Veterinary Biologic, Feed or Feed Additive depending on what country the product is registered or sold in; however, because SCCL manufactures our bovine dried colostrum products in Canada, we are regulated by the Canadian Food Inspection (CFIA), Canadian Centre for Veterinary Biologics (CCVB). Bovine colostrum is sold only as a Veterinary Biologic in Canada and must comply with the regulations and standards for Veterinary Biologics regardless of whether SCCL sells in Canada or exports our calf, lamb and goat products around the world. As a Veterinary Biologic, bovine colostrum is categorized as an antibody product (specifically, Bovine Immunoglobulin G or Bovine IgG) with the claim to “aid in the prevention of failure of passive transfer (FPT)” in newborn calves, lambs or goats.
How is the designation earned?
The facility manufacturing the Veterinary Biologic AND each product produced by the facility requires licensing by the CFIA-CCVB. Facility or Establishment Licenses and Product Licenses are required to be renewed on an annual basis once initial approval is granted. To gain licensure, a comprehensive application must be submitted, reviewed and approved by the CFIA-CCVB that proves each product meets the requirements of purity, potency, safety and efficacy in the target species and according to the label’s directions before the product can be sold or distributed in Canada or exported around the world. The manufacturing facility or establishment must undergo a comprehensive on-site inspection including contract facilities that are used for testing, packaging, storage or contract manufacturing of the finished product. This establishment pre-licensing inspection is performed the CFIA-CCVB, and physical and administrative inspections are also required on an on-going basis of the licensed establishment and their contracts to maintain both Establishment and Product licenses. Currently, SCCL is inspected by the CFIA-CCVB at a minimum of every 12 months.
What criteria do Veterinary Biologic products need to meet to earn it?
Colostrum as a Veterinary Biologics must meet requirements to ensure that it is pure or free from defined micro-organisms with specific specifications or limits and with tests approved by the regulatory authority; that it is potent and the active ingredient or Bovine IgG is functional and present at the indicated amount that has been proven to be effective; that it is safe to use in the target species and should not cause unwarranted reactions; and that it is effective and provides the protection or benefit that is expected and stated by the approved claim when used as directed. Each of the purity, potency, safety and efficacy of a Veterinary Biologic must be proven to the regulatory authority prior to licensing by submitting robust research data, test results and observations that are reviewed by the regulatory authority and measured against a defined set of standards or requirements.