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Glossary Item

Human product excipients list : approved biological excipients

Effective 2 July 2019 to 14 March 2020

Preferred Term: approved biological excipients

Other Terms:

Definition:

Biological excipients are highly processed substances that are components of commercially packaged human therapeutic products, laboratory materials or food products. The following substance groups are considered excipients for human therapeutic products, laboratory materials or products intended for human consumption only and are excipients only when ready for retail sale without any further processing:

  1. Alcohols

  2. Citric acid

  3. Cultures of Saccharomyces cerevisiae (or a derivative of a pure culture of Saccharomyces cerevisiae)

  4. Essential oils

  5. Esters

  6. Fish oil (other than salmon oil)

  7. Gelatine

  8. Glucosamine, chondroitin or chitosan of aquatic animal origin (except if derived from fish of the family Salmonidae or intended for veterinary therapeutic use in aquatic animals)

  9. Highly processed biochemicals derived from wool grease (including cholesterol, cholecalciferol vitamin D3, lanolin and lanolin alcohols)

  10. Homeopathic preparations

  11. Lactic acid

  12. Lactose

  13. Natural flavourings

  14. Pectins

  15. Plant acids

  16. Plant extracts (other than flours or powders)

  17. Plant gums

  18. Plant juices

  19. Plant oils

  20. Plant waxes

  21. Purified amino acids (other than those derived from neural material)

  22. Purified antibiotics or antimycotics manufactured without using materials of terrestrial animal or avian origin (except if intended for veterinary therapeutic use in aquatic animals)

  23. Purified avermectin compounds manufactured without using materials of terrestrial animal or avian origin (except if intended for veterinary therapeutic use in aquatic animals)

  24. Purified corticosteroid manufactured without using materials of terrestrial animal or avian origin

  25. Purified milbemycin compounds manufactured without using materials of terrestrial animal or avian origin (except if intended for veterinary therapeutic use in aquatic animals)

  26. Resins

  27. Starches

  28. Sugars

  29. Tinctures

  30. Vinegars

  31. Vitamins or provitamins

  32. Water

  33. Xanthan gum