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

December 2, 2016

Health Canada is notifying stakeholders of an interim approach concerning the implementation of Establishment Licensing requirements for certain Active Pharmaceutical Ingredients (APIs) that are of lower risk and widely used outside of the pharmaceutical industry, as communicated to stakeholders in the August 4, 2016 DEL Bulletin #2.  Health Canada considers the listed APIs, which are currently used as pharmaceutical excipients, or as ingredients in natural health products (NHP), foods, cosmetics and that meet recognised standards other than GMPs, as atypical APIs for the purpose of this notice.

Health Canada has compiled a list of atypical APIs and is presenting an opportunity for the public to provide comments. The consultation document can be found at the following link:

Importers of the listed atypical APIs and finished dosage form importers of products formulated using listed atypical APIs, which are only manufactured against standards other than GMP, 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.  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 finished dosage form fabricator and the DIN-holder are responsible to assure the safety of the drug by meeting all 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 Ingredient List

• 4-Aminobenzoic Acid
• Acetic Acid
• Alkyl Benzoate
• Allantoin
• Almond Oil
• Aluminum Hydroxide
• Ammonium Chloride
• Anyhdrous Alcohol (Alcohol Anhydrous)
• Ascorbic Acid
• Avobenzone
• Benzalkonium Chloride
• Benzethonium Chloride
• Benzoic Acid
• Benzophenone
• Benzyl Alcohol
• Bisdisulizole Disodium
• Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine (as Bemotrizinol)
• Calamine
• Calcium Carbonate
• Calcium Chloride
• Calcium Undecylenate
• Camphor
• Carboxymethylcellulose
• Cellulose (as Methylcellulose) and Derivatives
• Cetylpyridinium Chloride
• Charcoal (Activated Charcoal)
• Chlorhexidine Digluconate
• Chlorobutanol
• Chloroxylenol
• Chlorphenesin
• Chlorpheniramine
• Cinoxate
• Citric Acid
• Coal Tar
• Cod Liver Oil
• Colloidal Oatmeal
• Copper Undecylenate
• D&C Red No. 28
• Dequalinium Chloride
• Diethanolamine Methoxycinnamate
• Dimethicone
• Dioxybenzone
• Disodium Edetate
• Domiphen Bromide
• Drometrizole Trisiloxane (as Silatrizole or Ecamsule)
• Dyclonine
• Egg Yolk Phospolipids
• Ensulizole
• Enzacamene
• Ethanol (Ethyl Alcohol)
• Ethyl Hexyl Methoxy Cinnamate
• Ethylhexyl Salicylate
• Ferric Oxide
• Fish Oil
• Fluorescein Sodium
• Fluoride (as Sodium Fluoride)
• Gelatin
• Glucose (as D-Glucose or Dextrose)
• Glycerin (as Glycerine)
• Glycerol
• Glycine
• Glycol
• Haloprogin
• Hexylresorcinol
• Homomenthyl Salicylate
• Homosalate
• Hydrochloric Acid
• Hydroquinone
• Iron III Hydroxide
• Isopropanol (Isopropyl Alcohol)
• Lactose
• L-Alanine
• L-Alanyl-L-Glutamine
• Lanolin
• L-Arginine
• L-Aspartic Acid
• L-Cysteine
• L-Glutamic Acid
• L-Glutathione
• L-Histidine
• L-Isoleucine
• L-Leucine
• L-Lysine Acetate
• L-Methionine
• L-Phenylalanine
• L-Proline
• L-Serine
• L-Threonine
• L-Tyrosine
• L-Valine
• Magnesium Carbonate
• Magnesium Chloride
• Magnesium Hydroxide
• Magnesium Oxide
• Medium Chain Triglycerides
• Menthol
• Meradimate
• Methylene Blue
• Mineral Oil
• Nitrofurazone
• Oat Fibre
• Octinoxate
• Octisalate
• Octocrylene
• Octyl Dimethyl
• Octyl Methoxycinnamate
• Octyl Salicylate
• Olive Oil
• Oxybenzone (Benzophenone-3)
• Padimate A
• Padimate O
• Patent Blue Sodium
• Peanut Oil
• Pectin
• Petrolatum (Petroleum Jelly)
• Phenol
• Phenylbenzimidazole Sulfonic Acid
• Phosphoric Acid
• Piroctone (as Piroctone Olamine or Piroctone Ethanolamine)
• Polycarbophil Calcium
• Polyethylene Glycol
• Polyhexanide
• Polyvinyl Alcohol
• Potassium Chloride
• Potassium Phosphate
• Povidone
• Pramoxine
• Pyrithione Disulfide
• Pyrithione Zinc
• Resorcinol
• Salicyl Alcohol
• Selenium Sulfide
• Silica Gel
• Silicon Dioxide
• Silicone
• Sodium Acetate
• Sodium Ascorbate
• Sodium Bicarbonate
• Sodium Chloride
• Sodium Glycerophosphate
• Sodium Hydroxide
• Sodium Phosphate
• Sodium Sulfadimethoxine
• Soya-Bean Oil (Soybean Oil)
• Sulfur
• Sulisobenzone
• Terephtalydidene Dicamphor Sulfonic Acid
• Thymol
• Titanium Dioxide
• Tolnaftate
• Triclosan
• Triclocarban
• Triethanolamine Salicylate
• Trolamine Salicylate
• Trypan Blue
• Tryptophan
• Undecylenic Acid
• Urea
• Zinc Acetate
• Zinc Carbonate
• Zinc Chloride
• Zinc Citrate
• Zinc Gluconate
• Zinc Omadine
• Zinc Oxide
• Zinc Pyrithione
• Zinc Sulfate
• Zinc Undecylenate