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

November 23, 2017

Health Canada is notifying stakeholders of the interim approach concerning the implementation of Drug Establishment Licensing requirements for certain Active Pharmaceutical Ingredients (APIs) used in the fabrication of human pharmaceutical drugs that are also used outside of the pharmaceutical industry.  Health Canada considers the listed APIs, which are currently used as pharmaceutical excipients, or as ingredients in natural health products (NHPs), foods, cosmetics and that meet recognised standards other than Good Manufacturing Practices (GMPs), as atypical APIs for the purpose of this Notice.

The List of atypical APIs is appended to this Notice.

Please refer to the List of atypical APIs regularly, as it may be amended by Health Canada, or at the request of stakeholders. Stakeholders’ requests to include or exclude APIs from this List should be accompanied with an appropriate rationale and should be sent to api_questions_ipa@hc-sc.gc.ca for consideration.

Importers of the listed atypical APIs and drug in dosage form importers of products formulated using listed atypical APIs, which are fabricated, packaged, labelled and tested 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.  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 Ingredient List

  • 1,3-Butanediol
  • Acetic Acid
  • Adenine
  • Allantoin (5-Ureidohydantoin)
  • Almond Oil
  • Aluminum Hydroxide
  • Ammonium Chloride
  • Avobenzone
  • Benzalkonium Chloride
  • Benzethonium Chloride
  • Benzoic Acid
  • Benzophenone-3
  • Benzophenone-4
  • Benzophenone-8
  • Benzyl Alcohol
  • Beta-carotene
  • Bisdisulizole Disodium
  • Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine (as Bemotrizinol)
  • Caffeine
  • Calamine
  • Calcium Carbonate
  • Calcium Chloride
  • Calcium Undecylenate
  • Camphor
  • Carbamide
  • Carbonic Acid Monosodium Salt
  • Carboxymethyl Cellulose (sodium salt)
  • Cellulose (as Methylcellulose) and Derivatives
  • Cetylpyridinium Chloride
  • Charcoal (Activated Charcoal)
  • Chlorhexidine Digluconate
  • Chlorhexidine Gluconate
  • Chlorobutanol
  • Chloroxylenol
  • Chlorphenesin
  • Choline Chloride
  • Cinoxate
  • Citric Acid
  • Coal Tar
  • Cocoa Butter
  • Cod Liver Oil
  • Colloidal Oatmeal
  • Copper Undecylenate
  • Corn Starch
  • DEA-Methoxycinnamate
  • Dequalinium Chloride
  • Diethanolamine Methoxycinnamate
  • Dimethicone
  • Dioxybenzone
  • Disodium Edetate
  • Domiphen Bromide
  • Drometrizole Trisiloxane (as Silatrizole or Ecamsule)
  • Dyclonine
  • Ecamsule
  • Egg Yolk Phospolipids
  • Ensulizole
  • Enzacamene (4-Methylbenzylidene camphor)
  • Ethanol (Alcohol Anhydrous)
  • Ethanol (Ethyl Alcohol)
  • Eucalyptol
  • Ferric Oxide
  • Fish Oil
  • Fluoride (as Sodium Fluoride)
  • Gelatin
  • Glucose (as D-Glucose or Dextrose)
  • Glycerol / Glycerine / Glycerin
  • Glycine
  • Glycol
  • Glyoxyldiureide
  • Haloprogin
  • Hard Fat
  • Hexylresorcinol
  • Homomenthyl Salicylate
  • Homosalate
  • Hydrated aluminum silicate
  • Hydrochloric Acid
  • Hydroquinone
  • Iodochlorhydroxyquin
  • Inositol
  • Isopropanol (Isopropyl Alcohol)
  • Kaolin
  • Lactic Acid
  • L-Alanine
  • Lanolin
  • L-Arginine
  • L-Aspartic Acid
  • L-Cysteine
  • L-Glutamic Acid
  • L-Glutathione
  • L-Histidine
  • Lipoic Acid (Alpha Lipoic Acid)
  • 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
  • Mannitol
  • Medium Chain Triglycerides
  • Menthol
  • Menthyl 2-Aminobenzoate
  • Menthyl Anthranilate
  • Meradimate
  • Mineral Oil
  • Nitrofurazone
  • Oat Fibre
  • Octinoxate
  • Octisalate
  • Octocrylene
  • Octyl Methoxycinnamate
  • Octyl Salicylate
  • Oleic Acid
  • Olive Oil
  • Omega-3-Ethyl Esters
  • Oxybenzone (Benzophenone-3)
  • PABA (4-Aminobenzoic Acid)
  • Padimate A
  • Padimate O (Octyl dimethyl PABA)
  • p-Aminobenzoic acid
  • Peanut Oil
  • Pectin
  • Peracetic Acid
  • Petrolatum (Petroleum Jelly)
  • Phenol
  • Phenylbenzimidazole (Ensulizole, Phenylbenzimidazole Sulfonic Acid)
  • Phosphoric Acid
  • Polyaminopropyl Biguanide (PAPB)
  • Polycarbophil Calcium
  • Polyethylene Glycol
  • Polyhexanide
  • Polyvinyl Alcohol
  • Potassium Acetate
  • Potassium Chloride
  • Potassium Citrate
  • Potassium Phosphate
  • Povidone
  • Pramoxine
  • Propyl Alcohol
  • Propylene Glycol
  • Pyrithione Disulfide
  • Pyrithione Zinc
  • Resorcinol
  • Selenium Sulfide
  • Silica (Silicon Dioxide)
  • Silicone
  • Slippery Elm Bark Powder
  • Sodium Acetate
  • Sodium Ascorbate
  • Sodium Bicarbonate
  • Sodium Carbonate
  • Sodium Chloride
  • Sodium Citrate
  • Sodium Gluconate
  • Sodium Glycerophosphate
  • Sodium Hydrogen Carbonate
  • Sodium Hydroxide
  • Sodium Phosphate
  • Sorbitol
  • Soya-Bean Oil (Soybean Oil)
  • Sulfur
  • Sulisobenzone
  • Talc
  • Taurine
  • Terephtalydidene Dicamphor Sulfonic Acid
  • Theobroma Oil
  • Thymol
  • Titanium Dioxide
  • Tolnaftate
  • Topical Starch
  • Triclocarban
  • Triclosan
  • Triethanolamine Salicylate
  • Trolamine Salicylate
  • Tryptophan
  • Undecylenic Acid
  • Urea
  • Vitamin B1 (Thiamine)
  • Vitamin B5 (Pantothenic Acid)
  • Vitamin C (Ascorbic Acid)
  • Vitamin E
  • Wool Fat
  • Zinc Acetate
  • Zinc Carbonate
  • Zinc Chloride
  • Zinc Citrate
  • Zinc Gluconate
  • Zinc Omadine
  • Zinc Oxide
  • Zinc Pyrithione
  • Zinc Sulfate
  • Zinc Undecylenate

 

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