Proposed Schedule F Amendment Open for Consultation

March 5, 2012 By

By: Manushvi Chadha, BPharm, RA Cert
NHP, Cosmetic and Drug Regulatory Affairs Associate
March 5, 2012

Project # 1663 is Health Canada’s new initiative for the purpose of adding certain enzymes to Schedule F of the Food and Drugs Act. If the proposal were to go through, it would mean that these enzymes (in the proposed strength) would be deemed “drugs” and would only be available on prescription.

The following enzymes have been proposed to be added to Schedule F:

  • Pancrelipase
  • Pancreatin
  • Pancreatic extracts

Under the following conditions:

– Where the strength per dosage unit exceeds 20,000 USP units of lipase activity


– When indicated for the treatment of pancreatic exocrine insufficiency.

These enzymes will continue to be available as Natural Health Products (NHPs) under the current Pancreatic Enzymes abbreviated labelling standard (which indicates a maximum strength of 10000 USP units of lipase activity per day). The pancreatic exocrine insufficiency claim is not currently available for NHP products.

Pancreatic exocrine insufficiency (PEI) is a condition where the enzymes secreted by the pancreas are not produced in adequate amounts, leading to an inability to digest food. Cystic fibrosis, chronic inflammation of the pancreas, or blockage of the pancreatic ducts are conditions that may cause PEI. Health Canada has come about this proposal after the reviewing the available scientific literature for the enzymes regarding toxicity, pharmacological properties and therapeutic uses. They have determined that the response to these enzymes may vary greatly between individuals.

Due to this variation, it is important that the condition be directly supervised by a health practitioner and the enzyme levels in the body be regularly monitored as there are undesirable side effects associated with excessive dosing (such as scarring of the large intestine).

At present, the consultation is open for Project # 1663 and will close on April 30th, 2012 and industry is encouraged to submit comments for the same.


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