Exclusions from the Human Pathogens and Toxins Act
This Statement of Administrative Intent (SAI) is intended to clarify the exclusions from the application of the Human Pathogens and Toxins Act (HPTA).
- Natural Environment
The HPTA states in Section 4 (a) that a human pathogen or toxin that is in an environment in which it naturally occurs is excluded from the HPTA as long as it has not been cultivated or intentionally collected or extracted.
The HPTA does not apply to:
- A human pathogen and toxin that is still in the environment in which it naturally occurs if it remains in the medium (i.e. humans, animals, and/or the environment) from which it was collected, even if the sample has been modified by other ingredients, such as stabilizers; and,
- Any samples that have been processed, as long as the pathogen or toxin itself has not been extracted.
The HPTA does apply to any human pathogens and toxins that have been extracted immunoprecipitated, concentrated, collected, amplified, cultivated, refined, cultured, and/or grown from such samples.
- A Regulated Drug
The HPTA also states in Section 4 (b) that a human pathogen or toxin is excluded from the HPTA if it is a drug in dosage form whose sale is permitted or otherwise authorized under the Food and Drugs Act or contained in such a drug.
For example, the HPTA does not apply to any pathogen or toxin in a drug approved for sale in Canada, that has been issued a Notice of Compliance and a Drug Identification Number.
If you have any questions about whether the sale of a particular a drug in dosage form, is permitted or authorized under the Food and Drugs Act, please contact:
Therapeutic Products Directorate
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