Canada Issues Guidance on Determining Rx Drug Classification
Health Canada has issued guidance on Determining Prescription Status for Human and Veterinary Drugs that explains the principles and factors that the agency considers when deciding whether a drug should be classified as a prescription or non-prescription product.
The guidance applies to both human and veterinary drugs and to all additions and removals from the list of prescription drugs that replaced the Food and Drug Regulations' "Schedule F" in 2012, although it does not apply to decisions as to whether a drug should be a controlled substance.
The guidance is intended to make the classification decision-making process more transparent by explaining the three broad principles that govern a determination as to prescription status:
- Whether supervision by a medical practitioner is necessary
- The level of uncertainty in respect to the drug, its use or its effects that justifies supervision by a practitioner; or
- Whether use of the drug can cause harm to human or animal health or a risk to public health and the harm or risk can be mitigated by a practitioner's supervision.
Health Canada: Determining Prescription Status for Human and Veterinary Drugs