Questions and Answers - Prescription Drug List

• General Questions
• Format of Prescription Drug List
• Administrative Process
• Miscellaneous

General Questions

1. How has Schedule F in the Food and Drug Regulations changed?

Previously, a regulatory amendment was needed to give a drug prescription status by adding it to Schedule F to the Food and Drug Regulations, or to switch its status from prescription to nonprescription by removing it from Schedule F.

As part of the Jobs, Growth and Long-term Prosperity Act (Bill C-38), which received Royal Assent on June 29, 2012, the Government amended the Food and Drugs Act to give the Minister of Health certain powers, including the power to establish a list that sets out prescription drugs.

Subsequent to changes to the Food and Drugs Act, the Food and Drug Regulations required amendments to replace the previous regulatory process with a more efficient administrative process, the Prescription Drug List.

2. What replaced Schedule F to the Food and Drug Regulations?

Schedule F to the Food and Drug Regulations was replaced by a list of prescription drugs, called the Prescription Drug List.

3. Has this change affected the safety, quality and efficacy of prescription drugs?

No. This new approach has not impacted the safety, quality and efficacy of drugs in Canada. All drug submissions to Health Canada continue to be subject to the same rigorous scientific assessments prior to determining whether to make a drug a prescription drug. These changes have not affected the way the sale, advertising, or import of prescription drugs are regulated in Canada.

4. Has the Prescription Drug List changed which drugs are considered prescription drugs?

No. Drugs that were previously listed in Schedule F to the Food and Drug Regulations are included in the Prescription Drug List.

5. Does the Prescription Drug List affect my ability to get prescription drugs?

There is no impact on access to prescription drugs.

Format of Prescription Drug List

1. What does the Prescription Drug List look like?

The Prescription Drug List will look different than the previous Schedule F.

Schedule F was divided into Part I and Part II:

• Part I listed medicinal ingredients that, when found in a drug, required a prescription for human use and for veterinary use;
• Part II listed medicinal ingredients that, when found in a drug, required a prescription for human and veterinary use, except those drugs labelled for veterinary use only or in a form unsuitable for human use.

The Prescription Drug List is divided into two:

• A list of medicinal ingredients that, when found in a drug, require a prescription for human use; and
• A list of medicinal ingredients that, when found in a drug, require a prescription for veterinary use.

All prescription veterinary drugs are listed in the veterinary drug section of the Prescription Drug List. If a veterinary drug product with a drug identification number is not on this list, it is considered a nonprescription drug.

2. How can I access the Prescription Drug List?

The Prescription Drug List is accessible via the Health Canada website.

Administrative Process

1. Who makes the decision to add or remove a medicinal ingredient from the Prescription Drug List?

The Minister of Health delegates the authority to a senior official within the Health Products and Food Branch of Health Canada, who makes a decision following a recommendation from a Health Canada committee of scientific experts.

2. When will Health Canada add or remove a medicinal ingredient from the Prescription Drug List?

Typically, the addition of a medicinal ingredient to the Prescription Drug List is triggered by a company submitting an application to Health Canada for a drug that is new to the Canadian market.

Sometimes, Health Canada may add a medicinal ingredient that was authorized as a nonprescription drug to the Prescription Drug List. This type of addition may be triggered by new information that comes to the Department's attention through post-market activities or a drug submission.

Switches from prescription to nonprescription status are initiated by a request from a company in the form of a drug submission.

Drug submissions contain information and data regarding the drug's safety, quality and efficacy. After reviewing this data, Health Canada may determine that the drug should be available by prescription only, or that nonprescription sale is appropriate.

3. What does Health Canada consider when adding or removing a medicinal ingredient from the Prescription Drug List?

There are three principles and their associated factors that Health Canada considers when deciding whether to make a drug available by prescription only. The three broad principles are found in Section  C.01.040.3 of the Food and Drug Regulations, and are as follows:

1. Supervision by a practitioner is necessary
   1. for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in respect of which the drug is recommended for use, or
   2. to monitor a disease, disorder or abnormal physical state, or its symptoms, in respect of which the drug is recommended for use, or to monitor the use of the drug.
2. The level of uncertainty respecting the drug, its use or its effects justifies supervision by a practitioner.
3. Use of the drug can cause harm to human or animal health or a risk to public health and the harm or the risk can be mitigated by a practitioner's supervision.

The way in which Health Canada interprets the principles, along with their associated factors, are explained in the guidance document - Determining Prescription Status for Human and Veterinary Drugs.

The broad principles encompass factors that Health Canada has considered in making decisions about prescription status for over 20 years. These factors were previously listed in a policy entitled "Factors for Listing Drugs in Schedule F". This more detailed guidance document replaces that policy.

The prescription factors are generally consistent with other international regulators.

4. What is the process for adding a medicinal ingredient to the Prescription Drug List?

The process is as follows:

• Health Canada evaluates data from a drug submission to assess the safety, quality and efficacy of a drug and whether it should be available by prescription only.
• Health Canada scientific staff make a recommendation to the existing Health Canada committee of scientific experts (referred to in this document as the Committee) to add a medicinal ingredient to the Prescription Drug List.
• Following endorsement by the Committee the following steps occur (in this order):
  • For drugs that are new to the Canadian market:
    • Notice of decision posted to the Health Canada website, informing the public of the Minister's decision and rationale regarding the addition.
    • External stakeholders are informed of the addition via email.
  • For medicinal ingredients that are currently regulated as nonprescription products^{Footnote 1}:
    • Notice of consultation posted to the Health Canada website regarding the Minister's intent to add a medicinal ingredient to the Prescription Drug List, including:
      • Notification that Health Canada will undertake a consultation
      • Rationale for proposed addition.
    • 75 day consultation
    • Health Canada evaluates the comments received during the consultation:
      • Where the comments raise important questions related to the proposed addition, the proposal is returned to the Committee for further consideration.
      • Where the comments support the proposed addition, the decision is made to revise Prescription Drug List.
    • Notice of decision posted to Health Canada website, including:
      • A summary of comments received and Health Canada's response.
      • The Minister's decision to add the medicinal ingredient.
    • External stakeholders informed of addition by email.
    • The medicinal ingredient is added to the Prescription Drug List 6 months after the notice of decision is posted.

5. What is the process for removing a medicinal ingredient from the Prescription Drug List?

The process is as follows:

• Health Canada evaluates data from a drug submission to assess the safety, quality and efficacy of a medicinal ingredient and whether it should be available by prescription only.
• Health Canada scientific staff make a recommendation to the existing Health Canada committee of scientific experts to remove a medicinal ingredient from the Prescription Drug List.
• Following endorsement  by the Committee, the following steps occur (in this order):
  • Notice of consultation posted to the Health Canada website regarding the Minister's intent to remove a medicinal ingredient from the Prescription Drug List, including:
    • Notification that Health Canada will undertake a consultation.
    • Rationale for proposed removal.
  • 75 day consultation
  • Health Canada evaluates the comments received during the consultation:
    • Where the comments raise important questions related to the proposed removal, the proposal is returned to the Committee for further consideration.
    • Where the comments support the proposed removal, the decision is made to revise the Prescription Drug List.
  • Notice of decision posted to Health Canada website, including:
    • A summary of comments received and Health Canada's response.
    • The Minister's decision to remove the medicinal ingredient.
  • External stakeholders informed of removal by email.
  • The medicinal ingredient is removed from the Prescription Drug List 6 months after the notice of decision is posted.

6. What happens to authorized products on the market that are affected by an addition or removal of a medicinal ingredient from the Prescription Drug List?

In cases where the addition or removal of a medicinal ingredient from the Prescription Drug List affects products currently on the market, Health Canada will ensure that manufacturers of the affected products on the market are informed of the notice of consultation recommending the addition or removal from the Prescription Drug List when it is posted to the Health Canada website. These manufacturers will then have an opportunity to read about Health Canada's intention for transitioning affected products to prescription or to nonprescription status (as the case may be) and to provide input to the consultation. The final outcome of the consultation is posted in the form of a notice of decision which comes into effect 6 months later. Should the final outcome of the consultation be to go forward with the addition or removal, Health Canada will continue to provide guidance to manufacturers who need to transition their products.

Manufacturers of the affected products on the market will need to make a submission to Health Canada typically to obtain approval of updated labelling for their previously approved products. The 6 month delay in implementation after the notice of decision allows manufacturers of affected products sufficient time to obtain Health Canada's approval of their updated labelling. Manufacturers can sell affected products with updated labelling only after the notice of decision comes into effect (that is, 6 months after the notice has been posted to the Health Canada website), and at that point can no longer sell their products with the previously approved labelling.

7. What is the role of the Health Canada committee of scientific experts?

The committee of scientific experts is responsible for determining that the principles and factors regarding prescription status are appropriately applied and that the sale of the drug by prescription is appropriate.

8. Has the scientific evidence required by the Food and Drug Regulations to assess the safety, quality and efficacy of prescription drugs changed?

No. The scientific evidence required by the Food and Drug Regulations to assess the safety, quality and efficacy of a prescription drug has not changed.

All drug submissions to Health Canada are subject to rigorous safety, quality and efficacy assessments prior to approval. This includes assigning a drug prescription status or a change in a drug's status from prescription to nonprescription.

9. Will Health Canada provide the rationale for revisions made to the Prescription Drug List?

Each time a medicinal ingredient is added or removed from the Prescription Drug List, the rationale for the change is provided in a notice posted to the Health Canada website.

10. What happened to the medicinal ingredients proposed for addition to Schedule F before the announcement of the new Prescription Drug List was made? Were they added to Schedule F?

Regulatory amendments to add certain medicinal ingredients that were proposed for addition to Schedule F of the Food and Drug Regulations proceeded - these particular amendments were completed prior to Schedule F being removed. All other medicinal ingredients that were proposed for addition to Schedule F will follow the process to add medicinal ingredients to the Prescription Drug List.

Miscellaneous

1. Is there a guidance document on the Prescription Drug List?

The guidance document Determining Prescription Status for Human and Veterinary Drugs explains the three principles and their associated factors that Health Canada considers when deciding whether to make a drug available by prescription only.

2. Has the Drug Product Database changed?

The only change to the Drug Product Database was the terminology used to identify the status of a product. Specifically:

• 'Schedule F' was changed to 'Prescription';
• 'Schedule F Recommended' was changed to 'Prescription Recommended'.

3. Has the definition of practitioner changed?

The definition in the Food and Drug Regulations now reads: "practitioner" means a person who:

1. Is entitled under the laws of a province to treat patients with a prescription drug; and
2. Is practising their profession in that province.

The definition has only changed to remove reference to Schedule F.

4. Did Health Canada review the medicinal ingredients previously listed in Schedule F to the Food and Drug Regulations before moving them to the Prescription Drug List to determine if they should remain prescription?

No. The medicinal ingredients previously listed in Schedule F to the Food and Drug Regulations have been included in the Prescription Drug List, with changes only being made to correct inconsistencies in the way in which some medicinal ingredients are listed.

5. Are prescription drugs still required to include "Pr" on their labels?

Yes. Prescription drugs are still required to include "Pr" on their labels.

6. Does this new process change the way natural health products are regulated?

No. Natural health products (NHPs) continue to be regulated in the same way under the Natural Health Products Regulations.

7. Does the Prescription Drug List affect the way controlled substances or narcotics are regulated?

No. Controlled substances and narcotics continue to be scheduled according to the Controlled Drugs and Substances Act (CDSA) and the Narcotic Control Regulations. The CDSA and its Regulations provide a legislative and regulatory framework for the control of substances that can alter mental processes and that may produce harm to the health of an individual or to society when diverted or misused.

Health Canada considers several factors in determining if, and in which schedule, a substance should be regulated under the CDSA and its related regulations. Such factors include the likelihood of abuse or misuse of the substance, the danger it represents to the safety of the public, and the usefulness of the substance as a therapeutic agent.

8. Does the Prescription Drug List affect which nonprescription products are sold "behind-the-counter" in pharmacies?

No, it does not as this is not determined at the federal level.

It is important to understand that there are two levels of decision-making at play in Canada. First, at the federal level drug products will be given prescription or nonprescription status.

After the federal decision, the provinces and territories then can further restrict the conditions of sale of these products, however they cannot be less stringent. Thus for example, a federally nonprescription product could be assigned prescription status by a province or territory. However, a product that federally has prescription status cannot be given nonprescription status by a province or territory - it must maintain its prescription status in all of Canada.

For most provinces and territories, restrictions on the conditions of sale are based on recommendations made by National Association of Pharmacy Regulatory Authorities (NAPRA). NAPRA recommends that products be placed on one of three schedules (I, II, III), each reflecting a different level of restrictions (prescription, behind-the-counter, etc.) or the products are unscheduled. More detailed information about the  NAPRA schedules can be found on their website.

More information on behind-the-counter products can be obtained from your provincial or territorial government or NAPRA.