Draft for Consultation: Guide on extending expiration dates of marketed drugs in response to drug shortages

This page is for consultation purposes only and may change. Learn about the consultation and how to provide your feedback. The consultation closes on March 8, 2025.

Disclaimer: This document does not constitute legislation. In the event of any inconsistency or conflict between the legislation and this document, the legislation takes precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the legislation and the applicable administrative policies.

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Overview

Introduction

Health Canada is responsible for helping people in Canada maintain and improve their health. This is done, in part, through our commitment and actions to help address and mitigate the harm to public health caused by drug shortages. Our goal is to help ensure that people in Canada have access to the drugs they need when they need them.

Sections C.10.014 to C.10.021 of the Food and Drug Regulations (FDR) (Extended expiration date regulations) allow for the expiration date of specified drug product lots or batches to be extended to help prevent or mitigate a drug shortage under certain conditions. The extension of an expiry date of specified drug product lots or batches to address a shortage would be an exceptional measure.

For ease of reference, lots and batches are used as interchangeable terms for the purposes of this guidance and will be referred to as batches for the remainder of the document.

All drug product batches with extended expiration dates will be listed on the List of Drugs with Extended Expiration Dates (Extended Expiration Date List). This list is incorporated by reference into the FDR and is updated as needed.

Learn more about drug shortages and the roles of various parties in addressing them.

Purpose

This guidance document will help regulated parties (market authorization holders (MAHs) and drug establishment licence (DEL) holders) understand how to comply with the regulations.

Specifically, it will help you understand section C.010.014 to C.10.021 of the FDR by outlining:

Note: For the purposes of this document, MAH is used interchangeably with manufacturer (see Definitions section).

Scope and application

The extended expiration date regulations apply to any drug (defined in Section 2 of the Food and Drugs Act (FDA)) that has received a Drug Identification Number (DIN), is in shortage or at risk of shortage and for which a shortage could present a risk of injury to human health.

Health Canada interprets risk of injury to human health due to a shortage as the likelihood that the interruption, lack or delay of treatment due to a shortage could cause harm to human health.

Sex- and gender-based analysis plus (SGBA Plus): Advancing equity, diversity and inclusion

Health Canada has a formal, corporate commitment to applying a sex- and gender-based analysis plus (SGBA Plus) approach to develop, implement and evaluate our activities. This includes our research, surveillance, legislation, policies, regulations, programs and services. This is in keeping with the federal government's commitment to gender-based analysis plus (GBA Plus).

The SGBA Plus process is an intersectional approach to assess how a range of factors interact and intersect with each other and broader systems of power. Examples of factors are sex, gender, age, race, ethnicity, socioeconomic status, disability, sexual orientation, cultural background, migration status and geographic location.

Conducting this analysis helps us to understand how intersecting identity factors, histories, power relations, distribution of resources and individuals' lived realities contribute to differences in accessing health-related resources and health outcomes. By applying SGBA Plus, we can engage in responsive and inclusive health research and develop policies, services, programs and other initiatives to promote greater health equity.

When engaging in this regulatory framework, we encourage you to conduct an SGBA Plus analysis and also take necessary steps to mitigate any possible negative impacts on particular groups.

Learn more about SGBA Plus analysis and assessment:

Note about guidance documents in general

Guidance documents provide assistance to industry on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.

Guidance documents are administrative, not legal, instruments. This means that Health Canada may consider alternative approaches to meeting the regulatory requirements that stakeholders may propose. However, to be acceptable, alternate approaches to the principles and practices described in this document must be supported by adequate justification. Stakeholders should discuss their proposals with Health Canada in advance so that the regulator can determine whether the applicable statutory or regulatory requirements can be met.

In accordance with its regulatory authorities and its mandate under the Food and Drugs Act, Health Canada may request other information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, efficacy or quality of a therapeutic product. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read in conjunction with the relevant sections of the regulations and other applicable guidance documents.

Responsibilities of regulated parties and Health Canada

Responsibilities of MAHs

MAHs must:

Responsibilities of DEL holders

DEL holders must:

Responsibilities of Health Canada

Health Canada, will:

As appropriate, Health Canada may seek additional information to support the proposal to extend the expiration date of a specified drug product batch.

We conduct compliance and enforcement activities related to these regulatory requirements as per our Compliance and enforcement policy for health products (POL-0001).

Understanding the regulations

The regulatory framework for extending expiration dates

The Extended expiration date regulations (sections C.10.014 to C.10.021 of the FDR) allow for the printed expiration date of specified drug product batches to be extended by adding them to the Extended Expiration Date List.

As per subsection C.01.001(1) of the FDR, an expiration date for a drug in dosage form is the earlier date of the following:

When drug product batches are added to the list, the MAH has provided sufficient evidence demonstrating that the product can be used safely and will comply with its specifications until at least its extended expiration date.

There is no requirement to re-label a batch with its extended expiration date. Required communication of the extended expiration date for the drug product will occur through:

  • Health Canada's inclusion of the batch's extended expiration date online on the Extended Expiration Date List
  • the MAH's communication to its DEL holders
  • the DEL holder's communication to its customers

Other communications may be issued by Health Canada on a case-by-case basis.

Health Canada may also notify provincial and territorial partners who will communicate, as needed, with implicated parties such as hospitals and pharmacy regulatory authorities.

The following sections outline the process of adding a specified drug product batch to the Extended Expiration Date List. This includes both regulatory requirements and additional policy requirements.

Process of adding a specified drug product batch to the Extended expiration date list

Health Canada will consider adding a specified drug product batch to the Extended Expiration Date List if all of the following criteria are met:

  1. There is a shortage or risk of shortage of the drug.
  2. A shortage of the drug, if it were to occur, presents a risk of injury to human health.
  3. Extending the expiration date of the specified drug product batch will help prevent or mitigate a shortage.
  4. Sufficient evidence has been provided to Health Canada demonstrating that the specified drug product batch can be used safely and will comply with its product specifications until at least the extended expiration date.

Health Canada will review all available options to mitigate a shortage (for example, exceptional importation, expiration date extension, collaborating with MAHs). An expiration date extension will generally be accepted if:

Assessing the risk of injury to human health

Expiration date extensions will be considered in response to the harm to public health and the impact that a shortage will have on the Canadian health system. Impactful shortages will generally be determined to be Tier 3 shortages. Tier 3 shortages are assigned by a Tier Assignment Committee (TAC), which includes federal, provincial and territorial governments, health care professionals and industry stakeholders.

Refer to Tier 3 drug shortages for additional information about Tier 3 shortages including a list of all drugs that Health Canada considers to be in a Tier 3 shortage status.

Health Canada will consider adding a drug product batch to the Extended Expiration Date List if there is sufficient evidence demonstrating that the extended expiration date will prevent or mitigate a drug shortage. For example, there may be instances where there is supply remaining at the MAH, wholesale, healthcare system, or patient level that is nearing expiration. Extending the expiration date of specified batches, in such cases, could increase the supply or decrease demand for the drug.

Expiration date extensions will not be considered for economic reasons.

Evidence of quality for specified drug product batches past their initial printed expiration date

In order to extend the expiration date of a specified drug product batch beyond its printed expiration date, there must be sufficient evidence demonstrating that the product can continue to be used safely and comply with its specifications.

The relevant Health Canada and International Council on Harmonisation (ICH) guidelines should be consulted. These guidelines include recommendations to confirm the stability of drug products, as well as the data required to establish and extend expiration dates. Examples of such documents include:

In general, MAHs are encouraged to review existing accelerated and long-term stability data to determine if it supports continued compliance of the drug product specifications beyond the printed expiration date.

Examples of data that can be used to support extended expiration dates for specific drug product batches include:

MAHs are encouraged to reach out to Health Canada at drugshortages.prop.notif-penuriesmedicaments@hc-sc.gc.ca prior to submitting a proposal form to discuss potential justifications for expiration date extensions in response to shortages. Given their intended use, stability profile and process for determining their initial shelf-life, MAHs of biologics, biosimilars and vaccines are encouraged to reach out to Health Canada if considering submitting a proposal.

How to submit an expiration date extension proposal

Health Canada has developed a process by which MAHs can submit a proposal to add a drug product batch to the Extended Expiration Date List in response to a drug shortage. The MAH must provide sufficient evidence and justification that the specified drug product batch can continue to be used safely and comply with specifications for the proposed extended expiration date period.

Submit a completed proposal for Health Canada's review to drugshortages.prop.notif-penuriesmedicaments@hc-sc.gc.ca

The proposal should include:

Note: The proposal form will be developed and added to this guidance document if/when the Extended expiration date amendments are finalized.

Health Canada review

Health Canada will review the form with the proposed extended expiration date and justification that was provided via the proposal.

Health Canada may request clarifications during its review or ask for additional information or testing results. Response timeframes will be specified in the request.

There are a three potential outcomes of Health Canada's review:

  1. Health Canada accepts the proposal with the extended expiration date.
  2. Health Canada accepts the proposal with a modified expiration that is shorter than what was submitted in the proposal. A shorter expiration date extension may be granted because:
    • The shorter expiration date is what is needed to prevent or mitigate the shortage. In some cases, such extensions may be extended if required.
    • The data does not support the proposed expiration date extension. In some cases, Health Canada may request additional testing to support a longer expiration date extension.
  3. Health Canada rejects the proposal and does not update the Extended Expiration date List because:
    • the expiration date extension will not mitigate or prevent the shortage
    • other options are being pursued or are in place to mitigate or prevent the shortage
    • the data provided by the MAH to justify the proposed expiration date extension was not adequate

Adding drug product batches to the Extended Expiration Date List

Once the proposal is accepted, Health Canada will notify the MAH by email and add the specified drug product batch to the Extended Expiration Date List. Health Canada will notify the MAH in advance or on the day that the specified batch is added to the List. Once a drug product batch is added to the List, the product can continue to be sold and used until the extended expiration date on the List.

As per sections C.10.015 and C.10.016 of the FDR, the following information is posted publicly on the List:

If the MAH wishes to further extend an expiration date, it may submit a new extended expiration date proposal.

Health Canada may shorten the extended expiration date or remove it from the List (see section below for further details) to address the changing circumstances of a drug shortage. This is a case-by-case decision. Health Canada will engage the MAHs in a timely manner on any changes.

Notification requirements

The MAH is required to notify DEL holder(s) to whom it sold the specified drug product batch, within 5 days after the day it is notified, that the specified drug product batch has been added to the Extended Expiration Date List. A DEL holder is required to notify any persons to whom it sold the specified drug product batch, within 5 days after the day they are notified, that the specified drug product batch have been added to the list.

Notification strategies will be reviewed as part of the proposal form.

For clarification, a person is an individual or an organization as defined in section 2 of the Criminal Code.

Removing batches of a drug from the Extended Expiration Date List

Examples of conditions where Health Canada may remove a drug product batch from the Extended Expiration Date List include:

Health Canada is responsible for notifying the MAH that the specified batch is removed from the list. The MAH is responsible for notifying the DEL holders or persons it sold the specified batch to that the drug batch has been removed from the List. The DEL holder is responsible for notifying any persons it sold the specified batch to of the batch's removal from the List. Notifications should be done immediately.

Health Canada may also issue communications about the removal of a drug product batch from the list.

A drug product batch that is past its extended expiration date on the Extended Expiration Date List or a batch that is no longer on the list can no longer be sold and should no longer be used.

Adverse drug reporting

Requirements under the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) on reporting adverse drug reactions apply to all specified drug product batches that have been added onto the Extended Expiration Date List.

The Guide to authorities under the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) provides information on how to report.

If you are a manufacturer reporting an adverse drug reaction, refer to Report an adverse reaction to a drug: industry.

If you are a hospital reporting an adverse drug reaction, refer to Report an adverse reaction to a drug: hospital.

It is recommended that your report include a note that the drug batch that you suspect may have caused the adverse reaction has an extended expiration date. Include the extended expiration date, and the drug batch in your report.

Definitions

Batch (or lot):

a specific quantity of material produced in a process or series of processes so that it is expected to be homogeneous within specified limits. In the case of continuous production, a batch may correspond to a defined fraction of the production. The batch size can be defined either by a fixed quantity or by the amount produced in a fixed time interval. (ICH Harmonised Tripartite Guideline on Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7)

Batch and lot are interchangeable. For ease of reference, batch will be used to signify batch and lot.

Drug establishment licence (DEL):
A licence issued to a person in Canada pursuant to Division 1A of the FDR to conduct licensable activities in a building that has been inspected and assessed as being in compliance with the requirements of Divisions 2 to 4 of the FDR.
Drug identification number (DIN):

An 8-digit numerical code assigned by Health Canada to each drug product marketed under the FDR.

A DIN uniquely identifies the following product characteristics:

  • manufacturer
  • brand name
  • medicinal ingredient or medicinal ingredients
  • strength of medicinal ingredient or medicinal ingredients
  • pharmaceutical form
  • route of administration
Expiration date:

(a) in the case of a drug in dosage form, the earlier of the following dates, expressed at minimum as a year and month:

  • (i) the date up to and including which the drug maintains its labelled potency, purity and physical characteristics, and
  • (ii) the date after which the manufacturer recommends that the drug not be used; and

(b) in the case of an active ingredient, whichever of the following dates is applicable, expressed at minimum as a year and month:

  • (i) the retest date, or
  • (ii) the date after which the manufacturer recommends that the active ingredient not be used (FDR, C.01.001)
Extended expiration date:
in respect of a specified lot batch or batch, the date set out in column 2 of the List of Drugs with Extended Expiration Dates.
Incorporation by reference:

A term to describe a mechanism, which allows a document or list that is not in the text of the regulations, in whole or in part, to be made a part of the regulations.

Health Canada uses incorporation by reference to:

  • achieve policy and regulatory objectives
  • leverage existing documents
  • maintain agile regulatory frameworks that can more quickly adapt to changes in science or technology, or in response to an emerging health or safety risk
  • contribute to regulatory alignment with the provinces and territories and to international cooperation on matters of trade, without compromising health and safety
Inner label:
the label on or affixed to an immediate container of a food or drug (FDR, section A.01.010).
Lot number (or batch number):
any combination of letters and/or figures which can be used to trace a drug being manufactured and/or in distribution (FDR, A.01.010).
Manufacturer or distributor:
a person, including an association or partnership, who under their own name, or under a trade-, design or word mark, trade name or other name, word or mark controlled by them, sells a food or drug; (FDR, A.01.010).
Market authorization holder (MAH):
Refer to manufacturer or distributor definition
Outer label:
means the label on or affixed to the outside of a package of a food or drug (FDR, section A.01.010).
Package/label:
to put a drug in its immediate container or to affix the inner or outer label to the drug (FDR, C.01A.001(1))
Person:
an individual or an organization as defined in section 2 of the Criminal Code (FDA, section 2)
Shortage:
In respect of a drug, a situation in which the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for the drug is unable to meet the demand for the drug in Canada. (FDR, C.01.014.8 (2))
Specifications:

a detailed description of a drug, the raw material used in a drug or the packaging material for a drug and includes

  • (a) a statement of all properties and qualities of the drug, raw material or packaging material that are relevant to the manufacture, packaging and use of the drug, including the identity, potency and purity of the drug, raw material or packaging material,
  • (b) a detailed description of the methods used for testing and examining the drug, raw material or packaging material, and
  • (c) a statement of tolerances for the properties and qualities of the drug, raw material or packaging material. (FDR, C.02.002)
Specified batch:
a lot or batch of a drug set out in column 1 of the List of Drugs with Extended Expiration Dates.

Resources

Legislation and regulations

Policies and Guides

Web pages/Associated documents

Contact Us

To submit a proposal to add a batch of drug onto the Extended Expiration Date List, contact us at drugshortages.prop.notif-penuriesmedicaments@hc-sc.gc.ca.

For questions about drug shortage and discontinuation regulations, contact the Health Product Shortages Directorate at hpsdpdcorr-corrdgppsdp@hc-sc.gc.ca.

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