Draft for consultation: Extended expiration date list
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About the list
The List of Drugs with Extended Expiration Dates, also known as the Extended Expiration Date List, would specify lots or batches of drugs authorized in Canada that may be sold until an extended expiration date to help prevent or mitigate the impacts of a drug shortage in Canada. Sections C.10.014 to C.10.021 of the proposed amendments to the Food and Drug Regulations (FDR) establish this list and set out the regulatory requirements for listed drugs.
For information on extending expiration dates, consult:
How the list would be maintained
This list would be incorporated by reference in the proposed regulations. Health Canada would maintain and update this list as required in line with our Incorporation by Reference Policy.
Lots or batches of drugs may be added to the list if:
- there is a shortage or risk of shortage of the drug
- a shortage of the drug, if it were to occur, could present a risk of injury to human health
- the lot or batch will comply with the specifications for that drug until at least the extended expiration date in column 2 of the table
When drug product lots or 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.
Column 1 Lot or batch number |
Column 2 Extended expiration date | Brand name of drug, medicinal ingredient(s) | Manufacturer name | Drug identification number (DIN) | Printed expiration date | Date added to the list |
---|---|---|---|---|---|---|
N/A | N/A | N/A | N/A | N/A | N/A | N/A |
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