Regulatory requirements prior to distributing Canadian drugs outside Canada

Drug Establishment Licensing Bulletin 163, January 8, 2024

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The United States Food and Drug Administration (US FDA) approved a new importation program for Canadian drugs into the state of Florida on January 5, 2024. This program operates under US federal regulations. It's designed to address high drug prices in the United States.

Health Canada is issuing this DEL bulletin to remind stakeholders of certain relevant regulatory obligations.

The Food and Drug Regulations (regulations) prohibit drug establishment licence (DEL) holders from distributing Canadian drugs for use outside Canada if this could cause or worsen a drug shortage.

Health Canada is monitoring the situation in Florida and in other states where the FDA is reviewing importation program proposals. We're engaging stakeholders as needed.


DEL holders must not distribute certain Canadian-authorized and labelled drugs for use outside Canada if this could cause or worsen a shortage. This prohibition has been in effect since November 27, 2021.

Under the regulations, DEL holders must:

This prohibition does not apply to:

Learn more about the regulatory provisions:

Contact us

Email the Drug Shortages Division at

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