Regulatory requirements prior to distributing Canadian drugs outside Canada
Drug Establishment Licensing Bulletin 163, January 8, 2024
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Summary
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.
Background
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:
- assess whether their decision to distribute drugs meant for the Canadian market outside Canada could cause or worsen a shortage
- keep records of these assessments
This prohibition does not apply to:
- drugs intended for the Canadian market and sold outside of Canada if the sale will not cause or worsen a drug shortage in Canada
- drugs that are not intended for the Canadian market and are manufactured solely for export
- people purchasing or dispensing drugs for individual use
Learn more about the regulatory provisions:
Contact us
Email the Drug Shortages Division at Drug.shortages-Penurie.de.medicament@hc-sc.gc.ca.
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