2019-27474: Importation of Prescription Drugs
Public comment closed .
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The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its regulations to implement a provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow importation of certain prescription drugs from Canada. If the rule is finalized as proposed, States or certain other non-federal governmental entities would be able to submit importation program proposals to FDA for review and authorization. An importation program could be co-sponsored by a pharmacist, a wholesaler, or another State or non-federal governmental entity. The rule, when finalized, would contain all requirements necessary for a State or other non-federal governmental entity and its co-sponsors, if any, to demonstrate that their importation program will pose no additional risk to the public's health and safety. In addition, the proposed rule would require that the State or non-federal governmental entity and its co-sponsors, if any, explain why their program would be expected to result in a significant reduction in the cost of covered products to the American consumer.
The agency’s own summary, as published.
What this changes
Amends 2 parts of the Code of Federal Regulations — the standing rules this notice rewrites.
Rulemaking docket
We haven’t pulled this rulemaking’s full docket yet. View docket FDA-2019-N-5711 on Regulations.gov →
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