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FDA Releases Prescription Drug Importation Proposed Rule

December 19, 2019

FDA Releases Prescription Drug Importation Proposed Rule

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Mary Mullaney, Director, Hospital Payment Policies

The Food and Drug Administration (FDA) released a proposed rule and draft guidance addressing the importation of prescription drugs. The proposed rule would allow importation of certain prescription drugs from Canada. The draft guidance specifically addresses the importation of FDA-approved drugs that were also authorized for sale in a foreign country in which the drugs were originally intended to be marketed.

Under the proposed rule, states or certain other non-federal governmental agencies would be able to submit proposals to the FDA for the review and authorization of a project allowing for importation of certain drugs from Canada. These programs would be authorized by the FDA to manage the importation of certain prescription drugs that are approved in Canada and meet the conditions in an FDA-approved drug application. Eligible prescription drugs would have to be relabeled with the required U.S. labeling prior to importation, undergo testing for authenticity and degradation, and ensure that the drugs meet established specifications and standards. Entities would be required to explain why their program would be expected to result in a significant reduction in the cost of the covered drug to consumers. 

Manufacturers of FDA-approved drugs would be able to import versions of these FDA-approved drugs that they sell in foreign countries. The manufacturer or person authorized by the manufacturer would be required to establish with the FDA that the foreign version is the same as the version sold in the U.S. If this condition is met, the FDA would allow the drug to be labeled for sale in the U.S. and imported.

The documents will be published in the Federal Register on Dec. 23, 2019. Comments on the proposed rule are due 75 days after the date of publication. Comments on the draft guidance are due 60 days after the date of publication.

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