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Imports of Drugs from Canada Would be Allowed Under FDA Proposals

Friday, December 20, 2019
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration has issued a proposed rule that would allow for imports of certain prescription drugs from Canada. The FDA has also announced the availability of a new draft guidance for industry that describes an alternate route drug manufacturers could follow to facilitate imports of prescription drugs.

For more information, please contact FDA consultant Domenic Veneziano at (202) 734-3939.

According to the FDA, the proposed rule would allow states and certain other non-federal government entities to submit importation program proposals for FDA review and authorization. An importation program could be co-sponsored by a pharmacist, a wholesaler, or another state or non-federal governmental entity. Eligible prescription drugs would have to be relabeled with the required U.S. labeling prior to importation and undergo testing for authenticity, degradation, and compliance with established specifications and standards. These programs would also have to demonstrate significant cost reductions to U.S. consumers.

Key aspects of the proposed rule include the following.

- The supply chain for each drug under an importation plan would be limited to one manufacturer, one foreign seller, and one importer.

- Once it is shown that the importer has consistently imported eligible prescription drugs in accordance with the rule, it would be able to submit a supplemental proposal to add foreign sellers or importers.

- The foreign seller would have to be a party licensed by Health Canada as a wholesaler and registered with the FDA as a foreign seller.

- The importer would have to be a wholesaler or pharmacist licensed to operate in the U.S.

- Both the foreign seller and the importer would be subject to the supply chain security requirements proposed in this rule and under the Federal Food, Drug, and Cosmetic Act.

- After an import proposal is authorized, the importer would submit a pre-import request at least 30 days prior to the scheduled arrival or entry for consumption of a shipment containing an eligible prescription drug, whichever is earlier.

- Entry and arrival would be limited to the port of entry authorized by the FDA.

- The importer or authorized customs broker would be required to electronically file a formal entry for consumption in the Automated Commercial Environment for each eligible prescription drug imported or offered for import into the U.S.

- Imports of noncompliant drugs would be subject to refusal of entry.

The draft guidance describes procedures drug manufacturers could follow to obtain an additional national drug code for certain FDA-approved prescription drugs, including biological products, that were originally manufactured and intended to be marketed in a foreign country. The FDA states that the use of an additional NDC would allow greater flexibility for drug companies to offer these products at a lower price than what their current distribution contracts require. The draft guidance also recommends that the drug manufacturer include a statement on the product’s label and in the prescribing information to help pharmacists to accurately identify, dispense, and bill for these products.

Comments on the proposed rule are due by March 9 and comments on the draft guidance are due by Feb. 21.

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