Compliance News | January 3, 2020

Proposed Guidance on Rx Importation

On December 23, 2019, the Food and Drug Administration (FDA) published guidance on two pathways to promote access to safe, lower-cost prescription drugs:

  • Pathway 1 would permit demonstration projects allowing prescription drugs to be imported from Canada under Section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
  • Pathway 2 would allow manufacturers of FDA-approved drugs to import versions of their drugs that they sell in other countries.

Those pathways were announced in 2019 as part of a “Safe Importation Action Plan.”

Proposed Guidance on Rx Importation

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Proposal to implement pathway 1

A Notice of Proposed Rulemaking (NPRM) would implement Pathway 1 of its plan to permit limited importation of prescription drugs from Canada. The NPRM would permit states or certain other non-federal governmental entities to submit time-limited Section 804 Importation Program (SIP) proposals to the FDA for review and authorization.

The importation program could be co-sponsored by a pharmacist, wholesaler or another state or nonfederal governmental entity. Applications would have to demonstrate that the proposed importation program would pose no additional risk to the public’s health and safety and would result in a significant reduction in the cost of covered prescriptions.

Public comments on the NPRM must be filed on or before March 9, 2020.

Proposal to implement pathway 2

The FDA also published draft guidance concerning Pathway 2 of the importation plan. The draft guidance describes procedures to obtain an additional National Drug Code for an FDA-approved prescription drug that is imported into the United States.

The FDA requests comments on the draft guidance by February 21, 2020.

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