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FDA Finalizes Rules To Import Prescription Drugs From Canada

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The U.S. Food and Drug Administration on Thursday issued Final Rule to help provide more affordable drugs to American patients as part of the Safe Importation Action Plan.

An Executive Order President Donald Trump signed in July allows states to import certain prescription drugs from Canada that can be sold in domestic market at a cheaper price.

The final rule implements a provision of federal law that allows FDA-authorized programs to import certain prescription drugs from Canada under specific conditions ensuring no additional risk to the public's health and safety while achieving a significant reduction in the cost of covered products to the American consumer.

The final guidance for industry describes procedures drug manufacturers can follow to facilitate importation of prescription drugs, including biological products, that are FDA-approved, manufactured abroad, and authorized for sale in any foreign country.

"Today's action is an important part of FDA's priorities to promote choice and competition. The Safe Importation Action Plan aims to clearly describe procedures to import drugs that would lower prices and improve access while also maintaining the high quality and safety Americans expect and deserve," said FDA Commissioner Stephen M. Hahn. He added that FDA will continue to assess and act on opportunities to increase competition in the prescription drug market and help reduce the cost of medicines.

The rule allows U.S. states and Indian tribes to submit importation program proposals to the FDA for review and authorization. In future, this privilege will be applicable to pharmacists and wholesalers in certain circumstances, the federal drug agency said in a press release.

Eligible prescription drugs would have to be relabeled with the required U.S. labeling and undergo testing for authenticity, degradation and to ensure that the drugs meet established specifications and standards. These drugs must be sold to the American consumer at a significantly reduced cost.

The final guidance describes procedures for a drug manufacturer to obtain a National Drug Code (NDC) for certain FDA-approved prescription drugs.

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