The US Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) published a new Safe Importation Action Plan creating two potential pathways for the safe importation of certain drugs initially intended for foreign markets. The first potential pathway allows the FDA to authorize pilot or demonstration projects developed by states, wholesalers or pharmacists on how they would import certain Canadian drugs that are versions of FDA-approved drugs and manufactured adhering to FDA standards. Conditions included would require the assurance that the importation poses no additional risks to the public’s health and would achieve significant cost savings to the American consumer. The second potential pathway would allow manufacturers of FDA-approved drugs to use a new National Drug Code (NDC) to import the US versions of the drugs they sell in foreign countries. Under this pathway, the manufacturer or entity would have to establish that the foreign version is the same as the US version and appropriately label the drug for sale in the US. Thes new potential pathways are a significant move towards reducing drug prices and improving access to medicine for Americans.

Source: https://www.hhs.gov/about/news/2019/07/31/hhs-new-action-plan-foundation-safe-importation-certain-prescription-drugs.html