Providing a VOICE for Texas' MULTIDISCIPLINARY CANCER CARE TEAMS and the PATIENTS THEY SERVE since 1988
Meetings & Education
Patient Advocacy Organizations
TxSCO Hurricane Harvey Recovery Resources
State & Federal Resources
Find A Clinical Trial
Off-Label Use Literature
National Professional Organizations
TxSCO Corporate Members
Become a Corporate Member
Industry News Archive
HHS Issues Plan Outlining 2 Paths for Prescription Drug Importation
The U.S. Department of Health and Human Services (HHS) announced today that HHS and the U.S. Food and Drug Administration (FDA) are publishing a
Safe Importation Action Plan
that outlines two potential pathways that would lay the foundation for the importation of certain drugs originally intended for foreign markets.
Pathway 1: A Notice of Proposed Rulemaking (NPRM) would rely on the authority in the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) section 804 to authorize demonstration projects to allow importation of drugs from Canada.
Pathway 2: Manufacturers could import versions of FDA-approved drug products that they sell in foreign countries that are the same as the U.S. versions. Under this pathway, manufacturers would use a new National Drug Code (NDC) for those products, potentially allowing them to offer a lower price than what their current distribution contracts require.
Read the HHS press release
Read the administration's Action Plan
Tweets by OSSatACCC