{"id":31201,"date":"2024-01-26T10:32:38","date_gmt":"2024-01-26T15:32:38","guid":{"rendered":"https:\/\/avalere.com\/?p=31201"},"modified":"2024-01-26T14:21:05","modified_gmt":"2024-01-26T19:21:05","slug":"status-of-us-prescription-drug-importation-pathways","status":"publish","type":"post","link":"https:\/\/advisory.avalerehealth.com\/insights\/status-of-us-prescription-drug-importation-pathways","title":{"rendered":"Status of US Prescription Drug Importation Pathways"},"content":{"rendered":"

Patient Affordability and Access to Prescription Drugs<\/span><\/b>\u00a0<\/span><\/p>\n

As federal and state policymakers consider policies to lower drug costs, state drug importation has been proposed as a way to increase patient affordability and access to prescription drugs. The <\/span>Section 804 Importation Program (SIP)<\/span><\/a> allows states to request authority from the US Food and Drug Administration (FDA) to import prescription drugs from Canada. In January 2024, the FDA <\/span>authorized<\/span><\/a> the first SIP, requested by Florida, opening the door to state drug importation and the possibility of other states receiving subsequent authorization.\u00a0<\/span>\u00a0<\/span><\/p>\n

What Does Prescription Drug Importation Look Like Without SIPs?<\/span><\/b>\u00a0<\/span><\/p>\n

Currently, the importation of prescription drugs is subject to varying levels of federal oversight, depending on whether it is classified as commercial or personal importation. Shipments deemed to be for commercial use are subject to all labeling and quality requirements under US statute for the approval and sale of that product. Shipments deemed to be for personal use are not subject to the same level of FDA scrutiny. Without clear health risks or evidence of intent for commercial sale, the FDA permits the importation of select prescription drugs that meet the following criteria:<\/span>\u00a0<\/span><\/p>\n