FDA Develops Drug Supply Chain Security Act Implementation Plan

Food and Drug Administration (FDA) has developed a 10-year plan for implementation of the Drug Supply Chain Security Act. The plan includes implementation time frames for actions including developing regulations to establish standards for licensing wholesale drug distributors and establishing a system for wholesale drug distributor reporting to FDA and a public database with licensing information. In addition, the agency plans to publish standards and develop regulations for the interoperable data exchange to enhance secure tracing at the package level. As part of the implementation plan, FDA is seeking information and comments on proposed “Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format,” published in a February 20, 2014 Federal Register notice (PDF). Comments are due by April 21, 2014, and may be submitted following the instructions in the Federal Register notice.