FDA/Pharma Supply Chain 10 Year Plan
Drug Supply Chain Security Act Implementation Plan Food and Drug Administration (FDA) has developed a 10 year plan (see infographic) for implementation of the Drug Supply Chain Security Act. Link Here 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 the proposed “Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format,” Federal Notice PDF Link Comments are due by April 21, 2014, and may be submitted following the instructio...