Pharmaceutical Supply Chain Security: A View From the Pharmaceutical Research and Manufacturers of America

Abstract

The introduction of counterfeit drugs into the supply chain poses risks to patients. Supply chain security is of paramount concern to the pharmaceutical industry, and companies employ a variety of technologies that can be used to authenticate packaged pharmaceuticals. Serialization of individual package units coupled with the use of machine-readable codes should permit the electronic tracking and tracing of these units throughout the supply chain. Progress on establishing identification and information technology standards is moving forward, but many complexities must be resolved, such that full implementation is still some years away. Several states are implementing pedigree requirements. To prevent the proliferation of differing state requirements, the Food and Drug Administration should take a leadership role in establishing clear federal guidelines and implement the pedigree requirements under the Prescription Drug Marketing Act.