Much interest and controversy abounds regarding the benefits and perils associated with the importation of pharmaceuticals. The Internet has provided an uncertain vehicle for such importation especially as it pertains to two key areas: product authentication and product integrity.
As a result, questions exist as to whether other U.S. entities may provide a more legitimate and safer alternative to the Internet for supplying imported prescription pharmaceuticals into the United States. One such avenue may be the involvement of U.S. pharmaceutical wholesale distributors in the importation process. The pros and cons of that concept are addressed herein. This essay examines various facets of the U.S. pharmaceutical supply chain with a focus upon legal and regulatory requirements currently in place. In addition, challenges facing the U.S. pharmaceutical supply chain, such as counterfeit drugs, are discussed, as well as what is being done to address those issues in terms of operational and technological approaches. Lastly, domestic and international legal and regulatory implications for drug importation by non-manufacturers, as well as importation’s potential impact on the integrity of the U.S. pharmaceutical supply chain, are assessed. The U.S. pharmaceutical supply chain currently provides for a closed system wherein safeguards have been established to help ensure product integrity. While issues have arisen in the past, the U.S. pharmaceutical wholesale distribution industry has taken significant steps in strengthening its systems to help prevent counterfeit drugs from entering the U.S. pharmaceutical supply chain. In addition, while emerging technologies such as Radio Frequency Identification (RFID) provide promise, significant work is still needed to ensure effective implementation and consistent results. As such, given today’s environment, the infusion of imported drugs into theU.S. pharmaceutical supply chain from foreign non-manufacturing sources may work to substantially undermine the integrity of the U.S. pharmaceutical supply chain.