Stakeholders face challenges and benefits from a more secure pharmaceutical supply chain, writes Jill Wechsler.
Beginning Jan. 1, 2015, manufacturers and distributors will need to have in place systems able to transmit information on prescription drug movement in the United States from plant, to packagers and various wholesalers and distributors, and ultimately to dispensers. FDA is charged by the Drug Supply Chain Security Act (DSCSA), a key component of the Drug Quality and Security Act (DQSA) of 2013, to issue guidance and rules for establishing such a process and is consulting with all stakeholders on viable approaches and policies (1).
FDA held a public workshop in May 2014 (2) to gain input from manufacturers and other supply-chain parties on developing standards for what eventually will be an interoperable tracking system for prescription drugs. FDA officials and industry leaders further reviewed DSCSA requirements, along with broader supply-chain security issues, at a June conference in Washington, D.C. sponsored by the Parenteral Drug Association (PDA). Read More