The US Food and Drug Administration (FDA) has issued draft guidance on the Drug Supply Chain Security Act (DSCSA) to help identify and trace drug products in the supply chain. Dr Paul Dunn, chair of the International Hologram Manufacturers Association (IHMA) considers these and argues that a product identifier initiative by itself cannot be considered an authentication solution under ISO 12931.
Regulation continues to drive concerns for those involved in pharmaceutical manufacturing, production and distribution with governments, national agencies and those with responsibility for law enforcement. This has led the sector to protect itself from criminals and counterfeiters through the DSCSA among other legislation.
While some requirements began in 2014 with other key requirements following in recent years, the new requirements - development of standards and the system for product tracing - will continue to be phased in until 2023 with the FDA committed to working with trading partners and other stakeholders to effectively implement the new requirements.