USA – FDA overdue on guidance as DSCSA deadline looms

Legal experts advised the pharmaceutical industry to start preparing now to meet the November 2023 deadline for having fully electronic interoperable systems in place for tracking  products through the supply chain under the Drug Supply Chain Security Act (DSCSA).

Food and drug law attorneys outlined ways the industry can meet these requirements at a 15 April traceability forum on DSCSA implementation sponsored by the Healthcare Distributors Association (HDA).

The experts advised beginning work immediately to build the systems to meet upcoming DSCSA requirements. However, said one attorney, FDA’s heel-dragging on issuing guidance is hampering industry efforts…