USA – Industry calls for withdrawal of FDA electronic tracing guidance

Pharmaceutical distributors urge the US Food and Drug Administration (FDA) to immediately withdraw its guidance setting parameters for establishing electronic systems to trace products through the supply chain. A trade association for distributors claims the agency overreached its statutory authority in seeking  access to private electronic tracing information among trading partners.

The guidance, published in June, laid the groundwork for the data architecture systems needed to build the electronic, interoperable systems called for in the Drug Supply Chain Security Act (DSCSA), scheduled for implementation on 27 November 2023. In August, the agency granted the industry a 30-day extension to comment on the guidance. (RELATED: FDA details plans for DSCSA implementation in four guidances, Regulatory Focus 4 June 2021; Updated: FDA grants industry 30-day extension to comment on track and trace guidance, Regulatory Focus 2 August 2021)…