USA – Industry urges FDA to do more to help companies prepare for DSCSA

The pharmaceutical industry urged the US Food and Drug Administration (FDA) to take a more “assertive and forward-leaning” approach in assisting pharmaceutical manufacturers prepare their track and trace systems for full implementation of the Drug Supply Chain Security Act (DSCSA) once these systems go live in November 2024.

The Healthcare Distribution Alliance (HDA) also asserted that FDA has not provided any further direction to industry since a stabilization policy went into effect in the summer, and that in the absence of agency direction, some trading partners are “delaying making any necessary investments and commitments necessary for DSCSA compliance.”

These comments are in response to FDA’s request for information (RFI) in November 2023 on industry’s progress in implementing the interoperable systems and processes for enhanced drug distribution requirements under DSCSA. In August 2023, FDA announced it would be giving firms a one-year reprieve or “stabilization period” from DSCSA track and trace requirements to give companies more time to prepare. (RELATED: FDA gives firms one-year reprieve from DSCSA track and trace requirements, Regulatory Focus 25 August 2023)…