The US Food and Drug Administration (FDA) on 3 June released four guidances on its plans for implementing the Drug Supply Chain Security Act (DSCSA), setting the agency’s expectations for how pharmaceutical manufacturers should comply with new product tracing requirements.
They address situations that can increase the risk of suspect products entering the supply chain, expectations for product identifiers, interoperable electronic tracing of products and definitions of suspect and counterfeit products.
“Ensuring the quality of prescription drugs and safeguarding the integrity of pharmaceutical distribution are crucial roles the FDA plays in protecting the health of the American public. Illegitimate and unsafe products must be kept out of the US drug supply chain,” announced Donald Ashley, director of the Office of Compliance for FDA’s Center for Drug Evaluation and Research.
These guidances were soon expected; last month they were awaiting clearance from the Office of Management and Budget (OMB). (RELATED: Four FDA guidances related to DSCSA awaiting OMB sign-off, Regulatory Focus 12 May 2021). Under the Paperwork Reduction Act of 1995, federal agencies must regularly submit guidance documents and regulations to OMB for review to ensure their cost-effectiveness and compliance with government best practices…