The FDA recently published guidance to help the pharma industry detect suspicious and illegitimate products within the pharmaceutical supply chain. These regulations, established under the Drug Supply Chain Security Act (DSCSA), concentrate on product tracing, verification, and identification for specific drug products distributed in the U.S. So far this year, the agency has released more than…
What to consider before renewing your serialization contract
As we kickstart the last quarter of 2021, the federal deadline for full interoperability in pharmaceutical serialization, as dictated by the DSCSA (Drug Supply Chain Security Act), will soon reach its two-year countdown on November 27. Since November 2018, all manufacturers, including virtual manufacturers and brand owners, have been required to serialize products at the…
Ensuring accuracy and compliance during repackaging
The accuracy of serialization data and compliance by trading partners provides the foundation for compliance with the Drug Supply Chain Security Act (DSCSA). During the pharmaceutical packaging process, however, there may be unplanned events that jeopardize the integrity of the data, reduce productivity and increase operational costs. Equipment jams, power failures, product damage during handling…
FDA shares guidance to protect the pharma supply chain
FDA has issued guidance documents to help pharmaceutical stakeholders identify illegitimate products and remove them from the supply chain. Two of the documents are final, while another two are draft guidance. “Ensuring the quality of prescription drugs and safeguarding the integrity of pharmaceutical distribution are crucial roles the FDA plays in protecting the health of…