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Category: DSCSA

Friday, May 11, 2018

FDA New Draft Guidance Review by Lachman

On Tuesday, the US Food and Drug Administration (FDA) published new draft guidance to help trading partners in the pharmaceutical supply chain request waivers or exemptions from requirements in the Drug Supply Chain and Security Act (DSCSA). The DSCSA, which was signed into law in 2013, aims to build a system by 2023 to identify and trace pharmaceuticals as they are distributed through the US supply chain, including the requirement of placing unique identifiers on medicine packaging that can... Read More
at Friday, May 11, 2018
DSCSA FDA Lachman Consultants Pharmaceutical Donors Supply Chain

Thursday, March 8, 2018

A Starting Point for DSCSA Data Compliance

The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 to improve the safety and security of medication distribution and dispensing in the United States, by keeping illegitimate product out of the supply chain.  Its detailed and multi phased implementation is changing the ways transactions happen, from manufacturers to the wholesale channel and finally to points of dispensing and patients.  There are many incremental steps along the path to full adoption, which began in 2-13... Read More
at Thursday, March 8, 2018
Compliance DSCSA Pharmaceutical Donors