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  • jwgilbreath

DSCSA…what’s the purpose?

So, some of you may wonder why the Drugs Supply Chain Security Act (DSCSA) was passed through legislation. Nationally it was recognized that there were (and still are) situations of illegitimate products that are circulating within the United States. This really came to a head when in 2012 multiple people developed menengitis (and many died associated with this) due to negligent operations New England Compounding Center In Massachusetts. Prior to this, various states had a mish mash of laws related to supply chain security. So following this path, federally the DSCSA was introduced and passed and signed into law (November 21, 2013).

FDA was given the charge to start the process of moving the law forward with various regulations and guidance documents. Due to the complexity of the law, it was decided to little by little move the requirements forward over a 10 year time span. During the 10 year cycle, various "milestones" were required moving from the beginning with just wholesalers and third party logistics facilities having to initiate certain processes to the ultimate milestone to be required on November 27, 2023. Basically all entities that are part of the treatment of patients (unless specifically not required by DSCSA) will be required to be compliant in various ways. In a future post I will discuss requirements pre- November 27 to after November 27, 2023.

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