Tag Archives: request for verification

DSCSA

DSCSA Makes M&A More Complex/Risky/Costly

When companies are thinking about merging or acquiring (M&A) other companies, or product lines from other companies, they typically engage in a process known as “due diligence” to discover any hidden risks that might come along with the action.  In the pharma industry the risks are huge, so this activity is intense and costly.  Discovery of larger risks than expected can result in the abandonment of the M&A plan, or can result in the adjustment of the price—usually downward.  Now that pharma supply chain companies in the US are required to retain detailed transaction information about every purchase and sale of prescription drugs for six years, and must respond to verification requests over the life of the product, due diligence is now more complex and risky, and so it is more important than ever. Continue reading DSCSA Makes M&A More Complex/Risky/Costly →

Aggregation, DSCSA, wholesaler

Wholesaler Confusion Over DSCSA Aggregation Explained

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iStock_000028920134XSmallWhile listening to a monthly Drug Supply Chain Security Act (DSCSA) call hosted by one of the Big-3 wholesale distributors I heard a comment that snapped me out of my conference call-induced stupor.  Unfortunately I was in a location where I could not take notes so I don’t remember the exact comments that were made, but I remember what it was that brought me back to full consciousness.

The comment made me realize in a jolt why the Big-3—or at least the one running this monthly call—may be unwilling to give up on their claims that they will need aggregation data to accompany shipments of prescription drugs from manufacturers as early as November 2019.  It may have to do with a mis-interpretation of their handling of saleable returned product within the DSCSA.  Let me explain. Continue reading Wholesaler Confusion Over DSCSA Aggregation Explained →

PIA, POD, Randomization

DSCSA: Congress Should Have Mandated Randomization

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iStock_000015967853SmallerCongress should have mandated randomization of drug serial numbers, but they did not, so it is up to each manufacturer to recognize the importance it would bring to the protection of their brands and of the supply chain.  Let me explain.

The text of the Drug Supply Chain Security Act (DSCSA) was developed last year by Congressional staff in consultation/negotiation with various lobbying organizations—primarily the Prescription Drug Security Alliance (PDSA).  The effect of the legislation is to create a way of protecting the U.S. pharmaceutical supply chain that relies primarily on product identifier authentication (PIA) (see “Product Identifier Authentication” and “The Aggregation Hoax and PIA”) for at least the first 10 years and possibly beyond. Continue reading DSCSA: Congress Should Have Mandated Randomization →