Drug verification is at the heart of most pharma serialization regulations. It is the point at which someone in the supply chain or a patient uses the unique identifier on the drug package to determine that the drug is probably authentic, or definitely is not. We can tell a lot about the intent of a … Continue reading Drug Verification: EU Vs US
M&A of drug manufacturers are going to be more complex and more risky than they have in the past. That means they will be more costly too.
Has the FDA realized they should focus on just the actual DSCSA requirements? Maybe.
PDSA fears the potential inability of some manufacturers to verify, in the DSCSA sense, certain drugs between now and November of 2019.
While 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, … Continue reading Wholesaler Confusion Over DSCSA Aggregation Explained
Congress 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 … Continue reading DSCSA: Congress Should Have Mandated Randomization
In my last essay I touched on the use of Product Identifier Authentication, or PIA, as an alternative to the collection and distribution of aggregation data to allow wholesale distributors and repackagers to meet the verification requirements of the Drug Supply Chain Security Act (DSCSA). Starting in November of 2018 for repackagers and in November … Continue reading Product Identifier Authentication (PIA)
As 2020 transitioned to 2021, we took another step closer toward the implementation of 2023 Drug Supply Chain Security Act, Phase II. From manufacturers to wholesalers, pharmacies and other stakeholders, many uncertainties are swirling around the subject, so today we are writing to try to dispel some of the concern. Let’s start with an overview … Continue reading Drug Supply Chain Security Act, Phase II: Here’s what you MUST know
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