Back on July 3, 2018 the FDA issued a notice of “inspectional observations”—known as an “FDA Form 483”—containing observations that appeared to the inspector to be potential violations of certain sections of the Drug Supply Chain Security Act (DSCSA). The FDA recently posted the form on their website, but did not post the response from the company. I assume McKesson would have contested it. Without knowing what McKesson said to the FDA in response, let’s take a closer look at the FDA’s logic and come up with our own thoughts. Continue reading McKesson’s DSCSA 483 Explained
Both, the Drug Supply Chain Security Act (DSCSA) in the US and the Falsified Medicines Directive (FMD) in the EU make use of unique identifier verification in one way or another. Under the FMD, verification is the centerpiece of patient protection. Under the DSCSA, verification is used as a tool to help resolve higher risk use cases, like saleable returns to wholesale distributors, and anytime someone becomes “suspicious” about a collection of drug packages. On the surface, verification of unique identifiers seems simple, but there are some sticky problems that make it complex in some circumstances (see also “Drug Verification: EU Vs US”). Continue reading What’s So Hard About Unique Identifier Verification?
In Part 2 of this series I explained exactly what the “special privileges” are in the Drug Supply Chain Security Act (DSCSA) for wholesale distributors who purchase directly from the manufacturer, the exclusive distributor of the manufacturer, or a repackager who buys directly from the manufacturer (see “DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 1”, and “DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 2”). In this third part, I will explain why all of this matters to drug manufacturers and how, in some situations, the “Big-3” wholesale distributors may not want to handle your product after the end of this year. Continue reading DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 3
In Part 1 of this series I explained how the “Big-3” wholesale distributors in the U.S. changed their buying practices back in the mid-2000s so now they only buy their inventory directly from each drug manufacturer. But in a small number of cases, that isn’t possible. In those cases, they are forced to buy from an exclusive distributor, or from a company who buys pre-packaged drugs from the NDA- or ANDA-holder. (See “DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 1”.) And I pointed out that the DSCSA contains “special privileges” for any wholesale distributor who can buy direct from the manufacturer. In this second part, I will explain exactly what these “special privileges” are in the Drug Supply Chain Security Act (DSCSA). Continue reading DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 2