I am writing this from Mumbai India where I am scheduled to speak at the Systech Uniquity Conference, but I will be home by the time you read this. I just won’t have time to publish a new essay this week due to the incredibly long flights I need to get home. So, here is a re-posting of a great essay from May 9, 2016.
DSCSA: Kit, Repack, Combo Product, or Just A ‘Collection’?
Medical convenience kits are exempt from the Drug Supply Chain Security Act (DSCSA). But be careful. Continue reading DSCSA: Kit, Repack, Combo Product, or Just A ‘Collection’?…Again
Medical convenience kits are exempt from the Drug Supply Chain Security Act (DSCSA). But be careful. Just because you and your customers have called your product “a kit” for years doesn’t mean that Congress and the FDA call it that under the DSCSA. In fact, many products that have historically been referred to as “medical convenience kits” will be treated under the DSCSA as a repackaged drug, a combination product, or worse, just a collection of device(s) and drug(s). Let’s take a closer look. Continue reading DSCSA: Kit, Repack, Combo Product, or Just A ‘Collection’?
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