This week I am posting one of my favorite essays from last fall because at this moment, I am in the middle of moving my home and office from one side of the Chicago metro area to the other to be closer to our kids. Also at this moment, the FDA is almost eight months late in publishing the grandfathering guidance that was mandated by the DSCSA. Here it is again.
Regulations often make use of a concept known as “grandfathering” to soften a given deadline so that it is easier for companies to meet. When allowed, grandfathering allows a company to continue doing something after a regulatory deadline that mandates a change, as long as one or more pre-conditions apply. For example, Section 582(a)(5)(B) of the Drug Supply Chain Security Act (DSCSA) allows wholesale distributors, and repackagers to sell drugs that were already within the supply chain on January 1, 2015 without passing the necessary transaction data. This makes sense because companies were not obligated to supply that data before that date and so some of the assertions required in the Transaction Statement would not be true (among other problems that grandfathering eliminates). [Of course, Continue reading Will Manufacturers Be Able To Grandfather Products In Their DC And 3PL?→
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
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