The Real Cost of DSCSA Compliance
Here’s a number that should get your attention: $5,000 to $20,000. That’s what most pharmaceutical organizations pay compliance consultants to develop a single DSCSA Standard Operating Procedure.
And that’s just the beginning. Add in 3-6 months of your team’s time, countless revision cycles, legal reviews, and the constant anxiety of wondering if you’ve covered everything the FDA expects to see.
Now imagine this scenario: FDA inspectors arrive at your facility for an unannounced inspection. Within the first hour, they ask to review your Drug Supply Chain Security Act procedures. You hand over what you have—maybe it’s outdated, maybe it’s incomplete, maybe it’s a patchwork of documents you’ve been meaning to organize.
