For years, DSCSA enforcement focused upstream manufacturers and wholesalers.
That phase is complete.
FDA inspections are now evaluating medical practices that purchase, store, and administer Rx products in-office. And they’re asking for documented proof of sourcing, traceability, and reconciliation.
This isn’t theoretical. It’s operational.
The New York Department of State just completed a statewide sweep of MedSpa providers 87 violations, suspended licenses, and revoked credentials. If your practice administers Botox, fillers, or any injectable, here is what you need to know about your drug supply chain before someone shows up at your door.
They don’t need to walk into your office anymore.
With finalized guidance on Remote Regulatory Assessments (RRAs), FDA can now:
• Request your SOPs, purchasing records, and inventory logs
• Review your DSCSA documentation
• Evaluate your compliance remotely
• Decide next steps — without ever stepping onsite
No time to “get ready.”
Here’s the shift most people are missing:
Your documentation is now your inspection.
If it’s incomplete, informal, or inconsistent that’s exactly what FDA sees.
And that’s what they act on.
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