The Differences Between The DSCSA, FDA Rules and Guidance

From reading the responses to the FDA docket requesting public feedback on standards for interoperable information exchange, I think it is time to review the difference between laws, FDA Rules and FDA guidance, like those stemming from the Drug Supply Chain Security Act (DSCSA).  It appears that some people might be confusing these a little. Dr.

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2 thoughts on “The Differences Between The DSCSA, FDA Rules and Guidance”

  1. Agree with your analysis and your advice to start before guidence. While FDA guidence IS only that, investors and litigators demand effort to conform to best practice.

  2. Dirk, I’m still confused over how dispensers will need to comply with the receipt if T-HIS for each and every drug SKU they order, daily, weekly, monthly…order lines are voluminous! So the idea is wholesalers will send e-THIS to pharmacies but how will pharmacies receive, store, catalogue and retrieve upon request? Do they need their Pharmacy IS provider to write a program to do this or will wholesalers store on an account specific cloud platform and facilitate retrieval from there?

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