The Healthcare Distribution Management Association (HDMA) recently updated their “HDMA Qs and As on the Drug Supply Chain Security Act (DSCSA)” to version 2.0. This is a very well thought through document that will help companies understand how wholesale distributors are interpreting confusing or ambiguous sections of the law. The document leans heavily toward questions about how wholesale distributors will need to react in various situations, but it will also be a resource that manufacturers, repackagers and dispensers will want to obtain and review. What is really needed is for someone to do the same kind of analysis for questions that mainly affect those other supply chain entities.
(BTW: Another great resource for all types of companies who need to understand the new law is “The Drug Supply Chain Security Act Explained” by Dirk Rodgers.)
The table on contents of the updated HDMA document includes the following categories of questions and answers:
- FDA’s Dec 31, 2014 Compliance Policy Guidance
- Saleable Returns
- Nonsaleable Returns
- Suspect and Illegitimate Product
- Data-Transmission and ASN-Related Questions
- Exceptions to Transaction Data Requirements
- Grandfathered Product
I highly recommend this updated guide.
And if you have an interest in adding serial number randomization to your global compliance solution, make sure you sign up for the third webinar in the series that Riya Cao of LSPediA and I are conducting. Our next webinar in the series will cover that topic in some detail. Register here for the event occurring on April 14, 2015. You can also register to listen to the recordings of our earlier webinars.