This past week I have been on a vacation with my family in the Caribbean so I do not have a topical essay for you this week, except to announce the availability of the second edition of The Drug Supply Chain Security Act Explained. The full title is “The Drug Supply Chain Security Act Explained: Second Edition, Plus Explanations Of Key FDA DSCSA Guidances”. This time the book is available as a paperback and at the much more affordable price of only US$59.99.
I am working on a Kindle version that should be available soon for the same price. I may also offer the book in eBook (PDF) form (this was the only form the first edition was sold as, see “The ‘DSCSA Explained’“) but I have not yet figured out how that would be offered for sale. Let me know if you are interested in that form.
For now, the only way to get the new book is through CreateSpace.com (an Amazon publishing company), Amazon.com (including the EU Amazon sites: UK, GDR and FR), and potentially a few other places. For reasons I don’t have an explanation for (because I don’t understand it myself) I get a significant benefit from purchases that are made through CreateSpace.com and since you can use your normal Amazon account to make the purchase there, why not buy it that way? At the moment I write this, only CreateSpace indicates the book is immediately available. The Amazon sites may indicate that the book is not currently available (“out of print”), but that will be resolved in the next day or so as they get set up to sell it.
This new edition has 352 pages, which is significantly more than the first edition. It has been updated and for the first time includes more than two dozen of the best DSCSA-related RxTrace essays from the last two plus years. These include essays that explain the FDA Guidances that were published up to the moment the book was published. This new content helps add vital context to various aspects of the DSCSA to help provide a deeper understanding of the many impacts of the law. The new edition also includes a concept index, and a lot more references.
This new edition is aimed at helping drug manufacturers, wholesale distributors, repackagers, dispensers, CMO/CPOs, 3PLs, solution providers, regulators, lawyers and students, gain a full understanding of this important new law.
Check it out. I think you will find the new low price combined with the expanded content very inviting.