I was on the HDMA’s website last week doing some research for one of my clients, and I found that the HDMA has updated their highly regarded Q&A document that provides answers to questions related to the U.S. Drug Supply Chain Security Act (DSCSA). I have reviewed this document before in its previous incarnation and view it as one of the best resources out there for all supply chain participants (see “InBrief: HDMA Updates DSCSA Q&A“). Each time they update it they tweak their answers to previous questions to reflect their latest thinking, and they add new questions that have come up in the industry more recently and provide clear and complete answers to those questions.
Like I said in my previous essay about it, the Q&A generally stick pretty close to the kind of questions and answers that a wholesale distributor might have. However, with this new update, they have expanded the coverage to help answer some of the more sticky questions that all supply chain stakeholders will have. I can’t recommend this updated document enough for everyone.
The updated document can be found on the HDMA’s website. The page that contains the download link to the latest update (Version 3) is kind of hidden within their “Pharmaceutical Traceability” page. You have to scroll down to the “Resources” heading near the bottom of the page, and then expand the “HDMA Guidelines and Documents” pull-down for the list of their traceability documents. Look for “HDMA Questions and Answers on the Drug Supply Chain Security Act (Version 3)”.
The table of contents (“Index of Questions”) is below. The sections in bold are new in this latest update:
- FDA’s Dec 31, 2014 Compliance Policy Guidance
- Saleable Returns
- Nonsaleable Returns
- Suspect and Illegitimate Product
- 340b Questions
- Dispenser Related Questions
- Exempt Products
- Data-Transmission and ASN-Related Questions
- Exceptions to Transaction Data Requirements
- Grandfathered Product
In this version there are a total of 50 very detailed questions and very detailed answers. This document, when combined with the other HDMA DSCSA related documents listed below, represents the best free overall resource for understanding the DSCSA. Those other HDMA documents include:
- Supply Chain Product Transaction Scenarios: Drug Supply Chain Security Act Implementation (Updated December 2014) (see “The HDMA Supply Chain Product Transaction Scenarios For DSCSA“);
- EDI Guidelines for the 856 Advance Ship Notice to Support Implementation of DSCSA (July 2014, with Business Examples Updated in December 2014) (see “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again“);
- HDMA ASN Exceptions Guidelines for the Drug Supply Chain Security Act (see “DSCSA Exception Handling: A Preview of Your Next Surprise Headache“);
- HDMA Guidelines for Bar Coding in the Pharmaceutical Supply Chain (this one is getting a little dated, but is still useful to drug manufacturers, see “Updated HDMA Bar Code Guidance: A Must Read“).
All of these documents are available for immediate download on the same page as the Q&A document.
We are still waiting for the FDA to publish the 2015 guidance documents that the DSCSA mandated for publication by November 27, 2015 (see “FDA DSCSA Deadline Passes Quietly“). I’ll let you know when we see them.
For a line-by-line explanation of the DSCSA, check out my book, “The Drug Supply Chain Security Act Explained“. And until the end of 2015 you can get a copy free of my ebook by subscribing to RxTrace. For offer details, see “Why Subscribe To RxTrace?“. When you combine my ebook with a subscription to RxTrace, you will be the most informed person in your company, not only regarding the U.S. DSCSA, but also all other drug serialization and track and trace regulations around the world!
And don’t forget to anonymously fill out the 2016 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz. Read about it here.