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. Continue reading InBrief: HDMA Updates DSCSA Q&A
Tag Archives: pharmaceutical supply chain
Progress Toward Serialization!?
Last week I announced the availability of the 2015 RxTrace U.S. Pharma Traceability Survey Results that are sponsored by Frequentz. You should download a free copy of the report here. This week I want to look at another interesting finding taken directly from the report. It shows that progress is being made by drug manufacturers, repackagers and CMO/CPOs toward meeting the 2017 (2018 for repackagers) deadline for adding serial numbers to the drug packages they produce for the U.S. market. That requirement comes from the Drug Supply Chain Security Act (DSCSA) enacted in November of 2013.
One of the many questions we asked Continue reading Progress Toward Serialization!?
2015 RxTrace U.S. Pharma Traceability Survey Results, Sponsored by Frequentz Now Available!
I am proud to announce the free availability of the 2015 RxTrace U.S. Pharma Traceability Survey Results, sponsored by Frequentz. You can download the new free report here.
This year’s results were very interesting because most of the responses came in during the critical time just before the 2015 DSCSA requirements were to go into effect. The questions asked were designed to elicit opinions on a wide range of topics, including the respondent company’s ability to meet the regulations on time, their technology choices and practices. This year Continue reading 2015 RxTrace U.S. Pharma Traceability Survey Results, Sponsored by Frequentz Now Available!
InBrief: The Rx-360 Traceability Data Exchange Architecture White Paper
Last week, Rx-360, a pharma supply chain consortium aimed at patient safety through a secure supply chain, quietly published the white paper on Traceability Data Exchange Architecture (TDEA) (see “Pharma Supply Chain Companies Organize To Establish Global Traceability Data Exchange Architecture”).
This is a new addition of major importance to the thin collection of public resources companies have available to understand the scope and the specifics of pharma serialization and traceability regulations around the world—and that’s just the first half of the document. In fact, that half is so complete and well written that it should be downloaded and read immediately by anyone facing those regulations anywhere in the world…especially if Continue reading InBrief: The Rx-360 Traceability Data Exchange Architecture White Paper
DSCSA “Serial Numbers”
I often write about the fact that drug manufacturers and repackagers that sell into the U.S. market must put “serial numbers”, or “serialize” their drug packages and homogeneous cases before November 27, 2017, but what exactly does that mean?
Let’s break it down. The Drug Supply Chain Security Act (DSCSA) defines the term “Product identifier” this way:
“PRODUCT IDENTIFIER.—
The term ‘product identifier’ means a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the product.” (Section 581[14])
Back in March of 2010—3 ½ years before Congress passed the DSCSA—the FDA published final guidance called “Guidance for Industry, Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages”, which defined the term “standardized numerical identifier (SNI)” this way: Continue reading DSCSA “Serial Numbers”
When Will The DSCSA Ever Require Investments In Aggregation?
I have been outspoken on the question of whether or not the Drug Supply Chain Security Act (DSCSA) requires companies in the supply chain to provide their customers with serial number-based aggregation data prior to 2023. In my view, it does not, but others disagree, saying that there are requirements in the law that lead to the need for aggregation data during that time. I do not agree with that either. If you would like to review those arguments and find out exactly what “aggregation data” is, here is a list of RxTrace essays you should read:
| Date Published | Title/link |
| March 26th, 2012 | Pharma Aggregation: How Companies Are Achieving Perfection Today |
| November 22nd, 2013 | DQSA: Will U.S. Pharma Distributors Mandate Aggregation Data In Phase 1? |
| February 10th, 2014 | Does The DQSA Require Manufacturers To Provide Aggregation Data? Survey Says… |
| June 9th, 2014 | The Aggregation Hoax and PIA |
BUT WHAT ABOUT AFTER 2023?
The DSCSA requires the FDA to conduct at least 5 topical public meetings between now and Continue reading When Will The DSCSA Ever Require Investments In Aggregation?
Is An ASN Really The Best Way to Pass Lot-Based DSCSA Transaction Data?
We are now more than six weeks past the date that the DSCSA originally mandated drug manufacturers, repackagers and wholesale distributors to pass Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) to their customers in the U.S. and save a copy for six years (see “DSCSA: A Closer Look At The Six-Year Record-Keeping Requirement”). Of course, just before Christmas, the FDA pushed out that part of the requirement until May 1, 2015 to ensure that the requirement did not induce or exacerbate drug shortages (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1”).
Despite the delay, many companies are already passing the required data to their trading partners through Electronic Data Interchange (EDI) Advance Shipment Notices (ASNs) (see “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again”). In fact, the vast majority of companies have Continue reading Is An ASN Really The Best Way to Pass Lot-Based DSCSA Transaction Data?
Interoperability And The DSCSA
I just arrived home from a vacation in Aruba so I missed out on the winter weather many of you experienced last week. Here are a few pictures to help warm you up!
While I was in Aruba I spent some time thinking about interoperability as it applies to the provisions of the U.S. Drug Supply Chain Security Act (DSCSA). The text of the law uses the term “interoperable” multiple times with regard to the exchange of data between trading partners, but interestingly, it does not define the term. That leaves the definition of the term up to the FDA.
Before we look at the FDA’s definition of “interoperable”, let’s Continue reading Interoperability And The DSCSA
