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: Traceability
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
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?
Pharmaceutical Traceability Forum Offers Strategic and Solution Focused Discussions to Prepare Organizations for the Upcoming Compliance Deadlines
RxTrace is pleased to announce a partnership with the Pharmaceutical Traceability Forum, taking place March 30-April 1 in Boston, MA. In line with the upcoming regulatory and compliance deadlines, the Pharmaceutical Traceability Forum is the #1 event bringing together the brightest minds in the industry to discuss personal experiences and best strategies for preparing your serialization programs for 2015 and beyond.
Download the event agenda or request a copy via e-mail.
The Forum program, created for Continue reading Pharmaceutical Traceability Forum Offers Strategic and Solution Focused Discussions to Prepare Organizations for the Upcoming Compliance Deadlines
What will happen next? The 2015 RxTrace U.S. Pharma Traceability Survey, Sponsored by Frequentz
For the second year in a row RxTrace is partnering with Frequentz to conduct a survey about U.S. Pharma Traceability. This year the survey has been improved with separate sets of questions for each segment of the supply chain and also for companies who are not actual supply chain members. The survey asks questions about the readiness of companies for the 2015 requirements of the DSCSA as well as preparations for the 2017 serialization requirements. A few of the questions are the same as last year so we can track any change in thinking.
Click here to take the 2015 survey.
The answers you provide Continue reading What will happen next? The 2015 RxTrace U.S. Pharma Traceability Survey, Sponsored by Frequentz
Global Traceability Data Exchange: Troubled Waters Ahead
As we near the end of 2014, several important pharma traceability deadlines around the world are approaching. Besides the U.S. Drug Supply Chain Security Act (DSCSA), these include deadlines in Brazil and South Korea. Of course, each regulation is different. Now that the initial implementation of the exchange of transaction data in the U.S. is widely being implemented in Electronic Data Exchange (EDI) Advance Ship Notices (ASNs), the next hurdle for drug manufacturers will be to deploy serialization technologies on their U.S. and Korea market packaging lines. The data exchange technology problem will shift to Brazil, and that’s where I see trouble. Continue reading Global Traceability Data Exchange: Troubled Waters Ahead
The Future of Healthcare Supply Chain Security
Let’s take a brief pause from our in-the-moment work on meeting today’s healthcare supply chain security needs and consider what the supply chain will look like in the future. Because of regulations and laws enacted in 2012 and 2013 in the U.S., and expected in 2014 in the E.U., we know more today about how healthcare supply chain security will work In 2024 than looking forward in any previous 10 year period. In the last two years the U.S. and the E.U. have enacted legislation and introduced regulations that will have a profound impact on the security of these major supply chains in ten years. These include:
- In the U.S.:
- In the E.U.:
- The Falsified Medicines Act (FMA)
- The Harmonized Unique Device Identification Framework
- The anticipated Delegated Acts related to the FMA
Continue reading The Future of Healthcare Supply Chain Security
