Last week the FDA announced it will coordinate one or more pilot(s) to assist in the development of the electronic, interoperable system that will identify and trace drugs in the U.S. under the Drug Supply Chain Security Act (DSCSA) in its Enhanced Drug Distribution Security (EDDS) phase starting in 2023. Once they start work on pilot planning, they will call for proposals from stakeholders and others. But they can’t start until they get permission from the Office of Management and Budget (OMB), and they won’t even ask OMB for permission until they collect comments on the proposed collection of information associated with establishing the pilot program. Believe it or not, that was the Continue reading What Should FDA Pilot?
This week at the Healthcare Distribution Alliance (HDA) Distribution Management Conference and Expo (DMC) the HDA and ValueCentric will provide much more detail around the new master data sharing service they plan to make available in July. The new service—named “Origin”—is intended to provide members of the pharma supply chain with a single directory of master data for all prescription drugs marketed in the United States (see Origin website). That is, it is a database of master data wrapped within a cloud-based service.
Origin master data is composed Continue reading Dawn of HDA’s Origin, The Key to DSCSA Compliance
Because of all the major news and developments over the last six months, it has taken me way too long to fully cover the Healthcare Distribution Alliance’s (HDA’s) 2016 Serialization Readiness Survey of drug manufacturers. In my defense, I did cover it partially in my report of the HDA 2016 Traceability Seminar (see “HDA Delivers Home Run To Record-Breaking Audience”), but the other news from that event seemed to overshadow the survey results. The HDA survey executive summary was so well done, and the results so important that it deserves closer scrutiny. So here is my coverage, better late than never. Continue reading HDA’s 2016 Serialization Readiness Survey
There are a number of misconceptions floating around the industry right now about what will happen in November of 2023, when the Enhanced Drug Distribution Security (EDDS) phase mandated by the Drug Supply Chain Security Act (DSCSA) begins. It is surprising where you hear some of these, but they are all based on mis-reads of the DSCSA law itself. I’ll explain the myths, and then I will try to provide extracts from the DSCSA that expose them as myths. Continue reading 5 Myths About The DSCSA In 2023
Part 1 of this essay provided a wealth of hyperlinks into the Code of Federal Regulations (CFR) and FDA guidance documents with content related to placing the National Drug Code in human- and machine-readable form onto drug packages prior to November 27, 2017 (see “Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 1”). In Part 2, we will look at how the Drug Supply Chain Security Act (DSCSA) will change, or add-to, the requirements found in those earlier specifications. And finally, we will be able to answer the question in the essay title.
HOW THE DSCSA CHANGES THE NDC AND BARCODE REQUIREMENTS FOR DRUG PACKAGES
First of all, the DSCSA does not change anything Continue reading Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 2
I was initially disappointed in the FDA Drug Supply Chain Security Act (DSCSA) Pilots Workshop that was held at FDA headquarters last week, but in the end, the outcome appeared to fit the need. Going in, I knew not to expect the FDA to convey any information to the attendees, so that is not why I was disappointed. I attended the public DSCSA workshop they held back in May of 2014 so I already knew their typical approach for workshops like these (see “The 2014 FDA DSCSA Workshop”). I knew that the purpose of the workshop was to inform the FDA, not to inform the attendees. I would estimate that about one out of every four attendees were expecting the opposite, and I would bet a significant percentage of those had not even read the DSCSA once. But that’s not why I was disappointed.
I was initially disappointed because Continue reading The 2016 FDA Pilots Workshop
It’s time to think about what is likely to happen in 2016 with regard to pharma serialization and traceability. As part of that, let me remind you right off the top to fill out the 2016 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz. You don’t have to be a subscriber to respond and the results will also be open to everyone in the coming months.
So what about 2016? I think Continue reading RxTrace Preview of 2016
The use of Electronic Data Interchange (EDI) Advance Ship Notices (ASNs) in the U.S. pharmaceutical supply chain has expanded over the last year, due entirely to its recognition by the FDA as a valid method for passing the Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) as required by the Drug Supply Chain Security Act (DSCSA). The Healthcare Distribution Management Association (HDMA) has encouraged that expansion by publishing a “how-to” guide for meeting the requirements of the DSCSA using an ASN (see “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again”).
Although not everything has worked out Continue reading Will EPCIS Event Exchange Replace EDI ASNs for DSCSA Someday?