Happy New Year, 2018 is here! Last year, the FDA announced a series of three Drug Supply Chain Security Act (DSCSA) Public Meetings (see “FDA Announces New DSCSA Pilot Program and Public Meeting Series”). So far they have held two (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals” and “FDA DSCSA Public Meeting #2, Still A Gulf”). One more is left in that series, to be held on February 28, 2018. Continue reading 2018: The Year of FDA DSCSA Public Meetings
The gulf in expectations and goals exposed in the first FDA Drug Supply Chain Security Act (DSCSA) Public Meeting back in August (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals” and “HDA Schools FDA On DSCSA”) was still visible in the second meeting last week. There is still one more announced meeting scheduled for February 28, 2018 for the FDA and the industry to align (see “FDA Announces New DSCSA Pilot Program and Public Meeting Series”). Based on my observations at these first two meetings, I’m not going to hold my breath. The FDA is likely to announce more meetings in 2018.
The FDA did adjust their position on at least one thing after the August meeting. Continue reading FDA DSCSA Public Meeting #2, Still A Gulf
Last week the Healthcare Distribution Alliance (HDA) submitted nine pages of comments in response to the FDA’s Request For Comments in docket number FDA-2017-N-3857 (find their submission here). It is worthwhile for you to read because the HDA generally sets the gold standard for detailed analysis of the Drug Supply Chain Security Act (DSCSA), and because this one is particularly pertinent to discussions going on at the FDA and around the industry right now. Continue reading HDA Schools FDA On DSCSA
The FDA held the first of three scheduled DSCSA public meetings last week. This one focused on:
- The vision for 2023; and,
- The enhanced drug distribution security (EDDS) needs related to tracing prescription drugs at the package level.
The meeting started off with short presentations by representatives from:
- Biotechnology Innovation Organization (BIO)
- Association for Accessible Medicines (AAM)
- Healthcare Distribution Alliance (HDA)
- National Association of Chain Drug Stores (NACDS)
- American Pharmacists Association (APhA)
In the short time they were each given, these speakers Continue reading FDA DSCSA Public Meeting #1 Exposes Gulf In Goals
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