Tag Archives: DSCSA Pilots

DSCSA, Interoperability

DSCSA: Interoperable Data Exchange In 2023

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Lots of people have been talking lately about what interoperable data exchange in the US pharma supply chain will look like after the Enhance Drug Distribution Security (EDDS) phase of the Drug Supply Chain Security Act (DSCSA) takes effect in November 2023 (see “Does Interoperability Change In 2023?”, “5 Myths About The DSCSA In 2023” and “Interoperability And The DSCSA”). 

Increasingly, I’ve heard the opinion expressed that there will surely be multiple approaches adopted for exchanging data, and so it will be necessary for all of those approaches to be made interoperable with each other.  Proponents of this idea claim it is unrealistic to expect a single approach to be accepted by all companies in the supply chain and therefore, having to deal with multiple approaches is inevitable.  This kind of talk makes me nervous.  Here’s why.

Continue reading DSCSA: Interoperable Data Exchange In 2023 →
DSCSA

FDA Announces Start Of DSCSA Voluntary Piloting Program

Starting tomorrow companies in the US supply chain wishing to volunteer to participate in FDA-sanctioned Drug Supply Chain Security Act (DSCSA) pilots will have just 30 days to apply.  Applicants are asked to propose pilots aimed at the goals of the FDA program.  These include:

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DSCSA

HDA Responds To FDA Waivers, Exceptions, Exemptions Draft Guidance

Unlike the implication of this drawing, FDA does hear and care about submitted comments.

The Healthcare Distribution Alliance (HDA) recently posted their response to the latest draft Drug Supply Chain Security Act (DSCSA) guidance published by the FDA.  That draft guidance explains how, when and why companies in the US pharma supply chain can apply for waivers, exemptions and exceptions to provisions in the DSCSA (see “FDA Draft Guidance: How To Apply For A Waiver, Exception or Exemption”).  As usual, the HDA took close to the full sixty day comment period to respond.  The comment period closed last Monday. Continue reading HDA Responds To FDA Waivers, Exceptions, Exemptions Draft Guidance →

DSCSA

What Should FDA Pilot?

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? →

FDA

FDA Announces New DSCSA Pilot Program and Public Meeting Series

Yesterday the FDA published a preview of two announcements related to the Drug Supply Chain Security Act (DSCSA).  One was announcing a new pilot program, “…to assist in development of the electronic, interoperable system that will identify and trace certain prescription drugs as these are distributed within the United States.”  That is, the system that will comprise the “Enhanced Drug Distribution Security” (EDDS) system in 2023.  The other announcement was for a series of DSCSA public meetings—also intended to work on the system in 2023.  Both announcements include a docket for use by stakeholders and the public to submit written comments to the FDA. Continue reading FDA Announces New DSCSA Pilot Program and Public Meeting Series →

EPCIS

InBrief: Pharma Supply Chain Leaders, Stop Throwing Interoperability Under The Bus

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57558052_smallerDuring the report out and follow-up discussion at last week’s FDA Drug Supply Chain Security Act (DSCSA) Pilots Workgroup (see “The 2016 FDA Pilots Workshop”) I heard an example of the industry throwing interoperability under the bus.  That is, setting us all up for major complications down the road that could easily be avoided if the leaders would just address interoperability right today.  One of the long-time leaders of the use of serialization and traceability in the U.S. pharma industry spoke up in front of the entire assembly and said that there existed a general “agreement” within the industry that “not everyone will use EPCIS”.  That is, not everyone will use GS1’s Electronic Product Code Information Services (EPCIS) standard for meeting the DSCSA, and consequently, the FDA and the industry will need to allow other formats of the data in 2023.  I just about fell out of my chair. Continue reading InBrief: Pharma Supply Chain Leaders, Stop Throwing Interoperability Under The Bus →

FDA Workshop

The 2016 FDA Pilots Workshop

2016-04-05 14.11.09.reducedI 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 →

FDA Workshop

FDA To Hold DSCSA Pilots Workshop

FDALogoAs we saw last fall, the FDA is planning to conduct at least one pilot project in 2016 to fulfill its DSCSA mandate to do so.  The pilot should focus on the 2023 DSCSA technologies and processes (see “FDA Looking For Consulting Org To Run DSCSA Pilots“).  Today we learned that a pilot will indeed occur this year, and the FDA wants your input into its design and goals.  To accomplish that quickly, the FDA will establish a docket next Tuesday for collecting written comments, and a public workshop for collecting verbal comments.

The last DSCSA public workshop Continue reading FDA To Hold DSCSA Pilots Workshop →