Tag Archives: UDI

Bringing UDI and the Global UDI Database to Life

1491-125x125_Static_DatesRxTrace is proud to sponsor the 2014 UDI Implementation Workshop to be held in Baltimore on May 20-22.  The UDI Implementation Workshop is specifically for Class III medical device manufacturers who are in immediate need of information and guidance from the UDI experts at the FDA to meet their September 24, 2014 compliance deadline, and for those Class I and II Device manufacturers that need to jumpstart their UDI adoption efforts.

The FDA UDI Team will conduct a roll-up-your sleeves / deep-dive workshop covering all components of the UDI regulation and the Global UDI Database (GUDID) guidance.  This workshop is strictly focused on critical information exchange, expanded interaction, and heightened networking designed to deliver immediate and actual results in your UDI implementation initiative.  If you need to meet the September deadline, don’t miss this workshop.  It is perfectly timed to give you the boost you need to be ready on time. Continue reading Bringing UDI and the Global UDI Database to Life

Is Your Drug Exempt From The Federal Drug Supply Chain Security Act?

Exempt signEver since the Drug Quality and Security Act (DQSA) was signed into law last November (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”), more and more people are asking the question, “Does my drug have to follow the DQSA?”.  Recently I was on a monthly industry call put on by one of the Big 3 wholesale distributors to discuss the Drug Supply Chain Security Act (DSCSA), which is Title II of the DQSA.

I was surprised how many people asked the wholesaler if their specific product was covered or exempt.  Of course, asking a wholesale distributor if your own product must follow a particular Federal law is not likely to get a usable response and that was true in this case, but it did not stop the next person from asking the same kind of question.

In fact, no one can answer that question for you.  Even the FDA can’t answer that question for you.  I can’t answer that question for you.  Only YOU can answer that question based on your knowledge of your product’s characteristics and a careful reading of certain provisions of the DSCSA.  I can help you with that part.  Continue reading Is Your Drug Exempt From The Federal Drug Supply Chain Security Act?

The Future of Healthcare Supply Chain Security

Businessman looking through binocularsLet’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:

Continue reading The Future of Healthcare Supply Chain Security

Senators Propose Amendments To S. 959

BillAs many of you pointed out to me in private emails last Friday after I had claimed that things had been quiet, there had indeed been some significant activity on S. 959, “Pharmaceutical Quality, Security, and Accountability Act” (PQSA) that occurred last week.  Even though the bill was awaiting action on the Senate floor, the bill managers in the Senate are apparently able to pull it back and amend it, and that’s what they did.  The bill is a combination of the “Pharmaceutical Compounding Quality and Accountability Act” and the “Drug Supply Chain Security Act” and my interest is in the latter so I will limit my analysis to that part of the current bill.

The amendments are fairly light and sprinkled throughout.  Most have little to no affect on the meaning or implementation of the bill–these include reformatting, corrections and minor logical adjustments–but there are a few things that are notable. Continue reading Senators Propose Amendments To S. 959

Fall Conference Season Preview

ConferenceI am a fan of attending conferences because, in addition to hearing thought-provoking presentations by knowledgeable speakers, you get to connect with the other attendees to learn what they are doing and thinking.  That’s why it is so important to select the right conferences.  Your goal should be to find the conferences that attract the best attendees so that you have the opportunity to make new connections and get updates from your existing ones.  Of course, the speakers Continue reading Fall Conference Season Preview

Can HIBCC Withstand The GS1 Tide In Medical Device Identification?

I was recently asked to help a small medical device manufacturer switch all of their medical device-related product codes from Health Industry Business Communications Council (HIBCC) Universal Product Numbers (UPN) to GS1 Global Trade Item Numbers (GTIN).  Historically, the pharmaceutical supply chain has used GS1 GTINs but the medical device supply chain has predominantly used HIBCC UPNs, so a switch like that seemed to be against the grain.  I asked them, “Why are you abandoning HIBCC codes for GS1 codes?”

The answer was a little startling Continue reading Can HIBCC Withstand The GS1 Tide In Medical Device Identification?

Should GS1 Continue Developing ePedigree Standards?

Photo by immrchris

Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.For the first time since GS1 produced the Drug Pedigree Messaging Standard (DPMS) standard in 2005, GS1 has just published a call-to-action for the formation of a new standards development group to focus on a new pedigree-related standard.  The new group will be called the “Pedigree Security, Choreography and Checking Service (PSCCS) Mission Specific Work Group (MSWG)”.  According to the call-to-action:

“This group will develop standards to allow pharmaceutical supply chain parties striving to meet pedigree regulation requirements, by gathering and checking pedigree event data.  Standards will also address data confidentiality and security.  This MSWG will create

        A) standard for security framework applicable to EPCIS and,

        B) pedigree checking services.”

This group’s output will not be a self-contained pedigree standard, per se, but Continue reading Should GS1 Continue Developing ePedigree Standards?

FDA Proposed UDI: The GUDID Database

The FDA is proposing the creation of a Global Unique Device Identification Database (GUDID), a publicly accessible database that would hold information about each medical device marketed in the U.S.  The GUDID has some similarities with GS1’s Global Data Synchronization Network (GDSN) but rather than accepting the use of GS1’s standard and service, they appear to have decided to roll their own.  Is that a good idea or will it just result in unsynchronized duplication?  Is there a way to use GDSN to serve GUDID (or vice versa)?  Could the GUDID concept work for drugs too? Continue reading FDA Proposed UDI: The GUDID Database