The U.S. FDA is poised to publish their final Unique Device Identification (UDI) rule any day now. The publication was due earlier in the summer but has apparently been held up in the review by the Office of Management and Budget (OMB) without any kind of accurate timeline. The organizers of this year’s UDI Conference are hoping the FDA will be able to announce its publication at their event this Thursday and Friday in Baltimore. I understand that not everyone is looking forward to its publication, but some are kind of tired of waiting for it. I’ll bet Jay Crowley and his team Continue reading What The UDI Date Format Says About FDA’s Direction
Last week the FDA published draft, non-binding guidance for their recommended unique facility identifier (UFI) for use in registering foreign and domestic drug establishments. Last year, Congress passed the FDA Safety and Innovation Act (FDASIA) to address safety concerns induced by inspection gaps of facilities outside the United States and other issues (see “The Supply Chain Provisions Of The FDA Safety & Innovation Act”). In that law, Congress required the FDA to come up with some way of uniquely identifying all foreign and domestic facilities that are involved in the manufacture and importation of drugs. This new guidance is the response. Continue reading FDA Chooses DUNS For Unique Facility Identifier
Last fall the U.S. Congress passed the Food and Drug Administration Safety and Innovation Act, or FDASIA, and the bill was signed into law by President Obama. The purpose of the legislation was primarily to re-authorize user fees that are paid by manufacturers of drugs, medical devices and biologics, but the law also contains quite a few other things. Readers of RxTrace will recall that the well-organized attempt to add a nationwide track & trace requirement to the bill failed (see “PDUFA Will Not Include RxTEC”), but a number of very significant supply chain security elements did make it into the law under the title “Title VII—Drug Supply Chain” (see the full text of the law here). A closer look at these provisions is long overdue. Continue reading The Supply Chain Provisions Of The FDA Safety & Innovation Act
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?
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?
Linear barcodes? 2D barcodes? RFID? Manipulated DNA stands? Microscopic pattern recognition? Mental telepathy? Which Automatic Identification / Data Capture (AIDC) technology(ies) can you expect on the medical devices you buy in the U.S. supply chain in the future? This is the second in a multi-part series of essays examining various aspects of the recently proposed Unique Device Identification (UDI) rule by the U.S. Food and Drug Administration (FDA) (see last week’s essay, “FDA Proposed UDI: A Revolution In Number Assignment”.
The proposed FDA UDI rule requires the use of human readable and at least one AIDC technology to carry the new standardized identifier on all non-exempt devices and/or their packages. An AIDC technology is a way of Continue reading FDA Proposed UDI: AIDC Requirements
Like so many others, I had been patiently awaiting the publication of the U.S. Food and Drug Administration’s (FDA’s) Unique Device Identification (UDI) proposed rules. Now that they are out I’ve been studying them and I think I will have enough to say about them that I will cover the topic in a multi-part series. Today I want to look at just one of the differences between the FDA’s proposed UDI rule for medical devices and their National Drug Code (NDC), the pharmaceutical unique identifier. The NDC structure was first conceived by the FDA back in 1969. For more about the history of the NDC see my essay “Anatomy Of The National Drug Code”.
The thing I find fascinating is that at the same time they created the NDC for drugs back in 1969 they also created a comparable identifier for medical devices. They called it the National Health Related Item Code (NHRIC). Both the NDC and the NHRIC were voluntary until 1972 when the FDA made Continue reading FDA Proposed UDI: A Revolution In Number Assignment
The U.S. Food and Drug Administration (FDA) published their “Standardized Numerical Identification (SNI) for Prescription Drug Packages – Final Guidance” document almost two years ago (see my essay “FDA Aligns with GS1 SGTIN For SNDC” from back then). The guidance was published as purely non-binding recommendations that reflected the Agency’s current thinking, but in my opinion it is a nice piece of work and can be used as a practical guide, as far as it goes, for implementing drug serialization programs today.
Why is that? It’s because drug manufacturers and repackagers need to serialize all of their prescription drugs that enter the state of California in 2015/2016. Can those companies make use of the FDA’s SNI guidance to comply with the serialization requirements of the California Pedigree Law? I will answer that question in this essay, but first Continue reading Anatomy Of An FDA SNI