Waiting For The Senate To Act On A Track & Trace Bill, Again

us-senate-logoImportant 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.The U.S. House of Representatives made quick work of the new bipartisan, bicameral compounding and track & trace bill draft that was circulated only last Wednesday evening (see “InBrief: Important New Bicameral Draft Of A Pharma Supply Chain Security Bill”).  They interrupted their debate over defunding “ObamaCare”, the Patient Protection and Affordable Care Act (PPACA), for a quick voice vote on the newly numbered H.R. 3204, Drug Quality and Security Act (DQSA) and it passed (see the draft bill here).

So now we are waiting for the Senate to take action, just as we have for the last 3 months since the House of Representatives voted to pass their earlier bill with drug supply chain track & trace provisions, H.R. 1919, Safeguarding America’s Pharmaceuticals Act, back in June (see “InBrief: The Pharma Track & Trace Bill Has Passed the U.S. House Of Representatives“ and “Still Waiting For The Senate”).  The Senate had their own Continue reading Waiting For The Senate To Act On A Track & Trace Bill, Again

InBrief: Important New Bicameral Draft Of A Pharma Supply Chain Security Bill

US CapitolImportant 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.I just arrived in California a couple hours ago to attend the next California Board of Pharmacy ePedigree Committee meeting later this morning.  I was expecting to check into my hotel and go to bed, but as soon as I turned my phone back on I received multiple notices that a new bipartisan, bicameral draft of a pharma supply chain security bill was being circulated for review and comment.  The email from the Senate HELP Committee was timestamped at 9:54pm EDT on Wednesday and they want people to comment on it by noon on Thursday.  Wow.  I still hope to get some sleep tonight, but I wanted to Continue reading InBrief: Important New Bicameral Draft Of A Pharma Supply Chain Security Bill

UDI And The Approaching End Of The NDC

UDI Barcode Cake
UDI Barcode Cake from last week’s UDI Conference

To be honest, I was somewhat surprised when Jay Crowley announced during last week’s UDI Conference that the U.S. FDA had published the final rules for Unique Device Identification (UDI).  Its publication starts the clock on a host of new requirements designed to identify most medical devices in the U.S. market with the same standard approach.  That is expected to result in the reduction of errors made by medical professionals and also increase the accuracy and efficiency of the supply chain.  I’ve become a little jaded about healthcare Automatic Identification and Data Capture (AIDC) deadlines lately and so the fact that one actually happened caught me slightly off-guard.  Of course, UDI was Continue reading UDI And The Approaching End Of The NDC

InBrief: FDA Publishes Final UDI Rule

UDI.1453-125x125_01The FDA has finally published the long-awaited final rule on Unique Device Identification (UDI).  I was in the audience at the UDI Conference this morning when Jay Crowley of the FDA made the announcement.  Sparkling juice was distributed to the entire audience of 400+ attendees shortly after the announcement.  See “FDA finalizes new system to identify medical devices“).

Yesterday Mr. Crowley arrived at the conference opening with a short beard.  George Wright IV suggested that perhaps he wasn’t shaving until the final rule was published.  Sure enough, he arrived this morning with the beard shaved off.  He was due to Continue reading InBrief: FDA Publishes Final UDI Rule

InBrief: California Proposes Breakthrough ePedigree Regulation On Drop Shipments

dropShipmentImportant 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.Late last Friday the California Board of Pharmacy published a proposed regulation for pharmaceutical drop shipments under their ePedigree law that is scheduled to go into effect in 2015 through 2017.  See the text of the proposed regulation for “Electronic Pedigree Requirements for Drop Shipments” here, the notice of its proposed action here, and their “Initial Statement of Reasons” here.  The Board is now seeking public comments on the proposed text through October 28, 2013.

The Board had asked for public input into the operation of drop shipments in the past to assist it with drawing up the regulation, which was mandated by Continue reading InBrief: California Proposes Breakthrough ePedigree Regulation On Drop Shipments

What The UDI Date Format Says About FDA’s Direction

Jay CrowleyThe 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

FDA Chooses DUNS For Unique Facility Identifier

The DUNS NumberLast 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