Rumors abound that the Drug Quality and Security Act (DQSA), H.R. 3204 will be debated and voted on in the Senate any day now (see “Waiting For The Senate To Act On A Track & Trace Bill, Again”). It already passed the House of Representatives back in September and the text is a compromise between the bill managers in both the House and the Senate, so everyone expects it to pass and be signed into law by President Obama. No one (except maybe some folks who don’t like the compounding part) wants to see its progress slowed, but there is a problem with the track and trace part that must be addressed before it is adopted or its implementation will quickly run into difficulties. Continue reading The Flaw That Must Be Addressed in H.R. 3204, The Drug Quality and Security Act
Tag Archives: pharmaceutical supply chain
How Smooth Will Industry Deployment of the ePedigree Laws Be? Take a Good Look At Healthcare.gov
When either the California ePedigree law or the federal law go into full effect, how smooth will that rollout be? While there are big differences between those implementations and the deployment of Healthcare.gov, the U.S. federal government’s new health insurance exchange website that is part of the Patient Protection and Healthcare Affordable Care Act (often referred to as the ACA, or “Obamacare”), I think the troubles it is experiencing may be an example of how the ePedigree system will work on initial rollout. That’s right, I’m predicting a nightmare, especially if it’s the California law that rolls out. Continue reading How Smooth Will Industry Deployment of the ePedigree Laws Be? Take a Good Look At Healthcare.gov
InBrief: Comments on H.R. 3204 by FDA’s Dr. Ilisa Bernstein at PSM Interchange 13
Dr. Ilisa Bernstein, Pharm.D, JD, Deputy Director of the U.S. FDA Office of Compliance in the Center for Drug Evaluation and Research (CDER), delivered the keynote address at yesterday’s Partnership for Safe Medicines (PSM) Interchange 2013 event (see “Dr Ilisa Bernstein of FDA CDER Office of Compliance To Keynote PSM Interchange”).
Her presentation covered the full range of activities that the FDA is currently pursuing to improve the security of the U.S. pharmaceutical supply chain, including their efforts to implement the new powers they were given by Congress in last year’s FDA Safety and Innovation Act (FDASIA). Continue reading InBrief: Comments on H.R. 3204 by FDA’s Dr. Ilisa Bernstein at PSM Interchange 13
Eli Lilly: “Serialization Needs Standardization”
Last month, Eli Lilly posted a video about their serialization initiative on YouTube. It features Grant Lindman, Manager of Lilly’s Global Anti-Counterfeiting Operations, and David Colombo, Commercial Implementation Leader of Lilly’s Global Serialization Program talking about their global serialization program. It is worth a listen. Continue reading Eli Lilly: “Serialization Needs Standardization”
InBrief: California Proposes Breakthrough ePedigree Regulation On Drop Shipments
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
FDA Chooses DUNS For Unique Facility Identifier
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
Working With CMOs Under California ePedigree
So far in RxTrace I have explored the possible implications of the California pedigree law on drug repackagers, 3PLs, VMI relationships and, of course wholesale distributors. Now let’s take a closer look at the murky world of the contract manufacturing organization (CMO). I call this world “murky” only because you have to look very carefully at the relationship between a CMO and the contracting manufacturer to fully understand how the pedigree law might be applied. And even then you are going to have to check with the California Board of Pharmacy because the law is so confusing in this area. Continue reading Working With CMOs Under California ePedigree
3PL Operation Under California ePedigree
Another one of the many types of businesses that will need to make changes to their operations in California once the pharmaceutical ePedigree law goes into effect is the third party logistics provider (3PL) business. There are a number of important differences between wholesale distributors and 3PLs, and because there seem to be confusion over the wording of the California law and recent comments made by California Board of Pharmacy officials regarding 3PLs (at least I’m confused), companies should be careful about their implementations. I do not have the answers and this is not legal advice, so please check with the Board and your lawyer to confirm anything you read here, but I will tell you my current thinking on the subject. Continue reading 3PL Operation Under California ePedigree
