Tag Archives: FDA

DQSA of 2013

DQSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure

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iStock_000021010135XSmallIf there is one overriding lesson exposed by my essays last week it is that the companies in the U.S. pharmaceutical supply chain must quickly organize to work out technology and process issues that stand in the way of an efficient implementation of phase 1 of Title II of the Drug Quality and Security Act of 2013 (see “DQSA: Getting To Electronic Transaction Data Exchange” and “DQSA: Will U.S. Pharma Distributors Mandate Aggregation Data In Phase 1?”).  Title II of the DQSA is the Drug Supply Chain Security Act (DSCSA).

The law gives the FDA one year to publish guidance containing standards for use by companies in the supply chain for the exchange of Continue reading DQSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure →

DQSA of 2013

DQSA: Will U.S. Pharma Distributors Mandate Aggregation Data In Phase 1?

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worker with stacker at warehouseI attended the Healthcare Distribution Management Association (HDMA) Track and Trace Seminar held in Crystal City, VA on November 11-13, 2013.  I was particularly interested in the session called “Distributor Case Studies and Updates”, as were a lot of other people.  The speakers were:

Each speaker gave a brief presentation about their current serialization and pedigree programs before taking questions as a panel.  As you would expect, all of the preparation these companies have done up to this point has been aimed squarely at the California pedigree law which would have gone into effect for wholesalers in California in mid-2016.  But, Continue reading DQSA: Will U.S. Pharma Distributors Mandate Aggregation Data In Phase 1? →

DQSA of 2013

DQSA: Getting To Electronic Transaction Data Exchange

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Files transfer.While we wait for President Obama to sign the Drug Quality and Security Act of 2013 (DQSA, a.k.a. H.R. 3204) we can be confident it will become law in the next week or so.  This President has been presented with over 740 bills so far in his Presidency and he has signed all but two.  He has 10 days to sign the bill or it becomes law anyway but there might be some delay in the process between passage by the Senate and when the President is presented with the bill.

My interest in the DQSA of 2013 is only the Drug Supply Chain Security Act (DSCS) which is Title II within the overall bill.  I’m going to keep referring to it as the DQSA of 2013 but be aware that I probably won’t ever write about the compounding part, Title I.  If that is what brought you here, sorry, look elsewhere.

It is not law yet, but we can now be 100% sure it will be very soon.  Even before the bill was Continue reading DQSA: Getting To Electronic Transaction Data Exchange →

exemptions

Drug-Device Combo Products Under State And Federal Pedigree Laws

Metered dose inhaler drug-device combination product
Metered dose inhaler drug-device combination product

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.Both the California ePedigree law and the potential federal pedigree law that currently exists within the womb that is H.R. 3204 contain an exemption for drug-device combination products.  This is an expanding category of products so this exemption is worthy of a closer look.

The drug-device combo product exemption language included in the California Business and Professions Code, 4034(g)(9), is almost identical to the language in H.R. 3204, 581(24)(B)(xii).  There is a reason for that.  They are both based on part of the FDA’s definition for a drug-device combination product, found in 21 CFR 3.2 (e). Continue reading Drug-Device Combo Products Under State And Federal Pedigree Laws →

Federal Pedigree

The Flaw That Must Be Addressed in H.R. 3204, The Drug Quality and Security Act

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DQSA ePedigree timeline.ZoomRumors 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 →

FDA

InBrief: Comments on H.R. 3204 by FDA’s Dr. Ilisa Bernstein at PSM Interchange 13

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PSM mug logoDr. 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 →

Partnership For Safe Medicines

Dr Ilisa Bernstein of FDA CDER Office of Compliance To Keynote PSM Interchange

Dr.Bernstein-picture-200x300The Partnership for Safe Medicines (PSM) announced recently that Ilisa Bernstein, Pharm.D, JD, Deputy Director of the U.S. FDA Office of Compliance in the Center for Drug Evaluation and Research (CDER), will be the keynote speaker at their annual Interchange event next Thursday, October 24, 2013 at the Newseum in Washington DC.  RxTrace is a media partner for the event again this year and I plan to attend.

According to the PSM website:

“The annual Interchange brings together policymakers, pharmaceutical manufacturers, patient advocates, law enforcement, healthcare professionals, and anti-counterfeiting companies to discuss the problem and solutions to the global scourge of pharmaceutical counterfeiting.”

Dr. Bernstein Continue reading Dr Ilisa Bernstein of FDA CDER Office of Compliance To Keynote PSM Interchange →

EPCIS

Will Use Of EPCIS Force Everyone To Use GS1 Identifiers?

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EPCISOver the last five years the larger companies in the U.S. pharmaceutical supply chain have increasingly aligned around GS1’s Electronic Product Code Information Services (EPCIS) standard for holding and communicating serialization-based events.  The hope and expectation by many of these manufactures and others in the supply chain is that EPCIS will be the standard that ensures supply-chain-wide interoperability in any future track and trace or ePedigree system that the federal government might impose.  On its surface it appears that EPCIS is designed around GS1’s family of serialized identifiers, which are based on GS1’s GS1 Company Prefix (GCP) (see “Anatomy of a GTIN” and “Your GS1 Company Prefix: An Enterprise Resource“).  This includes Continue reading Will Use Of EPCIS Force Everyone To Use GS1 Identifiers? →