Tag Archives: pharmaceutical supply chain

Global Alignment

The Future of Healthcare Supply Chain Security

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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 →

DQSA of 2013

DQSA: How Should Transaction Data Be Exchanged?

FDALogoThe U.S. FDA just published a docket asking for public input into standards for the interoperable exchange of information for tracing of human, finished, prescription drugs in paper or electronic format.  Ironically, they will accept responses to the docket in either paper or electronic format.  Comments should be submitted to the FDA within 60 days.  If my calculation is correct, you have until April 21st to submit your comments.

This docket was expected because the Drug Supply Chain Security Act (DSCSA), enacted last November, gives the FDA one year to publish a draft guidance document that establishes standards for the interoperable exchange of that type of information, and they are required to consult with the industry and other interested parties [see Section 582(a)(2)].  I have written about this requirement and the short time after the guidance is published before the members of the supply chain must make use of those standards (see “The Flaw That Must Be Addressed in H.R. 3204, The Drug Quality and Security Act” and “DQSA: Getting To Electronic Transaction Data Exchange“).  This docket fulfills the first of many mandates that the FDA is facing in

Continue reading DQSA: How Should Transaction Data Be Exchanged? →

RxTrace, RxTrace Traceability Survey

Announcing The 2014 RxTrace U.S. Pharma Traceability Survey

iStock_000028920134XSmallWith the enactment of the Drug Supply Chain Security Act of 2013 (DSCSA) last week (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law“) I have decided to conduct an annual survey of U.S. pharma traceability preparedness.  You can fill out the survey by clicking on this link:  Take the 2014 RxTrace U.S. Pharma Traceability Survey Now.

The answers you provide anonymously will be aggregated to provide a view of the thinking of the industry, solution providers, regulators, academics and more, in addition to a view of the preparedness of the industry to meet the new federal pharmaceutical traceability law.  Please make sure your company is represented in the data that is collected.  The survey is Continue reading Announcing The 2014 RxTrace U.S. Pharma Traceability Survey →

Florida Pedigree

Preemption: What Does It Mean?

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State pedigree laws rearviewOn November 27, 2013 President Barack Obama signed the Drug Quality and Security Act of 2013 (DQSA) into law (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law“).  That act has many provisions, but one is to preempt all existing and future state pharmaceutical serialization and pedigree laws like those that previously existed in California and Florida.  Because of the preemption language contained within the DQSA, the information contained within many previous RxTrace essays is now obsolete.  Some essays are entirely obsolete and some are only partially obsolete.  This is because many of these essays contain ideas and discussion about topics that will also apply to the new federal law in almost the same way that they applied to the California and/or other state laws that are now inoperative.  In those cases, the ideas and discussion are not obsolete, only their application to the state law(s) is now obsolete.

To address this issue I have Continue reading Preemption: What Does It Mean? →

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 →

Federal Pedigree

All Eyes On The U.S. Senate Tonight

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U.S. Capitol building, Senate wing. The flag above the wing indicates that the Senate is in session.
U.S. Capitol building, Senate wing. The flag above the wing indicates that the Senate is in session.  Photo by Dirk.  Click to enlarge.

The effort to enact a nationwide pharmaceutical serialization law that would preempt all state laws has been going on for four or five years now, and this evening could be the culmination of all of those efforts.  The U.S. Senate calendar for today makes the passage of H.R. 3204, the Drug Quality and Security Act a top priority.  It finally looks like it is going to happen.

The official Senate calendar for today includes the following as the first order of business:

“                         CALENDAR OF BUSINESS

Monday, November 18, 2013

SENATE CONVENES AT 2:00 P.M.

PENDING BUSINESS

H.R. 3204 (ORDER NO. 236)

An act to amend the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain security, and for other purposes. Continue reading All Eyes On The U.S. Senate Tonight →