All Eyes On The U.S. Senate Tonight

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



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. (Nov. 14, 2013.)


H.R. 3204 (ORDER NO. 236)

1.–Ordered, That on Monday, November 18, 2013, if cloture is not invoked on the Wilkins nomination, the Senate resume Legislative Session and immediately vote on the motion to invoke cloture on H.R. 3204, 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; provided, that if cloture is invoked on the bill, all post-cloture time be yielded back, the pending amendments be withdrawn and the Senate vote on passage of H.R. 3204.    Ordered, That with respect to the cloture motion on H.R. 3204, the mandatory quorum required under Rule XXII be waived. (Nov. 14, 2013.)”

The Senate will convene at 2:00pm EST and the action on H.R. 3204 is slated to begin around 5:30pm EST, although you can’t always count on those times.  Whenever the Senate is in session you can watch their streaming video online at  You can bet I’ll be watching later today.

I have written a little bit about H.R. 3204 in Rxtrace (see these essays) but, believe it or not, I have been holding back a little.  I didn’t want to write very much about the details because until recently it wasn’t obvious that it was going to pass.  If the bill is passed by the Senate without amendments, the only thing that will stand in the way of it becoming law will be a signature from President Obama.  I’m not aware of any hint of his plan for the bill, but I can’t believe there would be any reason he would veto it.

The President would have three choices of action.  Vetoing it would kill the bill entirely and proponents would have to start all over again in the Congress.  Or the President could either sign it into law or ignore it, in which case it automatically becomes a law after 10 days.  Very few Presidents in history have let a bill become a law by ignoring it so that isn’t likely here either.

If the bill is passed by the Senate tonight I believe you can finally count on it being a law within 10 days.  And then the clocks start.  The bill contains lots of references to provisions that become effective after some number of years (see “The Flaw That Must Be Addressed in H.R. 3204, The Drug Quality and Security Act”).

There are lots of things that would be triggered by passage of the law.  No doubt, the most important one is that the California pedigree law would immediately become inoperative.  That is, all of the “clocks” in that law—like January 1, 2015 for 50% of all drugs being serialized and pedigreed, etc.—would stop and disintegrate into irrelevance along with those of all other state pedigree laws.  For that reason, many of my past essays in RxTrace will also become irrelevant at the same moment.

My current plan is to identify every RxTrace essay that would contain obsolete information about state pedigree laws and add a banner to the top of them that explains that some or all of the information contained in them is no longer applicable.  I’m not sure how many essays that will be but I’m assuming as many as 75% of them.  I am just skeptical enough to not want to put any energy into that process until the bill passes the Senate without amendment.

And then I will begin writing about topics surrounding the DQSA.  And there are a lot of them.  Industry implementation of the supply chain security part of the DQSA will not be a piece of cake.  Fortunately I haven’t met anyone who thinks that it would be, although I have heard rumors of companies who would consider backing off of their programs if/when H.R. 3204 passes.

Backing off would be a mistake, but reevaluating your entire serialization and e-pedigree program and repositioning it to meet the new requirements and timeline is a good idea.  I will write about that topic as soon as the bill becomes a law.  Watch for it, maybe later on this week!


2 thoughts on “All Eyes On The U.S. Senate Tonight”

  1. Thanks for the great coverage of this topic. I’m new to this aspect of drug manufacture and distribution, and have missed some of the history of serialization efforts. News coverage of HR 3204 generally mentions preemption of the California law, which specifies earlier dates for required serialization. Does HR3204 specifically preempt the CA law, i.e., let manufacturers off the hook for the period between when CA would take effect and when 3204 takes effect?

    1. Willie S,
      Welcome to RxTrace and to the world of pedigree mandates. The answer to your question is a qualified “yes”. Yes, the DQSA (H.R. 3204) does specifically preempt all state pedigree laws, including California, but there are requirements that your company will need to follow as soon as it is signed by the President. If you only look at the serialization requirement, then yes, there is a gap between when manufacturers would have been required to begin serializing product for California (1-1-2015) and for the federal DQSA (late November 2017). But if you look at the pedigree requirements the federal requirements are actually more rigorous for manufacturers, requiring them to pass lot-based paper or electronic pedigrees for all drug shipments to all customers starting on 1-1-2015. In California you would have only needed to do that for 50% of your drug shipments on that date, and you could have chosen any one of three different ways to measure the “50%” so that it was in your favor.

      Some manufacturers who were preparing for California would tell you that the serialization part turned out to be expensive, but at least it was something that could be understood and accomplished. It turned out that the data exchange part was the biggest headache. Of course, that was with electronic pedigrees and unit-level serial numbers had to be in every pedigree, and you had to apply a digital signature to each pedigree. The federal transaction information, transaction history and transaction statements (combined they are “pedigree-like”) are not quite so complex and you can start out with paper rather than electronic, but don’t underestimate the chore even that will be for you.

      Keep following RxTrace, ask questions and talk to people who have been doing this for a while.

      Good luck,

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