Last month I published an essay that analyzed the exemption language related to combination products contained in the old California pedigree law and in H.R. 3204, which was later signed into law as the Drug Quality and Security Act (DQSA) (see “Drug-Device Combo Products Under State And Federal Pedigree Laws”). In that essay I showed how these exemptions were very similar because both were based on the existing definition of a “combination product” from 21 CFR 3.2(e). My assessment of the effect of the wording in the old California pedigree law is still valid, in my opinion, but I now believe my analysis of the language in H.R. 3204 was incorrect. Here is why. Continue reading Correction: Your Drug or Biologic Combination Product Is Probably NOT Exempt From The DQSA
On 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?
According to the White House website, President Barack Obama signed H.R. 3204, the Drug Quality and Security Act (DQSA), into law a short time ago, bringing to a successful conclusion efforts by the industry and consumer groups to create a national pharmaceutical serialization and track & trace regulation that eliminates the patchwork of state laws in addition to new regulations for compounding pharmacies.
Many people and organizations contributed to this successful effort and they all deserve congratulations, but I believe the organizations with the most responsibility for this conclusion is the California State legislature and the California Board of Pharmacy in Continue reading It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law
I 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:
- Chris J. Anderson, Director, Quality Systems, Cardinal Health, Inc.
- Steve Tadevich, Director, Product Serialization Technologies, McKesson Corporation
- Heather Zenk, PharmD, Vice President, Business Integration, AmerisourceBergen Corporation
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?
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
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.
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
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
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