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 … Continue reading Correction: Your Drug or Biologic Combination Product Is Probably NOT Exempt From The DQSA →
With 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. … Continue reading Announcing The 2014 RxTrace U.S. Pharma Traceability Survey →
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 … Continue reading Preemption: What Does It Mean? →
If 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 … Continue reading DQSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure →
Q1. What is RxTrace About? A1. RxTrace is a compliance blog primarily about the DSCSA requirements in the US. Q2. I need compliance assistance, can i contact Rxtrace? A2. Yes! You can contact the author through the “Contact Christian” page. Q3. Why are you writing this blog? A3. I really enjoy writing (perhaps too much, … Continue reading FAQ’s →
