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 … Continue reading It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law
The U.S. Senate has passed H.R. 3204, the Drug Quality and Security Act (DQSA) with a voice vote, sending the important legislation to the desk of President Barack Obama. The President is expected to sign it happily. In an email to members, John M. Gray, President and CEO of the Healthcare Distribution Management Association (HDMA) … Continue reading U.S. Senate Passes H.R. 3204 With A Voice Vote
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 … Continue reading The Flaw That Must Be Addressed in H.R. 3204, The Drug Quality and Security Act
Dr. 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 … Continue reading InBrief: Comments on H.R. 3204 by FDA’s Dr. Ilisa Bernstein at PSM Interchange 13
You can safely ignore some things in the DSCSA. Just be careful when you do. Know why you are able to ignore them.
FDA posts grandfathering guidance, HDA posts barcode guidance and ANVISA posts implementation guide.
Maybe it’s because they know it isn’t worth it.
To meet the DSCSA 2023 deadline, the industry must organize and work with the FDA.
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