Obama signs Drug Quality and Security Act into law - SecuringIndustry.com

SecuringIndustry.com - Obama signs Drug Quality and Security Act into law:

"President Obama has signed H.R. 3204 into law, setting the wheels in motion for the FDA to develop a national track-and-trace system to secure the pharmaceutical supply chain.

The aim of the Drug Quality and Security Act (DQSA) is to "minimise opportunities for contamination, adulteration, diversion, or counterfeiting," whilst also clarifying the FDA's authority to regulate compounding pharmacies, according to the White House."

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Breaking news: US Senate clears track-and-trace bill - SecuringIndustry.com

SecuringIndustry.com - Breaking news: US Senate clears track-and-trace bill:

"The US Senate passed H.R. 3204 by unanimous voice vote today, bringing a national track-and-trace system for medicines and new laws governing compounding pharmacies to the brink of fruition.

With the House having given its blessing to H.R. 3204- also known as the Drug Quality and Security Act (DQSA) - at the end of September, all that remains now is for the bill to be passed to President Obama for signature."

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HDMA’s 2013 Track-and-Trace Conference: Right Here Waiting for H.R. 3204 - FDA Law Blog

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FDA Law Blog: HDMA’s 2013 Track-and-Trace Conference: Right Here Waiting for H.R. 3204:

"With fingers crossed, attendees looked ahead to the future of track-and-trace. Panelists expressed that the national system will hopefully make it harder for bad actors to corrupt the integrity of the supply chain, as the current patchwork of state pedigree laws allows bad actors to shop around for more lenient states. It is hoped that this bill will put everyone on a level playing field and reduce loopholes."

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All Eyes On The U.S. Senate Tonight - RxTrace

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Updated November 24, 2025

The original post didn't age well.

You might also be interested in:

Drug Supply Chain Security Act (DSCSA) - FDA.gov

---  the original post follows below  ---

Hold your breath. Let's see if the U.S. Senate will pass this bill, 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.)

All Eyes On The U.S. Senate Tonight - RxTrace:

"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."

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End game for US medicines traceability bill? - SecuringIndustry.com

Updated Oct 28, 2015:  It passed, and is now enacted. Here's the full text:
Text of the Drug Quality and Security Act (govtrack.us)

= = = original post follows = = =

Prospects for the Drug Quality and Security Act (H.R. 3204) are not so promising . . .

SecuringIndustry.com - End game for US medicines traceability bill?:

"Govtrack.us is currently putting the chances of the bill being enacted at 42 per cent. The Congressional Budget Office (CBO) estimates that H.R. 3204 will authorise the collection of $27m in user fees for fiscal years 2014-2018."

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Congress Clarifies Drug Compounding, Tracking Policies

Updated 12/12/2022

The links in the original post broke.

You might also be interested in:

• Human Drug Compounding - FDA.gov
• Drug Supply Chain Security Act (DSCSA) - FDA.gov

---  the original link follows below  ---

Congress Clarifies Drug Compounding, Tracking Policies:

"After months of public hearings and negotiations, Democrat and Republican leaders of the House Energy & Commerce Committee and the Senate Health, Education, Labor and Pensions Committee unveiled a compromise bill last week. No one gets all they wanted from H.R. 3204, the Drug Quality and Security Act, but it provides more clarity and predictability to drug oversight programs and moves forward initiatives designed to enhance the safety and quality of medicines in the US."

Follow this link to the draft bill, Drug Quality and Security Act (PDF)

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     California (earn a training affidavit):

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