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

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Updated November 24, 2025

The original post didn't age well.

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

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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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Survey Finds S.B. 959 Would Require 4 in 10 Compounding Pharmacies Surveyed to Abandon the Pharmacy Profession

New Poll Finds Senate Bill 959 Would Require 4 in 10 Compounding Pharmacies Surveyed to Abandon the Pharmacy Profession | Business Wire:

"A recent poll of independent compounding pharmacies by PCCA shows that 4 in 10 of the pharmacies surveyed would be required to abandon the pharmacy profession under the terms of Senate Bill 959, The Pharmaceutical Quality, Security, and Accountability Act."

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House Version of Compounding Legislation Emerges, Contrasts With Senate Approach

Updated November 22, 2025

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Human Drug Compounding - FDA.gov:
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding

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House Version of Compounding Legislation Emerges, Contrasting Sharply With Senate Approach:

"Now legislators will be tasked with negotiating out differences in their legislative approaches. The PQSA is significantly more rigorous toward the compounding industry than the Compounding Clarity Act, and also includes track and trace legislative measures. The significant differences and approaches between the two pieces of legislation mean it could be months before any legislation stands a chance of reaching President Barack Obama's desk."

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Business Owners May Face $100-Per-Day Penalty Under ObamaCare | Fox

Updated September 30, 2025

The original link broke.

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Business Owners May Face $100-Per-Day Penalty Under ObamaCare | Fox Small Business Center:

"Small business owners who thought they were off the hook for ObamaCare regulations until 2015 may be in for an expensive wake-up call next month.

Beginning Oct. 1, any business with at least one employee and $500,000 in annual revenue must notify all employees by letter about the Affordable Care Act’s health-care exchanges, or face up to a $100-per-day fine."


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Modified Senate Legislation Emerges, Would Reform Compounding Regulation, Track and Trace

Modified Senate Legislation Emerges, Would Reform Compounding Regulation, Track and Trace:

"Background

Both the Senate and House of Representatives have been working independently of one another to push forward measures on both compounding and track and trace. On the Senate side, the two measures have been combined into a single bill, the Pharmaceutical Quality, Security and Accountability Act (PQSA Act), while on the House side the measures are proceeding separately."

Follow this link to a draft of the Pharmaceutical Quality, Security and Accountability Act (PQSA Act) - PDF

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Senate Bill S.959 - Text of Pharm Compounding Quality & Accountability Act

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Updated October 13, 2021

You might also like:

Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry - FDA.gov

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Here's a link to the bill's text as it progresses through Congress.

S.959 - 113th Congress (2013-2014) - A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to compounding drugs. - Bill Text | Congress.gov | Library of Congress:

"A BILL - To amend the Federal Food, Drug, and Cosmetic Act with respect to compounding drugs."

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• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

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California Board of Pharmacy weighs in on RxTEC proposal

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More on potential e-Pedigree touchpoints . . .

Henry Waxman, U.S. Congressman.
 (Photo credit: Wikipedia)

SecuringPharma - California Board of Pharmacy weighs in on RxTEC proposal:

"The California Board of Pharmacy in the US has written an open letter to Representative Henry Waxman calling for a federal approach to pharmaceutical traceability that provides the same or greater protection to the public as its electronic pedigree system due to come into effect between 2015 and 2017.

The letter to Waxman - who serves as ranking member of the House Energy and Commerce Committee - also takes a swipe at the Pharmaceutical Traceability Enhancement Code (RxTEC) system enshrined in the Securing Pharmaceutical Distribution Integrity Act of 2012, saying that it is a "less robust, and less secure, supply chain infrastructure.""

'via Blog this'

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