Senate Approves 21st Century Cures Act, Sending It to President Barack Obama's Desk | US News

Read the announcement: Senate Approves 21st Century Cures Act, Sending It to President Barack Obama's Desk | US News:

"Congress has approved a bill overhauling the development of medical treatments and cures that is likely to be one of the last pieces of legislation President Barack Obama will sign into law before he leaves office.

The Senate voted 94-5 on Wednesday to approve the bill, the 21st Century Cures Act, which will hasten how drugs and medical devices are reviewed and authorized by the Food and Drug Administration."

'via Blog this'

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Cures Act Headed To President - HME News

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Vitter’s Demands Hold Up Compounding-Pharmacy Bill - Bloomberg

Vitter’s Demands Hold Up Compounding-Pharmacy Bill - Bloomberg:

"One lawmaker’s effort to alter Obamacare is holding up final action by Congress on legislation that would expand U.S. regulation of compounding pharmacies linked to meningitis deaths last year.

The Senate is poised to approve the measure to broaden the U.S. Food and Drug Administration’s oversight of compounding pharmacies. Ninety-nine senators have agreed to pass the legislation that the House passed without a roll call vote, Democratic and Republican lawmakers said.

Republican Senator David Vitter of Louisiana wants the vote on compounding pharmacies coupled with consideration of his proposal to deny lawmakers and their staffs employer contributions when they buy medical insurance on the exchanges set up under the new health-care law. As a result, senators may have to spend a week on work that could be done in minutes."

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US Senate & House - Drug Quality and Security Act

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Updated May 3, 2023

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

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This is promising news, cooperation and agreement between the House and Senate (and across the aisle), to converge on what could likely become final legislation. Stay tuned!

US Senate Committee on Health, Education, Labor, & Pensions: Newsroom - Press Releases:

" “This legislation will improve the safety of compounded drugs by clarifying the oversight responsibilities of the FDA over large-volume compounders and by holding facilities to high quality standards. This bill also calls for an unprecedented tracing system that will track prescription drugs from manufacturing to distribution. I commend the bipartisan spirit that brought this compromise proposal together.” "

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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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The US House Finally Introduces A Compounding Pharmacy Bill | Pharmalot

Updated October 2, 2025

The original link broke.

You might also be interested in:

Compounding and the FDA: Questions and Answers - FDA.gov
https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers

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The US House Finally Introduces A Compounding Pharmacy Bill | Pharmalot:

"A long-awaited compounding pharmacy bill from the US House of Representatives has finally been introduced and, like a Senate bill introduced earlier this year, offers greater authority to the FDA. But while a key organization representing pharmacists is backing the effort, consumer advocacy groups remain concerned that both bills create loopholes that may create dangers for patients."

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

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Share Your CMS Round 2 Concerns With Congress

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AAHomecare Blog: Get a Bigger BANG for the August Recess Buck:

"Resources

For tips on how to talk to Congress and be more effective in the political process, download our 10 Step Guides in the AAHomecare Grassroots Toolbox.

For details about the bidding program and the reasonable alternative, the market pricing program, go to www.aahomecare.org/advocacy.

Find your Representative and Senators’ phone numbers and email addresses in our congressional directory."


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Senate In Recess - Didn't Vote On Track-and-Trace, Compounding Bill

Updated December 30, 2025

The original link didn't age well.

You might still be interested in:

FDA - Human Drug Compounding:

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

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Senate puts off vote for track-and-trace, compounding bill | Drug Store News:

"The Senate was expected to take up a bill designed to secure the drug supply chain and establish a list of "do not compound" medications, but left for recess Friday without voting on it.

The bill, S. 959, the Pharmaceutical Quality, Security and Accountability Act, had received some support from groups like the National Community Pharmacists Association, which supported the bill's goal of enhancing security, but expressed reservations about the compounding provision."

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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

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

- - -  original post follows below  - - -

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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Draft Compounding Pharmacy Bill by the House

A nice article with the latest details . . .

FDA Law Blog: Proposed Draft of House Compounding Legislation Released, Comments Wanted by Thursday June 20, 2013:

"This bill does not define a “compounding pharmacy” or create a “compounding manufacturer” category, unlike the pending Senate Health, Education, Labor and Pensions Committee (“HELP”) legislation (S. 959)."

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