New Legislation Will Provide Relief for Rural Home Medical Equipment Suppliers and Their Patients - PR Newswire

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Read the full article: New Legislation Will Provide Relief for Rural Home Medical Equipment Suppliers and Their Patients -  PR Newswire:

"Legislation to delay a new round of cuts to rural and non-bid area suppliers and provide additional fixes to the Medicare competitive bidding program for home medical equipment (HME) was introduced late yesterday in the Senate. The lead sponsors for the Patient Access to Durable Medical Equipment Act (S. 2736), are Senators John Thune (R-S.D.) and Heidi Heitkamp (D-N.D.).

This bipartisan, non-controversial, and budget-neutral bill will:" . . .

'via Blog this'

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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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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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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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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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US Senate & House - Drug Quality and Security Act

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Updated May 3, 2023

You might also be interested in:

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

---  the original post follows below  ---

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

You might also like:

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

---  the original post follows below  ---

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

---  the original post follows below  ---

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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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

---  the original post follows below  ---

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

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

- - -  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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Pt & Disability Groups Support Bill to Begin Market Pricing System for HME in Medicare

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Patient and Disability Groups Support Bill to Begin Market Pricing System for Home Medical Equipment in Medicare - PR Newswire:

"More than 30 patient advocacy and consumer groups endorsed a bill in Congress that would replace Medicare's current "competitive bidding" program for durable medical equipment with a better market pricing system that preserves access to homecare. Millions of Americans use medically required durable medical equipment and services at home, including oxygen therapy, wheelchairs, and hospital beds.

The bill, H.R. 6490, was introduced in the House of Representatives by a bipartisan group of lawmakers in September and has gained strong bipartisan support from several dozen members of Congress. The bill would replace the current, controversial bidding program with a more sustainable system, says the American Association for Homecare."

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