Want to know who is Supporting Congress' Agreement on the Drug Quality and Security Act--Read this

WHAT THEY’RE SAYING: DRUG QUALITY AND SECURITY ACT

September 27, 2013

   

Leading National Health and Patient Organizations Strongly Support Breakthrough Bipartisan Agreement to Improve Drug Safety

“This compromise legislation addresses the issues that led to the NECC tragedy, protects the physician-patient-pharmacist relationship, maintains critical patient access to compounded medications, and strengthens the pharmaceutical supply chain.” - NCPA

WASHINGTON, DC – Earlier this week, House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Senate HELP Committee Chairman Tom Harkin (D-IA) announced bipartisan, bicameral legislation to address high-risk drug compounding practices and strengthen America’s pharmaceutical supply chain. H.R. 3204 – the Drug Quality and Security Act – builds upon the Energy and Commerce Committee’s extensive efforts to improve drug safety and help prevent a future public health crisis like the 2012 meningitis outbreak tied to the New England Compounding Center.

In addition to the bill’s introduction, momentum continues to build around this important effort as dozens of groups have voiced their support. A sampling of the support is provided below:

National Community Pharmacists Association (NCPA)

“This compromise proposal provides a balanced and effective approach to address critical and complex issues surrounding compounded medications, as well as strengthening our nation’s pharmaceutical supply chain. NCPA applauds the House for moving this legislation in expeditious fashion, and urge members to vote in favor of this bipartisan compromise. … NCPA commends the Congress for crafting bipartisan legislation that addresses the New England Compounding Center (NECC) tragedy, ensures quality standards for all compounded pharmaceuticals, and maintains patient access to vital compounded medications.”

Cancer Leadership Council (On Behalf of 21 Cancer Organizations)

“Cancer patients and providers support a pharmaceutical distribution system that will protect against the counterfeit medicines that have put cancer patients at risk in the recent past. Distribution system protections

another recall

The Compounding Shop: FDA News Release - Lack of Sterility Assurance of Drug Products

By Newsroom America Feeds at 11:00 am EasternUPDATED 09/27/2013. Budesonide solution, used for nasal irrigation, from The Compounding Shop may be contaminated and should not be used or administered to patients. Originally posted 05/08/2013http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMe

Highlights of Federal Compounding legislation Draft

Among other highlights, the legislation:

• Distinguishes compounders engaged in traditional pharmacy practice from those making large volumes of compounded drugs without individual prescriptions. Compounders who wish to practice outside the scope of traditional pharmacy practice can register as outsourcing facilities, but those who choose to remain traditional pharmacies will continue to be primarily regulated by State Boards of Pharmacy as they are in current law.
• Defines the Food and Drug Administration’s (FDA’s) role in oversight of outsourcing facilities.  Outsourcing facilities would be subject to FDA oversight in much the same way as traditional manufacturers.  FDA will know who these outsourcers are and what they are making, receive adverse event reports about compounded drugs, and have the authority and resources to conduct risk-based inspections.  The legislation will give providers and patients the option of purchasing product from outsourcing facilities that comply with FDA quality standards.
• Offers providers and patients better information about compounded drugs.  The legislation directs FDA to make a list of FDA-regulated outsourcing facilities available on FDA’s website, requires detailed labeling on compounded drugs, and prohibits false and misleading advertising.
• Clarifies current federal law regarding pharmacy compounding.  The legislation strikes unconstitutional provisions in current law, resolving the patchwork of current federal regulation and applying a uniform standard nationwide.

quoted from here

Bicameral Pact Uses Market Forces To Push Compounders Toward Voluntary Federal Oversight Lawmakers late Wednesday (Sept. 26) struck a bicameral, bipartisan drug compounding agreement that departs from previous proposals by ditching volume limits and a three-part test in favor of a voluntary regulatory scheme for sterile compounders.

subscription required to read entire story

Are we there yet? Bicameral Congressional group posts news about a track-and-trace agreement September 26, 2013

Regulation of compounding pharmacies will be included in the new Drug Quality and Security Act

 

Confirming that, indeed, Congressional committees have been working hard behind the scenes to completea compromise draft legislation that will encompass both the longstanding effort for national rules on trackingpharmaceutical shipments, and the more recent effort to give FDA more authority to regulate compounding pharmacies, several Congressmen issued news releases on Sept. 25 announcing their success. The actual bill remains to be revealed, at least as of early on Sept. 26. 

 

Senator Tom Harkin (D-IA), chairman of the Senate Health, Education and Labor Committee, issued astatement that commended “the bipartisan spirit that brought this compromise proposal together” in the form of what will now be called the Drug Quality and Security Act.  “Today we are taking a notable step toward completing the important work of improving the security of our pharmaceutical supply chain and clarifying the regulation of drug compounding,” said a statement from Fred Upton (R-MI), chairman of the House Energy and Commerce committee. “This step will help us protect the health and safety of the American people,” said Energy and Commerce Committee Chairman Fred Upton (R-MI).

 

Interestingly, the issue of drug compounding seems to have superseded that of track-and-trace legislation in the discussions. The Senate bill put forward earlier this year included regulation of compounding; the House bill did not. Given that track-and-trace legislation has been debated and wrestled with since around 2006, while the compounding topic only appeared within the past year, there was a risk that the ongoing legislative efforts for track and trace could have been derailed by the compounding issue.

Continue to read here