Griffith, Green, DeGette Support Bipartisan, Bicameral Compounding Agreement Friday, Sep 27 -Congressman Morgan Griffith (R-VA), Congressman Gene Green (D-TX), and Congresswoman Diana DeGette (D-CO) participated in a series of Energy and Commerce hearings on the drug compounding issue. They recently introduced the Compounding Clarity Act (H.R. 3089), and today signed on as cosponsors of the Drug Quality and Security Act. The Drug Quality and Security Act, which incorporates some of the Compounding Clarity Act, is a bipartisan, bicameral first step to help ensure the safety of compounding drugs. It also will work to prevent a national public health crisis like the 2012 fungal meningitis outbreak tied to the New England Compounding Center (NECC). 64 deaths and 750 confirmed cases of fungal meningitis resulted from tainted steroid injections from the NECC.Griffith said, “The Drug Quality and Security Act is a first step at clarifying current law. It eliminates perceived confusion that existed as a result of court decisions on advertising related to compounding drugs and adopts the notification provisions that were in the Griffith-Green-DeGette Compounding Clarity Act. The Drug Quality and Security Act leaves a large portion of existing law intact. It also leaves many areas of practice where clarification may still be needed, particularly as it relates to office use, repackaging, and nuclear pharmacies. Along with my colleagues, I will continue working to oversee the FDA’s interpretation and implementation of this law.” Green said, “The Drug Quality and Security Act is a positive step forward toward enhancing public health and ensuring that compounded drugs are safe and dependable. I am proud to have worked with my colleagues Reps. Griffith and DeGette in pressing for enhanced FDA oversight of compounding. While I believe the FDA dropped the ball with regards to the NECC, with this law they must succeed where in the past they failed. This bill still lacks clarity in many important areas: office use, how nuclear pharmacies are regulated, and repackaging of sterile products. I look forward to working with my colleagues to provide meaningful oversight of the FDA to make sure another NECC type outbreak never happens again and to make sure they are using the type of enforcement discretion necessary to preserve patients’ access to critical medicine.”DeGette said, “The deadly fungal meningitis outbreak that sickened hundreds across the United States last year represented a tragic failure of the compounding drug manufacturing system and made clear we must have a stronger and more effective regulatory framework to oversee that system. That is why I was proud to join with my friends and colleagues Congressmen Griffith and Green earlier this month in introducing legislation that ultimately served as a foundation for the Drug Quality and Security Act introduced today. Today’s bipartisan, bicameral bill will take important steps forward to develop a more robust regulatory framework that can save people’s lives. I know my colleagues and I look forward to the passage of this bill and to continuing to work to ensure we take every step possible to secure the compounding drug manufacturing chain, and protect the lives of American patients.”
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Saturday, September 28, 2013
Friday, September 27, 2013
House Expected to Vote Tomorrow in Compounding Legislation
U.S. House may take up pharmacy compounding bill on Saturday
September 27
BY MARK MORRIS
The Kansas City Star
With the U.S. House expected Saturday to consider a compromise bill to regulate pharmacy compounding, interest groups have weighed in on the merits of the legislation.Read more here: http://www.kansascity.com/2013/09/27/4513137/us-house-may-take-up-pharmacy.html#storylink=cpy
A Confusing Attempt to Cure Compounding Pharmacies By Paul M. Barrett September 27, 2013
Remember the panic about compounding pharmacies? These are state-licensed retail businesses that mix and sell medications, but without the federal safety approval required for mass-produced drugs. No? How about the scandal last yearinvolving a Massachusetts pharmacy whose tainted back-pain steroids led to hundreds of serious infections and more than 60 deaths, many related to meningitis?
Oh, yes, that you recall. Scary stuff.
Now that you’re focused, here’s the news: Congress has finally moved to give the Food and Drug Administration greater authority over compounding pharmacies. This week, negotiators from the House and Senate came up with a compromise billdesigned to prevent another fiasco like last fall’s misadventure with the since-closed New England Compounding Center in Framingham, Mass.
Unfortunately, the compromise seems convoluted, requires only voluntary participation by compounding pharmacies, and has already provoked a vow of resistance from the targeted businesses. In other words: more confusion ahead.
Lawmakers said they aimed to give the FDA greater authority to oversee and inspect compounding pharmacies in the way the agency already supervises traditional drug manufacturers. In a twist, though, compounding pharmacies wouldn’t be required to submit to this oversight. The proposed legislation would rely on market forces to provide the incentive for pharmacies to open up to the FDA. Presumably, doctors and hospitals would prefer to acquire specially designed remedies from businesses willing to host FDA inspectors.
Well, maybe. Or maybe cut-rate, low-quality pill-and-serum mills would remain in the shadows, hoping to sell to just enough customers to stay in business. Given the terrifying experience in Massachusetts last year, it seems odd that the option would remain with the manufacturers.
continue to read here
IACP Member Alert: IACP: COMPROMISE COMPOUNDING BILL WILL NOT ADVANCE QUALITY AND SAFETY!
The International Academy of Compounding Pharmacists (IACP) believes that the compromise compounding bill that has emerged from Congress will not protect the American public; contains significant gaps because it does not provide key definitions to govern compounding practice; and does not take into account any of the input from the compounding profession provided to Congress over the last year.
Click here to read more http://bit.ly/18vhnx9
Question Three of the Day, September 27, 2013, What happens when you try to apply the Compounding Quality Act (a part of the Drugs Quality and Security Act) to a situation in the future that is like the NECC outbreak?
Assume NECC does not elect to be an outsourcing facility. Assume that the FDA nonetheless after receiving information from the states attempts to take enforcement action against NECC. What do you think NECC's response would be? We are so glad you showed up to save all these people FDA, come on in, look around, gather evidence, do your job?? I think not. I think you would get the same response as in the past--FDA we didn't elect to be under your authority so go away--FDA would then have to go to court and hope for the best! And hope that they could get court action before anyone died.
NCPA Urges Passage of Compounding Reform, Drug Security Bill September 27, 2013
ALEXANDRIA, Va., Sept. 27, 2013 /PRNewswire-USNewswire/ — The National Community Pharmacists Association (NCPA) today endorsed The Drug Quality and Security Act in letters to House and Senate leaders urging approval of the measure.
The bill has two major provisions. First, it would preserve patient access to customized medications prepared by independent community pharmacies while taking steps to enhance protections against a recurrence of the meningitis outbreak linked to the New England Compounding Center (NECC) and exacerbated by the lack of oversight by the Food and Drug Administration (FDA) and Massachusetts state health officials. Second, it would establish a uniform standard for securing the nation’s pharmaceutical supply chain.
The legislation would accomplish both goals by preserving current law and creating a voluntary “outsourcing facility” registration , and reflects a bipartisan, House and Senate agreement announced earlier this week by U.S. House Energy & Commerce Committee Chair Fred Upton (R-Mich.) and Ranking Member Henry Waxman (D-Calif.) and U.S. Senate Health, Education, Labor and Pensions Committee Chair Tom Harkin (D-Iowa) and Ranking Member Lamar Alexander (R-Tenn.). The efforts of Reps. Morgan Griffith (R-Va.), Gene Green (D-Texas), Diana DeGette (D-Colo.), and Sen. Pat Roberts (R-Kan.) also proved critical to reaching a final compromise.
“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 CEO B. Douglas Hoey, RPh, MBA wrote in his letter to lawmakers. “When off-the-shelf manufactured drugs are not an option, community pharmacists prepare or compound customized medications for individual patients. NCPA commends 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.”
Throughout the process, NCPA was heavily engaged in advocating for common-sense solutions that promoted safety, preserved access for patients, and protected small business community pharmacies from burdensome, unfunded mandates. Some of those efforts were highly visible such as when a NCPA official and a NCPA member and pharmacy owner delivered expert testimony before Congressional hearings or when NCPA articulated these views in the media. In other instances, NCPA members and staff lent their expertise and technical advice through countless meetings and other interactions with policymakers.
As a result, in The Drug Quality and Security Act, Congress developed balanced legislation to address critical needs while avoiding provisions in previous legislation that, while well-intended, was problematic for community pharmacists.
“Independent pharmacies have a long and successful history of protecting patient safety while preserving patient access to vital medications,” Hoey concluded. “This compromise legislation appropriately 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.”
The National Community Pharmacists Association (NCPA®) represents the interests of America’s community pharmacists, including the owners of more than 23,000 independent community pharmacies. Together they represent an $88.5 billion health care marketplace, dispense nearly 40% of all retail prescriptions , and employ more than 300,000 individuals, including over 62,000 pharmacists. To learn more go to www.ncpanet.org or read NCPA’s blog, The Dose, at http://ncpanet.wordpress.com/.
SOURCE National Community Pharmacists Association (NCPA)
Subscribe to:
Posts (Atom)