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
Friday, September 27, 2013
NCPA Urges Passage of Compounding Reform, Drug Security Bill September 27, 2013
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)