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NPCA, NACDS back compounding reform, drug security bill
September 27th, 2013
ALEXANDRIA, Va. – The National Community Pharmacists Association and the National Association of Chain Drug Stores have endorsed The Drug Quality and Security Act, which aims to improve regulation of pharmacy compounding and security of the pharmacy supply chain.
NCPA expressed its support of the legislation on Friday to congressional lawmakers in letters to House and Senate leaders urging approval of the measure. Also on Friday, NACDS sent a letter to key committee leaders in the House and Senate expressing its support for the legislation.
The bill has two key provisions. First, NCPA said, it would preserve patient access to customized medications prepared by community pharmacies while taking steps to bolster protections against a recurrence of the meningitis outbreak linked to the New England Compounding Center (NECC). Second, the legislation would establish a uniform standard for securing the nation's pharmaceutical supply chain, according to NCPA.
The legislation would achieve both objectives by preserving current law and creating a voluntary "outsourcing facility" registration, NCPA said, adding that the measure reflects a bipartisan House and Senate agreement announced earlier this week by House Energy & Commerce Committee Chair Fred Upton (R., Mich.) and Ranking Member Henry Waxman (D., Calif.) and 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 were key to reaching a final compromise, the association added.
"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 chief executive officer B. Douglas Hoey wrote in the letters.
Hoey pointed out that when off-the-shelf manufactured drugs aren't an option, community pharmacists are able to 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," he stated.
In its letter, NACDS said the measure makes strong efforts to ensure the health and safety of the American public.
"We believe [the agreement] will help guarantee patient safety through a more secure supply chain and appropriate and improved oversight of compounding activities," NACDS stated in the letter. "We believe that the reforms contained within the legislation meet the overarching goal of protecting patients while allowing chain pharmacies to operate effectively and efficiently in dispensing needed medications."
NACDS noted that the bill sets one national standard for supply chain regulation, rather than a patchwork of state laws and regulations. "Chain pharmacy has made significant investments to ensure that the U.S. pharmaceutical distribution system is one of the safest in the world, and your legislation will only improve and strengthen the process for all stakeholders," the letter said.
The association also pointed to the bill's clarification and call for an additional regulatory track for sterile compounding to help safeguard patient safety. "This is a large step in helping avoid tragedies such as last year's national meningitis outbreak," NACDS explained in the letter. "At the same time, we appreciate the agreement's protection of traditional compounding practices largely performed by retail pharmacists."
*Editor's Note: Article updated with comment from NACDS.