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Senate passes bill to bolster Rx supply chain
November 18th, 2013
ARLINGTON, Va. – The National Association of Chain Drug Stores and the National Community Pharmacists Association hailed the Senate's passage of the Drug Quality and Security Act, which provides more uniformity for regulation of the pharmaceutical supply chain, including pharmacy compounding.
NACDS said the legislation (H.R. 3204) passed the Senate by voice vote on Monday. The measure was passed by the House of Representatives late last month.
"The passage of this bill will help ensure the health and safety of patients. This is a large step in helping avoid tragedies such as last year's national meningitis outbreak. At the same time, we appreciate the bill's protection of traditional compounding practices largely performed by retail pharmacists," NACDS president and chief executive officer Steve Anderson said in a statement on the Senate's approval of the legislation.
"Chain pharmacy has made significant investments to ensure that the U.S. pharmaceutical distribution system is one of the safest in the world, and this legislation will only improve and strengthen the process for all stakeholders."
Specifically, the bill sets one national standard for supply chain regulation, rather than the current patchwork of state laws and regulations, NACDS noted. The measure also clarifies and creates an additional regulatory framework for sterile compounding to help protect patient safety.
According to NACDS, the legislation creates a more secure supply chain and establishes better oversight of pharmacy compounding while balancing the need to safeguard patients and enable chain pharmacies to operate effectively and efficiently.
"In addition to the champions in the House of Representatives — including chairman of the U.S. House Energy and Commerce Committee, Fred Upton (R., Mich.) who helped to negotiate the legislation and advance it to approval in the House — we thank chairman Tom Harkin (D., Iowa) and ranking member Lamar Alexander (R., Tenn.) of the Senate Committee on Health, Education, Labor and Pensions for their leadership in moving this comprehensive bill through the Senate to final passage," Anderson added. "We urge President Obama to move swiftly in signing this pro-patient legislation into law."
NCPA CEO B. Douglas Hoey emphasized the importance of compounded medications to community pharmacy patients.
"When manufactured drugs are not an option, community pharmacists prepare, or compound, customized medications to meet a variety of individual health needs. H.R. 3204 leaves regulation of this vital and long-accepted practice by independent community pharmacies to state boards of pharmacy, where it should be. It also establishes a voluntary, regulatory pathway for companies to register as outsourcing facilities subject to standards and inspection by the Food and Drug Administration," Hoey explained. "Thus, the legislation should help prevent a recurrence of the tragic meningitis outbreak linked to the New England Compounding Center (NECC), while preserving patient access to individual medications compounded by local pharmacies in response to a doctor's request."
Hoey added that the legislation will add important protections to enhance the security and integrity of the U.S. pharmaceutical supply chain. "H.R. 3204 should give Americans additional confidence in the prescription drugs that community pharmacies dispense. It also was carefully crafted to avoid burdening pharmacy small businesses with cumbersome requirements or new unfunded mandates," he stated. "This important legislation strikes the right balance on two major issues for independent community pharmacists. We appreciate all the efforts of House and Senate leaders to craft this bill and we encourage President Obama to sign it into law."
The Healthcare Distribution Management Association (HDMA) noted that the Senate vote paves the way for the establishment of a national traceability framework for prescription drugs.
"The federal pre-emption of state laws to further strengthen the U.S. pharmaceutical supply chain represents one of the most significant legislative accomplishments for our industry and is especially important for the health care providers and pharmacies — and their patients — who count on the safe and efficient distribution of prescription medicines," HDMA president and CEO John Gray stated Monday. "Thanks to the commitment and hard work of the U.S. Congress, the 50-state patchwork of regulations will be replaced with one federal solution, ensuring the seamless movement and traceability of pharmaceuticals throughout the supply chain.
"This victory is the culmination of nearly a decade's worth of work by HDMA and all those who championed this issue," Gray added. "We applaud Congress for passing legislation to establish one national solution for a safer, more secure pharmaceutical supply chain, and urge President Obama to swiftly sign the bill into law."