New law aims to ensure drug quality, security

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WASHINGTON — Pharmacy organizations have praised last month’s enactment of a federal comprehensive supply chain and compounding law.

The Drug Quality and Security Act boosts the Food and Drug Administration’s authority to regulate compounding pharmacies that ship drugs across state lines. Its approval came a year after tainted injectable drugs from a Massachusetts compounding pharmacy resulted in a meningitis outbreak that killed 64 people across the country.

At the same time, the statute distinguishes between large-scale operations such as the New England Compounding Center in Framingham, Mass., which was blamed for the outbreak, and traditional compounding pharmacies, which will continue to be regulated by state boards of pharmacy.

The law “will help ensure the health and safety of patients,” National Association of Chain Drug Stores president and chief executive officer Steve Anderson says. “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.”

Anderson also hailed the law’s creation of a single national standard for supply chain regulation as opposed to 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 this legislation will only improve and strengthen the process for all stakeholders,” he said.

He thanked supporters of the legislation including House Energy and Commerce Committee chairman Fred Upton (R., Mich.), and Senate health committee chairman Tom Harkin (D., Iowa) Meanwhile, B. Douglas Hoey, CEO of the National Community Pharmacists Association, said the statute “strikes the right balance on two major issues for independent community pharmacists.”

“When manufactured drugs are not an option, community pharmacists prepare, or compound, customized medications to meet a variety of individual health needs,” he noted.

The legislation “leaves regulation of this vital and long-accepted practice by independent community pharmacies to state boards of pharmacy, where it should be,” Hoey said. “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.

“Thus, the legislation should help prevent a recurrence of the tragic meningitis outbreak linked to the New England Compounding Center while preserving patient access to individual medications compounded by local pharmacies in response to a doctor’s request,” he said.

John Gray, president and CEO of the Healthcare Distribution Management Association, praised the law’s creation of a national traceability framework for prescription drugs.

Gray said the federal preemption of state laws to bolster the supply chain is “one of the most significant legislative accomplishments for our industry and is especially important for the health care providers, pharmacies and their patients — who count on the safe and efficient distribution of prescription medicines.”


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