Senate passes Drug Quality and Security Act

Bill replaces 'patchwork' of state pharmaceutical supply chain regulations with single federal law, strengthens regulations of compounding pharmacies

NEW YORK — A bill that would implement federal tracking and tracing of drugs and strengthen federal regulations on pharmacy compounding has passed in the Senate and will go to President Barack Obama for his signature.

The Senate passed via voice vote the Drug Quality and Security Act, which would give the Food and Drug Administration new authority in the so-called downstream supply chain, which refers to the path drugs take from manufacturers to providers and patients, complementing the agency's regulatory power over the upstream supply chain, the path they take from raw materials to finished products.

Another provision of the bill would grant the FDA new power to regulate compounding pharmacies that produce large volumes of drugs without individual prescriptions, while distinguishing between sterile compounding of injected drugs and traditional compounding of products like mouthwashes and topical ointments. That provision was designed to address the safety issues in compounding pharmacies that came to the public's attention with last year's fungal meningitis outbreak linked to the New England Compounding Center, in which hundreds of patients were sickened and dozens died.

The bill's passage received praise from Washington-based trade organizations.

The National Association of Chain Drug Stores noted that the bill "establishes one national standard for supply-chain regulation as opposed to an unworkable patchwork of state laws and regulations," and noted the "significant investments" chain pharmacy retailers have made in the safety of the U.S. drug distribution system.

"The passage of this bill will help ensure the health and safety of patients," NACDS president and CEO Steve Anderson said. "This is a large step in helping avoid such tragedies as last year's national meningitis outbreak."

Meanwhile, the HDMA, which represents primary healthcare distributors, also praised the replacement of a 50-state patchwork of regulations with a single federal one.

"Today, the Senate voted to establish a national traceability framework for prescription medicines," HDMA president and CEO John Gray said. "The federal preemption 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 healthcare providers and pharmacies and their patients who count on the safe and efficient distribution of prescription medicines."

The National Community Pharmacists Association highlighted the bill's compounding provisions.

“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," NCPA CEO B. Douglas 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 NECC, while preserving patient access to individual medications compounded by local pharmacies in response to a doctor’s request."

The Generic Pharmaceutical Association, a trade group representing generic drug manufacturers, also praised the bill.

“Establishing a predictable, reliable national standard for electronic prescription medicine tracking further safeguards our nation’s prescription drug supply and protects patients,” GPhA president and CEO Ralph Neas said. “This bipartisan bill is the culmination of years of hard work from Congress and stakeholders at every level of the supply chain. Modernizing the nation’s prescription drug tracking system enhances the ability of regulators to limit risks posed by counterfeit or adulterated products and reassures patients that the generic medicines they receive are secure from the manufacturer all the way to the pharmacy.”

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