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Compounding bill now law

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Obama’s signature creates ‘outsourcing facilities’ under federal law

Most pharmacies will be unaffected by a compounding bill signed into law today by President Obama. The law appears to strike a reasonable balance between creating new federal oversight for large-volume compounding operations and allowing the nation’s pharmacists to provide traditional compounding services to individual patients. But not everyone agrees that the law will protect the public as intended.

The President signed H.R. 3204, the Drug Quality and Security Act, into law in an Oval Office ceremony this afternoon. In addition to creating FDA oversight for “outsourcing facilities,” the new law creates track-and-trace requirements for drug products that will take effect over the next 10 years. This latter part of the law will affect all pharmacies as technology is incorporated into packaging so that manufacturers can track unit-level drug products as they move through the nation’s supply chain.

“APhA is grateful to Congress, staffers, and the President for their focus on this challenging issue,” APhA Executive Vice President and CEO Thomas E. Menighan, BSPharm, MBA, ScD (Hon), FAPhA said. “APhA played the critical role of a voice for the individual pharmacist throughout the drafting of this legislation by maintaining active involvement and communication with the Senate HELP committee. Throughout the process, we supported protecting patients from harm by improperly manufactured drug products while ensuring patient access to needed and properly prepared compounded medications.”

As previously reported on pharmacist.com, the law distinguishes between compounders engaged in traditional pharmacy practice from those making large volumes of compounded drugs without individual prescriptions creates a system of voluntary registration and defines FDA’s role in oversight of outsourcing facilities; offers providers and patients information about compounded drugs; and clarifies current federal law regarding pharmacy compounding.

More specifically, traditional pharmacies will continue to be primarily regulated by state boards of pharmacy. But compounders who wish to practice outside the scope of traditional pharmacy practice will be able to register voluntarily as outsourcing facilities that are subject to FDA oversight in much the same way as traditional manufacturers. Providers and patients would have the option of purchasing products from outsourcing facilities that comply with FDA quality standards.

Most pharmacy groups supported the bill, which is not expected to affect most pharmacies. In a letter to the Senate before that body gave final approval to the bill, APhA wrote, “Our members were concerned about being forced to register with the FDA, and this legislation would allow traditional pharmacies to continue to be regulated by state boards of pharmacy while creating outsourcing facilities that would be subject to FDA oversight.”

The Academy of Managed Care Pharmacy has criticized the bill, saying its “limited scope” prevents it from achieving its main goal of “protect[ing] the public from the unauthorized compounding of drugs.” AMCP wrote in a media release, “Only those facilities that volunteer to register will be subject to the FDA, which will leave the public no better off. Facilities that compound drugs, are not licensed pharmacies, and choose not to register with the FDA will continue to ‘escape’ regulation and oversight.” AMCP added that a licensed pharmacy that also registers as an outsourcing facility will be subject to dual regulation that “will lead to administration and regulatory confusion, creating opportunities for gaps in responsibility and accountability.”

FDA Commissioner Margaret A. Hamburg, MD, touched briefly on the compounding bill recently to say that FDA supported the bill, according to Michael Ghobrial, PharmD, JD, APhA Associate Director of Health Policy. Hamburg said that H.R. 3204 is not as comprehensive as FDA would have hoped but that the measure will help. She noted that FDA is concerned with the current regulatory oversight of compounding pharmacies, but clarified that the concern is with very-large-volume drug compounders shipping high-risk products, such as sterile injectables, across state lines—not with compounding in traditional “mom and pop” pharmacies.

Related to track and trace, the proposed legislation would develop a pathway to unit-level tracing in 10 years; would strengthen licensure requirements for wholesale distributors and third-party logistics providers; and would establish nationwide drug serial numbers.

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