Citing safety concerns, drug industry stakeholders and public health organizations are urging lawmakers to uphold FDA oversight and enforcement of the 2013 Drug Quality and Security Act (DQSA), an Outsourcing-Pharma.com article details. Recently, the appropriations committee discussed a proposed amendment that would “break down the line between traditional drug compounders and outsourcing facilities.”1 Concerns over the issue were expressed to House and Senate appropriators by the Pew Charitable Trusts, in collaboration with the Biotechnology Innovation Organization (BIO), the Pharmaceutical Research and Manufacturers of America (PhRMA), and other industry stakeholders. In the letter, Pew urges lawmakers to preserve the current prescription requirement in compounding law.
Elizabeth Jungman, director of Public Health Programs at The Pew Charitable trusts, told Outsourcing-Pharma that “legislation that would allow traditional compounders to make stockpiles of supplies of drugs without adhering to appropriate quality standards would fundamentally undermine the patient protections Congress put into place in 2013. One of the most controversial aspects lately, has really been the line between what type of activity can happen at a traditional compounder – which is primarily regulated by the state – as opposed to what really needs to take place in an outsourcing facility that is subject to federal regulation… it’s important to draw that line very clearly.”1
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