The U.S. House of Representatives has reportedly passed by voice vote a bill (H.R. 3204) to strengthen the Food and Drug Administration’s (FDA’s) oversight of human drug compounding and the pharmaceutical supply chain. Known as the Drug Quality and Security Act, the legislation seeks to address concerns raised about the manufacturing and distribution of compounded drugs after an investigation linked a fungal meningitis outbreak to tainted steroid injections from a Massachusetts facility.
Negotiated by the Senate Health, Education, Labor and Pensions Committee and House Energy and Commerce Committee, the measure, if enacted, would clarify “FDA’s authority over the compounding of human drugs” and directs the agency to engage in two-way communication with state regulators. In addition to eliminating “unconstitutional provisions of Section 503A of the Federal Food, Drug, and Cosmetic Act (FFDCA) that created uncertainty regarding the laws governing compounding,” the new rules would permit drug compounding entities to register as “outsourcing facilities” subject to FDA oversight while preserving “the practice of traditional pharmacy compounding occurring in community pharmacies.” The legislation would also create “a uniform national standard for drug supply chain security to protect Americans against counterfeit drugs.”
“With the passage of this bill, the FDA will have the authority it needs, but we have to also make sure that they have the fortitude to take action on any compounding pharmacy that they see not up to the high level of standards the FDA sets, that all citizens expect,” said House Oversight and Investigations Subcommittee Chair Tim Murphy (R-Penn.). “The Drug Quality and Security Act will end these problems, we hope, end these inspection holidays, and reassure the American public that these medications, wherever they are manufactured, and most by compounding pharmacies, who do a superb job of maintaining sterile conditions, but in all cases the FDA will have the authority to make sure they have the inspections and they have the team that can go in there and take solid action when these centers do not adhere to those high standards.” See House Energy and Commerce Committee Press Release and Facts Sheet, September 28, 2013.