BETHESDA, MD 14 June 2013—The Senate Health, Education, Labor and Pensions (HELP) Committee on May 22 passed legislation to improve the safety of sterile compounding and give FDA explicit authority over a new class of drug makers called compounding manufacturers.
Senate bill 959, 
the Pharmaceutical Compounding Quality and Accountability Act, defines compounding manufacturers as entities that compound sterile drug products without a prescription and sell them across state lines or offer to do so. Under the terms of the act, compounding manufacturers would be regulated by FDA and have to follow many of the procedures expected of traditional drug manufacturers, which would remain under FDA's purview.
the Pharmaceutical Compounding Quality and Accountability Act, defines compounding manufacturers as entities that compound sterile drug products without a prescription and sell them across state lines or offer to do so. Under the terms of the act, compounding manufacturers would be regulated by FDA and have to follow many of the procedures expected of traditional drug manufacturers, which would remain under FDA's purview.
The act would leave traditional compounding under state supervision. So-called anticipatory compounding by traditional compounders would be permitted if the practice is allowed under state law. Anticipatory compounding would involve "limited quantities" of medication made for a patient when there is a history of the medication's use and the pharmacy and prescriber have an established relationship with the patient.
The bill's next stop is to the full Senate for consideration. ASHP stated its support (PDF)for the Senate's bill and urged the House to draft and pass similar legislation.
Janet Woodcock, chief of FDA's drugs division, on May 9 had urged Congress to act on the bill to help protect patients from tragedies such as last year's outbreak of fungal infections that were blamed on products made by the New England Compounding Center (NECC).
"In the absence of changes, these tragedies will happen again. There is no doubt about this," Woodcock said.
Exemptions for hospitals. The act states that pharmacies within health systems would not be considered compounding manufacturers. Hospitals would remain regulated as traditional pharmacies, even if they ship medications to out-of-state facilities that are part of the health system.
Under the terms of the act, any entity other than a hospital or health system that pools sterile products or repackages sterile, preservative-free vials would also be classified as a compounding manufacturer.
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