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PharMEDium Encourages Swift Action to Strengthen Federal Oversight of Advanced Sterile Compounding
Date:4/15/2013

WASHINGTON, April 15, 2013 /PRNewswire/ -- PharMEDium appreciates Congress' efforts to reexamine oversight of pharmacy compounding in the wake of the deadly meningitis outbreak. PharMEDium provides a valuable service on which hospitalized patients depend and feels strongly that oversight of the compounding pharmacy industry is in need of reform.

Today, the safety of patients depends on the patchwork of ambiguous federal jurisdiction and inconsistent state regulatory approaches. For example, the production of compounded sterile preparations (CSPs) in anticipation of a prescription is a difficult practice for states to oversee, especially when these preparations are shipped across state lines. Accordingly, PharMEDium believes Congress must move swiftly to clarify FDA's legal authority over the compounding pharmacy industry, distinguish it from the appropriate role of state boards of pharmacy, strengthen governing standards, and facilitate effective inspections and enforcement.

Many of the medications administered to hospitalized patients today are not manufactured by traditional pharmaceutical manufacturers in the specific composition and doses the modern practice of medicine requires. Many hospitals have determined it is simply more efficient and safe to outsource admixing CSPs in anticipation of the hospital pharmacy's dispensing these preparations to a patient. Forcing hospitals to make these sterile preparations would not improve the safety or quality of care, and could have the opposite effect. In a recent survey of hospitals, the HHS Office of Inspector General found that an abrupt shortage of CSPs from outside pharmacies would create "life-threatening major disruptions" in 11 percent of responding hospitals and would have "non-life-threatening but great impact" on an additional 48 percent.

PharMEDium believes that clear standards for compounding should enhance the safety of sterile compounding.  In additio
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SOURCE PharMEDium
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