PharMEDium Encourages Swift Action To Strengthen Federal Oversight of Advanced Sterile Compounding
Contact: Bob Szafranski
312-863-9135 (mobile) 312-240-2687 (work)
FOR IMMEDIATE RELEASE
WASHINGTON, DC—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 addition to the standards established by the U.S. Pharmacopeia (USP), applicable good manufacturing practices (GMP) should be used by FDA to inspect facilities that perform this service. These standards would distinguish those compounding processes that begin with FDA-approved and inspected sterile ingredients and those that start with non-sterile active pharmaceutical ingredients (API, or bulk powders), which involve the highest level of risk.
In our years of experience as a registrant with the FDA, we have found that FDA alone has the expertise to apply appropriate GMP standards to oversee this sector of the industry. PharMEDium and other leading CSP hospital-outsourcers have benefited from years of FDA inspections, leading to enhanced safety protocols and the development of best practices. While additional resources may be required to expand FDA oversight to all compounding pharmacies that engage in the interstate supply of compounded sterile preparations in anticipation of a prescription, patient safety is worth that investment.
PharMEDium stands ready to help Congress better understand this critical service and to work with Congress to prevent future incidents of patient harm by strengthening regulatory oversight through legislation that clarifies federal oversight of compounded sterile preparations.
Who we are:
is one of the nation’s leading providers of hospital pharmacy-outsourced, sterile admixture services with centers in four states and thousands of acute care hospital customers nationwide. Our qualified personnel and state-of-the-art centers are registered with the FDA, licensed by states as compounding pharmacies and governed by our own rigorous quality standards. We begin the compounding process with sterile FDA-approved drugs from FDA-approved drug manufacturers. It is our mission to be the preeminent provider of choice for hospital customers and to attain the highest degree of integrity in the compounding of sterile preparations.
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