Compounding Pharmacy Business Plan

Compounding Pharmacy Business Plan-75
In addition, IU Health plans to seek accreditation from the Pharmacy Compounding Accreditation Board, a not-for-profit organization that has accredited 170 of the 3,000 pharmacies that provide sterile compounding.

In addition, IU Health plans to seek accreditation from the Pharmacy Compounding Accreditation Board, a not-for-profit organization that has accredited 170 of the 3,000 pharmacies that provide sterile compounding.

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Other factors include hospitals' increased reliance on compounding pharmacies because of drug shortages, the rising costs of compounded drugs and broader questions about safety and risk.

Mercy Health System in Chesterfield, Mo., UC San Diego Health System and Vanderbilt University Medical Center in Nashville, for example, are moving forward with plans to either assume all compounding activity or take on more low- and medium-risk compounding in an effort to decrease reliance on external sources.

However, he said, the system is not likely to handle all compounding at its facilities, notably because of high-risk products that require additional testing.

The growing costs of certain drugs in short supply, which are increasingly made by compounding pharmacies when the commercial options are not available, is another factor driving more hospitals to reevaluate compounding.“We can save some money doing it ourselves,” Shaw said.

At one point, the system considered building a facility that could sell compounded drugs to providers outside of the system but put that plan on hold, in part because of uncertainty around the patchwork of existing state and federal regulations.

Lawmakers and state officials are pressing the FDA to establish clearer definitions of compounding.

“It allows us to control the quality of the product that is going out,” he said.

“This is where that makes sense from a system standpoint.”Kleiss said a combination of drug shortages, expected cost savings and enhanced quality control are the driving factors behind Mercy's decision.

“We've got to provide a safe drug to the patient first.”Hospitals have long relied on compounders as sources of certain drugs. As a result, an industry traditionally made up of small “mom-and-pop” compounding pharmacies turned into one that now includes national compounding companies, many of which are backed by private equity firms and other investors.

Some estimates put two of the largest players—Pharmedium and Ameridose—at a combined 70% market share.

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