Magazine article Drug Topics

Missouri Mulls Compounding Regs

Magazine article Drug Topics

Missouri Mulls Compounding Regs

Article excerpt

The Missouri pharmacy board's proposal to require pharmacies doing sterile compounding to pay for expensive outside testing of every such prescription has raised red flags in community pharmacy circles.

During a five-hour meeting last month, pharmacy board members and pharmacists went item-by-item through the nine pages of proposed sterile compounding regulations. Several revisions were made, but at the end of the day, the mandate for outside testing of sterile compounded Rxs remained as the board tries to respond to the case of Robert Courtney, a Kansas City iR.Ph. who admitted diluting chemotherapy drugs.

And that response is a big concern to many community R.Ph.s who fear that such costly testing would put an extreme financial burden on patients who need such medications. There's also worry that the regulations could drive some smaller pharmacies out of sterile compounding altogether.

Pharmacists emphasized the need to develop criteria that allow them flexibility to meet their patients' needs, said Roy Fitzwater, CEO, Missouri Pharmacy Association. "We support anything that protects the public, as long as it's not onerous to practitioners who must comply with it. If you're making a one-time medication for one patient, testing is going to add incredible cost. If you drive small pharmacies out, patients have no other options."

The board's proposal was derived from USP and ASHP sterile compounding guidelines, said Eric Everett, co-owner of O'Brien's Pharmacy, Kansas City. It includes three risk levels and more testing as the risk level rises. At highest risk level, compounds would have to be tested for sterility, endotoxins, and potency.

"In my practice, we are basically in compliance with virtually everything the board has recommended. But at the other end of the spectrum are pharmacies that are going to have to make a significant commitment of time and money or else not do it," said Everett. …

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