The state Senate passed a bill Wednesday requiring compounding pharmacies that custom-mix sterile drugs to obtain a special license from the state pharmacy board, submit to annual inspections, and report more information about their operations. But, unlike the plan approved last month by the House, it temporarily exempts a large segment of the industry: hospital pharmacies.
Instead, the bill would create a commission to review oversight of hospital pharmacies and make recommendations by July 2015. If no change is made by then, the hospitals would become subject to the same rules as other compounding pharmacies.
“A hospital is a very different setting from a manufacturer's setting,” said Anuj Goel, vice president of legal and regulatory affairs at the Massachusetts Hospital Association. He noted that hospitals monitor their drug quality and are subject to outside reviews conducted by accreditation boards and the Centers for Medicare & Medicaid Services, which are not done at wholesale drugmakers. “Hospitals have always been and continue to be regulated.”
But federal site visits to hospital pharmacies happen irregularly, and state inspections are done as part of overall hospital licensing. The state pharmacy board now has no role in inspecting the hospital pharmacies, though it does license their pharmacists.
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