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Thursday, October 31, 2013
State Senate compounding bill exempts hospital pharmacies By Chelsea Conaboy | GLOBE STAFF OCTOBER 31, 2013
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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Senate has adjoined; Schedule for Monday November 4, 2013
We prepare a Daily Summary with each day's expected Senate schedule.
Senate Floor Schedule for Monday, November 4, 2013
The Senate stands adjourned until 2:00pm on Monday, November 4, 2013. Following any Leader remarks, the Senate will resume consideration of the motion to proceed to S.815, the Employee Non-Discrimination Act. During Thursday’s session of the Senate, cloture was filed on the motion to proceed to S.815. At 5:00pm, the Senate will proceed ...
November 4, 2013
The Senate stands adjourned until 2:00pm on Monday, November 4, 2013. Following any Leader remarks, the Senate will resume consideration of the motion to proceed to S.815, the Employee Non-Discrimination Act. During Thursday’s session of the Senate, cloture was filed on the motion to proceed to S.815. At 5:00pm, the Senate will proceed ...
November 4, 2013
FDA outlines plan to combat drug shortages Toni ClarkeReuters Facebook Twitter LinkedIn GooglePlus Email 41 minutes ago
The Food and Drug Administration released a strategic plan for preventing drug shortages Thursday and proposed a rule to require drug and biotechnology companies to promptly notify the agency of potential disruptions to the supply of medically important drugs.
The plan and proposal come in response to a 2011 order from President Barack Obama to solve the problem of drug shortages. Between 2005 and 2011 the number of new shortages quadrupled to 251. That figure declined to 117 in 2012 but there were still more than 300 ongoing shortages at the end of the year.
The 2012 Food and Drug Administration Safety and Innovation Act called for the FDA to improve its response to imminent or existing drug shortages and to address the underlying causes. The act also gave the FDA new authority to require drug manufacturers to notify it of potential supply disruptions.
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