Archive for September 2016
FDA to Conduct Public Hearings on Off-Label Communications
The U.S. Food and Drug Administration has announced plans to conduct a public hearing next month to obtain input on issues relating to the dissemination of information by manufacturers about the use of off-label medications. While the FDA’s job is to regulate how drug and device makers communicate about their products through approved labels, many…
Read MoreBlame it on Inflation: Civil Monetary Penalties Increase
The U.S. Department of Health and Human Services (HHS) has published an interim final rule that adjusts for inflation the maximum civil monetary penalties (CMP) that HHS agencies are authorized to assess or enforce. The changes became effective Sept. 6, and are applicable only to civil penalties assessed after Aug. 1, 2016, whose associated violations…
Read MoreFlorida Board of Pharmacy rule amends requirement for hours of operation
Florida community pharmacies no longer must operate at a minimum of 40 hours per week, thanks to a Florida Board of Pharmacy rule change. Late last month, the board amended the rule regulating hours of operation to read: “Any person who receives a community pharmacy permit pursuant to Section 465.018, F.S., and commences to operate…
Read MoreCMS proposes changes to PACE designed to modernize program
The Centers for Medicare and Medicaid (CMS) is proposing a number of changes to the regulations that control the Programs of All-Inclusive Care for the Elderly. PACE, as it is known, allows seniors, most of whom are eligible for Medicare and Medicaid, to live and receive care at home instead of in a skilled nursing…
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