Friday, December 6, 2013

Sixth Question of the Day December 6, 2013 How many of these compounding issues have been resolved in your state? How many did the DQSA resolve?

The urgent issues that emerged in late 2012 have an additional emphasis. These include:
  • Compounding or manufacturing: Is it clear which compounded drug orders meet the state-regulated standard and which cross into a manufacturing regulatory category?
  • Definitions: Uniform and up-to-date definitions of compounding, wholesale, specialty and hospital-based pharmacies.  Clear language about "sterile" and "non-sterile" compounding.
  • Inspection of facilities: How often, by whom, under what conditions. What kind of independent accreditation or evaluation is in place?
  • Enforcement: Which agencies or boards, state or federal, take action when violations or omissions occur? What levels of penalties are in place? Who can order the closure of an operating pharmacy?
  • Funding: Inspection and enforcement agencies have varied levels of budgets and personnel to complete inspections and enforcement.
  • Transparency: Are records of inspections publicly or adequately available to policymakers and federal and state regulatory entities?
  • Single-use injectibles:  Vials sometimes are over-filled and have no preservative added. The makes costs higher, while repeat injection use by some providers brings additional dangers of contamination and infection.
  • quoted from here

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