The Recent Issues
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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