I was involved in the committee that wrote these regulations.  In their present form, they will significantly restrict the ability of physicians to practice medicine WITHOUT any demonstrated improvement in patient care.  At the current time, we have not seen an epidemic of problems related to immediate-use type injections in physician offices.  Regulations should result in improvement in patient safety and outcomes; the emergency regulations result in increased documentation burdens and ultimately in patient expense.  The law requires that regulations be written.  It requires inspections.  The law does not require that every type of mixing have the same requirements for documentation and training.  Immediate-use mixing is low risk and the documentation requirements and the handling requirements should be minimal.