Thank you for the opportunity to comment on the regulations that are insuring the safe care of our patients.   In the past several years, regulatory actions from other entities such as the Joint Commission and the Centers for Medicare and Medicaid have added additional constraints to the delivery of medications to patients within our hospitals, and long term care environments.   Pressure has been applied to pharmacists and pharmacies to supply medications in a “ready for administration” form even though a commercially available product is not available for administration.   Additional shortages and back order issues have hampered our goal of meeting the regulatory compliance of all entities.  Consequently, pharmacies and pharmacists are having to comply to the Joint Commission requirements while also satisfying the handling and repackaging standards set forth through 18 VAC 110-20-10 and furthermore by USP 795 and 797 guidelines.     

Unfortunately, there have been consequences recently in an attempt to meet the regulatory intent(s), specifically, ordering from outside compounding pharmacies.   While the process of ordering the premade products complied with the law, the pharmacists and pharmacies could not confidently insure the pedigree of the product.   While I want to ensure the best and safest products for my patients, I must also abide by the laws and regulations set forth from the various regulatory agencies, including the BOP.    Please consider the ever-evolving demands on the services of the pharmacists and pharmacies prior to instituting more regulations or enforcement of regulations that induce pharmacists and pharmacies to use resources outside the realm of their immediate control.   Ideally, we want to insure the pedigree of the medications we provide with the resources readily available, but often, we are spending more time and resources trying to conform to the demands of the law versus understanding the needs of our patients and working within reasonable standards that insure the safety of the product.    Again, I appreciate the opportunity to comment and I look forward to being involved in any activities regarding adaptation to regulations that increase the safe delivery of pharmaceutical care to our patients.

Kurt Bell, RPh, MSHA